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CompletedNCT04634409BLAZE-4Updated Jul 1, 2022Results posted

A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness

A Phase 2 interventional study of Bamlanivimab and Etesevimab in COVID-19, sponsored by Eli Lilly and Company. Completed at 141 sites in 3 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-07-01.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
1,755
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

The purpose of this study is to measure how well monoclonal antibodies work, either alone or in combination, against the virus that causes COVID-19. Study drug(s) will be given to participants with early symptoms of COVID-19. Samples will be taken from the back of the nose to determine how much virus is in the body at various times during the study. Participation could last about 12 or 24 weeks and includes at least 1 visit to the study site, with the remainder of assessments performed in the home, local clinic, or by phone.

02

Conditions studied

  • COVID-19

Browse trials for

03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 1,755 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • For low-risk participant arms 9-11 only: Are greater than or equal to (≥)18 and less than (\<)65 years of age at the time of randomization and do not have the risk factors defined in the bullet point directly below

  • For high-risk participant arms 12 and 13 only:

    -- Are ≥18 years of age and satisfy at least one of the following risk factors at the time of screening

    • Are ≥65 years of age
    • Have a body mass index (BMI) ≥ 35
    • Have chronic kidney disease
    • Have type 1 or type 2 diabetes
    • Have immunosuppressive disease
    • Are currently receiving immunosuppressive treatment, or

    • Are ≥55 years of age AND have

      • cardiovascular disease, OR
      • hypertension, OR
      • chronic obstructive pulmonary disease or other chronic respiratory disease

  • For high-risk participant arms 12 and 13 only:

    • Are 12-17 years of age (inclusive) AND satisfy at least one of the following risk factors at the time of screening

      • Have a BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htm
      • Have sickle cell disease
      • Have congenital or acquired heart disease
      • Have neurodevelopmental disorders, for example, cerebral palsy
      • Have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)
      • Have asthma or reactive airway or other chronic respiratory disease that requires daily medication for control
      • Have type 1 or type 2 diabetes
      • Have chronic kidney disease
      • Have immunosuppressive disease, or
      • Are currently receiving immunosuppressive treatment.

For high-risk participants arm 14 only:

  • Are ≥12 years of age and satisfy at least one of the following risk factors at the time of screening Are ≥65 years of age
  • Are adults (≥18 years of age) with BMI >25 kg/m2 , or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts
  • Have chronic kidney disease
  • Have type 1 or type 2 diabetes
  • Have immunosuppressive disease
  • Are currently receiving immunosuppressive treatment
  • Have cardiovascular disease (including congenital heart disease) or hypertension
  • Have chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
  • Have sickle cell disease
  • Have neurodevelopmental disorder (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
  • Have a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19]
  • Are currently not hospitalized
  • Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion, nasal congestion or runny nose, new loss of smell, chills
  • Must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion
  • Are men or non-pregnant women who agree to contraceptive requirements
  • Understand and agree to comply with planned study procedures
  • Agree to the collection of nasopharyngeal swabs and venous blood
  • The participant or legally authorized representative give signed informed consent and/or assent

Exclusion criteria

Exclusion Criteria:

  • For low-risk participants only: BMI ≥35
  • Have oxygen saturation (SpO2) less than or equal to (≤)93 percent (%) on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) \<300, respiratory rate ≥30 per minute, heart rate ≥125 per minute
  • Require mechanical ventilation or anticipated impending need for mechanical ventilation
  • Have known allergies to any of the components used in the formulation of the interventions
  • Have hemodynamic instability requiring use of pressors within 24 hours of randomization
  • Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
  • Have any co-morbidity requiring surgery within \<7 days, or that is considered life-threatening within 29 days
  • Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study
  • Have a history of a positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test prior to the one serving as eligibility for this study
  • Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing
  • Have received treatment with a SARS-CoV-2 specific monoclonal antibody
  • Have a history of convalescent COVID-19 plasma treatment
  • For low-risk arms only: have received a SARS-CoV-2 vaccine or have participated in a previous SARS-CoV-2 vaccine study and are currently blinded to treatment allotment
  • Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed
  • Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Are pregnant or breast feeding
  • Are investigator site personnel directly affiliated with this study
  • Have body weight \<40 kilograms
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,755 participants (actual)

Study arms

  • Placebo comparator
    Placebo (Pbo)

    Treatment 1: Pbo administered intravenously (IV). Treatment 8: Pbo For 700 mg Bamlanivimab (BAM) + 500 mg VIR-7831 (Amendment (C-e)) administered IV. Treatment 11: Pbo For 175 mg Bebtelovimab (BEB) \& 700 mg BAM +1400 mg Etesevimab ( ETE) +175 mg BEB (Low Risk Participants) administered IV. Pooled Placebo (Addendum 4, IV) administered IV. Pooled Placebo (Addendum 4, SC) administered SC.

    Drug: Placebo

  • Experimental
    BAM + ETE

    Treatment 2: 175 mg BAM +350 mg ETE administered IV. Treatment 3: 700 mg BAM +1400 mg ETE administered IV. Treatment 4: 2800 mg BAM +2800 mg ETE administered IV. Treatment 6: 350 mg BAM +700 mg ETE administered IV. Unintentional Dosing: 700 mg BAM +700 mg ETE administered IV. 700 mg BAM + 1400 mg ETE 30-min (Addendum (2)) administered IV. 700 mg BAM + 1400 mg ETE 15-min (Addendum (2)) administered IV.

    Drug: Bamlanivimab · Drug: Etesevimab

  • Experimental
    BAM

    Treatment 5: 700 mg BAM administered IV. 700 mg BAM 15-min (Addendum (2)) administered IV.

    Drug: Bamlanivimab

  • Experimental
    BAM + VIR-7831

    Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) administered IV.

    Drug: Bamlanivimab · Drug: VIR-7831

  • Experimental
    BEB

    Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) administered IV. Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) administered IV. 70 mg BEB 140 mg/Min (Addendum 4, IV) administered IV. 175 mg BEB 140 mg/Min (Addendum 4, IV) administered IV. 175 mg BEB 350 mg/Min (Addendum 4, IV) administered IV. 1750 mg BEB 350 mg/Min (Addendum 4, IV) administered IV. 280 mg BEB (Addendum 4, SC) administered SC. 560 mg BEB (Addendum 4, SC) administered SC.

    Drug: Bebtelovimab

  • Experimental
    BAM+ ETE + BEB

    Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) administered IV. Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants) administered IV. Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB(Amendment (g), High Risk, Updated Centers for Disease Control and Prevention (CDC) Criteria) administered IV. 175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV) administered IV.

    Drug: Bamlanivimab · Drug: Etesevimab · Drug: Bebtelovimab

Interventions

  • DrugBamlanivimab

    Administered IV.

    Also known as: LY-CoV555, LY3819253

  • DrugEtesevimab

    Administered IV.

    Also known as: LY-CoV016, LY3832479

  • DrugPlacebo

    Administered IV.

  • DrugVIR-7831

    Administered IV.

    Also known as: GSK4182136

  • DrugBebtelovimab

    Administered IV.

    Also known as: LY-CoV1404, LY3853113

06

What researchers measure

Primary outcomes

  1. Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27

    Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Relevance Sequence Imputation (RSI). RSI is defined as follows: If Day 7 SARS-CoV-2 viral load is missing, then Day 7 will be imputed using data from the first available for Day 5, Day 3, Day 11, or Day 1.

    Time frame: Day 7

  2. Treatment 7-8, Amendments (C-e): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27

    Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).

    Time frame: Day 7

  3. Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27

    Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).

    Time frame: Day 7

Secondary outcomes

  1. Treatment 12 -13, Amendment (f) High Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27

    Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).

    Time frame: Day 7

  2. Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27

    Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).

    Time frame: Day 7

  3. Addendum (2): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27

    Missing data is estimated using Relevance Sequence Imputation (RSI). RSI is defined as follows: If Day 7 SARS-CoV-2 viral load is missing, then Day 7 will be imputed using data from the first available for Day 5, Day 3, Day 11, or Day 1.

    Time frame: Day 7

  4. Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27

    Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).

    Time frame: Day 7

  5. Addendum (4) Arm B - Subcutaneous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27

    Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).

    Time frame: Day 7

  6. Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

    Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from any Cause

    Time frame: Baseline through Day 29

  7. Treatment 7-8, Amendment (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

    Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from Any Cause

    Time frame: Baseline through Day 29

  8. Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

    Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

    Time frame: Baseline through Day 29

  9. Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

    Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

    Time frame: Baseline through Day 29

  10. Treatment 14 Amendment (f) High Risk Participants, Updated CDC Criteria: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

    Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

    Time frame: Baseline through Day 29

  11. Treatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load

    Least squares mean (LSM) change from baseline was calculated using a mixed model repeating measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. Viral load is reported as normalized viral and is unitless.

