AzTrials
AzTrials

COVID-19Phase 2BLAZE-4NCT04634409

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

A Phase 2 study testing Bamlanivimab, Etesevimab and VIR-7831 in people with COVID-19, run by Eli Lilly and Company at 141 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
COVID-19
What is being tested?
Bamlanivimab, Etesevimab and VIR-7831
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,755 participants
Where
141 sitesin 3 countries
Study dates
29 Oct 2020to 18 Oct 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 44Show fewer
  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

141 sites in 3 countries.

141 sites in 3 countries

United States127 sites

  • Smart Cures Clin Research

    Anaheim, California, 92806

  • VITALINK - Anderson

    Anderson, South Carolina, 29621

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • CARE ID

    Annandale, Virginia, 22003

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Great Lakes Research Group, Inc.

    Bay City, Michigan, 48706

  • Gadolin Research, LLC

    Beaumont, Texas, 77702

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Synergy Healthcare LLC

    Bradenton, Florida, 34208

  • Gwinnett Research Inst

    Buford, Georgia, 30519

  • Hope Clinical Research

    Canoga Park, California, 91303

  • Valley Medical Primary Care

    Centerville, Ohio, 45459

  • Onsite Clinical Solutions, LLC

    Charlotte, North Carolina, 28226

  • Univ Diab & Endo Consult

    Chattanooga, Tennessee, 37411

  • Ann & Robert H Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • Hometown UC and Rch- Cincy

    Cincinnati, Ohio, 45215

  • Carolina Medical Research - Clinton

    Clinton, South Carolina, 29325

  • Paramount Rch Sol - College Pk

    College Park, Georgia, 30349

  • Future Innovative Treatments LLC

    Colorado Springs, Colorado, 80907

  • IACT Health - VHC

    Columbus, Georgia, 31904

  • Aventiv Research Inc

    Columbus, Ohio, 43213

  • Urgent Care Specialists, LLC

    Columbus, Ohio, 43214

  • Remington-Davis, Inc

    Columbus, Ohio, 43215

  • Conroe Willis Medical Research

    Conroe, Texas, 77304

  • Crossroads Clinical Research

    Corpus Christi, Texas, 78413

  • VCT-Covina

    Covina, California, 91723

  • B S & W Med Center

    Dallas, Texas, 75246

  • Urgent Care Specialists, LLC

    Dayton, Ohio, 45424

  • META Medical Research Institute

    Dayton, Ohio, 45432

  • Franciscan Health Hammond

    Dyer, Indiana, 46311

  • Neighborhood Healthcare

    Escondido, California, 92025

  • Qualmedica Research Evansville

    Evansville, Indiana, 47715

  • Revive Research Institute

    Farmington Hills, Michigan, 48334

  • Sky Clinical Prime and Health Wellness Clinic

    Fayette, Mississippi, 39069

  • Holy Cross Hospital Inc.

    Fort Lauderdale, Florida, 33308

  • Baylor - Fort Worth

    Fort Worth, Texas, 76104

  • North Texas Clinical Trials, LLC

    Fort Worth, Texas, 76104

  • VITALINK - Gaffney

    Gaffney, South Carolina, 29340

  • East Carolina University

    Greenville, North Carolina, 27834

  • Carolina Medical Research - Greenville

    Greenville, South Carolina, 29607

  • VITALINK - Greenville

    Greenville, South Carolina, 29615

  • I R & Health Center, Inc.

    Hialeah, Florida, 33012

  • Encore Medical Research

    Hollywood, Florida, 33021

  • Elixia CRC

    Hollywood, Florida, 33023

  • Houston Methodist Research Ins

    Houston, Texas, 77030

  • Next Level Urgent Care

    Houston, Texas, 77057

  • Accurate Clinical Management, LLC.

