COVID-19
Conditions
Brief 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.
Interventions
DRUGBamlanivimab
Administered IV.
DRUGEtesevimab
Administered IV.
DRUGPlacebo
Administered IV.
DRUGVIR-7831
Administered IV.
DRUGBebtelovimab
Administered IV.
Sponsors
AbCellera Biologics Inc.
Shanghai Junshi Bioscience Co., Ltd.
GlaxoSmithKline
Vir Biotechnology, Inc.
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Includes open label arms
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 7 | 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. |
| Treatment 7-8, Amendments (C-e): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | 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). |
| Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | 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). |
| Addendum (4) Arm B - Subcutaneous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | 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). |
| Pharmacokinetics (PK): Mean Concentration of Etesevimab | Day 29 | Pharmacokinetics (PK): Mean Concentration of Etesevimab |
| Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | Baseline through Day 29 | Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from any Cause |
| Treatment 7-8, Amendment (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | Baseline through Day 29 | Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from Any Cause |
| Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | Baseline through Day 29 | Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause |
| Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | Baseline through Day 29 | Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause |
| Treatment 14 Amendment (f) High Risk Participants, Updated CDC Criteria: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | Baseline through Day 29 | Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause |
| Treatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | Baseline, Day 7 | 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. |
| Treatment 7-8 Amendments (C-e): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | Baseline, Day 7 | 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. |
| Pharmacokinetics (PK): Mean Concentration of Bebtelovimab | Day 29 | Pharmacokinetics (PK): Mean Concentration of Bebtelovimab |
| Treatment 9-11 Amendment (f), Low Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | Baseline, Day 7 | 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. |
| Treatment 12 -13 Amendment (f), High Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | Baseline, Day 7 | 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. |
| Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | Baseline, Day 7 | 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. |
| Addendum 4, IV: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | Baseline, Day 7 | 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. |
| Addendum 4, SC: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | Baseline, Day 7 | 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. |
| Addendum (2): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | Baseline, Day 7 | 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. |
| Treatment 12 -13, Amendment (f) High Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | 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). |
| Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution | Day 7 | 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. |
| Treatment 7-8 Amendments (C-e): Percentage of Participants Demonstrating Symptom Resolution | Day 7 | 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. |
| Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Resolution | Day 7 | 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. |
| Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Resolution | Day 7 | 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. |
| Treatment 14, Amendment (g) High Risk Participants Updated CDC Criteria Amendment (g): Percentage of Participants Demonstrating Symptom Resolution | Day 7 | 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. |
| Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement | Day 7 | 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. |
| Treatment 7-8 Amendments (C-E): Percentage of Participants Demonstrating Symptom Improvement | Day 7 | 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. |
| Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Improvement | Day 7 | 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. |
| Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Improvement | Day 7 | 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. |
| Treatment 14 Amendment (g): Percentage of Participants Demonstrating Symptom Improvement | Day 7 | 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. |
| 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 | Baseline through Day 29 | Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause |
| 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 | Baseline through Day 29 | Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause |
| 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 | Baseline through Day 29 | Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause |
| 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 | Baseline through Day 29 | Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause |
| Treatment 14 Amendment (g): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause | Baseline through Day 29 | Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause |
| Pharmacokinetics (PK): Mean Concentration of Bamlanivimab | Day 29 | PK: Mean Concentration of Bamlanivimab |
| Pharmacokinetics (PK): Mean Concentration of VIR-7831 | Day 29 | PK: Mean Concentration of VIR-7831 |
| Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | Day 7 | 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). |
| Addendum (2): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 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. |
Countries
Argentina, Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment 1: Pbo Participants received placebo (Pbo) administered intravenously (IV). | 155 |
| Treatment 2: 175 mg BAM +350 mg ETE Participants received 175 milligrams (mg) bamlanivimab (BAM) +350 mg etesevimab (ETE) administered IV. | 83 |
| Treatment 3: 700 mg BAM +1400 mg ETE Participants received 700 mg BAM +1400 mg ETE administered IV. | 158 |
| Treatment 4: 2800 mg BAM +2800 mg ETE Participants received 2800 mg BAM + 2800 mg ETE administered IV. | 103 |
| Treatment 5: 700 mg BAM Participants received 700 mg BAM administered IV. | 105 |
| Treatment 6: 350 mg BAM +700 mg ETE Participants received 350 mg BAM +700 mg ETE administered IV. | 101 |
| Unintentional Dosing: 700 mg Bamlanivimab +700 mg Etesevimab Participants received 700 mg bamlanivimab +700 mg etesevimab administered IV. | 20 |
| Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Participants received 700 mg BAM + 500 mg VIR-7831 administered IV. | 101 |
| Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) Participants received placebo administered IV. | 101 |
| Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) Amendment (f) Low Risk Participants:
Participants received 175 mg BEB administered IV. | 125 |
| Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) Amendment (f) Low Risk Participants:
Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV | 127 |
| Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) Amendment (f) Low Risk Participants:
Participants received placebo administered IV. | 128 |
| Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) Amendment (f) High Risk Participants:
Participants received 175 mg BEB administered IV. | 100 |
| Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants) Amendment (f) High Risk Participants:
Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV. | 50 |
| Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g), Updated CDC Criteria) Participants received 700 mg BAM +1400 mg ETE + 175 mg BEB administered IV for participants in updated CDC criteria. | 176 |
| 700 mg BAM 15-min (Addendum (2)) Participants received 700 mg BAM administered IV.
Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE. | 30 |
| 700 mg BAM + 1400 mg ETE 30-min (Addendum (2)) Participants received 700 mg BAM +1400 mg ETE administered IV.
Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE. | 6 |
| 700 mg BAM + 1400 mg ETE 15-min (Addendum (2)) Participants received 700 mg BAM +1400 mg ETE administered IV.
Addendum 2 explored the safety of accelerated intravenous (IV) administration of BAM alone and in combination with ETE. | 30 |
| Pooled Placebo (Addendum 4, IV) Participants received placebo administered IV. | 10 |
| 70 mg BEB 140 mg/Min (Addendum 4, IV) Participants received 70 mg BEB 140 mg/min IV. | 6 |
| 175 mg BEB 140 mg/Min (Addendum 4, IV) Participants received 175 mg BEB 140 mg/min IV. | 6 |
| 175 mg BEB 350 mg/Min (Addendum 4, IV) Participants received 175 mg BEB 350 mg/min IV. | 6 |
| 175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV) Participants received 175 mg BAM + 700 mg ETE + 1400 mg BEB 350 mg/min IV. | 6 |
| 1750 mg BEB 350 mg/Min (Addendum 4, IV) Participants received 1750 mg BEB 350 mg/min IV. | 6 |
| Pooled Placebo (Addendum 4, SC) Participants received Placebo SC. | 4 |
| 280 BEB (Addendum 4, SC) Participants received 280 mg BEB SC. | 6 |
| 560 mg BEB (Addendum 4, SC) Participants received 560 mg BEB SC. | 6 |
| Total | 1,755 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 | FG023 | FG024 | FG025 | FG026 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 3 | 1 | 1 | 3 | 1 | 1 | 1 | 3 | 3 | 11 | 8 | 15 | 3 | 2 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Other - As reported by Investigator | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 4 | 0 | 1 | 2 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 | 6 | 4 | 2 | 0 | 0 | 2 | 3 | 2 | 3 | 2 | 2 | 1 | 5 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Treatment 1: Pbo | Total | 560 mg BEB (Addendum 4, SC) | 280 BEB (Addendum 4, SC) | Pooled Placebo (Addendum 4, SC) | 1750 mg BEB 350 mg/Min (Addendum 4, IV) | 175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV) | 175 mg BEB 350 mg/Min (Addendum 4, IV) | 175 mg BEB 140 mg/Min (Addendum 4, IV) | 70 mg BEB 140 mg/Min (Addendum 4, IV) | Pooled Placebo (Addendum 4, IV) | 700 mg BAM + 1400 mg ETE 15-min (Addendum (2)) | 700 mg BAM + 1400 mg ETE 30-min (Addendum (2)) | 700 mg BAM 15-min (Addendum (2)) | Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB (Amendment (g), Updated CDC Criteria) | Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants) | Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) | Treatment 11: Pbo For 175 mg BEB & 700 mg BAM +1400 mg ETE +175 mg BEB (Low Risk Participants) | Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) | Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) | Treatment 8: Pbo For 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) | Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) | Unintentional Dosing: 700 mg Bamlanivimab +700 mg Etesevimab | Treatment 6: 350 mg BAM +700 mg ETE | Treatment 5: 700 mg BAM | Treatment 4: 2800 mg BAM +2800 mg ETE | Treatment 3: 700 mg BAM +1400 mg ETE | Treatment 2: 175 mg BAM +350 mg ETE |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 38.9 years STANDARD_DEVIATION 12.22 | 40.6 years STANDARD_DEVIATION 13.89 | 39.2 years STANDARD_DEVIATION 9.7 | 35.8 years STANDARD_DEVIATION 7.08 | 30.0 years STANDARD_DEVIATION 6.98 | 39.5 years STANDARD_DEVIATION 16.88 | 41.7 years STANDARD_DEVIATION 14.76 | 36.3 years STANDARD_DEVIATION 15.24 | 48.7 years STANDARD_DEVIATION 9.83 | 35.2 years STANDARD_DEVIATION 13.99 | 46.8 years STANDARD_DEVIATION 13.27 | 42.9 years STANDARD_DEVIATION 11.87 | 47.7 years STANDARD_DEVIATION 7.28 | 35.4 years STANDARD_DEVIATION 12.55 | 49.3 years STANDARD_DEVIATION 17.39 | 50.8 years STANDARD_DEVIATION 17.06 | 49.1 years STANDARD_DEVIATION 15.17 | 36.1 years STANDARD_DEVIATION 11.66 | 37.6 years STANDARD_DEVIATION 12.12 | 36.2 years STANDARD_DEVIATION 11.4 | 38.9 years STANDARD_DEVIATION 11.77 | 37.6 years STANDARD_DEVIATION 12.83 | 36.5 years STANDARD_DEVIATION 15.04 | 42.3 years STANDARD_DEVIATION 11.93 | 39.8 years STANDARD_DEVIATION 12.7 | 39.5 years STANDARD_DEVIATION 12.63 | 37.7 years STANDARD_DEVIATION 12.11 | 41.5 years STANDARD_DEVIATION 12.89 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 48 Participants | 497 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants | 1 Participants | 15 Participants | 49 Participants | 8 Participants | 19 Participants | 45 Participants | 45 Participants | 46 Participants | 27 Participants | 18 Participants | 3 Participants | 33 Participants | 28 Participants | 28 Participants | 47 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 104 Participants | 1228 Participants | 4 Participants | 2 Participants | 4 Participants | 4 Participants | 5 Participants | 5 Participants | 6 Participants | 6 Participants | 6 Participants | 26 Participants | 5 Participants | 15 Participants | 126 Participants | 42 Participants | 81 Participants | 83 Participants | 82 Participants | 78 Participants | 72 Participants | 80 Participants | 17 Participants | 66 Participants | 74 Participants | 70 Participants | 108 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 30 Participants | 0 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants | 0 Participants | 2 Participants | 3 Participants | 5 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 13 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 60 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 4 Participants | 1 Participants | 1 Participants | 4 Participants | 0 Participants | 4 Participants | 9 Participants | 3 Participants | 13 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 185 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 28 Participants | 13 Participants | 14 Participants | 29 Participants | 19 Participants | 19 Participants | 5 Participants | 15 Participants | 2 Participants | 7 Participants | 4 Participants | 7 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 8 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 8 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 71 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 3 Participants | 0 Participants | 6 Participants | 5 Participants | 8 Participants | 4 Participants | 4 Participants | 1 Participants | 5 Participants | 5 Participants | 2 Participants | 7 Participants | 6 Participants |
| Race (NIH/OMB) White | 132 Participants | 1410 Participants | 5 Participants | 5 Participants | 4 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 9 Participants | 27 Participants | 3 Participants | 27 Participants | 136 Participants | 32 Participants | 78 Participants | 90 Participants | 99 Participants | 97 Participants | 90 Participants | 74 Participants | 17 Participants | 84 Participants | 85 Participants | 91 Participants | 127 Participants | 68 Participants |
| Region of Enrollment United States | 155 Participants | 1755 Participants | 6 Participants | 6 Participants | 4 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 10 Participants | 30 Participants | 6 Participants | 30 Participants | 176 Participants | 50 Participants | 100 Participants | 128 Participants | 127 Participants | 125 Participants | 101 Participants | 101 Participants | 20 Participants | 101 Participants | 105 Participants | 103 Participants | 158 Participants | 83 Participants |
| Sex: Female, Male Female | 75 Participants | 909 Participants | 2 Participants | 1 Participants | 1 Participants | 5 Participants | 3 Participants | 1 Participants | 6 Participants | 3 Participants | 3 Participants | 13 Participants | 3 Participants | 12 Participants | 98 Participants | 26 Participants | 52 Participants | 72 Participants | 76 Participants | 63 Participants | 56 Participants | 52 Participants | 8 Participants | 48 Participants | 50 Participants | 55 Participants | 86 Participants | 39 Participants |
| Sex: Female, Male Male | 80 Participants | 846 Participants | 4 Participants | 5 Participants | 3 Participants | 1 Participants | 3 Participants | 5 Participants | 0 Participants | 3 Participants | 7 Participants | 17 Participants | 3 Participants | 18 Participants | 78 Participants | 24 Participants | 48 Participants | 56 Participants | 51 Participants | 62 Participants | 45 Participants | 49 Participants | 12 Participants | 53 Participants | 55 Participants | 48 Participants | 72 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 155 | 0 / 83 | 0 / 158 | 0 / 103 | 0 / 105 | 0 / 101 | 0 / 20 | 0 / 101 | 0 / 101 | 0 / 125 | 1 / 127 | 0 / 128 | 1 / 100 | 0 / 50 | 0 / 176 | 0 / 30 | 0 / 6 | 0 / 30 | 0 / 10 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 4 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 16 / 155 | 14 / 83 | 13 / 158 | 9 / 103 | 12 / 105 | 7 / 101 | 4 / 20 | 6 / 101 | 10 / 101 | 11 / 125 | 15 / 127 | 10 / 128 | 19 / 100 | 7 / 50 | 20 / 176 | 3 / 30 | 0 / 6 | 2 / 30 | 1 / 10 | 0 / 6 | 2 / 6 | 0 / 6 | 1 / 6 | 1 / 6 | 1 / 4 | 2 / 6 | 1 / 6 |
| serious Total, serious adverse events | 0 / 155 | 0 / 83 | 1 / 158 | 0 / 103 | 0 / 105 | 2 / 101 | 1 / 20 | 0 / 101 | 0 / 101 | 0 / 125 | 1 / 127 | 0 / 128 | 3 / 100 | 2 / 50 | 2 / 176 | 0 / 30 | 0 / 6 | 1 / 30 | 0 / 10 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 4 | 0 / 6 | 0 / 6 |
Outcome results
Primary
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
Population: Treatment 1-6 and Unintentional Dosing arms: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | 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 | 27.7 percentage of participants |
| Treatment 2: 175 mg BAM +350 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 5.27 | 12.2 percentage of participants |