    Time frame: Baseline, Day 7

  12. Treatment 7-8 Amendments (C-e): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load

    LSM change from baseline was calculated using a MMRM that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. Viral load is reported as normalized viral and is unitless.

    Time frame: Baseline, Day 7

  13. Treatment 9-11 Amendment (f), Low Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load

    LSM change from baseline was calculated using a MMRM that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. Viral load is reported as normalized viral and is unitless.

    Time frame: Baseline, Day 7

  14. Treatment 12 -13 Amendment (f), High Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load

    Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.

    Time frame: Baseline, Day 7

  15. Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load

    Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.

    Time frame: Baseline, Day 7

  16. Addendum 4, IV: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load

    Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.

    Time frame: Baseline, Day 7

  17. Addendum 4, SC: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load

    Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.

    Time frame: Baseline, Day 7

  18. Addendum (2): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load

    Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.

    Time frame: Baseline, Day 7

  19. Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution

    Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as all symptoms (excluding loss of appetite, taste, and smell) on the symptom questionnaire scored as absent (score of 0). Missing data was imputed using a non-responder imputation.

    Time frame: Day 7

  20. Treatment 7-8 Amendments (C-e): Percentage of Participants Demonstrating Symptom Resolution

    Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as all symptoms (excluding loss of appetite, taste, and smell) on the symptom questionnaire scored as absent (score of 0). Missing data was imputed using a non-responder imputation.

    Time frame: Day 7

  21. Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Resolution

    Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache, and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Missing data was imputed using a non-responder imputation.

    Time frame: Day 7

  22. Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Resolution

    Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache, and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Missing data was imputed using a non-responder imputation.

    Time frame: Day 7

  23. Treatment 14, Amendment (g) High Risk Participants Updated CDC Criteria Amendment (g): Percentage of Participants Demonstrating Symptom Resolution

    Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache, and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Missing data was imputed using a non-responder imputation.

    Time frame: Day 7

  24. Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement

    Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.

    Time frame: Day 7

  25. Treatment 7-8 Amendments (C-E): Percentage of Participants Demonstrating Symptom Improvement

    Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.

    Time frame: Day 7

  26. Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Improvement

    Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.

    Time frame: Day 7

  27. Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Improvement

    Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.

    Time frame: Day 7

  28. Treatment 14 Amendment (g): Percentage of Participants Demonstrating Symptom Improvement

    Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.

    Time frame: Day 7

  29. Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    Time frame: Baseline through Day 29

  30. Treatment 7-8 Amendments (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    Time frame: Baseline through Day 29

  31. Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    Time frame: Baseline through Day 29

  32. Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    Time frame: Baseline through Day 29

  33. Treatment 14 Amendment (g): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    Time frame: Baseline through Day 29

  34. Pharmacokinetics (PK): Mean Concentration of Bamlanivimab

    PK: Mean Concentration of Bamlanivimab

    Time frame: Day 29

  35. Pharmacokinetics (PK): Mean Concentration of Etesevimab

    Pharmacokinetics (PK): Mean Concentration of Etesevimab

    Time frame: Day 29

  36. Pharmacokinetics (PK): Mean Concentration of Bebtelovimab

    Pharmacokinetics (PK): Mean Concentration of Bebtelovimab

    Time frame: Day 29

  37. Pharmacokinetics (PK): Mean Concentration of VIR-7831

    PK: Mean Concentration of VIR-7831

    Time frame: Day 29

07

Results

Posted Jul 1, 2022

Participant flow

Participant flow — Overall Study
MilestoneTreatment 1: PboTreatment 2: 175 mg BAM +350 mg ETETreatment 3: 700 mg BAM +1400 mg ETETreatment 4: 2800 mg BAM +2800 mg ETETreatment 5: 700 mg BAMTreatment 6: 350 mg BAM +700 mg ETEUnintentional Dosing: 700 mg BAM +700 mg ETETreatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants)Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants)Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants)Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB(Amendment (g), High Risk,Updated CDC Criteria)700 mg BAM 15-min (Addendum (2))700 mg BAM + 1400 mg ETE 30-min (Addendum (2))700 mg BAM + 1400 mg ETE 15-min (Addendum (2))Pooled Placebo (Addendum 4, IV)70 mg BEB 140 mg/Min (Addendum 4, IV)175 mg BEB 140 mg/Min (Addendum 4, IV)175 mg BEB 350 mg/Min (Addendum 4, IV)175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV)1750 mg BEB 350 mg/Min (Addendum 4, IV)Pooled Placebo (Addendum 4, SC)280 mg BEB (Addendum 4, SC)560 mg BEB (Addendum 4, SC)
Started155831581031051012010110112512712810050176306301066666466
Received at least one dose of study drug155831581031051012010110112512712810050176306301066666466
Completed1488115096102991990911121141099246164306291066665466
Not completed728732111101313198412001000001000
Withdrew: Death000000000010100000000000000
Withdrew: Adverse event001001000000000000000000000
Withdrew: Lost to follow-up31131113311815327000000000000
Withdrew: Withdrawal by subject316420023232215001000001000
Withdrew: Other - as reported by investigator100000064012210000000000000

Outcome measures

PrimaryTreatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27

Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Relevance Sequence Imputation (RSI). RSI is defined as follows: If Day 7 SARS-CoV-2 viral load is missing, then Day 7 will be imputed using data from the first available for Day 5, Day 3, Day 11, or Day 1.

Time frame:
Day 7
Reported as:
Number · percentage of participants
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.27
percentage of participantsTreatment 1: PboTreatment 2: 175 mg BAM +350 mg ETETreatment 3: 700 mg BAM +1400 mg ETETreatment 4: 2800 mg BAM +2800 mg ETETreatment 5: 700 mg BAMTreatment 6: 350 mg BAM +700 mg ETEUnintentional Dosing: 700 mg BAM +700 mg ETE
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Greater Than 5.2727.7 (20.7 to 34.8)12.2 (5.1 to 19.3)10.8 (6.0 to 15.7)7.8 (2.6 to 12.9)14.3 (7.6 to 21.0)7.9 (2.7 to 13.2)10.0 (0.0 to 23.1)
Statistical analysis
  • Treatment 1: Pbo vs Treatment 2: 175 mg BAM +350 mg ETE · Regression, Logistic · p = 0.009273 · Odds ratio (or): 0.37 · 95% CI 0.18 to 0.78
  • Treatment 1: Pbo vs Treatment 3: 700 mg BAM +1400 mg ETE · Regression, Logistic · p = 0.000271 · Odds ratio (or): 0.32 · 95% CI 0.18 to 0.59
  • Treatment 1: Pbo vs Treatment 4: 2800 mg BAM +2800 mg ETE · Regression, Logistic · p = 0.000257 · Odds ratio (or): 0.23 · 95% CI 0.10 to 0.51
  • Treatment 1: Pbo vs Treatment 5: 700 mg BAM · Regression, Logistic · p = 0.013378 · Odds ratio (or): 0.44 · 95% CI 0.23 to 0.84
  • Treatment 1: Pbo vs Treatment 6: 350 mg BAM +700 mg ETE · Regression, Logistic · p = 0.000318 · Odds ratio (or): 0.24 · 95% CI 0.11 to 0.52
  • Treatment 1: Pbo vs Unintentional Dosing: 700 mg BAM +700 mg ETE · Regression, Logistic · p = 0.140563 · Odds ratio (or): 0.35 · 95% CI 0.09 to 1.41
PrimaryTreatment 7-8, Amendments (C-e): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27

Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).

Time frame:
Day 7
Reported as:
Number · percentage of participants
Treatment 7-8, Amendments (C-e): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
percentage of participantsTreatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))
Treatment 7-8, Amendments (C-e): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.279.9 (4.1 to 15.7)29.7 (20.8 to 38.6)
Statistical analysis
  • Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) vs Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) · Regression, Logistic · p = 0.000835 · Odds ratio (or): 0.27 · 95% CI 0.12 to 0.58
PrimaryTreatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27

Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).

Time frame:
Day 7
Reported as:
Number · percentage of participants
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
percentage of participantsTreatment 9: 175 mg BEB (Amendment (f), Low Risk Participants)Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants)Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.2712.0 (6.3 to 17.7)12.7 (6.9 to 18.5)19.8 (12.9 to 26.8)
Statistical analysis
  • Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) vs Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) · Regression, Logistic · p = 0.097231 · Odds ratio (or): 0.56 · 95% CI 0.28 to 1.11
  • Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) vs Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) · Regression, Logistic · p = 0.132360 · Odds ratio (or): 0.59 · 95% CI 0.30 to 1.17
SecondaryTreatment 12 -13, Amendment (f) High Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27

Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).