    Houston, Texas, 77065

  • 1960 Family Practice, PA

    Houston, Texas, 77090

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404

  • Franciscan St. Francis Health

    Indianapolis, Indiana, 46237

  • St.Vincent - Indy

    Indianapolis, Indiana, 46260

  • B S & W Med Center

    Irving, Texas, 75061

  • Zion Urgent Care Clinic

    Katy, Texas, 77494

  • Evergreen Health Research

    Kirkland, Washington, 98034

  • New Phase Research and Development

    Knoxville, Tennessee, 37909

  • Lakeland Regional Medical Center

    Lakeland, Florida, 33804

  • Chemidox Clinical Trials

    Lancaster, California, 93534

  • Excel Clinical Research

    Las Vegas, Nevada, 89109

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • SVG Clinical

    Las Vegas, Nevada, 89128

  • KLR Business Group, Inc. dba Arkansas Clinical Research

    Little Rock, Arkansas, 72205

  • Applied Rsch Ctr - Arkansas Inc.

    Little Rock, Arkansas, 72212

  • Ark Clinical Research

    Long Beach, California, 90806

  • Long Beach Clinical Trials LLC

    Long Beach, California, 90806

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048-5615

  • Central Georgia Infectious Disease

    Macon, Georgia, 31201

  • Tandem Clinical Research,LLC

    Marrero, Louisiana, 70072

  • BioPharma Family Practice Center McAllen

    McAllen, Texas, 78501

  • BRCR Medical Center, Inc

    McAllen, Texas, 78501

  • The Institute for Liver Health

    Mesa, Arizona, 85210

  • Hope Clinical Trials, Inc.

    Miami, Florida, 33165

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176

  • Bio-Medical Research, LLC

    Miami, Florida, 33184

  • Clinical Site Partners, LLC d/b/a CSP Miami

    Miami, Florida, 33186

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • Central Valley Research, LLC

    Modesto, California, 95350

  • Monroe Biomed Research

    Monroe, North Carolina, 28112

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Imperial Health Urgent Care Center - Moss Bluff

    Moss Bluff, Louisiana, 70611

  • Nola Research Works, LLC

    New Orleans, Louisiana, 70125

  • North Hills Medical Research

    North Richland Hills, Texas, 76180

  • Olive Branch Family Medical Center

    Olive Branch, Mississippi, 38654

  • Quality Clinical Research

    Omaha, Nebraska, 68114

  • Qualmedica Research, LLC

    Owensboro, Kentucky, 42301

  • Bay Area Infectious Diseases Associates

    Pasadena, Texas, 77505

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 18901

  • Jefferson Hosp for Neurosci

    Philadelphia, Pennsylvania, 19107

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Epic Medical Research

    Red Oak, Texas, 75154

  • Inland Empire Liver Foundation

    Rialto, California, 92377

  • Sky Clin Resch - Quinn HC

    Ridgeland, Mississippi, 39157

  • Baylor - Round Rock

    Round Rock, Texas, 78665

  • Sutter Institute For Medical Research

    Sacramento, California, 95816

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Wolverine Clinical Trials, LLC