| Treatment 3: 700 mg BAM +1400 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 5.27 | 10.8 percentage of participants |
| Treatment 4: 2800 mg BAM +2800 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 5.27 | 7.8 percentage of participants |
| Treatment 5: 700 mg BAM | 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 | 14.3 percentage of participants |
| Treatment 6: 350 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 5.27 | 7.9 percentage of participants |
| Unintentional 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 5.27 | 10.0 percentage of participants |
p-value: 0.00927395% CI: [0.18, 0.78]Regression, Logistic
p-value: 0.00027195% CI: [0.18, 0.59]Regression, Logistic
p-value: 0.00025795% CI: [0.1, 0.51]Regression, Logistic
p-value: 0.01337895% CI: [0.23, 0.84]Regression, Logistic
p-value: 0.00031895% CI: [0.11, 0.52]Regression, Logistic
p-value: 0.14056395% CI: [0.09, 1.41]Regression, Logistic
Primary
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
Population: Treatment 7-8, Amendments (C-e): All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 7-8, Amendments (C-e): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 9.9 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | Treatment 7-8, Amendments (C-e): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 29.7 percentage of participants |
p-value: 0.00083595% CI: [0.12, 0.58]Regression, Logistic
Primary
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
Population: Treatment 9-11 Amendment (f), Low Risk Participants: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 12.0 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 12.7 percentage of participants |
| Treatment 3: 700 mg BAM +1400 mg ETE | Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 19.8 percentage of participants |
p-value: 0.09723195% CI: [0.28, 1.11]Regression, Logistic
p-value: 0.1323695% CI: [0.3, 1.17]Regression, Logistic
Secondary
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
Population: Addendum (2): All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1: Pbo | Addendum (2): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -2.65 unitless | Standard Deviation 2.394 |
| Treatment 2: 175 mg BAM +350 mg ETE | Addendum (2): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -4.90 unitless | Standard Deviation 1.999 |
| Treatment 3: 700 mg BAM +1400 mg ETE | Addendum (2): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -4.37 unitless | Standard Deviation 2.128 |
Secondary
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
Population: Addendum (2): All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Addendum (2): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 16.7 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | Addendum (2): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 0.0 percentage of participants |
| Treatment 3: 700 mg BAM +1400 mg ETE | Addendum (2): Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 13.3 percentage of participants |
Secondary
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
Population: Addendum (4) Arm A - Intravenous: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 40.0 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 16.7 percentage of participants |
| Treatment 3: 700 mg BAM +1400 mg ETE | Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 50.0 percentage of participants |
| Treatment 4: 2800 mg BAM +2800 mg ETE | Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 0.0 percentage of participants |
| Treatment 5: 700 mg BAM | Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 16.7 percentage of participants |
| Treatment 6: 350 mg BAM +700 mg ETE | Addendum (4), Arm A - Intravenous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 33.3 percentage of participants |
Secondary
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
Population: Addendum (4) Arm B - Subcutaneous: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Addendum (4) Arm B - Subcutaneous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 25.0 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | Addendum (4) Arm B - Subcutaneous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 16.7 percentage of participants |
| Treatment 3: 700 mg BAM +1400 mg ETE | Addendum (4) Arm B - Subcutaneous: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 0.0 percentage of participants |
Secondary
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
Population: Addendum 4, IV: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1: Pbo | Addendum 4, IV: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -4.27 unitless | Standard Deviation 3.087 |
| Treatment 2: 175 mg BAM +350 mg ETE | Addendum 4, IV: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -4.39 unitless | Standard Deviation 2.334 |
| Treatment 3: 700 mg BAM +1400 mg ETE | Addendum 4, IV: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -4.40 unitless | Standard Deviation 3.188 |
