COVID-19Phase 2/3BLAZE-1NCT04427501

A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness

A Phase 2/3 study testing LY3819253, LY3832479 and LY3853113 in people with COVID-19, run by Eli Lilly and Company at 12 sites in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 0 years and older
Conditions the study is for: COVID-19
What is being tested?: LY3819253, LY3832479 and LY3853113
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 3,307 participants
Where: 12 sitesUnited States
Study dates: 17 Jun 2020to 21 Feb 2023
Phase: Phase 2/3
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 0 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Are currently not hospitalized. (Not applicable to participants in treatment arm 22.)
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. (Not applicable to participants in treatment arm 22.)
Must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion
Are males or females, including pregnant females who agree to contraceptive requirements
Understand and agree to comply with planned study procedures
Agree to the collection of nasopharyngeal swabs and venous blood. (Not applicable to participants in treatment arms 20-21.)

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The participant or legally authorized representative give signed informed consent and/or assent
Participants in treatment arms 7-9, 13-14, and 18-21 ONLY
Are greater than or equal to (≥)18 years of age and must satisfy at least one of the following at the time of screening
Are pregnant
Are ≥65 years of age
Have a body mass index (BMI) ≥35
Have chronic kidney disease (CKD)
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 (CVD), OR
hypertension, OR
chronic obstructive pulmonary disease (COPD) or other chronic respiratory disease
Are 12-17 years of age (inclusive) AND satisfy at least one of the following at the time of screening
Are pregnant
Have a body mass index (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
Participants in treatment arm 22 ONLY
Are 0 (≥ 32 weeks gestational age AND ≥ 1.5 kilograms [kg]) to 17 years of age (inclusive) AND satisfy at least one of the following risk factors at the time of screening
Are pregnant
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, autism, or Down syndrome (FAIR Health 2020; Spreat et al. 2020)
Have a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)
Have asthma, cystic fibrosis, reactive airways disease 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, or
Are less than (<) one year of age.
Have one or more COVID-19 symptoms
Shortness of breath/difficulty breathing
Fever
Sore throat
Nausea
Diarrhea
Tiredness
Headache
New loss of taste
Nasal congestion/runny nose
Chills
Stomachache
Vomiting
Cough
Muscle/body aches and pain
New loss of smell
Poor appetite or poor feeding (in babies)
Participants in treatment arm 23 ONLY:
Must have first positive result sample of current SARS-CoV-2 viral infection ≤3 days prior to start of treatment administration.
Participant can have COVID previously and still meet criteria for this addendum. Positive result needs to be from a current infection.
Are 0 (≥ 38 weeks gestational age and ≥ 3.3 kg) to <12 years of age at the time of screening, or are 12 to 17 and weighing <40 kg; and
Have mild to moderate COVID-19 disease, including one or more COVID-19 symptoms within the last 7 days
Shortness of breath/difficulty breathing
Fever
Sore throat
Nausea
Diarrhea
Tiredness
Headache
New loss of taste
Nasal congestion/runny nose
Chills
Malaise
Vomiting
Cough
Muscle/body aches and pain
New loss of smell
Poor appetite or poor feeding (in babies under 1 year old)

Who cannot join

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) less than (<)300, respiratory rate greater than or equal to (≥)30 per minute, heart rate ≥125 per minute due to COVID-19
Require mechanical ventilation or anticipated impending need for mechanical ventilation due to COVID-19
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

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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 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 received convalescent COVID-19 plasma treatment
Have participated in a previous SARS-CoV-2 vaccine study or have received a SARS-CoV-2 vaccine
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
Mothers who are breast feeding
Participants in Treatment Arm 22 ONLY
Have a diagnosis of Multisystem Inflammatory Syndrome in Children (MIS-C) in the opinion of the investigator
Are currently hospitalized for treatment of COVID-19. Other reasons for hospitalization are acceptable.
Participants in treatment arm 23 ONLY
SpO2 ≤ 93% on room air at sea level, or while on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity, respiratory rate ≥30 per minute, and heart rate ≥125 per minute due to COVID-19 (FDA February 2021)
Require mechanical ventilation or anticipated impending need for mechanical ventilation due to COVID-19
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 received treatment with a SARS-CoV-2 specific monoclonal antibody or remdesivir within 90 days before dosing.
Have received convalescent COVID-19 plasma treatment within 90 days before dosing
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 currently pregnant or breast feeding

