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A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness (BLAZE-4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04634409
Recruitment Status : Completed
First Posted : November 18, 2020
Results First Posted : July 1, 2022
Last Update Posted : July 1, 2022
Sponsor:
Collaborators:
AbCellera Biologics Inc.
Shanghai Junshi Bioscience Co., Ltd.
GlaxoSmithKline
Vir Biotechnology, Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Bamlanivimab Drug: Etesevimab Drug: Placebo Drug: VIR-7831 Drug: Bebtelovimab Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1755 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Includes open label arms
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Mono and Combination Therapy With Monoclonal Antibodies in Participants With Mild to Moderate COVID-19 Illness (BLAZE-4)
Actual Study Start Date : October 29, 2020
Actual Primary Completion Date : July 27, 2021
Actual Study Completion Date : October 18, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo (Pbo)

Treatment 1: Pbo administered intravenously (IV).

Treatment 8: Pbo For 700 mg Bamlanivimab (BAM) + 500 mg VIR-7831 (Amendment (C-e)) administered IV.

Treatment 11: Pbo For 175 mg Bebtelovimab (BEB) & 700 mg BAM +1400 mg Etesevimab ( ETE) +175 mg BEB (Low Risk Participants) administered IV.

Pooled Placebo (Addendum 4, IV) administered IV.

Pooled Placebo (Addendum 4, SC) administered SC.

Drug: Placebo
Administered IV.

Experimental: BAM + ETE

Treatment 2: 175 mg BAM +350 mg ETE administered IV.

Treatment 3: 700 mg BAM +1400 mg ETE administered IV.

Treatment 4: 2800 mg BAM +2800 mg ETE administered IV.

Treatment 6: 350 mg BAM +700 mg ETE administered IV.

Unintentional Dosing: 700 mg BAM +700 mg ETE administered IV.

700 mg BAM + 1400 mg ETE 30-min (Addendum (2)) administered IV.

700 mg BAM + 1400 mg ETE 15-min (Addendum (2)) administered IV.

Drug: Bamlanivimab
Administered IV.
Other Names:
  • LY-CoV555
  • LY3819253

Drug: Etesevimab
Administered IV.
Other Names:
  • LY-CoV016
  • LY3832479

Experimental: BAM

Treatment 5: 700 mg BAM administered IV.

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

Drug: Bamlanivimab
Administered IV.
Other Names:
  • LY-CoV555
  • LY3819253

Experimental: BAM + VIR-7831
Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) administered IV.
Drug: Bamlanivimab
Administered IV.
Other Names:
  • LY-CoV555
  • LY3819253

Drug: VIR-7831
Administered IV.
Other Name: GSK4182136

Experimental: BEB

Treatment 9: 175 mg BEB (Amendment (f), Low Risk Participants) administered IV.

Treatment 12: 175 mg BEB (Amendment (f), High Risk Participants) administered IV.

70 mg BEB 140 mg/Min (Addendum 4, IV) administered IV.

175 mg BEB 140 mg/Min (Addendum 4, IV) administered IV.

175 mg BEB 350 mg/Min (Addendum 4, IV) administered IV.

1750 mg BEB 350 mg/Min (Addendum 4, IV) administered IV.

280 mg BEB (Addendum 4, SC) administered SC.

560 mg BEB (Addendum 4, SC) administered SC.

Drug: Bebtelovimab
Administered IV.
Other Name: LY-CoV1404, LY3853113

Experimental: BAM+ ETE + BEB

Treatment 10: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), Low Risk Participants) administered IV.

Treatment 13: 700 mg BAM +1400 mg ETE +175 mg BEB (Amendment (f), High Risk Participants) administered IV.

Treatment 14: 700 mg BAM + 1400 mg ETE + 175 mg BEB(Amendment (g), High Risk, Updated Centers for Disease Control and Prevention (CDC) Criteria) administered IV.

175/700/1400 mg BAM + ETE + BEB 350 mg/Min (Addendum 4, IV) administered IV.

Drug: Bamlanivimab
Administered IV.
Other Names:
  • LY-CoV555
  • LY3819253

Drug: Etesevimab
Administered IV.
Other Names:
  • LY-CoV016
  • LY3832479

Drug: Bebtelovimab
Administered IV.
Other Name: LY-CoV1404, LY3853113




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

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

  3. Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 [ Time Frame: 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 :
  1. Treatment 12 -13, Amendment (f) High Risk Participants: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than 5.27 [ Time Frame: 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).

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

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

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

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

  6. Treatment 1-6 and Unintentional Dosing Arms: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause [ Time Frame: Baseline through Day 29 ]
    Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from any Cause

  7. Treatment 7-8, Amendment (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause [ Time Frame: Baseline through Day 29 ]
    Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death from Any Cause

  8. Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause [ Time Frame: Baseline through Day 29 ]
    Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

  9. Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause [ Time Frame: Baseline through Day 29 ]
    Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

  10. Treatment 14 Amendment (f) High Risk Participants, Updated CDC Criteria: Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause [ Time Frame: Baseline through Day 29 ]
    Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

  30. Treatment 7-8 Amendments (C-E): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause [ Time Frame: Baseline through Day 29 ]
    Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

  31. Treatment 9-11 Amendment (f), Low Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause [ Time Frame: Baseline through Day 29 ]
    Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

  32. Treatment 12 -13 Amendment (f), High Risk Participants: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause [ Time Frame: Baseline through Day 29 ]
    Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

  33. Treatment 14 Amendment (g): Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause [ Time Frame: Baseline through Day 29 ]
    Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

  34. Pharmacokinetics (PK): Mean Concentration of Bamlanivimab [ Time Frame: Day 29 ]
    PK: Mean Concentration of Bamlanivimab

  35. Pharmacokinetics (PK): Mean Concentration of Etesevimab [ Time Frame: Day 29 ]
    Pharmacokinetics (PK): Mean Concentration of Etesevimab

  36. Pharmacokinetics (PK): Mean Concentration of Bebtelovimab [ Time Frame: Day 29 ]
    Pharmacokinetics (PK): Mean Concentration of Bebtelovimab

  37. Pharmacokinetics (PK): Mean Concentration of VIR-7831 [ Time Frame: Day 29 ]
    PK: Mean Concentration of VIR-7831



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04634409


Locations
Show Show 141 study locations
Sponsors and Collaborators
Eli Lilly and Company
AbCellera Biologics Inc.
Shanghai Junshi Bioscience Co., Ltd.
GlaxoSmithKline
Vir Biotechnology, Inc.
Investigators
Layout table for investigator information
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Statistical Analysis Plan  [PDF] August 4, 2021

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04634409    
Other Study ID Numbers: 18160
J2X-MC-PYAH ( Other Identifier: Eli Lilly and Company )
First Posted: November 18, 2020    Key Record Dates
Results First Posted: July 1, 2022
Last Update Posted: July 1, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Access Criteria: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
URL: http://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Bamlanivimab
Antiviral Agents
Anti-Infective Agents