Time frame:
Day 7
Reported as:
Number · percentage of participants
Treatment 12 -13, Amendment (f) High Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
percentage of participantsTreatment 12: 175 mg BEB (Amendment (f), High Risk Participants)Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)
Treatment 12 -13, Amendment (f) High Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.2725.3 (16.7 to 33.8)12.0 (3.0 to 21.0)
SecondaryTreatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27

Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).

Time frame:
Day 7
Reported as:
Number · percentage of participants
Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
percentage of participantsTreatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB(Amendment (g), High Risk,Updated CDC Criteria)
Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.2717.6 (12.0 to 23.2)
SecondaryAddendum (2): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27

Missing data is estimated using Relevance Sequence Imputation (RSI). RSI is defined as follows: If Day 7 SARS-CoV-2 viral load is missing, then Day 7 will be imputed using data from the first available for Day 5, Day 3, Day 11, or Day 1.

Time frame:
Day 7
Reported as:
Number · percentage of participants
Addendum (2): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
percentage of participants700 mg BAM 15-min (Addendum (2))700 mg BAM + 1400 mg ETE 30-min (Addendum (2))700 mg BAM + 1400 mg ETE 15-min (Addendum (2))
Addendum (2): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.2716.7 (3.3 to 30.0)0.0 (0.0 to 0.0)13.3 (1.2 to 25.5)
SecondaryAddendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27

Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).

Time frame:
Day 7
Reported as:
Number · percentage of participants
Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
percentage of participantsPooled Placebo (Addendum 4, IV)70 mg BEB 140 mg/Min (Addendum 4, IV)175 BEB 140 mg/Min (Addendum 4, IV)175 BEB 350 mg/Min (Addendum 4, IV)175/700/1400 BAM+ETE+BEB 350mg/Min (Addendum 4, IV)1750 BEB 350 mg/Min (Addendum 4, IV)
Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.2740.0 (9.6 to 70.4)16.7 (0.0 to 46.5)50.0 (10.0 to 90.0)0.0 (0.0 to 0.0)16.7 (0.0 to 46.5)33.3 (0.0 to 71.1)
SecondaryAddendum (4) Arm B - Subcutaneous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27

Percentage of participants with SARS-CoV-2 viral load greater than 5.27 on Day 7. Missing data is estimated using Last Observation Carried Forward (LOCF).

Time frame:
Day 7
Reported as:
Number · percentage of participants
Addendum (4) Arm B - Subcutaneous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27
percentage of participantsPooled Placebo (Addendum 4, SC)280 mg BEB (Addendum 4, SC)560 mg BEB (Addendum 4, SC)
Addendum (4) Arm B - Subcutaneous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.2725.0 (0.0 to 67.4)16.7 (0.0 to 46.5)0.0 (0.0 to 0.0)
SecondaryTreatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from any Cause

Time frame:
Baseline through Day 29
Reported as:
Number · percentage of participants
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
percentage of participantsTreatment 1: PboTreatment 2: 175 mg BAM +350 mg ETETreatment 3: 700 mg BAM +1400 mg ETETreatment 4: 2800 mg BAM +2800 mg ETETreatment 5: 700 mg BAMTreatment 6: 350 mg BAM +700 mg ETEUnintentional Dosing: 700 mg Bamlanivimab +700 mg Etesevimab
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause0.6 (0.0 to 1.9)0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)
Statistical analysis
  • Treatment 1: Pbo vs Treatment 2: 175 mg BAM +350 mg ETE · Regression, Logistic · p = 0.769 · Odds ratio (or): 0.62 · 95% CI 0.02 to 15.57
  • Treatment 1: Pbo vs Treatment 3: 700 mg BAM +1400 mg ETE · Regression, Logistic · p = 0.494 · Odds ratio (or): 0.32 · 95% CI 0.01 to 8.12
  • Treatment 1: Pbo vs Treatment 4: 2800 mg BAM +2800 mg ETE · Regression, Logistic · p = 0.671 · Odds ratio (or): 0.50 · 95% CI 0.02 to 12.51
  • Treatment 1: Pbo vs Treatment 5: 700 mg BAM · Regression, Logistic · p = 0.663 · Odds ratio (or): 0.49 · 95% CI 0.02 to 12.27
  • Treatment 1: Pbo vs Treatment 6: 350 mg BAM +700 mg ETE · Regression, Logistic · p = 0.680 · Odds ratio (or): 0.51 · 95% CI 0.02 to 12.76
  • Treatment 1: Pbo vs Unintentional Dosing: 700 mg Bamlanivimab +700 mg Etesevimab · Regression, Logistic · p = 0.584 · Odds ratio (or): 2.51 · 95% CI 0.09 to 67.88
SecondaryTreatment 7-8, Amendment (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from Any Cause

Time frame:
Baseline through Day 29

No measurements were reported for this outcome.

SecondaryTreatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

Time frame:
Baseline through Day 29
Reported as:
Number · percentage of participants
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
percentage of participantsTreatment 9: 175 mg BEB (Amendment (f), Low Risk Participants)Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants)Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause1.6 (0.0 to 3.8)2.4 (0.0 to 5.0)1.6 (0.0 to 3.7)
Statistical analysis
  • Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) vs Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) · Regression, Logistic · p = 0.979 · Odds ratio (or): 1.02 · 95% CI 0.17 to 6.06
  • Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) vs Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) · Regression, Logistic · p = 0.675 · Odds ratio (or): 1.42 · 95% CI 0.27 to 7.39
SecondaryTreatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

Time frame:
Baseline through Day 29
Reported as:
Number · percentage of participants
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
percentage of participantsTreatment 12: 175 mg BEB (Amendment (f), High Risk ParticipantsTreatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause3.0 (0.0 to 6.3)4.0 (0.0 to 9.4)
SecondaryTreatment 14 Amendment (f) High Risk Participants, Updated CDC Criteria: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

Time frame:
Baseline through Day 29
Reported as:
Number · percentage of participants
Treatment 14 Amendment (f) High Risk Participants, Updated CDC Criteria: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause
percentage of participantsTreatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g) High Risk,Updated CDC Criteria)
Treatment 14 Amendment (f) High Risk Participants, Updated CDC Criteria: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause1.7 (0.0 to 3.6)
SecondaryTreatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load

Least squares mean (LSM) change from baseline was calculated using a mixed model repeating measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. Viral load is reported as normalized viral and is unitless.

Time frame:
Baseline, Day 7
Reported as:
Least squares mean · unitless
Treatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
unitlessTreatment 1: PboTreatment 2: 175 mg BAM +350 mg ETETreatment 3: 700 mg BAM +1400 mg ETETreatment 4: 2800 mg BAM +2800 mg ETETreatment 5: 700 mg BAMTreatment 6: 350 mg BAM +700 mg ETEUnintentional Dosing: 700 mg Bamlanivimab +700 mg Etesevimab
Treatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load-2.87 ± 0.149-3.54 ± 0.207-3.52 ± 0.148-3.13 ± 0.181-3.28 ± 0.180-3.74 ± 0.191-3.51 ± 0.419
Statistical analysis
  • Treatment 1: Pbo vs Treatment 2: 175 mg BAM +350 mg ETE · Mixed Models Analysis · p = 0.009 · Lsm difference: -0.67 · 95% CI -1.17 to -0.17
  • Treatment 1: Pbo vs Treatment 3: 700 mg BAM +1400 mg ETE · Mixed Models Analysis · p = 0.002 · Lsm difference: -0.65 · 95% CI -1.06 to -0.24
  • Treatment 1: Pbo vs Treatment 4: 2800 mg BAM +2800 mg ETE · Mixed Models Analysis · p = 0.263 · Lsm difference: -0.26 · 95% CI -0.72 to 0.20
  • Treatment 1: Pbo vs Treatment 5: 700 mg BAM · Mixed Models Analysis · p = 0.083 · Lsm difference: -0.41 · 95% CI -0.87 to 0.05
  • Treatment 1: Pbo vs Treatment 6: 350 mg BAM +700 mg ETE · Mixed Models Analysis · p = <0.001 · Lsm difference: -0.87 · 95% CI -1.35 to -0.40
  • Treatment 1: Pbo vs Unintentional Dosing: 700 mg Bamlanivimab +700 mg Etesevimab · Mixed Models Analysis · p = 0.149 · Lsm difference: -0.64 · 95% CI -1.52 to 0.23
SecondaryTreatment 7-8 Amendments (C-e): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load

LSM change from baseline was calculated using a MMRM that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. Viral load is reported as normalized viral and is unitless.