| Treatment 4: 2800 mg BAM +2800 mg ETE | Addendum 4, IV: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -4.49 unitless | Standard Deviation 1.925 |
| Treatment 5: 700 mg BAM | Addendum 4, IV: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -6.35 unitless | Standard Deviation 1.502 |
| Treatment 6: 350 mg BAM +700 mg ETE | Addendum 4, IV: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -4.76 unitless | Standard Deviation 2.217 |
Secondary
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
Population: Addendum 4, SC: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1: Pbo | Addendum 4, SC: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -3.47 unitless | Standard Deviation 3.934 |
| Treatment 2: 175 mg BAM +350 mg ETE | Addendum 4, SC: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -4.04 unitless | Standard Deviation 2.114 |
| Treatment 3: 700 mg BAM +1400 mg ETE | Addendum 4, SC: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -3.40 unitless | Standard Deviation 1.9 |
Secondary
Pharmacokinetics (PK): Mean Concentration of Bamlanivimab
PK: Mean Concentration of Bamlanivimab
Time frame: Day 29
Population: All randomized participants who received 700 mg BAM and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1: Pbo | Pharmacokinetics (PK): Mean Concentration of Bamlanivimab | 30.0 Microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 36.4 |
Secondary
Pharmacokinetics (PK): Mean Concentration of Bebtelovimab
Pharmacokinetics (PK): Mean Concentration of Bebtelovimab
Time frame: Day 29
Population: All randomized participants who received 175 mg BEB and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1: Pbo | Pharmacokinetics (PK): Mean Concentration of Bebtelovimab | 4.18 µg/mL | Geometric Coefficient of Variation 80.4 |
Secondary
Pharmacokinetics (PK): Mean Concentration of Etesevimab
Pharmacokinetics (PK): Mean Concentration of Etesevimab
Time frame: Day 29
Population: All randomized participants who received 1400 ETE and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1: Pbo | Pharmacokinetics (PK): Mean Concentration of Etesevimab | 105 µg/mL | Geometric Coefficient of Variation 36 |
Secondary
Pharmacokinetics (PK): Mean Concentration of VIR-7831
PK: Mean Concentration of VIR-7831
Time frame: Day 29
Population: All randomized participants who received 500 mg VIR-7831 and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1: Pbo | Pharmacokinetics (PK): Mean Concentration of VIR-7831 | 46.3 µg/mL | Geometric Coefficient of Variation 47.4 |
Secondary
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
Population: Treatment 12 -13 Amendment (f), High Risk Participants: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1: Pbo | Treatment 12 -13 Amendment (f), High Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -3.22 unitless | Standard Deviation 2.585 |
| Treatment 2: 175 mg BAM +350 mg ETE | Treatment 12 -13 Amendment (f), High Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -3.43 unitless | Standard Deviation 2.835 |
Secondary
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
Population: Treatment 12 -13 Amendment (f), High Risk Participants: All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Improvement values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Improvement | 42.4 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Improvement | 42.0 percentage of participants |
Secondary
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
Population: Treatment 12 -13 Amendment (f), High Risk Participants: All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Resolution values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Resolution | 50.5 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Demonstrating Symptom Resolution | 52.0 percentage of participants |
Secondary
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
Population: Treatment 12 -13 Amendment (f), High Risk Participants: All participants randomly assigned and who received any amount of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | 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 | 6.0 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | 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 | 6.0 percentage of participants |
Secondary
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
Population: Treatment 12 -13 Amendment (f), High Risk Participants: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | 3.0 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | 4.0 percentage of participants |
Secondary
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
