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TerminatedNCT04705597Updated Jul 3, 2023Results posted

Study to Evaluate the Safety, Tolerability, and Efficacy of BGE-175 in Hospitalized Adults With Coronavirus Disease 2019 (COVID-19) That Are Not in Respiratory Failure

A Phase 2 interventional study of BGE-175 and Placebo in Covid19, sponsored by BioAge Labs, Inc.. Terminated at 26 sites in 3 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-07-03.

Sponsored by BioAge Labs, Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated
The incidence of COVID-19 hospitalization cases decreased to a level that continued enrollment was no longer feasible
Phase
Phase 2
Study type
Interventional
Enrollment
194
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of BGE-175 in participants ≥ 50 years of age hospitalized with documented COVID-19.

Read the detailed description

This is a randomized, placebo-controlled, parallel-group, multicenter, double-blind study of BGE-175 administered PO or NG in participants ≥ 50 years of age and hospitalized with documented COVID-19 who are not yet in respiratory failure.

After signing informed consent, participants will be screened upon presentation at the hospital. Screening will include full physical examination, vital signs, safety laboratory evaluation, oxygen saturation, pre-diagnostics to measure prostaglandin D2 (PGD2) status, and baseline assessment of World Health Organization (WHO) Ordinal Scale for COVID-19. If confirmed that the participant qualifies for this protocol according to listed inclusion and exclusion criteria, participants will receive the first dose of study medication, PO. The participant will then receive study medication PO or NG (if intubated or unable to swallow medication) once daily, at approximately the same time each day for up to 13 additional days. Study medication will be administered in addition to standard of care deemed appropriate by the treating physician(s). Participants will be randomized to receive BGE-175 or placebo. Participants will be monitored daily for all relevant efficacy outcomes, oxygen saturation, and adverse events. Blood will be drawn periodically for safety laboratory measurements, plasma kinetics, lymphocyte subsets, C-reactive protein, and cytokines. Nasopharyngeal swabs will be collected to measure viral load. Participants will be monitored for 14 days after administration of the last dose (Day 28) and followed through Day 57.

02

Conditions studied

  • Covid19

Keywords

  • COVID-19
  • BGE-175
  • BioAge
  • Respiratory failure
03

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 194 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

BioAge Labs, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

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

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ability to voluntarily provide informed consent that is documented per local requirements
  • An understanding, ability, and willingness to fully comply with study procedures and restrictions
  • Hospitalized subjects with a confirmed SARS-CoV-2 infection
  • Laboratory (polymerase chain reaction [PCR]) confirmed infection with SARS-CoV-2
  • Age ≥ 50 years
  • COVID-19 illness of any duration, and oxygen saturation measurements ≤ 94% over 5 minutes on room air (Note: low flow oxygen is permitted, but room air oxygen saturation must be ≤ 94%)

  • Not in respiratory failure as defined by at least one of the following:

    1. Respiratory failure defined by requiring at least one of the following:

      • Endotracheal intubation and mechanical ventilation
      • Oxygen delivered by high-flow nasal cannula at flow rates > 20 L/min with fraction of delivered oxygen ≥ 0.5)
      • NIPPV
      • ECMO
      • Clinical diagnosis of respiratory failure (i.e., need for one of the preceding therapies, but preceding therapies are not being administered because it is unavailable in the current setting)
    2. Hemodynamic compromise (defined by systolic blood pressure \< 90 mm Hg, or diastolic blood pressure \< 60 mm Hg) or requiring vasopressors
    3. Multi-organ dysfunction/failure
  • Females subjects of childbearing potential must have a negative pregnancy test at screening or pre-treatment on Day 1
  • Male and female subjects of childbearing potential must agree to use methods of contraception that are consistent with local regulations for those participating in clinical studies

Exclusion criteria

Exclusion Criteria:

  • Participation in any other randomized, controlled clinical trial of an experimental treatment for COVID-19 (uncontrolled, compassionate use trials are allowed)
  • In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
  • Currently participating in a vaccination trial for SARS-CoV-2
  • Known positive test for influenza A or influenza B at the time of screening
  • Positive for human immunodeficiency virus (HIV) that is not controlled with current treatment
  • Hepatitis B surface antigen, or Hepatitis C positive at the time of screening. Subjects who are positive for Hepatitis C but have Hepatitis C virus (HCV) RNA below the limit of quantitation may be enrolled. Subjects with Hepatitis B, but with undetectable viral load, may be enrolled.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 × the upper limit of normal (ULN)
  • Stage 4 severe chronic kidney disease (i.e., estimated glomerular filtration rate [eGFR] \< 30 mL/min) or acute renal failure resulting in eGFR \< 30 mL/min