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
Massachusetts General Hospital
Boston, Massachusetts, 02114
B S & W Med Center
Dallas, Texas, 75246
Childrens Hospital of Michigan
Detroit, Michigan, 48201
Sky Clinical Prime and Health Wellness Clinic
Fayette, Mississippi, 39069
Bio-Medical Research, LLC
Miami, Florida, 33184
Monroe Biomed Research
Monroe, North Carolina, 28112
Clinnova Research - Redondo Beach
Redondo Beach, California, 90277
Sky Clin Resch - Quinn HC
Ridgeland, Mississippi, 39157
Sun Research Institute
San Antonio, Texas, 78215
Rophe Adult and Pediatric Medicine
Union City, Georgia, 30291
U of MA Mem Med Ctr
Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-Controlled, Phase 2/3 Study to Evaluate the Efficacy and Safety of LY3819253 and LY3832479 in Participants With Mild to Moderate COVID-19 Illness

The purpose of this study is to measure how well LY3819253 and LY3832479 work against the virus that causes COVID-19. LY3819253 and LY3832479 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 weeks and includes one required visit to the study site, with the remainder of assessments performed in the home or by phone.

Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm (Arm 22), open-label addendum to evaluate the pharmacokinetics and safety of LY3819253 and LY3832479. Enrollment began on March 31, 2021, and completed on September 24, 2021.

Pediatric participants, with mild to moderate COVID-19 illness, will enroll in a single-arm (Arm 23), open-label addendum to evaluate the pharmacokinetics and safety of LY3853113. Enrollment began on August 19, 2022, and completed on February 21, 2023.

Conditions: COVID-19
Being tested: LY3819253, LY3832479, LY3853113, Placebo
Medical subject headings: COVID-19

What participants receive

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

LY3819253Drug
Also called LY-CoV555, Bamlanivimab
Administered IV
LY3832479Drug
Also called LY-CoV016, Etesevimab
Administered IV
LY3853113Drug
Also called bebtelovimab
Administered IV
PlaceboDrug
Administered IV

Study groups in NCT04427501
Study group	Role	What they receive
LY3819253	Experimental	700 mg, 2800 mg, 7000 mg, LY3819253 administered intravenously (IV) Receives: Drug: LY3819253
LY3819253 + LY3832479	Experimental	350 mg, 700 mg, 2800 mg LY3819253 + 700 mg, 1400 mg, 2800 mg LY3832479 administered IV or subcutaneously (SQ) Receives: Drug: LY3819253; Drug: LY3832479
LY3819253 + LY3832479 (Pediatric Addendum, Arm 22)	Experimental	LY3819253 dose based upon weight (weight Group: ≥40 kilogram (kg) = 700 mg dose, >20 kg to <40 kg = 350 mg dose, >12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and LY3832479 dose based upon weight (weight Group: ≥40 kg = 1400 mg dose, >20 kg to <40 kg = 700 mg dose, >12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV. Receives: Drug: LY3819253; Drug: LY3832479
LY3853113 (Pediatric Addendum, Arm 23)	Experimental	LY3853113 dose based upon weight (Weight Group: ≥3.3 to ≤12 kg = 3 mg/kg dose, >12 to ≤20 kg = 43.75 mg dose, >20 to <40 kg = 87.5 mg dose, ≥40 kg = 175 mg dose) administered IV. Receives: Drug: LY3853113
Placebo	Placebo comparator	Placebo administered IV Receives: Drug: Placebo

What is being measured

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

Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups
COVID-19 Related Deterioration (yes/no) was defined as a participant experiencing COVID-19-related hospitalization (defined as 24 hours of acute care) or death from any cause by Day 29.
Measured: Baseline through Day 29
Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo
SARS-CoV-2 persistent high viral load (yes/no) was defined as ribonuclease P(RP) normalized viral load >=5.27 vs otherwise.
Measured: Day 7
Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load
SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), was used for the Day 11 value. If no measurements were available, the Day 11 viral load was treated as missing at random (MAR) in the analysis.
Viral load is reported as normalized viral load and is unitless.
Measured: Baseline, Day 11
Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)
An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other different situations will have medical or scientific judgment to determine if they are SAE. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality are reported in the Adverse Events section.
Measured: Baseline through Day 85
Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3819253 (Bamlanivimab)
Mean Concentration of Bamlanivimab in the presence of Etesevimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary.
Measured: Day 29 Post-dose
Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3832479 (Etesevimab)
Mean Concentration of Etesevimab in the presence of Bamlanivimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary.
Measured: Day 29 Post-dose
Phase 2/3, PK: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for Bebtelovimab [Arm 23]
AUC0-∞ for Bebtelovimab was reported.
Measured: Day 60 Post-dose