Population: Treatment 12 -13, Amendment (f) High Risk Participants: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 12 -13, Amendment (f) High Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 25.3 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | Treatment 12 -13, Amendment (f) High Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 12.0 percentage of participants |
Secondary
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
Population: Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1: Pbo | Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -4.00 unitless | Standard Error 2.514 |
Secondary
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
Population: Treatment 14 Amendment (f) High Risk, Participants Updated CDC Criteria: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 14 Amendment (f) High Risk Participants, Updated CDC Criteria: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | 1.7 percentage of participants |
Secondary
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
Population: Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 14, Amendment (f) High Risk Participants Updated CDC Criteria: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 | 17.6 percentage of participants |
Secondary
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
Population: Treatment 14, Amendment (g) High Risk Participants Updated CDC Criteria Amendment (g): All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Resolution values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 14, Amendment (g) High Risk Participants Updated CDC Criteria Amendment (g): Percentage of Participants Demonstrating Symptom Resolution | 47.2 percentage of participants |
Secondary
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
Population: Treatment 14 Amendment (g): All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Improvement values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 14 Amendment (g): Percentage of Participants Demonstrating Symptom Improvement | 38.6 percentage of participants |
Secondary
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
Population: Treatment 14 Amendment (g): All participants randomly assigned and who received any amount of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 14 Amendment (g): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause | 2.3 percentage of participants |
Secondary
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
Population: Treatment 1-6 and Unintentional Dosing Arms: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1: Pbo | Treatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -2.87 unitless | Standard Error 0.149 |
| Treatment 2: 175 mg BAM +350 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -3.54 unitless | Standard Error 0.207 |
| Treatment 3: 700 mg BAM +1400 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -3.52 unitless | Standard Error 0.148 |
| Treatment 4: 2800 mg BAM +2800 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -3.13 unitless | Standard Error 0.181 |
| Treatment 5: 700 mg BAM | Treatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -3.28 unitless | Standard Error 0.18 |
| Treatment 6: 350 mg BAM +700 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -3.74 unitless | Standard Error 0.191 |
| Unintentional Dosing: 700 mg BAM +700 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -3.51 unitless | Standard Error 0.419 |
p-value: 0.00995% CI: [-1.17, -0.17]Mixed Models Analysis
p-value: 0.00295% CI: [-1.06, -0.24]Mixed Models Analysis
p-value: 0.26395% CI: [-0.72, 0.2]Mixed Models Analysis
p-value: 0.08395% CI: [-0.87, 0.05]Mixed Models Analysis
p-value: <0.00195% CI: [-1.35, -0.4]Mixed Models Analysis
p-value: 0.14995% CI: [-1.52, 0.23]Mixed Models Analysis
Secondary
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
Population: Treatment 1-6 and Unintentional Dosing Arms: All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Improvement values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement | 33.5 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement | 45.1 percentage of participants |
| Treatment 3: 700 mg BAM +1400 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement | 48.5 percentage of participants |
| Treatment 4: 2800 mg BAM +2800 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement | 46.5 percentage of participants |
| Treatment 5: 700 mg BAM | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement | 49.5 percentage of participants |
| Treatment 6: 350 mg BAM +700 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement | 52.4 percentage of participants |
| Unintentional Dosing: 700 mg BAM +700 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Improvement | 40.0 percentage of participants |
p-value: 0.08295% CI: [0.94, 2.81]Regression, Logistic
p-value: 0.01895% CI: [1.11, 3.11]Regression, Logistic
p-value: 0.02195% CI: [1.09, 2.71]Regression, Logistic
p-value: 0.01195% CI: [1.16, 3.22]Regression, Logistic
p-value: 0.00395% CI: [1.3, 3.6]Regression, Logistic