  • Serious comorbidity, including:

    1. Myocardial infarction (within the last month)
    2. Moderate or severe heart failure (New York Heart Association [NYHA] class III or IV)
    3. Acute stroke (within the last month)
    4. Uncontrolled malignancy. Uncontrolled malignancy would include cancers that are not considered in remission, or solid tumor or hematological malignancies with evidence of disease progression in the past 3 months (i.e., there is evidence of disease progression by Response Evaluation Criteria in Solid Tumours [RECIST] or equivalent relevant criterion for the type of malignancy), and are not considered effectively managed with ongoing treatment as determined by the investigator
    5. Recent severe thromboembolic disease or evidence of severe thromboembolic disease defined as a current large vessel thromboembolic event or a thromboembolic event within the past 3 months (e.g., deep vein thrombosis [DVT], pulmonary embolism, ischemic stroke, transient ischemic attack) requiring interventional treatment. This exclusion does not prohibit prophylaxis for thromboembolic events, including those considered possible with concurrent SARS-CoV-2 infection.
  • History of severe allergic or anaphylactic reactions or hypersensitivity to the study drug
  • Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
194 participants (actual)

Study arms

  • Experimental
    BGE-175

    BGE-175 tablet to be taken by mouth once a day for 14 days

    Drug: BGE-175

  • Placebo comparator
    Placebo

    Placebo tablet to be taken by mouth once a day for 14 days

    Other: Placebo

Interventions

  • DrugBGE-175

    Drug

  • OtherPlacebo

    Placebo

06

What researchers measure

Primary outcomes

  1. Proportion of Participants Who Have Died or Progressed to Respiratory Failure

    Proportion of participants who have died or progressed to respiratory failure as defined by progressing to the need for high-flow nasal cannula O2 delivery, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at Day 28. The proportion of participants is represented as a percentage.

    Time frame: First dose date up to Day 28

Secondary outcomes

  1. Proportion of Participants Experiencing Treatment-emergent Adverse Events

    Proportion of participants experiencing treatment-emergent adverse events as measured by the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0. The proportion of participants is represented as a percentage.

    Time frame: First dose of treatment through study Day 57

  2. Survival

    Proportion of participants surviving at Day 14, Day 28, and Day 57. The proportion of participants is represented as a percentage.

    Time frame: Baseline through Day 57; at Day 14, Day 28 and Day 57

  3. Proportion of Subjects Who Survive Without Progression to Respiratory Failure Through Day 28

    Proportion of subjects who survive without progression to respiratory failure at Day 28. The proportion of participants is represented as a percentage.

    Time frame: First dose of treatment through Day 14, Day 28

  4. Time to Two Successive Negative Viral Titers in Nasopharyngeal Swabs

    Kaplan-Meier Estimate of Time to Two Successive Negative Viral Titers in Nasopharyngeal Swab (median)

    Time frame: Baseline through Day 28

  5. Time to Clinical Worsening From Baseline Value (Defined by Time to ≥ 1-point Worsening on WHO Ordinal Scale for COVID-19)

    Kaplan-Meier Estimate of Time to Clinical Worsening from Baseline Value. Time to clinical worsening from baseline value (defined by time to ≥ 1-point worsening on World Health Organization (WHO) Ordinal Scale for COVID-19). The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome.

    Time frame: First dose date up to Day 57

  6. Proportion of Patients Who Develop Critical COVID-19 Illness

    Proportion of patients who develop critical COVID-19 illness as defined by at least one of the following: A. RF defined based on resource utilization requiring at least one of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, ECMO, clinical diagnosis respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) B. Hemodynamic compromise (defined by systolic blood pressure \< 90 mm Hg, or diastolic blood pressure \< 60 mm Hg or requiring vasopressors) C. Multi-organ dysfunction/failure The proportion of participants is represented as a percentage.

    Time frame: First dose date up to Day 57

  7. Time to Clinical Improvement From Baseline Value (Defined by Time to ≥ 1-point Improvement on WHO Ordinal Scale for COVID-19 Score - Must be Maintained Through Day 28)

    Kaplan-Meier Estimate of Time to Clinical Improvement from Baseline Value. Time to clinical improvement defined by time to ≥ 1-point improvement on World Health Organization (WHO) Ordinal Scale for COVID-19 - must be maintained through Day 28. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome.

