A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients

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• Infections 6,688
• COVID-19 7,638
• Coronavirus Infections 928
• Severe Acute Respiratory Syndrome 382
• Syndrome 9,221

Keywords

• Coronavirus disease
• Severe acute respiratory syndrome coronavirus 2
• SARS-CoV-2
• COVID-19
• Asymptomatic

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 465 is above the median of 120 across 4,201 interventional studies indexed under Infections.

Lead sponsor

Grifols Therapeutics LLC is the lead sponsor of 43 studies on the registry; 4 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Study arms

• Experimental
  C19-IG 20% 1 g

  Participants will receive 1 gram (g) of C19-IG 20% subcutaneous (SC) infusion containing one syringe of 5 milliliters (mL) C19-IG 20% plus one syringe of 5 mL sterile 0.9% sodium chloride (NaCl) on Day 1.

  Biological: C19-IG 20% · Drug: 0.9% Sodium chloride

• Experimental
  C19-IG 20% 2 g

  Participants will receive 2 g of C19-IG 20% SC infusion containing two syringes 5 mL each of C19-IG 20% on Day 1.

  Biological: C19-IG 20%

• Placebo comparator
  Placebo

  Participants will receive C19-IG 20% matching placebo as SC infusion containing two syringes of 5 mL each sterile 0.9% NaCl injection on Day 1.

  Drug: 0.9% Sodium chloride

Interventions

• BiologicalC19-IG 20%

  Anti-COVID-19 Immune Globulin (Human) 20%

• Drug0.9% Sodium chloride

  C19-IG 20% matching placebo

Primary outcomes

1. Percentage of Asymptomatic Participants Who Remained Asymptomatic, i.e., Who Did Not Develop Symptomatic COVID-19 Through Day 14

   Participants were described as symptomatic if they a. experienced at least two of the following systemic symptoms: fever (≥38 ºC), chills, myalgia, headache, sore throat, cough, fatigue that interferes with activities of daily living, new olfactory/taste disorder(s), and vomiting/diarrhea, b. experienced at least one of the following respiratory signs/symptoms: new or worsening shortness of breath or difficulty breathing; c. experienced a peripheral oxygen saturation by pulse oximetry (SpO2) \<94% on room air; or d. had radiographical evidence of pneumonia. The percentage of participants who meet the primary endpoint within each treatment group was presented along with a two-sided exact (Clopper-Pearson) 95% confidence interval (CI).

   Time frame: Up to Day 14

Secondary outcomes

1. Change From Baseline in SARS-CoV-2 Viral Load (log10 Copies/mL)

   Mean change from baseline (CFB) in log10 SARS-CoV-2 viral load at Days 7 and 14 was assessed.

   Time frame: Baseline to Day 7 and Day 14

2. Percentage of Participants Who Remained in an Outpatient Setting and Maintained SpO2 ≥94% on Room Air on Day 3, Day 7, and Day 14

   An outpatient setting was defined as no hospitalization or intensive care unit (ICU) admission through Days 3, 7, and 14. The percentage of participants who remained in an outpatient setting and maintained SpO2 ≥94% on room air at each timepoint within each treatment group were presented along with a two-sided exact (Clopper-Pearson) 95% CI. p-value and 95% CI were not estimable for C19-IG 20% 1 g vs placebo as all participants had remained in an outpatient setting and maintained SpO2 ≥94% on Room Air in C19-IG 20% 1 g and placebo arm on Day 3.

   Time frame: Day 3, Day 7, and Day 14

3. Percentage of Participants Negative for SARS-CoV-2 by Polymerase Chain Reaction (PCR) Test at Multiple Timepoints Through Day 14 and Through Day 29

   The percentage of participants with negative SARS-CoV-2 by PCR through Day 14 and Day 29 within each treatment group was presented along with a two-sided exact (Clopper-Pearson) 95% CI.

