A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness
- Conditions
- COVID-19
- Interventions
- Registration Number
- NCT04634409
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1755
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BAM Bamlanivimab Treatment 5: 700 mg BAM administered IV. 700 mg BAM 15-min (Addendum (2)) administered IV. Placebo (Pbo) Placebo Treatment 1: Pbo administered intravenously (IV). Treatment 8: Pbo For 700 mg Bamlanivimab (BAM) + 500 mg VIR-7831 (Amendment (C-e)) administered IV. Treatment 11: Pbo For 175 mg Bebtelovimab (BEB) \& 700 mg BAM +1400 mg Etesevimab ( ETE) +175 mg BEB (Low Risk Participants) administered IV. Pooled Placebo (Addendum 4, IV) administered IV. Pooled Placebo (Addendum 4, SC) administered SC. BAM + ETE Etesevimab Treatment 2: 175 mg BAM +350 mg ETE administered IV. Treatment 3: 700 mg BAM +1400 mg ETE administered IV. Treatment 4: 2800 mg BAM +2800 mg ETE administered IV. Treatment 6: 350 mg BAM +700 mg ETE administered IV. Unintentional Dosing: 700 mg BAM +700 mg ETE administered IV. 700 mg BAM + 1400 mg ETE 30-min (Addendum (2)) administered IV. 700 mg BAM + 1400 mg ETE 15-min (Addendum (2)) administered IV. BAM + VIR-7831 Bamlanivimab Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) administered IV. BAM + VIR-7831 VIR-7831 Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) administered IV. BAM + ETE Bamlanivimab Treatment 2: 175 mg BAM +350 mg ETE administered IV. Treatment 3: 700 mg BAM +1400 mg ETE administered IV. Treatment 4: 2800 mg BAM +2800 mg ETE administered IV. Treatment 6: 350 mg BAM +700 mg ETE administered IV. Unintentional Dosing: 700 mg BAM +700 mg ETE administered IV. 700 mg BAM + 1400 mg ETE 30-min (Addendum (2)) administered IV. 700 mg BAM + 1400 mg ETE 15-min (Addendum (2)) administered IV. BEB Bebtelovimab Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) administered IV. Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) administered IV. 70 mg BEB 140 mg/Min (Addendum 4, IV) administered IV. 175 mg BEB 140 mg/Min (Addendum 4, IV) administered IV. 175 mg BEB 350 mg/Min (Addendum 4, IV) administered IV. 1750 mg BEB 350 mg/Min (Addendum 4, IV) administered IV. 280 mg BEB (Addendum 4, SC) administered SC. 560 mg BEB (Addendum 4, SC) administered SC. BAM+ ETE + BEB Bamlanivimab Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) administered IV. Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants) administered IV. Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB(Amendment (g), High Risk, Updated Centers for Disease Control and Prevention (CDC) Criteria) administered IV. 175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV) administered IV. BAM+ ETE + BEB Etesevimab Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) administered IV. Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants) administered IV. Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB(Amendment (g), High Risk, Updated Centers for Disease Control and Prevention (CDC) Criteria) administered IV. 175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV) administered IV. BAM+ ETE + BEB Bebtelovimab Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) administered IV. Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants) administered IV. Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB(Amendment (g), High Risk, Updated Centers for Disease Control and Prevention (CDC) Criteria) administered IV. 175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV) administered IV.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
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.
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 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: 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 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, 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 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 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 (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).
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 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
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 (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 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 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.
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).
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 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 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
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 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
Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Day 29 PK: Mean Concentration of Bamlanivimab
Pharmacokinetics (PK): Mean Concentration of Etesevimab Day 29 Pharmacokinetics (PK): Mean Concentration of Etesevimab
Pharmacokinetics (PK): Mean Concentration of VIR-7831 Day 29 PK: Mean Concentration of VIR-7831
Pharmacokinetics (PK): Mean Concentration of Bebtelovimab Day 29 Pharmacokinetics (PK): Mean Concentration of Bebtelovimab
Trial Locations
- Locations (138)
VITALINK - Anderson
🇺🇸Anderson, South Carolina, United States
Smart Cures Clin Research
🇺🇸Anaheim, California, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Ann & Robert H Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Remington-Davis, Inc
🇺🇸Columbus, Ohio, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
St.Vincent - Indy
🇺🇸Indianapolis, Indiana, United States
Accurate Clinical Management, LLC.
🇺🇸Houston, Texas, United States
Miami Cancer Institute at Baptist Health, Inc.