    Time frame: First dose date up to Day 28

  8. Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score

    Mean change from baseline in WHO Ordinal Scale for COVID-19 score World Health Organization (WHO) Ordinal Scale for COVID-19. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome.

    Time frame: Day 14/End of Treatment, Day 28, Day 57

  9. Number of Patients Who Had Intubation During the Study

    Proportion of Patients who had Intubation during the study defined as proportion of patients who had any documented intubation during the study.

    Time frame: First dose date up to Day 57

  10. Duration of Intubation

    Duration of Intubation (first post-dosing intubation)

    Time frame: First dose date up to Day 57

  11. Time to Discharge From Hospital Intensive Care Unit

    Time from intensive care unit admission to the recorded time of intensive care unit discharge

    Time frame: First dose date up to Day 57

  12. Number of Patients Who Had Supplemental Oxygen Administration

    Proportion of patients who had any documented post-dosing supplemental O2 administration during the study.

    Time frame: First dose date up to Day 57

  13. Duration of Supplemental Oxygen Administration

    Duration of participants receiving supplemental oxygen

    Time frame: First dose date up to Day 57

  14. Number of Patients Who Had Noninvasive Ventilation or High-flow Nasal Cannula O2 Administration

    Proportion of patients who had any documented post-dosing noninvasive ventilation or high-flow nasal cannula O2 administration.

    Time frame: First dose date up to Day 57

  15. Duration of Noninvasive Ventilation by Nonrebreather Mask or High-flow Nasal Cannula

    Duration of participants receiving noninvasive ventilation by nonrebreather mask or high-flow nasal cannula

    Time frame: First dose date up to Day 57

  16. Number of Patients Who Had Mechanical Ventilation.

    Proportion of patients who had any documented post-dosing mechanical ventilation.

    Time frame: First dose date up to Day 57

  17. Duration of Mechanical Ventilation

    Duration of participants receiving mechanical ventilation

    Time frame: First dose date up to Day 57

  18. Number of Patients Who Had Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO.

    Proportion of patients who had any documented post-dosing mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO.

    Time frame: First dose date up to Day 57

  19. Duration of Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO

    Duration of participants receiving mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO

    Time frame: First dose date up to Day 57

  20. Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2)

    Daily ratio of participants' oxygen saturation (SpO2) to fractional inspired O2 (SpO2/FiO2)

    Time frame: First dose date up to Day 28

  21. Time to Discharge From the Hospital

    Length (in days) of the time of hospitalization until medical discharge

    Time frame: First dose date up to Day 57

  22. Number of Patients With Re-hospitalization

    Proportion of patients who are hospitalized again after the discharge of first hospitalization.

    Time frame: First dose date up to Day 57

  23. Proportion of Participants Requiring Intensive Care Unit Admission

    Proportion of participants admitted to hospital intensive care unit post randomization. The proportion of participants is represented as a percentage.

    Time frame: First dose date up to Day 57

07

Results

Posted Jul 3, 2023

Participant flow

Participants were recruited across 3 countries (US, Brazil and Argentina). Participants were hospitalized with a confirmed lab PCR SARS-COV-2 infection. First Subject First Visit was on 26 May 2021 and Last Subject Last Visit was on 19May2022.

Participant flow — Overall Study
MilestoneAsapiprant (BGE-175)Placebo
Started9698
Completed7887
Not completed1811
Withdrew: Death169
Withdrew: Lost to follow-up10
Withdrew: Withdrawal by subject12

Outcome measures

PrimaryProportion of Participants Who Have Died or Progressed to Respiratory Failure

Proportion of participants who have died or progressed to respiratory failure as defined by progressing to the need for high-flow nasal cannula O2 delivery, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at Day 28. The proportion of participants is represented as a percentage.

Time frame:
First dose date up to Day 28
Reported as:
Count of participants · Participants
Proportion of Participants Who Have Died or Progressed to Respiratory Failure
ParticipantsAsapiprant (BGE-175)Placebo
Proportion of Participants Who Have Died or Progressed to Respiratory Failure3126
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · Regression, Logistic · p = 0.3312 · Odds ratio (or): 1.366 · 95% CI 0.728 to 2.562
SecondaryProportion of Participants Experiencing Treatment-emergent Adverse Events

Proportion of participants experiencing treatment-emergent adverse events as measured by the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0. The proportion of participants is represented as a percentage.

