A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness (BLAZE-4)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19
Eligibility 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
Sites / Locations
- University of Alabama at Birmingham
- The Institute for Liver Health
- Perseverance Research Center
- CRI of Arizona, LLC
- Fiel Family and Sports Medicine PC
- The Institute for Liver Health
- KLR Business Group, Inc. dba Arkansas Clinical Research
- Applied Rsch Ctr - Arkansas Inc.
- Smart Cures Clin Research
- Hope Clinical Research
- VCT-Covina
- Neighborhood Healthcare
- Chemidox Clinical Trials
- Ark Clinical Research
- Long Beach Clinical Trials LLC
- Cedars Sinai Medical Center
- Central Valley Research, LLC
- Inland Empire Liver Foundation
- Sutter Institute For Medical Research
- Wolverine Clinical Trials, LLC
- St. Joe Heritage HC-Santa Rosa
- Stanford University Hospital
- Mazur, Statner, Dutta, Nathan
- South Bay Clinical Research Institute
- Infect Disease Doctors Med Grp
- Allianz Research Institute
- Future Innovative Treatments LLC
- Georgetown Univ Sch of Med
- Synergy Healthcare LLC
- Holy Cross Hospital Inc.
- I R & Health Center, Inc.
- Encore Medical Research
- Elixia CRC
- Lakeland Regional Medical Center
- Panax Clinical Research
- Hope Clinical Trials, Inc.
- Miami Cancer Institute at Baptist Health, Inc.
- Bio-Medical Research, LLC
- Clinical Site Partners, LLC d/b/a CSP Miami
- Testing Matters Lab
- Advent Health Tampa
- Triple O Research Inst
- Encore Medical Research - Weston
- Clinical Site Partners, LLC DBA CSP Orlando
- Gwinnett Research Inst
- Paramount Rch Sol - College Pk
- IACT Health - VHC
- Central Georgia Infectious Disease
- Rophe Adult and Pediatric Medicine
- Rocky Mountain Clinical Research
- Ann & Robert H Lurie Children's Hospital of Chicago
- Great Lakes Clinical Trials
- Franciscan Health Hammond
- Qualmedica Research Evansville
- Franciscan St. Francis Health
- St.Vincent - Indy
- Qualmedica Research, LLC
- Tandem Clinical Research,LLC
- Imperial Health Urgent Care Center - Moss Bluff
- Nola Research Works, LLC
- University of Maryland Medical Center
- Massachusetts General Hospital
- U of MA Mem Med Ctr
- University of Michigan
- Great Lakes Research Group, Inc.
- Revive Research Institute
- Revival Research Institute
- Sky Clinical Prime and Health Wellness Clinic
- Olive Branch Family Medical Center
- Sky Clin Resch - Quinn HC
- Bio-Kinetic Clinical Applications, LLC
- Quality Clinical Research
- Excel Clinical Research
- Las Vegas Medical Research
- SVG Clinical
- Holy Name Medical Center
- Prime Global Research, LLC
- Onsite Clinical Solutions, LLC
- East Carolina University
- Monroe Biomed Research
- Carteret Medical Group
- PMG Research of Wilmington
- Valley Medical Primary Care
- Hometown UC and Rch- Cincy
- Aventiv Research Inc
- Urgent Care Specialists, LLC
- Remington-Davis, Inc
- Urgent Care Specialists, LLC
- META Medical Research Institute
- Ascension St. John Tulsa OK
- Children's Hospital of Philadelphia
- Jefferson Hosp for Neurosci
- Temple University Hospital
- VITALINK - Anderson
- Carolina Medical Research - Clinton
- VITALINK - Gaffney
- Carolina Medical Research - Greenville
- VITALINK - Greenville
- VITALINK - Spartanburg
- VITALINK - Union
- Univ Diab & Endo Consult
- New Phase Research and Development
- Gadolin Research, LLC
- Conroe Willis Medical Research
- Crossroads Clinical Research
- B S & W Med Center
- Baylor - Fort Worth
- North Texas Clinical Trials, LLC
- Houston Methodist Research Ins
- Next Level Urgent Care
- Accurate Clinical Management, LLC.
- 1960 Family Practice, PA
- B S & W Med Center
- Zion Urgent Care Clinic
- BioPharma Family Practice Center McAllen
- BRCR Medical Center, Inc
- North Hills Medical Research
- Bay Area Infectious Diseases Associates
- Epic Medical Research
- Baylor - Round Rock
- Sun Research Institute
- Consano Clinical Research, LLC
- APD Clinical Research
- Crossroads Clin Rch-Victoria
- CLS Research Ctr, PLLC
- CARE ID
- Evergreen Health Research
- Sanatorio Sagrado Corazón
- Clínica Zabala
- Sanatorio de la Trinidad Mitre
- Clínica Privada Independencia
- Go Centro Medico San Nicolás
- Instituto de Investigaciones Clinicas Zarate
- Instituto Médico Rio Cuarto
- Clinica Central S.A.
- Centro de Investigaciones Clínicas - Clínica Viedma
- INECO Neurociencias Oroño
- Hospital San Roque
- Advanced Clinical Research, LLC
- Dorado Medical Complex Inc
- GCM Medical Group, PSC - Hato Rey Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo (Pbo)
BAM + ETE
BAM
BAM + VIR-7831
BEB
BAM+ ETE + BEB
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.
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.
Treatment 5: 700 mg BAM administered IV. 700 mg BAM 15-min (Addendum (2)) administered IV.
Treatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) administered IV.
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.
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.