🇺🇸Miami, Florida, United States
Bio-Medical Research, LLC
🇺🇸Miami, Florida, United States
Clinical Site Partners, LLC d/b/a CSP Miami
🇺🇸Miami, Florida, United States
SVG Clinical
🇺🇸Las Vegas, Nevada, United States
Hometown UC and Rch- Cincy
🇺🇸Cincinnati, Ohio, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
CRI of Arizona, LLC
🇺🇸Sun City West, Arizona, United States
Fiel Family and Sports Medicine PC
🇺🇸Tempe, Arizona, United States
Central Valley Research, LLC
🇺🇸Modesto, California, United States
Infect Disease Doctors Med Grp
🇺🇸Walnut Creek, California, United States
Hope Clinical Trials, Inc.
🇺🇸Miami, Florida, United States
Clinical Site Partners, LLC DBA CSP Orlando
🇺🇸Winter Park, Florida, United States
Paramount Rch Sol - College Pk
🇺🇸College Park, Georgia, United States
Central Georgia Infectious Disease
🇺🇸Macon, Georgia, United States
Gwinnett Research Inst
🇺🇸Buford, Georgia, United States
Zion Urgent Care Clinic
🇺🇸Katy, Texas, United States
BioPharma Family Practice Center McAllen
🇺🇸McAllen, Texas, United States
North Hills Medical Research
🇺🇸North Richland Hills, Texas, United States
Franciscan St. Francis Health
🇺🇸Indianapolis, Indiana, United States
Qualmedica Research Evansville
🇺🇸Evansville, Indiana, United States
Revival Research Institute
🇺🇸Sterling Heights, Michigan, United States
Las Vegas Medical Research
🇺🇸Las Vegas, Nevada, United States
BRCR Medical Center, Inc
🇺🇸McAllen, Texas, United States
Monroe Biomed Research
🇺🇸Monroe, North Carolina, United States
Aventiv Research Inc
🇺🇸Columbus, Ohio, United States
Jefferson Hosp for Neurosci
🇺🇸Philadelphia, Pennsylvania, United States
Ascension St. John Tulsa OK
🇺🇸Tulsa, Oklahoma, United States
Next Level Urgent Care
🇺🇸Houston, Texas, United States
Bay Area Infectious Diseases Associates
🇺🇸Pasadena, Texas, United States
Epic Medical Research
🇺🇸Red Oak, Texas, United States
1960 Family Practice, PA
🇺🇸Houston, Texas, United States
Crossroads Clinical Research
🇺🇸Corpus Christi, Texas, United States
Consano Clinical Research, LLC
🇺🇸Shavano Park, Texas, United States
Clínica Zabala
🇦🇷Ciudad de Buenos Aires, AR, Argentina
APD Clinical Research
🇺🇸Splendora, Texas, United States
CARE ID
🇺🇸Annandale, Virginia, United States
Clinica Central S.A.
🇦🇷Villa Regina, Rio Negro, Argentina
Centro de Investigaciones Clínicas - Clínica Viedma
🇦🇷Viedma, RN, Argentina
Advanced Clinical Research, LLC
🇵🇷Bayamon, Puerto Rico
Quality Clinical Research
🇺🇸Omaha, Nebraska, United States
CLS Research Ctr, PLLC
🇺🇸Webster, Texas, United States
KLR Business Group, Inc. dba Arkansas Clinical Research
🇺🇸Little Rock, Arkansas, United States
Applied Rsch Ctr - Arkansas Inc.
🇺🇸Little Rock, Arkansas, United States
Hope Clinical Research
🇺🇸Canoga Park, California, United States
VCT-Covina
🇺🇸Covina, California, United States
Neighborhood Healthcare
🇺🇸Escondido, California, United States
Long Beach Clinical Trials LLC
🇺🇸Long Beach, California, United States
Wolverine Clinical Trials, LLC
🇺🇸Santa Ana, California, United States
Ark Clinical Research
🇺🇸Long Beach, California, United States
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
South Bay Clinical Research Institute
🇺🇸Torrance, California, United States
Synergy Healthcare LLC
🇺🇸Bradenton, Florida, United States
Georgetown Univ Sch of Med
🇺🇸Washington, District of Columbia, United States
I R & Health Center, Inc.