Time frame:
Baseline, Day 7
Reported as:
Least squares mean · unitless
Treatment 7-8 Amendments (C-e): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
unitlessTreatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))
Treatment 7-8 Amendments (C-e): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load-3.56 ± 0.182-2.74 ± 0.184
Statistical analysis
  • Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) vs Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) · Mixed Models Analysis · p = 0.002 · Lsm difference: -0.82 · 95% CI -1.33 to -0.31
SecondaryTreatment 9-11 Amendment (f), Low Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load

LSM change from baseline was calculated using a MMRM that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. Viral load is reported as normalized viral and is unitless.

Time frame:
Baseline, Day 7
Reported as:
Least squares mean · unitless
Treatment 9-11 Amendment (f), Low Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
unitlessTreatment 9: 175 mg BEB (Amendment (f), Low Risk Participants)Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants)Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)
Treatment 9-11 Amendment (f), Low Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load-3.77 ± 0.198-4.00 ± 0.196-3.62 ± 0.198
Statistical analysis
  • Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) vs Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) · Mixed Models Analysis · p = 0.606 · Lsm difference: -0.14 · 95% CI -0.70 to 0.41
  • Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) vs Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) · Mixed Models Analysis · p = 0.170 · Lsm difference: -0.38 · 95% CI -0.93 to 0.17
SecondaryTreatment 12 -13 Amendment (f), High Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load

Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.

Time frame:
Baseline, Day 7
Reported as:
Mean · unitless
Treatment 12 -13 Amendment (f), High Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
unitlessTreatment 12: 175 mg BEB (Amendment (f), High Risk Participants)Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)
Treatment 12 -13 Amendment (f), High Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load-3.22 ± 2.585-3.43 ± 2.835
SecondaryTreatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load

Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.

Time frame:
Baseline, Day 7
Reported as:
Mean · unitless
Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
unitlessTreatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB(Amendment (g), High Risk,Updated CDC Criteria)
Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load-4.00 ± 2.514
SecondaryAddendum 4, IV: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load

Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.

Time frame:
Baseline, Day 7
Reported as:
Mean · unitless
Addendum 4, IV: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
unitlessPooled Placebo (Addendum 4, IV)70 mg BEB 140 mg/Min (Addendum 4, IV)175 BEB 140 mg/Min (Addendum 4, IV)175 BEB 350 mg/Min (Addendum 4, IV)175/700/1400 BAM+ETE+BEB 350mg/Min (Addendum 4, IV)1750 BEB 350 mg/Min (Addendum 4, IV)
Addendum 4, IV: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load-4.27 ± 3.087-4.39 ± 2.334-4.40 ± 3.188-4.49 ± 1.925-6.35 ± 1.502-4.76 ± 2.217
SecondaryAddendum 4, SC: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load

Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.

Time frame:
Baseline, Day 7
Reported as:
Mean · unitless
Addendum 4, SC: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
unitlessPooled Placebo (Addendum 4, SC)280 mg BEB (Addendum 4, SC)560 mg BEB (Addendum 4, SC
Addendum 4, SC: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load-3.47 ± 3.934-4.04 ± 2.114-3.40 ± 1.900
SecondaryAddendum (2): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load

Baseline is defined as the last non-missing assessment recorded on or prior to the date of first study drug injection. Viral load is reported as normalized viral and is unitless.

Time frame:
Baseline, Day 7
Reported as:
Mean · unitless
Addendum (2): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
unitless700 mg BAM 15-min (Addendum (2))700 mg BAM + 1400 mg ETE 30-min (Addendum (2))700 mg BAM + 1400 mg ETE 15-min (Addendum (2))
Addendum (2): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load-2.65 ± 2.394-4.90 ± 1.999-4.37 ± 2.128
SecondaryTreatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution

Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as all symptoms (excluding loss of appetite, taste, and smell) on the symptom questionnaire scored as absent (score of 0). Missing data was imputed using a non-responder imputation.

Time frame:
Day 7
Reported as:
Number · percentage of participants
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution
percentage of participantsTreatment 1: PboTreatment 2: 175 mg BAM +350 mg ETETreatment 3: 700 mg BAM +1400 mg ETETreatment 4: 2800 mg BAM +2800 mg ETETreatment 5: 700 mg BAMTreatment 6: 350 mg BAM +700 mg ETEUnintentional Dosing: 700 mg Bamlanivimab +700 mg Etesevimab
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution29.0 (21.9 to 36.2)28.0 (18.3 to 37.8)36.9 (29.4 to 44.5)32.0 (23.0 to 41.1)41.0 (31.5 to 50.4)32.7 (23.5 to 41.8)30.0 (9.9 to 50.1)
Statistical analysis
  • Treatment 1: Pbo vs Treatment 2: 175 mg BAM +350 mg ETE · Regression, Logistic · p = 0.890 · Odds ratio (or): 0.96 · 95% CI 0.53 to 1.73
  • Treatment 1: Pbo vs Treatment 3: 700 mg BAM +1400 mg ETE · Regression, Logistic · p = 0.141 · Odds ratio (or): 1.43 · 95% CI 0.89 to 2.29
  • Treatment 1: Pbo vs Treatment 4: 2800 mg BAM +2800 mg ETE · Regression, Logistic · p = 0.603 · Odds ratio (or): 1.15 · 95% CI 0.67 to 1.98
  • Treatment 1: Pbo vs Treatment 5: 700 mg BAM · Regression, Logistic · p = 0.048 · Odds ratio (or): 1.69 · 95% CI 1.00 to 2.84
  • Treatment 1: Pbo vs Treatment 6: 350 mg BAM +700 mg ETE · Regression, Logistic · p = 0.533 · Odds ratio (or): 1.19 · 95% CI 0.69 to 2.04
  • Treatment 1: Pbo vs Unintentional Dosing: 700 mg Bamlanivimab +700 mg Etesevimab · Regression, Logistic · p = 0.869 · Odds ratio (or): 1.09 · 95% CI 0.40 to 2.99
SecondaryTreatment 7-8 Amendments (C-e): Percentage of Participants Demonstrating Symptom Resolution

Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as all symptoms (excluding loss of appetite, taste, and smell) on the symptom questionnaire scored as absent (score of 0). Missing data was imputed using a non-responder imputation.

Time frame:
Day 7
Reported as:
Number · percentage of participants
Treatment 7-8 Amendments (C-e): Percentage of Participants Demonstrating Symptom Resolution
percentage of participantsTreatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))
Treatment 7-8 Amendments (C-e): Percentage of Participants Demonstrating Symptom Resolution35.6 (26.3 to 45.0)29.7 (20.8 to 38.6)
Statistical analysis
  • Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) vs Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) · Regression, Logistic · p = 0.374 · Odds ratio (or): 1.31 · 95% CI 0.72 to 2.35
SecondaryTreatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Resolution

Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache, and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Missing data was imputed using a non-responder imputation.

Time frame:
Day 7
Reported as:
Number · percentage of participants
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Resolution
percentage of participantsTreatment 9: 175 mg BEB (Amendment (f), Low Risk Participants)Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants)Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Resolution60.0 (51.4 to 68.6)50.8 (42.1 to 59.5)44.4 (35.8 to 53.1)
Statistical analysis
  • Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) vs Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) · Regression, Logistic · p = 0.015 · Odds ratio (or): 1.87 · 95% CI 1.13 to 3.08
  • Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) vs Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) · Regression, Logistic · p = 0.317 · Odds ratio (or): 1.29 · 95% CI 0.78 to 2.11
SecondaryTreatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Resolution

Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache, and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Missing data was imputed using a non-responder imputation.

Time frame:
Day 7
Reported as:
Number · percentage of participants
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Resolution
percentage of participantsTreatment 12: 175 mg BEB (Amendment (f), High Risk Participants)Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Resolution50.5 (40.7 to 60.4)52.0 (38.2 to 65.8)
SecondaryTreatment 14, Amendment (g) High Risk Participants Updated CDC Criteria Amendment (g): Percentage of Participants Demonstrating Symptom Resolution

Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom resolution (yes/no) is defined as a score of 0 for shortness of breath, feeling feverish, body aches and pains, sore throat, chills, and headache, and a score of 0 or 1 for cough and fatigue on the symptom questionnaire. Missing data was imputed using a non-responder imputation.

Time frame:
Day 7
Reported as:
Number · percentage of participants
Treatment 14, Amendment (g) High Risk Participants Updated CDC Criteria Amendment (g): Percentage of Participants Demonstrating Symptom Resolution
percentage of participants700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g))
Treatment 14, Amendment (g) High Risk Participants Updated CDC Criteria Amendment (g): Percentage of Participants Demonstrating Symptom Resolution47.2 (39.8 to 54.5)
SecondaryTreatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement

Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.