Secondary outcomes (19)

Phase 3: 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 changes in taste and smell. Each symptom 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). 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 (excluding the loss of appetite and changes in taste and smell symptoms). Missing data were imputed using non-responder imputation (NRI) method.
Measured: Day 11
Phase 3: 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 changes in taste and smell. Each symptom will be 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). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.
Measured: Day 11
Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
COVID-19 Related Deterioration (yes/no) is defined as a patient experiencing COVID-19-related hospitalization, Emergency Room Visit, or Death from any causes vs otherwise.
Measured: Baseline through Day 85
Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Change from baseline to Day 7 (±2 days) in SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 7 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 7 visit, but within 2 days (Day 5-Day 9), was used for the Day 7 value. If no measurements are available, the Day 7 viral load was treated as missing at random (MAR) in the analysis.
Viral load is reported as normalized viral and is unitless.
Measured: Baseline, Day 7
Phase 3: Time to Sustained Symptom Resolution
Sustained symptom resolution was defined as 2 consecutive assessments with 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. Participants who did not experience sustained symptom resolution by completion or early discontinuation of study were censored at the date of their last visit during. Additionally, participants who were hospitalized were censored at their date of hospitalization.
Measured: Baseline through Day 29
Phase 3: Time to SARS-CoV-2 Viral Clearance
Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
Measured: Baseline through Day 29
Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization
SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. This analysis included only participants whose symptoms developed no more than 8 days prior to randomization. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load is missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), will be used for the Day 11 value. If no measurements are available, the Day 11 viral load will be treated as MAR in the analysis.
Measured: Baseline, Day 11
Phase 2: 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 changes in taste and smell. Each symptom will be 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). Symptom resolution was defined as all symptoms (those scored 0-3) on the symptom questionnaire scored as absent (0). Symptom Resolution (yes/no) was defined as all symptoms (excluding the loss of appetite and changes in taste and smell symptoms) on the symptom questionnaire scored as absent vs otherwise.
Missing data were imputed using non-responder imputation (NRI) method.
Measured: Day 11
Phase 2: 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 changes in taste and smell. Each symptom will be 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). Symptom improvement was defined as a participant experiencing both: Symptoms on the symptom questionnaire scored as moderate or severe at baseline are subsequently scored as mild or absent, and Symptoms on the symptom questionnaire scored as mild or absent at baseline are subsequently scored as absent. Missing data were imputed using NRI method.
Measured: Day 11
Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab
(PK): Mean Concentration of Bamlanivimab alone and in the Presence of Etesevimab
Measured: Day 29 Post-dose
Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab
PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab
Measured: Day 29 Post-dose
Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause
Measured: Baseline through Day 85
Phase 2: Time to SARS-CoV-2 Viral Clearance
Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
Measured: Baseline through Day 29
Phase 2/3: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause [Arm 22]
Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related ER Visit, or Death from Any Cause.
Measured: Baseline through Day 29
Phase 2/3: Change From Baseline to Day 7 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load [Arm 22]
SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2.
Viral load is reported as normalized viral load and is unitless.
Measured: Baseline, Day 7
Phase 2/3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold [Arm 22]
SARS-CoV-2 persistent high viral load (yes/no) is defined as RP normalized viral load >5.27 vs otherwise. Percentage of response is calculated by n/Nx*100% (n = number of participants in the specified category, Nx = number of participants with non-missing values)
Measured: Day 7
Phase 2/3: Time to Complete Symptom Resolution [Arm 22]
Complete symptom resolution was defined as absence of all symptoms at a single timepoint.
Measured: Baseline through Day 29
Phase 2/3: Time to Sustained Complete Symptom Resolution [Arm 22]
Sustained complete symptom resolution is defined as the first of 2 consecutive days with complete symptom resolution.
Measured: Baseline through Day 29
Phase 2/3: Time to SARS-CoV-2 Viral Clearance [Arm 22]
Participants who did not experience SARS-CoV-2 viral clearance by completion or early discontinuation of study were censored at the date of their last visit.
Measured: Baseline through Day 29