p-value: 0.54695% CI: [0.52, 3.48]Regression, Logistic
Secondary
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
Population: Treatment 1-6 and Unintentional Dosing Arms: All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Resolution values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution | 29.0 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution | 28.0 percentage of participants |
| Treatment 3: 700 mg BAM +1400 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution | 36.9 percentage of participants |
| Treatment 4: 2800 mg BAM +2800 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution | 32.0 percentage of participants |
| Treatment 5: 700 mg BAM | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution | 41.0 percentage of participants |
| Treatment 6: 350 mg BAM +700 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution | 32.7 percentage of participants |
| Unintentional Dosing: 700 mg BAM +700 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Demonstrating Symptom Resolution | 30.0 percentage of participants |
p-value: 0.8995% CI: [0.53, 1.73]Regression, Logistic
p-value: 0.14195% CI: [0.89, 2.29]Regression, Logistic
p-value: 0.60395% CI: [0.67, 1.98]Regression, Logistic
p-value: 0.04895% CI: [1, 2.84]Regression, Logistic
p-value: 0.53395% CI: [0.69, 2.04]Regression, Logistic
p-value: 0.86995% CI: [0.4, 2.99]Regression, Logistic
Secondary
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
Population: Treatment 1-6 and Unintentional Dosing Arms: All participants randomly assigned and who received any amount of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | 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 | 1.9 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | 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 | 0.0 percentage of participants |
| Treatment 3: 700 mg BAM +1400 mg ETE | 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 | 0.0 percentage of participants |
| Treatment 4: 2800 mg BAM +2800 mg ETE | 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 | 0.0 percentage of participants |
| Treatment 5: 700 mg BAM | 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 | 1.0 percentage of participants |
| Treatment 6: 350 mg BAM +700 mg ETE | 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 | 0.0 percentage of participants |
| Unintentional Dosing: 700 mg BAM +700 mg ETE | 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 | 5.0 percentage of participants |
Secondary
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
Population: Treatment 1-6 and Unintentional Dosing arms: All participants randomly assigned and who received any amount of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | 0.6 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | 0.0 percentage of participants |
| Treatment 3: 700 mg BAM +1400 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | 0.0 percentage of participants |
| Treatment 4: 2800 mg BAM +2800 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | 0.0 percentage of participants |
| Treatment 5: 700 mg BAM | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | 0.0 percentage of participants |
| Treatment 6: 350 mg BAM +700 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | 0.0 percentage of participants |
| Unintentional Dosing: 700 mg BAM +700 mg ETE | Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | 0.0 percentage of participants |
p-value: 0.76995% CI: [0.02, 15.57]Regression, Logistic
p-value: 0.49495% CI: [0.01, 8.12]Regression, Logistic
p-value: 0.67195% CI: [0.02, 12.51]Regression, Logistic
p-value: 0.66395% CI: [0.02, 12.27]Regression, Logistic
p-value: 0.6895% CI: [0.02, 12.76]Regression, Logistic
p-value: 0.58495% CI: [0.09, 67.88]Regression, Logistic
Secondary
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
Population: Treatment 7-8, Amendment (C-E): All participants randomly assigned and who received any amount of study drug. No participants met the criteria (duration had to be 24 or more, and had to occur on Day 29 or before)
Secondary
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
Population: Treatment 7-8 Amendments (c-e): All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1: Pbo | Treatment 7-8 Amendments (C-e): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -3.56 unitless | Standard Error 0.182 |
| Treatment 2: 175 mg BAM +350 mg ETE | Treatment 7-8 Amendments (C-e): Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -2.74 unitless | Standard Error 0.184 |
p-value: 0.00295% CI: [-1.33, -0.31]Mixed Models Analysis
Secondary
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