Time frame:
Day 7
Reported as:
Number · percentage of participants
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement
percentage of participantsPlacebo175 mg Bamlanivimab +350 mg Etesevimab350 mg Bamlanivimab +700 mg Etesevimab700 mg Bamlanivimab +1400 mg Etesevimab2800 mg Bamlanivimab +2800 mg Etesevimab700 mg BamlanivimabUnintentional Dosing Arm: 700 mg Bamlanivimab +700 mg Etesevimab
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement33.5 (26.1 to 41.8)45.1 (34.4 to 55.9)48.5 (38.8 to 58.3)46.5 (38.7 to 54.3)49.5 (39.9 to 59.2)52.4 (42.8 to 61.9)40.0 (18.5 to 61.5)
Statistical analysis
  • Placebo vs 175 mg Bamlanivimab +350 mg Etesevimab · Regression, Logistic · p = 0.082 · Odds ratio (or): 1.62 · 95% CI 0.94 to 2.81
  • Placebo vs 350 mg Bamlanivimab +700 mg Etesevimab · Regression, Logistic · p = 0.018 · Odds ratio (or): 1.86 · 95% CI 1.11 to 3.11
  • Placebo vs 700 mg Bamlanivimab +1400 mg Etesevimab · Regression, Logistic · p = 0.021 · Odds ratio (or): 1.71 · 95% CI 1.09 to 2.71
  • Placebo vs 2800 mg Bamlanivimab +2800 mg Etesevimab · Regression, Logistic · p = 0.011 · Odds ratio (or): 1.93 · 95% CI 1.16 to 3.22
  • Placebo vs 700 mg Bamlanivimab · Regression, Logistic · p = 0.003 · Odds ratio (or): 2.17 · 95% CI 1.30 to 3.60
  • Placebo vs Unintentional Dosing Arm: 700 mg Bamlanivimab +700 mg Etesevimab · Regression, Logistic · p = 0.546 · Odds ratio (or): 1.34 · 95% CI 0.52 to 3.48
SecondaryTreatment 7-8 Amendments (C-E): Percentage of Participants Demonstrating Symptom Improvement

Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.

Time frame:
Day 7
Reported as:
Number · percentage of participants
Treatment 7-8 Amendments (C-E): Percentage of Participants Demonstrating Symptom Improvement
percentage of participantsTreatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))
Treatment 7-8 Amendments (C-E): Percentage of Participants Demonstrating Symptom Improvement43.6 (33.9 to 53.2)42.6 (32.9 to 52.2)
Statistical analysis
  • Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) vs Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) · Regression, Logistic · p = 0.888 · Odds ratio (or): 1.04 · 95% CI 0.60 to 1.82
SecondaryTreatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Improvement

Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.

Time frame:
Day 7
Reported as:
Number · percentage of participants
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Improvement
percentage of participantsTreatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants)Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants)
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Improvement34.9 (26.6 to 43.2)50.4 (41.6 to 59.2)46.8 (38.1 to 55.5)
Statistical analysis
  • Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) vs Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) · Regression, Logistic · p = 0.014 · Odds ratio (or): 1.88 · 95% CI 1.13 to 3.13
  • Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) vs Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) · Regression, Logistic · p = 0.057 · Odds ratio (or): 1.63 · 95% CI 0.98 to 2.71
SecondaryTreatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Improvement

Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.

Time frame:
Day 7
Reported as:
Number · percentage of participants
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Improvement
percentage of participantsTreatment 12: 175 mg BEB (Amendment (f), High Risk Participants)Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Improvement42.4 (32.7 to 52.2)42.0 (28.3 to 55.7)
SecondaryTreatment 14 Amendment (g): Percentage of Participants Demonstrating Symptom Improvement

Symptoms associated with COVID-19 were evaluated using a questionnaire that contains the following symptoms: cough, shortness of breath, feeling feverish, fatigue, body aches and pain, sore throat, chills, headache, loss of appetite, and loss in taste and smell. Each symptom (excluding loss of taste and smell) was scored daily by the participant as experienced during the past 24 hours with following rating and score: None or absent (0), Mild (1), Moderate (2) and Severe (3). Loss of taste and smell was scored as Yes (Y) or No (N). Symptom improvement (yes/no) is defined as a patient experiencing symptoms on the symptom questionnaire (excluding loss of appetite, taste, and smell) scored as moderate or severe (score of 2 or 3) at baseline are subsequently scored as mild or absent (score of 1 or 0), AND symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent.

Time frame:
Day 7
Reported as:
Number · percentage of participants
Treatment 14 Amendment (g): Percentage of Participants Demonstrating Symptom Improvement
percentage of participantsTreatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB(Amendment (g), High Risk,Updated CDC Criteria)
Treatment 14 Amendment (g): Percentage of Participants Demonstrating Symptom Improvement38.6 (31.4 to 45.8)
SecondaryTreatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

Time frame:
Baseline through Day 29
Reported as:
Number · percentage of participants
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
percentage of participantsTreatment 1: PboTreatment 2: 175 mg BAM +350 mg ETETreatment 3: 700 mg BAM +1400 mg ETETreatment 4: 2800 mg BAM +2800 mg ETETreatment 5: 700 mg BAMTreatment 6: 350 mg BAM +700 mg ETEUnintentional Dosing: 700 mg Bamlanivimab +700 mg Etesevimab
Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause1.9 (0.0 to 4.1)0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)0.0 (0.0 to 0.0)1.0 (0.0 to 2.8)0.0 (0.0 to 0.0)5.0 (0.0 to 14.6)
SecondaryTreatment 7-8 Amendments (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

Time frame:
Baseline through Day 29
Reported as:
Number · percentage of participants
Treatment 7-8 Amendments (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
percentage of participantsTreatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))
Treatment 7-8 Amendments (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause1.0 (0.0 to 2.9)0.0 (0.0 to 0.0)
SecondaryTreatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

Time frame:
Baseline through Day 29
Reported as:
Number · percentage of participants
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
percentage of participantsTreatment 9: 175 mg BEB (Amendment (f), Low Risk Participants)Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants)Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)
Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause1.6 (0.0 to 3.8)2.4 (0.0 to 5.0)1.6 (0.0 to 3.7)
SecondaryTreatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

Time frame:
Baseline through Day 29
Reported as:
Number · percentage of participants
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
percentage of participantsTreatment 12: 175 mg BEB (Amendment (f), High Risk Participants)Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)
Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause6.0 (1.3 to 10.7)6.0 (0.0 to 12.6)
SecondaryTreatment 14 Amendment (g): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

Time frame:
Baseline through Day 29
Reported as:
Number · percentage of participants
Treatment 14 Amendment (g): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause
percentage of participantsTreatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB(Amendment (g), High Risk,Updated CDC Criteria)
Treatment 14 Amendment (g): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause2.3 (0.1 to 4.5)
SecondaryPharmacokinetics (PK): Mean Concentration of Bamlanivimab

PK: Mean Concentration of Bamlanivimab

Time frame:
Day 29
Reported as:
Geometric least squares mean · Microgram/milliliter (µg/mL)
Pharmacokinetics (PK): Mean Concentration of Bamlanivimab
Microgram/milliliter (µg/mL)700 mg BAM
Pharmacokinetics (PK): Mean Concentration of Bamlanivimab30.0 ± 36.4
SecondaryPharmacokinetics (PK): Mean Concentration of Etesevimab

Pharmacokinetics (PK): Mean Concentration of Etesevimab

Time frame:
Day 29
Reported as:
Geometric least squares mean · µg/mL
Pharmacokinetics (PK): Mean Concentration of Etesevimab
µg/mL1400 mg ETE
Pharmacokinetics (PK): Mean Concentration of Etesevimab105 ± 36.0
SecondaryPharmacokinetics (PK): Mean Concentration of Bebtelovimab

Pharmacokinetics (PK): Mean Concentration of Bebtelovimab

Time frame:
Day 29
Reported as:
Geometric least squares mean · µg/mL
Pharmacokinetics (PK): Mean Concentration of Bebtelovimab
µg/mL175 mg BEB
Pharmacokinetics (PK): Mean Concentration of Bebtelovimab4.18 ± 80.4
SecondaryPharmacokinetics (PK): Mean Concentration of VIR-7831

PK: Mean Concentration of VIR-7831

Time frame:
Day 29
Reported as:
Geometric least squares mean · µg/mL
Pharmacokinetics (PK): Mean Concentration of VIR-7831
µg/mL500 mg VIR-7831
Pharmacokinetics (PK): Mean Concentration of VIR-783146.3 ± 47.4