Timeline

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

17 Jun 202021 Feb 2023

First posted11 Jun 2020
Study start17 Jun 2020
Primary completion21 Feb 2023
Study completion21 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (11)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 3,307 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04427501
Sponsor's protocol ID: 17947
Other IDs: J2W-MC-PYAB
Acronym: BLAZE-1
Status last verified: Apr 2024
First submitted: 9 Jun 2020
Last updated: 11 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Publications

Patel DR, Macpherson L, Bohm M, Upadhyaya H, Deveau C, Nirula A, Klekotka P, Williams M, Hufford MM. Efficacy and Safety of Low-Dose, Rapidly Infused Bamlanivimab and Etesevimab: Phase 3 BLAZE-1 Trial for Mild-to-Moderate COVID-19. Infect Dis Ther. 2024 Oct;13(10):2123-2134. doi: 10.1007/s40121-024-01031-z. Epub 2024 Sep 4.
PubMed 39230829
Upadhyaya HP, Chien JY, Long AJ, Bohm MS, Kallewaard NL, Macpherson LF, Patel DR, Hufford MM, Krull CJ, Ang JY, Chen P, Muller WJ, Potts JA, Quinn T, Williams M; BLAZE-1 Investigators. Pharmacokinetics, Efficacy, and Safety of a SARS-CoV-2 Antibody Treatment in Pediatric Participants: An Open-Label Addendum of a Placebo-Controlled, Randomized Phase 2/3 Trial. Infect Dis Ther. 2023 Jul;12(7):1861-1873. doi: 10.1007/s40121-023-00832-y. Epub 2023 Jun 17.
PubMed 37329415
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
Chen P, Behre G, Hebert C, Kumar P, Farmer Macpherson L, Graham-Clarke PL, De La Torre I, Nichols RM, Hufford MM, Patel DR, Naegeli AN. Bamlanivimab and Etesevimab Improve Symptoms and Associated Outcomes in Ambulatory Patients at Increased Risk for Severe Coronavirus Disease 2019: Results From the Placebo-Controlled Double-Blind Phase 3 BLAZE-1 Trial. Open Forum Infect Dis. 2022 Apr 7;9(5):ofac172. doi: 10.1093/ofid/ofac172. eCollection 2022 May.
PubMed 35493124
Dougan M, Azizad M, Mocherla B, Gottlieb RL, Chen P, Hebert C, Perry R, Boscia J, Heller B, Morris J, Crystal C, Igbinadolor A, Huhn G, Cardona J, Shawa I, Kumar P, Blomkalns A, Adams AC, Van Naarden J, Custer KL, Knorr J, Oakley G, Schade AE, Holzer TR, Ebert PJ, Higgs RE, Sabo J, Patel DR, Dabora MC, Williams M, Klekotka P, Shen L, Skovronsky DM, Nirula A. A Randomized, Placebo-Controlled Clinical Trial of Bamlanivimab and Etesevimab Together in High-Risk Ambulatory Patients With COVID-19 and Validation of the Prognostic Value of Persistently High Viral Load. Clin Infect Dis. 2022 Aug 24;75(1):e440-e449. doi: 10.1093/cid/ciab912.
PubMed 34718468
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
Meng X, Wang P, Xiong Y, Wu Y, Lin X, Lu S, Li R, Zhao B, Liu J, Zeng S, Zeng L, Wu Y, Lu Y, Zhang J, Liu D, Wang S, Lu H. Safety, tolerability, pharmacokinetic characteristics, and immunogenicity of MW33: a Phase 1 clinical study of the SARS-CoV-2 RBD-targeting monoclonal antibody. Emerg Microbes Infect. 2021 Dec;10(1):1638-1648. doi: 10.1080/22221751.2021.1960900.
PubMed 34346827
Dougan M, Nirula A, Azizad M, Mocherla B, Gottlieb RL, Chen P, Hebert C, Perry R, Boscia J, Heller B, Morris J, Crystal C, Igbinadolor A, Huhn G, Cardona J, Shawa I, Kumar P, Adams AC, Van Naarden J, Custer KL, Durante M, Oakley G, Schade AE, Holzer TR, Ebert PJ, Higgs RE, Kallewaard NL, Sabo J, Patel DR, Dabora MC, Klekotka P, Shen L, Skovronsky DM; BLAZE-1 Investigators. Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19. N Engl J Med. 2021 Oct 7;385(15):1382-1392. doi: 10.1056/NEJMoa2102685. Epub 2021 Jul 14.
PubMed 34260849
Gottlieb RL, Nirula A, Chen P, Boscia J, Heller B, Morris J, Huhn G, Cardona J, Mocherla B, Stosor V, Shawa I, Kumar P, Adams AC, Van Naarden J, Custer KL, Durante M, Oakley G, Schade AE, Holzer TR, Ebert PJ, Higgs RE, Kallewaard NL, Sabo J, Patel DR, Klekotka P, Shen L, Skovronsky DM. Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2021 Feb 16;325(7):632-644. doi: 10.1001/jama.2021.0202.
PubMed 33475701
Chen P, Nirula A, Heller B, Gottlieb RL, Boscia J, Morris J, Huhn G, Cardona J, Mocherla B, Stosor V, Shawa I, Adams AC, Van Naarden J, Custer KL, Shen L, Durante M, Oakley G, Schade AE, Sabo J, Patel DR, Klekotka P, Skovronsky DM; BLAZE-1 Investigators. SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19. N Engl J Med. 2021 Jan 21;384(3):229-237. doi: 10.1056/NEJMoa2029849. Epub 2020 Oct 28.
PubMed 33113295