    Santa Ana, California, 92705

  • St. Joe Heritage HC-Santa Rosa

    Santa Rosa, California, 95405

  • Perseverance Research Center

    Scottsdale, Arizona, 85254

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • VITALINK - Spartanburg

    Spartanburg, South Carolina, 29303

  • APD Clinical Research

    Splendora, Texas, 77372

  • Bio-Kinetic Clinical Applications, LLC

    Springfield, Missouri, 65802

  • Stanford University Hospital

    Stanford, California, 94305

  • Revival Research Institute

    Sterling Heights, Michigan, 48312

  • CRI of Arizona, LLC

    Sun City West, Arizona, 85375

  • Testing Matters Lab

    Sunrise, Florida, 33325

  • Advent Health Tampa

    Tampa, Florida, 33613

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

  • Fiel Family and Sports Medicine PC

    Tempe, Arizona, 85283

  • Prime Global Research, LLC

    The Bronx, New York, 10456

  • Mazur, Statner, Dutta, Nathan

    Thousand Oaks, California, 91360

  • South Bay Clinical Research Institute

    Torrance, California, 90503

  • The Institute for Liver Health

    Tucson, Arizona, 85712

  • Ascension St. John Tulsa OK

    Tulsa, Oklahoma, 74104

  • VITALINK - Union

    Union, South Carolina, 29379

  • Rophe Adult and Pediatric Medicine

    Union City, Georgia, 30291

  • Crossroads Clin Rch-Victoria

    Victoria, Texas, 77901

  • Infect Disease Doctors Med Grp

    Walnut Creek, California, 94598

  • Georgetown Univ Sch of Med

    Washington D.C., District of Columbia, 20007

  • CLS Research Ctr, PLLC

    Webster, Texas, 77598

  • Triple O Research Inst

    West Palm Beach, Florida, 33407

  • Allianz Research Institute

    Westminster, California, 92683

  • Encore Medical Research - Weston

    Weston, Florida, 33331

  • PMG Research of Wilmington

    Wilmington, North Carolina, 28401

  • Clinical Site Partners, LLC DBA CSP Orlando

    Winter Park, Florida, 32789

  • U of MA Mem Med Ctr

    Worcester, Massachusetts, 01605

Other trials in United States

Argentina11 sites

  • Sanatorio de la Trinidad Mitre

    CABA, Buenos Aires, C1039AAO

  • Sanatorio Sagrado Corazón

    Ciudad de Buenos Aires, AR, C1039AAC

  • Clínica Zabala

    Ciudad de Buenos Aires, AR, C1426AAM

  • Hospital San Roque

    Córdoba, 5000

  • Clínica Privada Independencia

    Munro, Buenos Aires

  • Instituto Médico Rio Cuarto

    Río Cuarto, Córdoba Province, X5800AEV

  • INECO Neurociencias Oroño

    Rosario, Santa Fe Province, S2000

  • Go Centro Medico San Nicolás

    San Nicolás de los Arroyos, Buenos Aires, B2900DPA

  • Centro de Investigaciones Clínicas - Clínica Viedma

    Viedma, Río Negro Province, 8500

  • Clinica Central S.A.

    Villa Regina, Río Negro Province, R8336

  • Instituto de Investigaciones Clinicas Zarate

    Zárate, Buenos Aires, 2800

Other trials in Argentina

Puerto Rico3 sites

  • Advanced Clinical Research, LLC

    Bayamón, 00961

  • Dorado Medical Complex Inc

    Dorado, 00646

  • GCM Medical Group, PSC - Hato Rey Site

    San Juan, 00917

Other trials in Puerto Rico

About this study

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)

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.

Conditions
COVID-19
Being tested
Bamlanivimab, Etesevimab, Placebo, VIR-7831, Bebtelovimab
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BamlanivimabDrug

    Also called LY-CoV555, LY3819253

    Administered IV.

  • EtesevimabDrug

    Also called LY-CoV016, LY3832479

    Administered IV.

  • PlaceboDrug

    Administered IV.

  • VIR-7831Drug

    Also called GSK4182136

    Administered IV.

  • BebtelovimabDrug

    Also called LY-CoV1404, LY3853113

    Administered IV.

Study groups in NCT04634409
Study groupRoleWhat they receive
Placebo (Pbo)Placebo comparatorTreatment 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.
Receives: Drug: Placebo
BAM + ETEExperimentalTreatment 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.
Receives: Drug: Bamlanivimab; Drug: Etesevimab
BAMExperimentalTreatment 5: 700 mg BAM administered IV. 700 mg BAM 15-min (Addendum (2)) administered IV.
Receives: Drug: Bamlanivimab
BAM + VIR-7831ExperimentalTreatment 7: 700 mg BAM + 500 mg VIR-7831 (Amendment (C-e)) administered IV.
Receives: Drug: Bamlanivimab; Drug: VIR-7831
BEBExperimentalTreatment 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.
Receives: Drug: Bebtelovimab
BAM+ ETE + BEBExperimentalTreatment 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.
Receives: Drug: Bamlanivimab; Drug: Etesevimab; Drug: Bebtelovimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    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.

    Measured: Day 7

  2. 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).

    Measured: Day 7

  3. 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).