Time frame:
First dose of treatment through study Day 57
Reported as:
Count of participants · Participants
Proportion of Participants Experiencing Treatment-emergent Adverse Events
ParticipantsAsapiprant (BGE-175)Placebo
Proportion of Participants Experiencing Treatment-emergent Adverse Events7371
SecondarySurvival

Proportion of participants surviving at Day 14, Day 28, and Day 57. The proportion of participants is represented as a percentage.

Time frame:
Baseline through Day 57; at Day 14, Day 28 and Day 57
Reported as:
Count of participants · Participants
Survival
ParticipantsAsapiprant (BGE-175)Placebo
Survival at Day 148993
Survival at Day 287987
Survival at Day 576972
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · Regression, Logistic · p = 0.4561 · Odds ratio (or): 0.574 · 95% CI 0.133 to 2.475
  • Asapiprant (BGE-175) vs Placebo · Regression, Logistic · p = 0.1559 · Odds ratio (or): 0.521 · 95% CI 0.212 to 1.282
  • Asapiprant (BGE-175) vs Placebo · Regression, Logistic · p = 0.1293 · Odds ratio (or): 0.498 · 95% CI 0.203 to 1.226
SecondaryProportion of Subjects Who Survive Without Progression to Respiratory Failure Through Day 28

Proportion of subjects who survive without progression to respiratory failure at Day 28. The proportion of participants is represented as a percentage.

Time frame:
First dose of treatment through Day 14, Day 28
Reported as:
Number · percentage of participants
Proportion of Subjects Who Survive Without Progression to Respiratory Failure Through Day 28
percentage of participantsAsapiprant (BGE-175)Placebo
Day 1469.5 (59.1 to 77.7)78.6 (69.0 to 85.5)
Day 2867.3 (56.9 to 75.8)73.4 (63.4 to 81.0)
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · Log Rank · p = 0.2687
SecondaryTime to Two Successive Negative Viral Titers in Nasopharyngeal Swabs

Kaplan-Meier Estimate of Time to Two Successive Negative Viral Titers in Nasopharyngeal Swab (median)

Time frame:
Baseline through Day 28
Reported as:
Median · days
Time to Two Successive Negative Viral Titers in Nasopharyngeal Swabs
daysAsapiprant (BGE-175)Placebo
Time to Two Successive Negative Viral Titers in Nasopharyngeal Swabs29 (29 to NA)29 (29 to NA)
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · Log Rank · p = 0.3977
SecondaryTime to Clinical Worsening From Baseline Value (Defined by Time to ≥ 1-point Worsening on WHO Ordinal Scale for COVID-19)

Kaplan-Meier Estimate of Time to Clinical Worsening from Baseline Value. Time to clinical worsening from baseline value (defined by time to ≥ 1-point worsening on World Health Organization (WHO) Ordinal Scale for COVID-19). The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome.

Time frame:
First dose date up to Day 57
Reported as:
Median · days
Time to Clinical Worsening From Baseline Value (Defined by Time to ≥ 1-point Worsening on WHO Ordinal Scale for COVID-19)
daysAsapiprant (BGE-175)Placebo
Time to Clinical Worsening From Baseline Value (Defined by Time to ≥ 1-point Worsening on WHO Ordinal Scale for COVID-19)NA (NA to NA)NA (NA to NA)
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · Log Rank · p = 0.2229
SecondaryProportion of Patients Who Develop Critical COVID-19 Illness

Proportion of patients who develop critical COVID-19 illness as defined by at least one of the following: A. RF defined based on resource utilization requiring at least one of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, ECMO, clinical diagnosis respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) B. Hemodynamic compromise (defined by systolic blood pressure \< 90 mm Hg, or diastolic blood pressure \< 60 mm Hg or requiring vasopressors) C. Multi-organ dysfunction/failure The proportion of participants is represented as a percentage.

Time frame:
First dose date up to Day 57
Reported as:
Count of participants · Participants
Proportion of Patients Who Develop Critical COVID-19 Illness
ParticipantsAsapiprant (BGE-175)Placebo
Proportion of Patients Who Develop Critical COVID-19 Illness3428
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · Regression, Logistic · p = 0.2941 · Odds ratio (or): 1.388 · 95% CI 0.752 to 2.561
SecondaryTime to Clinical Improvement From Baseline Value (Defined by Time to ≥ 1-point Improvement on WHO Ordinal Scale for COVID-19 Score - Must be Maintained Through Day 28)

Kaplan-Meier Estimate of Time to Clinical Improvement from Baseline Value. Time to clinical improvement defined by time to ≥ 1-point improvement on World Health Organization (WHO) Ordinal Scale for COVID-19 - must be maintained through Day 28. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome.