Population: Treatment 7-8 Amendments (C-E): All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Improvement values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 7-8 Amendments (C-E): Percentage of Participants Demonstrating Symptom Improvement | 43.6 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | Treatment 7-8 Amendments (C-E): Percentage of Participants Demonstrating Symptom Improvement | 42.6 percentage of participants |
p-value: 0.88895% CI: [0.6, 1.82]Regression, Logistic
Secondary
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
Population: Treatment 7-8 Amendments (c-e): All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Resolution values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 7-8 Amendments (C-e): Percentage of Participants Demonstrating Symptom Resolution | 35.6 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | Treatment 7-8 Amendments (C-e): Percentage of Participants Demonstrating Symptom Resolution | 29.7 percentage of participants |
p-value: 0.37495% CI: [0.72, 2.35]Regression, Logistic
Secondary
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
Population: Treatment 7-8 Amendment (C-E): No participants met the criteria (duration had to be 24 or more, and had to occur on Day 29 or before).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | 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 | 1.0 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | 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 | 0.0 percentage of participants |
Secondary
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
Population: Treatment 9-11 Amendment (f), Low Risk Participants: All randomized participants who received study drug and provided at least 1 postbaseline measure viral load measurement.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Treatment 1: Pbo | Treatment 9-11 Amendment (f), Low Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -3.77 unitless | Standard Error 0.198 |
| Treatment 2: 175 mg BAM +350 mg ETE | Treatment 9-11 Amendment (f), Low Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -4.00 unitless | Standard Error 0.196 |
| Treatment 3: 700 mg BAM +1400 mg ETE | Treatment 9-11 Amendment (f), Low Risk Participants: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load | -3.62 unitless | Standard Error 0.198 |
p-value: 0.60695% CI: [-0.7, 0.41]Mixed Models Analysis
p-value: 0.1795% CI: [-0.93, 0.17]Mixed Models Analysis
Secondary
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
Population: Treatment 9-11 Amendment (f), Low Risk Participants: All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and and had non-missing Symptom Improvement values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Improvement | 34.9 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Improvement | 50.4 percentage of participants |
| Treatment 3: 700 mg BAM +1400 mg ETE | Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Improvement | 46.8 percentage of participants |
p-value: 0.01495% CI: [1.13, 3.13]Regression, Logistic
p-value: 0.05795% CI: [0.98, 2.71]Regression, Logistic
Secondary
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
Population: Treatment 9-11 Amendment (f), Low Risk Participants: All randomized participants who received study drug, provided at least 1 postbaseline measure viral load measurement and had non-missing Symptom Resolution values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Resolution | 60.0 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Resolution | 50.8 percentage of participants |
| Treatment 3: 700 mg BAM +1400 mg ETE | Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Demonstrating Symptom Resolution | 44.4 percentage of participants |
p-value: 0.01595% CI: [1.13, 3.08]Regression, Logistic
p-value: 0.31795% CI: [0.78, 2.11]Regression, Logistic
Secondary
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
Population: Treatment 9-11 Amendment (f), Low Risk Participants: All participants randomly assigned and who received any amount of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | 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 | 1.6 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | 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 | 2.4 percentage of participants |
| Treatment 3: 700 mg BAM +1400 mg ETE | 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 | 1.6 percentage of participants |
Secondary
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
Population: Treatment 9-11 Amendment (f), Low Risk Participants: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment 1: Pbo | Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | 1.6 percentage of participants |
| Treatment 2: 175 mg BAM +350 mg ETE | Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | 2.4 percentage of participants |
| Treatment 3: 700 mg BAM +1400 mg ETE | Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause | 1.6 percentage of participants |
p-value: 0.97995% CI: [0.17, 6.06]Regression, Logistic
p-value: 0.67595% CI: [0.27, 7.39]Regression, Logistic