Adverse events

Collected over Baseline Up To 169 Days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment 1: Pbo0/155 (0%)0/155 (0%)16/155 (10.3%)
Treatment 2: 175 mg BAM +350 mg ETE0/83 (0%)0/83 (0%)14/83 (16.9%)
Treatment 3: 700 mg BAM +1400 mg ETE0/158 (0%)1/158 (0.6%)13/158 (8.2%)
Treatment 4: 2800 mg BAM +2800 mg ETE0/103 (0%)0/103 (0%)9/103 (8.7%)
Treatment 5: 700 mg BAM0/105 (0%)0/105 (0%)12/105 (11.4%)
Treatment 6: 350 mg BAM +700 mg ETE0/101 (0%)2/101 (2%)7/101 (6.9%)
Unintentional Dosing: 700 mg BAM +700 mg ETE0/20 (0%)1/20 (5%)4/20 (20%)
Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))0/101 (0%)0/101 (0%)6/101 (5.9%)
Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))0/101 (0%)0/101 (0%)10/101 (9.9%)
Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants)0/125 (0%)0/125 (0%)11/125 (8.8%)
Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants)1/127 (0.8%)1/127 (0.8%)15/127 (11.8%)
Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)0/128 (0%)0/128 (0%)10/128 (7.8%)
Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants)1/100 (1%)3/100 (3%)19/100 (19%)
Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)0/50 (0%)2/50 (4%)7/50 (14%)
Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g)), High Risk,Updated CDC Criteria)0/176 (0%)2/176 (1.1%)20/176 (11.4%)
700 mg BAM 15-min (Addendum (2))0/30 (0%)0/30 (0%)3/30 (10%)
700 mg BAM + 1400 mg ETE 30-min (Addendum (2))0/6 (0%)0/6 (0%)0/6 (0%)
700 mg BAM + 1400 mg ETE 15-min (Addendum (2))0/30 (0%)1/30 (3.3%)2/30 (6.7%)
Pooled Placebo (Addendum 4, IV)0/10 (0%)0/10 (0%)1/10 (10%)
70 mg BEB 140 mg/Min (Addendum 4, IV)0/6 (0%)0/6 (0%)0/6 (0%)
175 mg BEB 140 mg/Min (Addendum 4, IV)0/6 (0%)0/6 (0%)2/6 (33.3%)
175 mg BEB 350 mg/Min (Addendum 4, IV)0/6 (0%)0/6 (0%)0/6 (0%)
175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV)0/6 (0%)0/6 (0%)1/6 (16.7%)
1750 mg BEB 350 mg/Min (Addendum 4, IV)0/6 (0%)0/6 (0%)1/6 (16.7%)
Pooled Placebo (Addendum 4, SC)0/4 (0%)0/4 (0%)1/4 (25%)
280 mg BEB (Addendum 4, SC)0/6 (0%)0/6 (0%)2/6 (33.3%)
560 mg BEB (Addendum 4, SC)0/6 (0%)0/6 (0%)1/6 (16.7%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventTreatment 1: PboTreatment 2: 175 mg BAM +350 mg ETETreatment 3: 700 mg BAM +1400 mg ETETreatment 4: 2800 mg BAM +2800 mg ETETreatment 5: 700 mg BAMTreatment 6: 350 mg BAM +700 mg ETEUnintentional Dosing: 700 mg BAM +700 mg ETETreatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants)Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants)Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants)Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g)), High Risk,Updated CDC Criteria)700 mg BAM 15-min (Addendum (2))700 mg BAM + 1400 mg ETE 30-min (Addendum (2))700 mg BAM + 1400 mg ETE 15-min (Addendum (2))Pooled Placebo (Addendum 4, IV)70 mg BEB 140 mg/Min (Addendum 4, IV)175 mg BEB 140 mg/Min (Addendum 4, IV)175 mg BEB 350 mg/Min (Addendum 4, IV)175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV)1750 mg BEB 350 mg/Min (Addendum 4, IV)Pooled Placebo (Addendum 4, SC)280 mg BEB (Addendum 4, SC)560 mg BEB (Addendum 4, SC)
Pulmonary embolismRespiratory, thoracic and mediastinal disorders0/1550/830/1580/1030/1050/1011/200/1010/1010/1250/1270/1281/1000/500/1760/300/60/300/100/60/60/60/60/60/40/60/6
Meniscus injuryInjury, poisoning and procedural complications0/1550/830/1580/1030/1050/1010/200/1010/1010/1250/1270/1281/1000/500/1760/300/61/300/100/60/60/60/60/60/40/60/6
Femur fractureInjury, poisoning and procedural complications0/1550/830/1580/1030/1050/1010/200/1010/1010/1250/1270/1280/1001/500/1760/300/60/300/100/60/60/60/60/60/40/60/6
Psychotic disorderPsychiatric disorders0/1550/830/1580/1030/1050/1010/200/1010/1010/1250/1270/1280/1001/500/1760/300/60/300/100/60/60/60/60/60/40/60/6
Abortion spontaneousPregnancy, puerperium and perinatal conditions0/750/390/860/550/500/480/80/520/560/631/760/720/520/260/980/120/60/130/30/60/60/60/30/50/10/10/2
Cerebrovascular accidentNervous system disorders0/1550/830/1580/1030/1050/1010/200/1010/1010/1250/1270/1281/1000/500/1760/300/60/300/100/60/60/60/60/60/40/60/6
Infusion related reactionInjury, poisoning and procedural complications0/1550/830/1580/1030/1051/1010/200/1010/1010/1250/1270/1280/1000/500/1760/300/60/300/100/60/60/60/60/60/40/60/6
Road traffic accidentInjury, poisoning and procedural complications0/1550/830/1580/1030/1051/1010/200/1010/1010/1250/1270/1280/1000/500/1760/300/60/300/100/60/60/60/60/60/40/60/6
HypersensitivityImmune system disorders0/1550/831/1580/1030/1050/1010/200/1010/1010/1250/1270/1280/1000/500/1760/300/60/300/100/60/60/60/60/60/40/60/6
OsteomyelitisInfections and infestations0/1550/830/1580/1030/1050/1010/200/1010/1010/1250/1270/1280/1000/501/1760/300/60/300/100/60/60/60/60/60/40/60/6
Most frequent other events
Showing 10 of 152
Most frequent other events
EventTreatment 1: PboTreatment 2: 175 mg BAM +350 mg ETETreatment 3: 700 mg BAM +1400 mg ETETreatment 4: 2800 mg BAM +2800 mg ETETreatment 5: 700 mg BAMTreatment 6: 350 mg BAM +700 mg ETEUnintentional Dosing: 700 mg BAM +700 mg ETETreatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants)Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants)Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants)Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g)), High Risk,Updated CDC Criteria)700 mg BAM 15-min (Addendum (2))700 mg BAM + 1400 mg ETE 30-min (Addendum (2))700 mg BAM + 1400 mg ETE 15-min (Addendum (2))Pooled Placebo (Addendum 4, IV)70 mg BEB 140 mg/Min (Addendum 4, IV)175 mg BEB 140 mg/Min (Addendum 4, IV)175 mg BEB 350 mg/Min (Addendum 4, IV)175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV)1750 mg BEB 350 mg/Min (Addendum 4, IV)Pooled Placebo (Addendum 4, SC)280 mg BEB (Addendum 4, SC)560 mg BEB (Addendum 4, SC)
Nasal discomfortRespiratory, thoracic and mediastinal disorders0/1551/830/1580/1030/1050/1010/200/1010/1010/1250/1270/1280/1000/500/1760/300/60/300/100/60/60/60/60/61/40/60/6
ThrombocytosisBlood and lymphatic system disorders0/1550/830/1580/1030/1051/1010/200/1010/1010/1250/1270/1280/1000/500/1760/300/60/300/100/60/60/60/60/60/41/60/6
Diastolic dysfunctionCardiac disorders0/1550/830/1580/1030/1050/1010/200/1010/1010/1250/1270/1280/1000/500/1760/300/60/300/100/60/60/60/60/60/40/61/6
Infusion site extravasationGeneral disorders0/1550/830/1580/1030/1050/1010/200/1010/1010/1250/1270/1280/1000/500/1760/300/60/300/100/61/60/60/60/60/40/60/6
Non-cardiac chest painGeneral disorders0/1550/830/1580/1030/1050/1010/200/1010/1010/1250/1270/1280/1000/500/1760/300/60/300/100/61/60/60/60/60/40/60/6
TonsillitisInfections and infestations0/1550/830/1580/1030/1050/1010/200/1010/1011/1250/1270/1280/1000/500/1760/300/60/300/100/60/60/61/60/60/40/60/6
Amylase increasedInvestigations0/1550/830/1580/1030/1050/1010/200/1010/1010/1251/1271/1280/1000/500/1760/300/60/300/100/60/60/60/60/60/41/60/6
Blood creatine phosphokinase increasedInvestigations1/1550/830/1580/1030/1050/1010/200/1010/1010/1251/1270/1282/1000/500/1760/300/60/300/100/60/60/60/60/60/41/60/6
Lung neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/1550/830/1580/1030/1050/1010/200/1010/1010/1250/1270/1280/1000/500/1760/300/60/300/100/60/60/60/60/60/40/61/6
Pulmonary massRespiratory, thoracic and mediastinal disorders0/1550/830/1580/1030/1050/1010/200/1010/1010/1250/1270/1280/1000/500/1760/300/60/300/100/60/60/60/60/60/40/61/6

Baseline characteristics

All participants who received at least one dose of study drug.