Time frame:
First dose date up to Day 28
Reported as:
Median · days
Time to Clinical Improvement From Baseline Value (Defined by Time to ≥ 1-point Improvement on WHO Ordinal Scale for COVID-19 Score - Must be Maintained Through Day 28)
daysAsapiprant (BGE-175)Placebo
Time to Clinical Improvement From Baseline Value (Defined by Time to ≥ 1-point Improvement on WHO Ordinal Scale for COVID-19 Score - Must be Maintained Through Day 28)8 (6.0 to 10.0)6 (5.0 to 9.0)
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · Log Rank · p = 0.3325
SecondaryMean Change From Baseline in WHO Ordinal Scale for COVID-19 Score

Mean change from baseline in WHO Ordinal Scale for COVID-19 score World Health Organization (WHO) Ordinal Scale for COVID-19. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome.

Time frame:
Day 14/End of Treatment, Day 28, Day 57
Reported as:
Mean · score on a scale
Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score
score on a scaleAsapiprant (BGE-175)Placebo
Change at Day 14-1.2 ± 2.17-1.8 ± 1.76
Change at Day 28-1.2 ± 2.51-1.7 ± 2.11
Change at Day 57-2.7 ± 0.58-2.8 ± 0.42
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.0254 (Change at Day 14) · Mean difference (final values): 0.64 · 95% CI 0.08 to 1.2
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.1109 · Mean difference (final values): 0.53 · 95% CI -0.12 to 1.18
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.8640 · Mean difference (final values): 0.01 · 95% CI -0.10 to 0.12
SecondaryNumber of Patients Who Had Intubation During the Study

Proportion of Patients who had Intubation during the study defined as proportion of patients who had any documented intubation during the study.

Time frame:
First dose date up to Day 57
Reported as:
Count of participants · Participants
Number of Patients Who Had Intubation During the Study
ParticipantsAsapiprant (BGE-175)Placebo
Number of Patients Who Had Intubation During the Study1810
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · Regression, Logistic · p = 0.0919 · Odds ratio (or): 2.046 · 95% CI 0.89 to 4.706
SecondaryDuration of Intubation

Duration of Intubation (first post-dosing intubation)

Time frame:
First dose date up to Day 57
Reported as:
Mean · Days
Duration of Intubation
DaysAsapiprant (BGE-175)Placebo
Duration of Intubation11.8 ± 5.327.8 ± 7.96
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.749 · Mean difference (final values): 3.83 · 95% CI -0.42 to 8.08
SecondaryTime to Discharge From Hospital Intensive Care Unit

Time from intensive care unit admission to the recorded time of intensive care unit discharge

Time frame:
First dose date up to Day 57
Reported as:
Mean · days
Time to Discharge From Hospital Intensive Care Unit
daysAsapiprant (BGE-175)Placebo
Time to Discharge From Hospital Intensive Care Unit15.7 ± 7.6712.1 ± 8.55
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.1769 · Mean difference (final values): 3.69 · 95% CI -1.75 to 9.13
SecondaryNumber of Patients Who Had Supplemental Oxygen Administration

Proportion of patients who had any documented post-dosing supplemental O2 administration during the study.

Time frame:
First dose date up to Day 57
Reported as:
Count of participants · Participants
Number of Patients Who Had Supplemental Oxygen Administration
ParticipantsAsapiprant (BGE-175)Placebo
Number of Patients Who Had Supplemental Oxygen Administration8692
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · Regression, Logistic · p = 0.2621 · Odds ratio (or): 0.54 · 95% CI 0.184 to 1.586
SecondaryDuration of Supplemental Oxygen Administration

Duration of participants receiving supplemental oxygen

Time frame:
First dose date up to Day 57
Reported as:
Mean · days
Duration of Supplemental Oxygen Administration
daysAsapiprant (BGE-175)Placebo
Duration of Supplemental Oxygen Administration14.7 ± 1711.7 ± 14.81
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.2265 · Mean difference (final values): 2.81 · 95% CI -1.76 to 7.37
SecondaryNumber of Patients Who Had Noninvasive Ventilation or High-flow Nasal Cannula O2 Administration

Proportion of patients who had any documented post-dosing noninvasive ventilation or high-flow nasal cannula O2 administration.