🇺🇸Hialeah, Florida, United States
Encore Medical Research
🇺🇸Hollywood, Florida, United States
Lakeland Regional Medical Center
🇺🇸Lakeland, Florida, United States
Panax Clinical Research
🇺🇸Miami Lakes, Florida, United States
Encore Medical Research - Weston
🇺🇸Weston, Florida, United States
Triple O Research Inst
🇺🇸West Palm Beach, Florida, United States
Rophe Adult and Pediatric Medicine
🇺🇸Union City, Georgia, United States
Franciscan Health Hammond
🇺🇸Dyer, Indiana, United States
Qualmedica Research, LLC
🇺🇸Owensboro, Kentucky, United States
Tandem Clinical Research,LLC
🇺🇸Marrero, Louisiana, United States
U of MA Mem Med Ctr
🇺🇸Worcester, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Revive Research Institute
🇺🇸Farmington Hills, Michigan, United States
Bio-Kinetic Clinical Applications, LLC
🇺🇸Springfield, Missouri, United States
Excel Clinical Research
🇺🇸Las Vegas, Nevada, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
Onsite Clinical Solutions, LLC
🇺🇸Charlotte, North Carolina, United States
Valley Medical Primary Care
🇺🇸Centerville, Ohio, United States
Gadolin Research, LLC
🇺🇸Beaumont, Texas, United States
B S & W Med Center
🇺🇸Irving, Texas, United States
Baylor - Fort Worth
🇺🇸Fort Worth, Texas, United States
Houston Methodist Research Ins
🇺🇸Houston, Texas, United States
Evergreen Health Research
🇺🇸Kirkland, Washington, United States
Clínica Privada Independencia
🇦🇷Munro, Buenos Aires, Argentina
Go Centro Medico San Nicolás
🇦🇷San Nicolás, Buenos Aires, Argentina
Sanatorio Sagrado Corazón
🇦🇷Ciudad de Buenos Aires, AR, Argentina
Sanatorio de la Trinidad Mitre
🇦🇷Caba, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Zarate
🇦🇷Zárate, Buenos Aires, Argentina
Instituto Médico Rio Cuarto
🇦🇷Rio Cuarto, Cordoba, Argentina
Dorado Medical Complex Inc
🇵🇷Dorado, Puerto Rico
Hospital San Roque
🇦🇷Cordoba, Argentina
GCM Medical Group, PSC - Hato Rey Site
🇵🇷San Juan, Puerto Rico
The Institute for Liver Health
🇺🇸Tucson, Arizona, United States
Perseverance Research Center
🇺🇸Scottsdale, Arizona, United States
St. Joe Heritage HC-Santa Rosa
🇺🇸Santa Rosa, California, United States
Chemidox Clinical Trials
🇺🇸Lancaster, California, United States
Allianz Research Institute
🇺🇸Westminster, California, United States
Future Innovative Treatments LLC
🇺🇸Colorado Springs, Colorado, United States
Stanford University Hospital
🇺🇸Stanford, California, United States
IACT Health - VHC
🇺🇸Columbus, Georgia, United States
Mazur, Statner, Dutta, Nathan
🇺🇸Thousand Oaks, California, United States
Imperial Health Urgent Care Center - Moss Bluff
🇺🇸Moss Bluff, Louisiana, United States
Holy Cross Hospital Inc.
🇺🇸Fort Lauderdale, Florida, United States
Elixia CRC
🇺🇸Hollywood, Florida, United States
Testing Matters Lab
🇺🇸Sunrise, Florida, United States
Rocky Mountain Clinical Research
🇺🇸Idaho Falls, Idaho, United States
Great Lakes Clinical Trials
🇺🇸Chicago, Illinois, United States
Sky Clin Resch - Quinn HC
🇺🇸Ridgeland, Mississippi, United States
Great Lakes Research Group, Inc.
🇺🇸Bay City, Michigan, United States
Sky Clinical Prime and Health Wellness Clinic
🇺🇸Fayette, Mississippi, United States
Carteret Medical Group
🇺🇸Morehead City, North Carolina, United States
Olive Branch Family Medical Center
🇺🇸Olive Branch, Mississippi, United States
VITALINK - Spartanburg
🇺🇸Spartanburg, South Carolina, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States
Urgent Care Specialists, LLC
🇺🇸Dayton, Ohio, United States
META Medical Research Institute
🇺🇸Dayton, Ohio, United States
VITALINK - Gaffney
🇺🇸Gaffney, South Carolina, United States
Carolina Medical Research - Clinton
🇺🇸Clinton, South Carolina, United States
Crossroads Clin Rch-Victoria
🇺🇸Victoria, Texas, United States
Carolina Medical Research - Greenville
🇺🇸Greenville, South Carolina, United States
VITALINK - Greenville
🇺🇸Greenville, South Carolina, United States
VITALINK - Union
🇺🇸Union, South Carolina, United States
Univ Diab & Endo Consult
🇺🇸Chattanooga, Tennessee, United States
Baylor - Round Rock
🇺🇸Round Rock, Texas, United States
New Phase Research and Development
🇺🇸Knoxville, Tennessee, United States
Conroe Willis Medical Research
🇺🇸Conroe, Texas, United States
North Texas Clinical Trials, LLC
🇺🇸Fort Worth, Texas, United States
Sutter Institute For Medical Research
🇺🇸Sacramento, California, United States
Advent Health Tampa
🇺🇸Tampa, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
INECO Neurociencias Oroño
🇦🇷Rosario, Santa Fe, Argentina
Nola Research Works, LLC
🇺🇸New Orleans, Louisiana, United States
Prime Global Research, LLC
🇺🇸Bronx, New York, United States