    Measured: Day 7

Secondary outcomes (37)

  1. 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).

    Measured: Day 7

  2. 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).

    Measured: Day 7

  3. 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.

    Measured: Day 7

  4. 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).

    Measured: Day 7

  5. 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).

    Measured: Day 7

  6. 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

    Measured: Baseline through Day 29

  7. 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

    Measured: Baseline through Day 29

  8. 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

    Measured: Baseline through Day 29

  9. 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

    Measured: Baseline through Day 29

  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

    Percentage of Participants Who Experience COVID-19 Related Hospitalization or Death From Any Cause

    Measured: Baseline through Day 29

  11. 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.

    Measured: Baseline, Day 7

  12. 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.

    Measured: Baseline, Day 7

  13. 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.

    Measured: Baseline, Day 7

  14. 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.

    Measured: Baseline, Day 7

  15. 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.

    Measured: Baseline, Day 7

  16. 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.

    Measured: Baseline, Day 7

  17. 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.

    Measured: Baseline, Day 7

  18. 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.

    Measured: Baseline, Day 7

  19. 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.

    Measured: Day 7

  20. 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.

    Measured: Day 7

  21. 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.

    Measured: Day 7

  22. 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.

    Measured: Day 7

  23. 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.

    Measured: Day 7

  24. 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.

    Measured: Day 7

  25. 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.

    Measured: Day 7

  26. 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.

    Measured: Day 7

  27. 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.

    Measured: Day 7

  28. 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.

    Measured: Day 7

  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

    Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    Measured: Baseline through Day 29

  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

    Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    Measured: Baseline through Day 29

  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

    Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    Measured: Baseline through Day 29

  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

    Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    Measured: Baseline through Day 29

  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

    Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-19 Related Emergency Room Visit, or Death From Any Cause

    Measured: Baseline through Day 29

  34. Pharmacokinetics (PK): Mean Concentration of Bamlanivimab

    PK: Mean Concentration of Bamlanivimab

    Measured: Day 29

  35. Pharmacokinetics (PK): Mean Concentration of Etesevimab

    Pharmacokinetics (PK): Mean Concentration of Etesevimab

    Measured: Day 29

  36. Pharmacokinetics (PK): Mean Concentration of Bebtelovimab

    Pharmacokinetics (PK): Mean Concentration of Bebtelovimab

    Measured: Day 29

  37. Pharmacokinetics (PK): Mean Concentration of VIR-7831

    PK: Mean Concentration of VIR-7831

    Measured: Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2020
  2. Study start29 Oct 2020
  3. Primary completion27 Jul 2021
  4. Study completion18 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,755 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04634409
Sponsor's protocol ID
18160
Other IDs
J2X-MC-PYAH
Acronym
BLAZE-4
Status last verified
Jun 2022
First submitted
17 Nov 2020
Last updated
1 Jul 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Nichols RM, Macpherson L, Patel DR, Yeh WW, Peppercorn A. Effect of Bamlanivimab as Monotherapy or in Combination with Etesevimab or Sotrovimab on Persistently High Viral Load in Patients with Mild-to-Moderate COVID-19: A Randomized, Phase 2 BLAZE-4 Trial. Infect Dis Ther. 2024 Feb;13(2):401-411. doi: 10.1007/s40121-024-00918-1. Epub 2024 Jan 30.

    PubMed 38291279

  • Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.

    PubMed 35713300

  • Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

    PubMed 34473343

  • Nathan R, Shawa I, De La Torre I, Pustizzi JM, Haustrup N, Patel DR, Huhn G. A Narrative Review of the Clinical Practicalities of Bamlanivimab and Etesevimab Antibody Therapies for SARS-CoV-2. Infect Dis Ther. 2021 Dec;10(4):1933-1947. doi: 10.1007/s40121-021-00515-6. Epub 2021 Aug 10.

    PubMed 34374951

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bamlanivimab, Etesevimab and VIR-7831 in people with COVID-19, run by Eli Lilly and Company at 141 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 44 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in United States, Argentina, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04634409, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in