Time frame:
First dose date up to Day 57
Reported as:
Count of participants · Participants
Number of Patients Who Had Noninvasive Ventilation or High-flow Nasal Cannula O2 Administration
ParticipantsAsapiprant (BGE-175)Placebo
Number of Patients Who Had Noninvasive Ventilation or High-flow Nasal Cannula O2 Administration2623
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · Regression, Logistic · p = 0.5497 · Odds ratio (or): 1.223 · 95% CI 0.633 to 2.364
SecondaryDuration of Noninvasive Ventilation by Nonrebreather Mask or High-flow Nasal Cannula

Duration of participants receiving noninvasive ventilation by nonrebreather mask or high-flow nasal cannula

Time frame:
First dose date up to Day 57
Reported as:
Mean · days
Duration of Noninvasive Ventilation by Nonrebreather Mask or High-flow Nasal Cannula
daysAsapiprant (BGE-175)Placebo
Duration of Noninvasive Ventilation by Nonrebreather Mask or High-flow Nasal Cannula11.1 ± 13.275.4 ± 7
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.1172 · Mean difference (final values): 4.89 · 95% CI -1.27 to 11.05
SecondaryNumber of Patients Who Had Mechanical Ventilation.

Proportion of patients who had any documented post-dosing mechanical ventilation.

Time frame:
First dose date up to Day 57
Reported as:
Count of participants · Participants
Number of Patients Who Had Mechanical Ventilation.
ParticipantsAsapiprant (BGE-175)Placebo
Number of Patients Who Had Mechanical Ventilation.910
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · Regression, Logistic · p = 0.853 · Odds ratio (or): 0.914 · 95% CI 0.353 to 2.368
SecondaryDuration of Mechanical Ventilation

Duration of participants receiving mechanical ventilation

Time frame:
First dose date up to Day 57
Reported as:
Mean · days
Duration of Mechanical Ventilation
daysAsapiprant (BGE-175)Placebo
Duration of Mechanical Ventilation10.9 ± 4.997.7 ± 4.88
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.1991 · Mean difference (final values): 3.16 · 95% CI -1.86 to 8.18
SecondaryNumber of Patients Who Had Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO.

Proportion of patients who had any documented post-dosing mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO.

Time frame:
First dose date up to Day 57
Reported as:
Count of participants · Participants
Number of Patients Who Had Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO.
ParticipantsAsapiprant (BGE-175)Placebo
Number of Patients Who Had Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO.144
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · Regression, Logistic · p = 0.0166 · Odds ratio (or): 4.103 · 95% CI 1.293 to 13.027
SecondaryDuration of Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO

Duration of participants receiving mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO

Time frame:
First dose date up to Day 57
Reported as:
Mean · days
Duration of Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO
daysAsapiprant (BGE-175)Placebo
Duration of Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO8.7 ± 5.853 ± 1.41
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.1297 · Mean difference (final values): 4.56 · 95% CI -1.51 to 10.64
SecondaryDaily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2)

Daily ratio of participants' oxygen saturation (SpO2) to fractional inspired O2 (SpO2/FiO2)

Time frame:
First dose date up to Day 28
Reported as:
Mean · Ratio SpO2/FiO2
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2)
Ratio SpO2/FiO2Asapiprant (BGE-175)Placebo
Baseline2.9 ± 0.713.0 ± 0.63
Treatment Day 22.7 ± 0.812.9 ± 0.73
Treatment Day 32.5 ± 0.922.8 ± 0.75
Treatment Day 42.3 ± 0.922.7 ± 0.86
Treatment Day 52.3 ± 0.912.6 ± 0.90
Treatment Day 62.3 ± 0.892.5 ± 0.90
Treatment Day 72.5 ± 0.992.6 ± 0.93
Treatment Day 82.4 ± 0.882.7 ± 0.95
Treatment Day 92.3 ± 1.022.8 ± 0.95
Treatment Day 102.3 ± 1.112.9 ± 0.67
Treatment Day 112.4 ± 1.102.8 ± 0.64
Treatment Day 122.2 ± 0.932.9 ± 0.72
Treatment Day 132.2 ± 0.712.8 ± 0.71
Treatment Day 142.2 ± 0.773.0 ± 0.73
Time of Discharge Visit3.1 ± 0.363.2 ± 0.42
Follow up Day 283.2 ± 0.443.0 ± 0.85
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.1916 · Mean difference (final values): -0.14 · 95% CI -0.35 to 0.07
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.1097 · Mean difference (final values): -0.20 · 95% CI -0.44 to 0.05
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.0276 · Mean difference (final values): -0.33 · 95% CI -0.63 to -0.04
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.0463 · Mean difference (final values): -0.36 · 95% CI -0.71 to -0.01
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.0969 · Mean difference (final values): -0.33 · 95% CI -0.71 to 0.06
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.4367 · Mean difference (final values): -0.16 · 95% CI -0.57 to 0.25
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.6685 · Mean difference (final values): -0.10 · 95% CI -0.54 to 0.35
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.2287 · Mean difference (final values): -0.28 · 95% CI -0.73 to 0.18
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.1061 · Mean difference (final values): -0.43 · 95% CI -0.96 to 0.09
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.0415 · Mean difference (final values): -0.54 · 95% CI -1.06 to -0.02
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.1236 · Mean difference (final values): -0.44 · 95% CI -1.00 to 0.12
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.0097 · Mean difference (final values): -0.71 · 95% CI -1.23 to -0.18
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.0157 · Mean difference (final values): -0.57 · 95% CI -1.02 to -0.11
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.0010 · Mean difference (final values): -0.84 · 95% CI -1.32 to -0.36
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.6440 · Mean difference (final values): -0.07 · 95% CI -0.40 to 0.25
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.9869 · Mean difference (final values): -0.00 · 95% CI -0.60 to 0.59
SecondaryTime to Discharge From the Hospital