   Time frame: Day 3, Day 7, Day 14, and Day 29

4. Time to Negative SARS-CoV-2 PCR From Baseline Through Day 29

   The first negative test result was defined as the first PCR negative result after the first PCR positive result. Kaplan-Meier method was used for analysis. Participants who did not have any viral load data or had negative test results through the study were excluded from the KM analysis.

   Time frame: Baseline to Day 29

5. Percentage of Participants Who Required Oxygen (O2) Supplementation on or Before Day 29

   The percentage of participants requiring oxygen supplementation through Day 29 within each treatment group was presented along with a two-sided exact (Clopper-Pearson) 95% CI.

   Time frame: Up to Day 29

6. Duration of Any Oxygen Use Through Day 29

   The duration (number of days) of any oxygen use from Day 1 through Day 29 was calculated based on the start/stop date of using oxygen supplementation.

   Time frame: Up to Day 29

7. Absolute Value Score on a 7-point Ordinal Scale

   The ordinal scale is a 7-point scale ranging from 1 to 7 used to measure clinical status of a participant based on the following points: 1) death; 2) hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) hospitalized, requiring supplemental oxygen; 5) hospitalized, not requiring supplemental oxygen; 6) not hospitalized, limitation on activities; and 7) not hospitalized, no limitations on activities. A higher score indicates less severity.

   Time frame: Baseline, Day 7, 14, and 29

8. Mean Change From Baseline in the 7-point Ordinal Scale

   The ordinal scale is a 7-point scale ranging from 1 to 7 used to measure clinical status of a participant based on the following points: 1) death; 2) hospitalized, on invasive mechanical ventilation or ECMO; 3) hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) hospitalized, requiring supplemental oxygen; 5) hospitalized, not requiring supplemental oxygen; 6) not hospitalized, limitation on activities; and 7) not hospitalized, no limitations on activities. A higher score indicates less severity. The analysis was performed by using a linear mixed-effects model for repeated measures (MMRM).

   Time frame: Baseline to Day 7, Day 14, and Day 29

9. Percentage of Participants in Each Severity Category of the 7-point Ordinal Scale

   The ordinal scale is a 7-point scale ranging from 1 to 7 used to measure clinical status of a participant based on the following points: 1) death; 2) hospitalized, on invasive mechanical ventilation or ECMO; 3) hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) hospitalized, requiring supplemental oxygen; 5) hospitalized, not requiring supplemental oxygen; 6) not hospitalized, limitation on activities; and 7) not hospitalized, no limitations on activities.

   Time frame: Days 1, 7, 14, and 29

10. Change From Baseline in National Early Warning Score (NEWS)

    The NEWS has demonstrated an ability to classify participants at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure (BP), heart rate, level of consciousness \[Alert, Voice, Pain, Unresponsive\]). A score of 0 to 3 was allocated to each parameter except supplemental oxygen use (score of 0 or 2) and level of consciousness (score of 0 \[alert, normal health condition\] or 3 \[altered mental state/confusion, worst health condition\]). All parameter scores were summed to get an aggregate NEWS assessment. Scoring for NEWS ranges from 0 to 20, with higher scores meaning more severity/higher clinical risk: low risk (score 1 to 4); medium risk (score 5 to 6); high risk (score 7 to 20). The analysis is performed by using a linear MMRM.

    Time frame: Baseline to Day 7, Day 14, and Day 29

11. Percentage of Participants Who Required At Least One COVID-19 Related Medically Attended Visit (MAV) for Management/Treatment of COVID-19 Which May Have Occurred in Any Setting Through Day 29

    MAV for management/treatment of COVID-19 may have occurred in any setting e.g., emergency department, urgent care, outpatient clinic, or professional setting wherein direct in-person/telemedicine medical assessment and escalation of care for COVID-19 was provided by licensed healthcare personnel. The percentage of participants requiring at least one COVID-19-related MAV for management/treatment of COVID-19 (apart from routinely scheduled study-directed visits) within each treatment group was presented along with a two-sided exact (Clopper-Pearson) 95% CI.