Age, Continuous
Age, Continuous(years)Treatment 1: PboTreatment 2: 175 mg BAM +350 mg ETETreatment 3: 700 mg BAM +1400 mg ETETreatment 4: 2800 mg BAM +2800 mg ETETreatment 5: 700 mg BAMTreatment 6: 350 mg BAM +700 mg ETEUnintentional Dosing: 700 mg Bamlanivimab +700 mg EtesevimabTreatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants)Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants)Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants)Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g), Updated CDC Criteria)700 mg BAM 15-min (Addendum (2))700 mg BAM + 1400 mg ETE 30-min (Addendum (2))700 mg BAM + 1400 mg ETE 15-min (Addendum (2))Pooled Placebo (Addendum 4, IV)70 mg BEB 140 mg/Min (Addendum 4, IV)175 mg BEB 140 mg/Min (Addendum 4, IV)175 mg BEB 350 mg/Min (Addendum 4, IV)175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV)1750 mg BEB 350 mg/Min (Addendum 4, IV)Pooled Placebo (Addendum 4, SC)280 BEB (Addendum 4, SC)560 mg BEB (Addendum 4, SC)Total
Mean38.9 ± 12.2241.5 ± 12.8937.7 ± 12.1139.5 ± 12.6339.8 ± 12.7042.3 ± 11.9336.5 ± 15.0437.6 ± 12.8338.9 ± 11.7736.2 ± 11.4037.6 ± 12.1236.1 ± 11.6649.1 ± 15.1750.8 ± 17.0649.3 ± 17.3935.4 ± 12.5547.7 ± 7.2842.9 ± 11.8746.8 ± 13.2735.2 ± 13.9948.7 ± 9.8336.3 ± 15.2441.7 ± 14.7639.5 ± 16.8830.0 ± 6.9835.8 ± 7.0839.2 ± 9.7040.6 ± 13.89
Sex: Female, Male
Sex: Female, Male(Participants)Treatment 1: PboTreatment 2: 175 mg BAM +350 mg ETETreatment 3: 700 mg BAM +1400 mg ETETreatment 4: 2800 mg BAM +2800 mg ETETreatment 5: 700 mg BAMTreatment 6: 350 mg BAM +700 mg ETEUnintentional Dosing: 700 mg Bamlanivimab +700 mg EtesevimabTreatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants)Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants)Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants)Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g), Updated CDC Criteria)700 mg BAM 15-min (Addendum (2))700 mg BAM + 1400 mg ETE 30-min (Addendum (2))700 mg BAM + 1400 mg ETE 15-min (Addendum (2))Pooled Placebo (Addendum 4, IV)70 mg BEB 140 mg/Min (Addendum 4, IV)175 mg BEB 140 mg/Min (Addendum 4, IV)175 mg BEB 350 mg/Min (Addendum 4, IV)175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV)1750 mg BEB 350 mg/Min (Addendum 4, IV)Pooled Placebo (Addendum 4, SC)280 BEB (Addendum 4, SC)560 mg BEB (Addendum 4, SC)Total
Female7539865550488525663767252269812313336135112909
Male80447248555312494562515648247818317730531354846
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment 1: PboTreatment 2: 175 mg BAM +350 mg ETETreatment 3: 700 mg BAM +1400 mg ETETreatment 4: 2800 mg BAM +2800 mg ETETreatment 5: 700 mg BAMTreatment 6: 350 mg BAM +700 mg ETEUnintentional Dosing: 700 mg Bamlanivimab +700 mg EtesevimabTreatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants)Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants)Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants)Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g), Updated CDC Criteria)700 mg BAM 15-min (Addendum (2))700 mg BAM + 1400 mg ETE 30-min (Addendum (2))700 mg BAM + 1400 mg ETE 15-min (Addendum (2))Pooled Placebo (Addendum 4, IV)70 mg BEB 140 mg/Min (Addendum 4, IV)175 mg BEB 140 mg/Min (Addendum 4, IV)175 mg BEB 350 mg/Min (Addendum 4, IV)175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV)1750 mg BEB 350 mg/Min (Addendum 4, IV)Pooled Placebo (Addendum 4, SC)280 BEB (Addendum 4, SC)560 mg BEB (Addendum 4, SC)Total
Hispanic or Latino48244728283331827464545198491513300112012497
Not Hispanic or Latino104571087074661780727882838142126155266665544241228
Unknown or Not Reported32353203210000100110000003030
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment 1: PboTreatment 2: 175 mg BAM +350 mg ETETreatment 3: 700 mg BAM +1400 mg ETETreatment 4: 2800 mg BAM +2800 mg ETETreatment 5: 700 mg BAMTreatment 6: 350 mg BAM +700 mg ETEUnintentional Dosing: 700 mg Bamlanivimab +700 mg EtesevimabTreatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants)Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants)Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants)Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g), Updated CDC Criteria)700 mg BAM 15-min (Addendum (2))700 mg BAM + 1400 mg ETE 30-min (Addendum (2))700 mg BAM + 1400 mg ETE 15-min (Addendum (2))Pooled Placebo (Addendum 4, IV)70 mg BEB 140 mg/Min (Addendum 4, IV)175 mg BEB 140 mg/Min (Addendum 4, IV)175 mg BEB 350 mg/Min (Addendum 4, IV)175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV)1750 mg BEB 350 mg/Min (Addendum 4, IV)Pooled Placebo (Addendum 4, SC)280 BEB (Addendum 4, SC)560 mg BEB (Addendum 4, SC)Total
American Indian or Alaska Native20101101000021400000000000013
Asian441339404114231103300000000060
Native Hawaiian or Other Pacific Islander0020000200002011000000000008
Black or African American7567472155191929141328200100000011185
White132681279185841774909799907832136273279666664551410
More than one race1020100110011000000000000008
Unknown or Not Reported96725514485603600000000000071
Region of Enrollment
Region of Enrollment(Participants)Treatment 1: PboTreatment 2: 175 mg BAM +350 mg ETETreatment 3: 700 mg BAM +1400 mg ETETreatment 4: 2800 mg BAM +2800 mg ETETreatment 5: 700 mg BAMTreatment 6: 350 mg BAM +700 mg ETEUnintentional Dosing: 700 mg Bamlanivimab +700 mg EtesevimabTreatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e))Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants)Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants)Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants)Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants)Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants)Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g), Updated CDC Criteria)700 mg BAM 15-min (Addendum (2))700 mg BAM + 1400 mg ETE 30-min (Addendum (2))700 mg BAM + 1400 mg ETE 15-min (Addendum (2))Pooled Placebo (Addendum 4, IV)70 mg BEB 140 mg/Min (Addendum 4, IV)175 mg BEB 140 mg/Min (Addendum 4, IV)175 mg BEB 350 mg/Min (Addendum 4, IV)175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV)1750 mg BEB 350 mg/Min (Addendum 4, IV)Pooled Placebo (Addendum 4, SC)280 BEB (Addendum 4, SC)560 mg BEB (Addendum 4, SC)Total
United States1558315810310510120101101125127128100501763063010666664661755
08