Length (in days) of the time of hospitalization until medical discharge

Time frame:
First dose date up to Day 57
Reported as:
Mean · days
Time to Discharge From the Hospital
daysAsapiprant (BGE-175)Placebo
Time to Discharge From the Hospital10.8 ± 10.739.1 ± 9.09
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · ANCOVA · p = 0.2399 · Mean difference (final values): 1.69 · 95% CI -1.14 to 4.52
SecondaryNumber of Patients With Re-hospitalization

Proportion of patients who are hospitalized again after the discharge of first hospitalization.

Time frame:
First dose date up to Day 57
Reported as:
Count of participants · Participants
Number of Patients With Re-hospitalization
ParticipantsAsapiprant (BGE-175)Placebo
Number of Patients With Re-hospitalization67
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · Regression, Logistic · p = 0.8081 · Odds ratio (or): 0.869 · 95% CI 0.28 to 2.695
SecondaryProportion of Participants Requiring Intensive Care Unit Admission

Proportion of participants admitted to hospital intensive care unit post randomization. The proportion of participants is represented as a percentage.

Time frame:
First dose date up to Day 57
Reported as:
Count of participants · Participants
Proportion of Participants Requiring Intensive Care Unit Admission
ParticipantsAsapiprant (BGE-175)Placebo
Proportion of Participants Requiring Intensive Care Unit Admission2217
Statistical analysis
  • Asapiprant (BGE-175) vs Placebo · Regression, Logistic · p = 0.3193 · Odds ratio (or): 1.436 · 95% CI 0.704 to 2.929

Adverse events

Collected over From first dose of treatment through Study Day 57. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Asapiprant16/96 (16.7%)34/96 (35.4%)34/96 (35.4%)
Placebo10/98 (10.2%)32/98 (32.7%)32/98 (32.7%)
Most frequent serious events
Showing 10 of 50
Most frequent serious events
EventAsapiprantPlacebo
Respiratory failureRespiratory, thoracic and mediastinal disorders22/9621/98
Septic shockInfections and infestations9/964/98
Acute kidney injuryRenal and urinary disorders5/963/98
Pulmonary embolismRespiratory, thoracic and mediastinal disorders3/964/98
Pulmonary sepsisInfections and infestations3/964/98
Pneumonia bacterialInfections and infestations1/963/98
PneumoniaInfections and infestations2/960/98
Acute myocardial infarctionCardiac disorders2/960/98
Supraventricular tachycardiaCardiac disorders2/960/98
DiarrhoeaGastrointestinal disorders2/960/98
Most frequent other events
Most frequent other events
EventAsapiprantPlacebo
ConstipationGastrointestinal disorders15/9617/98
HyperglycaemiaMetabolism and nutrition disorders2/967/98
HypokalaemiaMetabolism and nutrition disorders1/967/98
HypophosphataemiaMetabolism and nutrition disorders5/963/98
DiarrhoeaGastrointestinal disorders5/961/98
Urinary tract infectionInfections and infestations5/963/98
Atrial fibrillationCardiac disorders5/961/98
PyrexiaGeneral disorders5/960/98
Non-cardiac chest painGeneral disorders0/965/98

Baseline characteristics

The Intent-to-Treat (ITT) Analysis Set includes all randomized participants and was used for baseline characteristics