    Time frame: Up to Day 29

12. Percentage of Participants Who Required Hospital Admission for Medical Care (Non-Quarantine Purposes) Through Day 29

    The percentage of participants requiring hospital admission through Day 29 within each treatment group was presented along with a two-sided exact (Clopper-Pearson) 95% CI.

    Time frame: Up to Day 29

13. Duration of Hospital Stay Through Day 29

    The duration (number of days) of hospitalization from post-randomization through Day 29 was calculated based on hospital admission and discharge dates recorded.

    Time frame: Up to Day 29

14. Percentage of Participants Who Required Intensive Care Unit (ICU) Admission or Initiation of ICU Level Care Through Day 29

    The percentage of participants requiring ICU admission through Day 29 within each treatment group was presented along with a two-sided exact (Clopper-Pearson) 95% CI. ICU level care is defined as the medical need for intensive or invasive monitoring; the immediate or impending need for the support of the airway, breathing, or circulation; and/or stabilization of acute severe, or life-threatening complications of COVID-19.

    Time frame: Up to Day 29

15. Duration of ICU Stay Through Day 29

    The duration (number of days) of ICU stay from post-randomization through Day 29 was calculated based on ICU admission and discharge dates recorded.

    Time frame: Up to Day 29

16. Percentage of Participants Requiring Invasive Mechanical Ventilation Through Day 29

    The percentage of participants requiring invasive mechanical ventilation through Day 29 within each treatment group was presented along with a two-sided exact (Clopper-Pearson) 95% CI.

    Time frame: Up to Day 29

17. Duration of Invasive Mechanical Ventilation Through Day 29

    The duration (number of days) on invasive mechanical ventilation from post randomization through Day 29 was calculated based on the start/stop dates of invasive mechanical ventilation.

    Time frame: Up to Day 29

18. All-Cause Mortality Through Day 29

    All-cause mortality rate is the percentage of participants in each treatment group who experienced mortality up to Day 29.

    Time frame: Up to Day 29

19. Percentage of Participants With Critical COVID-19 Illness

    Critical COVID-19 illness was defined as any one of the following: (a) requiring ICU admission or ICU level of care, (b) invasive mechanical ventilation, or (c) resulting in death by Day 29. The percentage of participants with critical COVID-19 illness defined above within each treatment group was presented along with a two-sided exact (Clopper-Pearson) 95% CI.

    Time frame: Up to Day 29

20. Length of Time to Clinical Progression to Critical COVID-19 Illness Through Day 29

    Length of time to clinical progression to critical COVID-19 illness was defined as the time to death, invasive mechanical ventilation, or ICU admission/requiring ICU level of care. ICU level care is defined as the medical need for intensive or invasive monitoring; the immediate or impending need for the support of the airway, breathing, or circulation; and/or stabilization of acute severe, or life-threatening complications of COVID-19. The time to clinical progression was estimated using the KM method.

    Time frame: Up to Day 29

21. Time to COVID-19 Symptoms Through Day 14

    Participants were described as symptomatic if they a. experienced at least two of the following systemic symptoms: fever (≥38℃), chills, myalgia, headache, sore throat, cough, fatigue that interferes with activities of daily living, new olfactory/taste disorder(s), and vomiting/diarrhea, b. experienced at least one of the following respiratory signs/symptoms: new or worsening shortness of breath or difficulty breathing, c. experienced a peripheral oxygen saturation by pulse oximetry (SpO2) \<94% on room air, or d. had radiographical evidence of pneumonia. Time to COVID-19 symptoms was defined as the time from study drug administration to the first time point when any of the above elements was fulfilled through Day 14. The time to COVID-19 symptoms was estimated using the KM method.

    Time frame: Up to Day 14

Baseline characteristics

Study documents

• Study protocol · Oct 13, 2021
• Statistical analysis plan · Dec 6, 2021

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

Individual participant data

Plan to share: No