Study locations

141 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35233, United States
  • The Institute for Liver Health
    Mesa, Arizona 85210, United States
  • Perseverance Research Center
    Scottsdale, Arizona 85254, United States
  • CRI of Arizona, LLC
    Sun City West, Arizona 85375, United States
  • Fiel Family and Sports Medicine PC
    Tempe, Arizona 85283, United States
  • The Institute for Liver Health
    Tucson, Arizona 85712, United States
  • KLR Business Group, Inc. dba Arkansas Clinical Research
    Little Rock, Arkansas 72205, United States
  • Applied Rsch Ctr - Arkansas Inc.
    Little Rock, Arkansas 72212, United States
  • Smart Cures Clin Research
    Anaheim, California 92806, United States
  • Hope Clinical Research
    Canoga Park, California 91303, United States
  • VCT-Covina
    Covina, California 91723, United States
  • Neighborhood Healthcare
    Escondido, California 92025, United States
  • Chemidox Clinical Trials
    Lancaster, California 93534, United States
  • Ark Clinical Research
    Long Beach, California 90806, United States
  • Long Beach Clinical Trials LLC
    Long Beach, California 90806, United States
  • Cedars Sinai Medical Center
    Los Angeles, California 90048-5615, United States
  • Central Valley Research, LLC
    Modesto, California 95350, United States
  • Inland Empire Liver Foundation
    Rialto, California 92377, United States
  • Sutter Institute For Medical Research
    Sacramento, California 95816, United States
  • Wolverine Clinical Trials, LLC
    Santa Ana, California 92705, United States
  • St. Joe Heritage HC-Santa Rosa
    Santa Rosa, California 95405, United States
  • Stanford University Hospital
    Stanford, California 94305, United States
  • Mazur, Statner, Dutta, Nathan
    Thousand Oaks, California 91360, United States
  • South Bay Clinical Research Institute
    Torrance, California 90503, United States
  • Infect Disease Doctors Med Grp
    Walnut Creek, California 94598, United States
  • Allianz Research Institute
    Westminster, California 92683, United States
  • Future Innovative Treatments LLC
    Colorado Springs, Colorado 80907, United States
  • Georgetown Univ Sch of Med
    Washington, District of Columbia 20007, United States
  • Synergy Healthcare LLC
    Bradenton, Florida 34208, United States
  • Holy Cross Hospital Inc.
    Fort Lauderdale, Florida 33308, United States
  • I R & Health Center, Inc.
    Hialeah, Florida 33012, United States
  • Encore Medical Research
    Hollywood, Florida 33021, United States
  • Elixia CRC
    Hollywood, Florida 33023, United States
  • Lakeland Regional Medical Center
    Lakeland, Florida 33804, United States
  • Panax Clinical Research
    Miami Lakes, Florida 33014, United States
  • Hope Clinical Trials, Inc.
    Miami, Florida 33165, United States
  • Miami Cancer Institute at Baptist Health, Inc.
    Miami, Florida 33176, United States
  • Bio-Medical Research, LLC
    Miami, Florida 33184, United States
  • Clinical Site Partners, LLC d/b/a CSP Miami
    Miami, Florida 33186, United States
  • Testing Matters Lab
    Sunrise, Florida 33325, United States
  • Advent Health Tampa
    Tampa, Florida 33613, United States
  • Triple O Research Inst
    West Palm Beach, Florida 33407, United States
  • Encore Medical Research - Weston
    Weston, Florida 33331, United States
  • Clinical Site Partners, LLC DBA CSP Orlando
    Winter Park, Florida 32789, United States
  • Gwinnett Research Inst
    Buford, Georgia 30519, United States
  • Paramount Rch Sol - College Pk
    College Park, Georgia 30349, United States
  • IACT Health - VHC
    Columbus, Georgia 31904, United States
  • Central Georgia Infectious Disease
    Macon, Georgia 31201, United States
  • Rophe Adult and Pediatric Medicine
    Union City, Georgia 30291, United States
  • Rocky Mountain Clinical Research
    Idaho Falls, Idaho 83404, United States
  • Ann & Robert H Lurie Children's Hospital of Chicago
    Chicago, Illinois 60611, United States
  • Great Lakes Clinical Trials
    Chicago, Illinois 60640, United States
  • Franciscan Health Hammond
    Dyer, Indiana 46311, United States
  • Qualmedica Research Evansville
    Evansville, Indiana 47715, United States
  • Franciscan St. Francis Health
    Indianapolis, Indiana 46237, United States
  • St.Vincent - Indy
    Indianapolis, Indiana 46260, United States
  • Qualmedica Research, LLC
    Owensboro, Kentucky 42301, United States
  • Tandem Clinical Research,LLC
    Marrero, Louisiana 70072, United States
  • Imperial Health Urgent Care Center - Moss Bluff
    Moss Bluff, Louisiana 70611, United States
  • Nola Research Works, LLC
    New Orleans, Louisiana 70125, United States
  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • U of MA Mem Med Ctr
    Worcester, Massachusetts 01605, United States
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
  • Great Lakes Research Group, Inc.
    Bay City, Michigan 48706, United States
  • Revive Research Institute
    Farmington Hills, Michigan 48334, United States
  • Revival Research Institute
    Sterling Heights, Michigan 48312, United States
  • Sky Clinical Prime and Health Wellness Clinic
    Fayette, Mississippi 39069, United States
  • Olive Branch Family Medical Center
    Olive Branch, Mississippi 38654, United States
  • Sky Clin Resch - Quinn HC
    Ridgeland, Mississippi 39157, United States
  • Bio-Kinetic Clinical Applications, LLC
    Springfield, Missouri 65802, United States
  • Quality Clinical Research
    Omaha, Nebraska 68114, United States
  • Excel Clinical Research
    Las Vegas, Nevada 89109, United States
  • Las Vegas Medical Research
    Las Vegas, Nevada 89113, United States
  • SVG Clinical
    Las Vegas, Nevada 89128, United States
  • Holy Name Medical Center
    Teaneck, New Jersey 07666, United States
  • Prime Global Research, LLC
    Bronx, New York 10456, United States
  • Onsite Clinical Solutions, LLC
    Charlotte, North Carolina 28226, United States
  • East Carolina University
    Greenville, North Carolina 27834, United States
  • Monroe Biomed Research
    Monroe, North Carolina 28112, United States
  • Carteret Medical Group
    Morehead City, North Carolina 28557, United States
  • PMG Research of Wilmington
    Wilmington, North Carolina 28401, United States
  • Valley Medical Primary Care
    Centerville, Ohio 45459, United States
  • Hometown UC and Rch- Cincy
    Cincinnati, Ohio 45215, United States
  • Aventiv Research Inc
    Columbus, Ohio 43213, United States
  • Urgent Care Specialists, LLC
    Columbus, Ohio 43214, United States
  • Remington-Davis, Inc
    Columbus, Ohio 43215, United States
  • Urgent Care Specialists, LLC
    Dayton, Ohio 45424, United States
  • META Medical Research Institute
    Dayton, Ohio 45432, United States
  • Ascension St. John Tulsa OK
    Tulsa, Oklahoma 74104, United States
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 18901, United States
  • Jefferson Hosp for Neurosci
    Philadelphia, Pennsylvania 19107, United States
  • Temple University Hospital
    Philadelphia, Pennsylvania 19140, United States
  • VITALINK - Anderson
    Anderson, South Carolina 29621, United States
  • Carolina Medical Research - Clinton
    Clinton, South Carolina 29325, United States
  • VITALINK - Gaffney
    Gaffney, South Carolina 29340, United States
  • Carolina Medical Research - Greenville
    Greenville, South Carolina 29607, United States
  • VITALINK - Greenville
    Greenville, South Carolina 29615, United States
  • VITALINK - Spartanburg
    Spartanburg, South Carolina 29303, United States
  • VITALINK - Union
    Union, South Carolina 29379, United States

Showing the first 100 of 141 sites across 3 countries.

09

References and documents

Publications

  • Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2. PubMed 35713300 ↗
  • Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2. PubMed 34473343 ↗
  • Nathan R, Shawa I, De La Torre I, Pustizzi JM, Haustrup N, Patel DR, Huhn G. A Narrative Review of the Clinical Practicalities of Bamlanivimab and Etesevimab Antibody Therapies for SARS-CoV-2. Infect Dis Ther. 2021 Dec;10(4):1933-1947. doi: 10.1007/s40121-021-00515-6. Epub 2021 Aug 10. PubMed 34374951 ↗

Study documents

  • Study protocol · May 18, 2021
  • Study protocol · Nov 11, 2020
  • Study protocol · Mar 16, 2021
  • Statistical analysis plan · Aug 4, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Csr

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04634409
Lead sponsor
Eli Lilly and Company
Collaborators
AbCellera Biologics Inc., Shanghai Junshi Bioscience Co., Ltd., GlaxoSmithKline, Vir Biotechnology, Inc.
Responsible party
Sponsor
First posted
Nov 18, 2020
Start date
Oct 29, 2020
Primary completion
Jul 27, 2021
Completion
Oct 18, 2021
Results posted
Jul 1, 2022
Last update
Jul 1, 2022

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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