Age, Customized
Age, Customized(Participants)Asapiprant (BGE-175)PlaceboTotal
Age 50 to less than 757171142
Age greater or equal to 75252752
Sex: Female, Male
Sex: Female, Male(Participants)Asapiprant (BGE-175)PlaceboTotal
Female444387
Male5255107
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Asapiprant (BGE-175)PlaceboTotal
Hispanic or Latino6968137
Not Hispanic or Latino243054
Unknown or Not Reported303
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Asapiprant (BGE-175)PlaceboTotal
Race — American Indian or Alaska Native000
Race — Asian000
Race — Black or African American10717
Race — Native Hawaiian or Other Pacific Islander000
Race — White7885163
Race — Other8614
Race — Not Reported000
Region of Enrollment
Region of Enrollment(Participants)Asapiprant (BGE-175)PlaceboTotal
North America212142
South America7577152
Baseline WHO ordinal scale
Baseline WHO ordinal scale(Participants)Asapiprant (BGE-175)PlaceboTotal
WHO ordinal scale score 312719
WHO ordinal scale score 48291173
WHO ordinal scale score 5202
08

Study locations

26 sites
  • Banner Health
    Mesa, Arizona 85202, United States
  • Velocity Clinical Research, Chula Vista
    Chula Vista, California 91911, United States
  • Long Beach Medical Center
    Long Beach, California 90806, United States
  • UCI Center for Clinical Research
    Orange, California 92868, United States
  • Sharp Memorial Hospital
    San Diego, California 92123, United States
  • North Colorado Medical Center
    Greeley, Colorado 80631, United States
  • Stamford Hospital
    Stamford, Connecticut 06904, United States
  • University of Florida - Health, Jacksonville
    Jacksonville, Florida 32209, United States
  • Baptist Health, Lexington
    Lexington, Kentucky 40503, United States
  • University of Maryland Medical System
    Baltimore, Maryland 21201, United States
  • Jadestone Clinical Research, LLC
    Silver Spring, Maryland 20904, United States
  • Clinica Privada Independencia
    Ciudad Autonoma de Buenos Aires, Buenos Aires C1426ABP, Argentina
  • Sanatorio De La Trinidad Mitre
    Buenos Aires, Buenos Aires F.D. C1039AAO, Argentina
  • Clinica Adventista Belgrano (CAB)
    Buenos Aires, Buenos Aires F.D. C1430EGF, Argentina
  • Hospital Universitário Cassiano Antônio de Moraes
    Vitória, Espírito Santo 29043-260, Brazil
  • Hospital Felicio Rocho (HFR)
    Belo Horizonte, Minas Gerais 30180-080, Brazil
  • Centro de Pesquisa Hospital Ana Nery Santa Cruz do Sul
    Santa Cruz do Sul, Rio Grande Do Sol 96835-090, Brazil
  • Hospital Ernesto Dornelles
    Porto Alegre, Rio Grande do Sul 90160-093, Brazil
  • Clínica Supera Oncologia
    Chapecó, Santa Catarina 89801-355, Brazil
  • Unidade de Pesquisa Clinica da Fundação Pio XII - Hospital de Amor de Barretos
    Barretos, São Paulo 14784-400, Brazil
  • Hospital das Clínicas da Faculdade de Medicina de Botucatu UNESP (HC-FMB/UNESP)
    Botucatu, São Paulo 18618-687, Brazil
  • Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP) - Centro de Pesquisa São Lucas
    Campinas, São Paulo 13060-904, Brazil
  • Fundação Faculdade Regional de Medicina de São José do Rio Preto
    São José do Rio Preto, São Paulo 15090-000, Brazil
  • Conjunto Hospitalar de Mandaqui
    São Paulo, São Paulo 02432, Brazil
  • Clinica de Alergia Martti Antila
    Sorocaba, São Paulo 18040-425, Brazil
  • Instituto Nacional de Infectologia Evandro Chagas / Fundação Oswaldo Cruz (FIOCRUZ)
    Rio de Janeiro, 21040-360, Brazil
09

References and documents

Study documents

  • Study protocol · Sep 7, 2021
  • Statistical analysis plan · Jun 1, 2022

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

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04705597
Lead sponsor
BioAge Labs, Inc.
Responsible party
Sponsor
First posted
Jan 12, 2021
Start date
Mar 18, 2021
Primary completion
Apr 20, 2022
Completion
May 19, 2022
Results posted
Jul 3, 2023
Last update
Jul 3, 2023

Study contacts

Richard G Wilkerson, MD
principal investigator · University of Maryland, Baltimore

Oversight

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

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