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Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-Controlled, Phase 2/3 Study to Evaluate the Efficacy and Safety of LY3819253 and LY3832479 in Participants With Mild to Moderate COVID-19 Illness
ClinicalTrials.gov ID: NCT04427501
Acronym / sponsor ID: BLAZE-1 / 17947
Conditions: COVID-19
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,307 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: AbCellera Biologics Inc., Shanghai Junshi Bioscience Co., Ltd.
Study start: 17 Jun 2020 (actual)
Primary completion: 21 Feb 2023 (actual)
Study completion: 21 Feb 2023 (actual)
First posted: 11 Jun 2020 (actual)
Results: Posted 7 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
LY3819253	Experimental	Drug: LY3819253700 mg, 2800 mg, 7000 mg, LY3819253 administered intravenously (IV)
LY3819253 + LY3832479	Experimental	Drug: LY3819253, Drug: LY3832479350 mg, 700 mg, 2800 mg LY3819253 + 700 mg, 1400 mg, 2800 mg LY3832479 administered IV or subcutaneously (SQ)
LY3819253 + LY3832479 (Pediatric Addendum, Arm 22)	Experimental	Drug: LY3819253, Drug: LY3832479LY3819253 dose based upon weight (weight Group: ≥40 kilogram (kg) = 700 mg dose, >20 kg to <40 kg = 350 mg dose, >12 kg to 20 kg = 175 mg dose and 1.5 kg to 12 kg = 15 mg/kg dose) and LY3832479 dose based upon weight (weight Group: ≥40 kg = 1400 mg dose, >20 kg to <40 kg = 700 mg dose, >12 kg to 20 kg = 350 mg dose and 1.5 kg to 12 kg = 30 mg/kg dose) administered IV.
LY3853113 (Pediatric Addendum, Arm 23)	Experimental	Drug: LY3853113LY3853113 dose based upon weight (Weight Group: ≥3.3 to ≤12 kg = 3 mg/kg dose, >12 to ≤20 kg = 43.75 mg dose, >20 to <40 kg = 87.5 mg dose, ≥40 kg = 175 mg dose) administered IV.
Placebo	Placebo comparator	Drug: PlaceboPlacebo administered IV

Who may qualify

Ages: 0 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (84 listed)

Are currently not hospitalized. (Not applicable to participants in treatment arm 22.)
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. (Not applicable to participants in treatment arm 22.)
Must have sample taken for test confirming viral infection no more than 3 days prior to starting the drug infusion
Are males or females, including pregnant females who agree to contraceptive requirements
Understand and agree to comply with planned study procedures

Key exclusion criteria (31 listed)

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) less than (<)300, respiratory rate greater than or equal to (≥)30 per minute, heart rate ≥125 per minute due to COVID-19
Require mechanical ventilation or anticipated impending need for mechanical ventilation due to COVID-19
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY3819253Also: LY-CoV555, BamlanivimabAdministered IV	Drug	LY3819253, LY3819253 + LY3832479, LY3819253 + LY3832479 (Pediatric Addendum, Arm 22)
LY3832479Also: LY-CoV016, EtesevimabAdministered IV	Drug	LY3819253 + LY3832479, LY3819253 + LY3832479 (Pediatric Addendum, Arm 22)
LY3853113Also: bebtelovimabAdministered IV	Drug	LY3853113 (Pediatric Addendum, Arm 23)
PlaceboAdministered IV	Drug	Placebo

Primary outcome

Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups
Time frame: Baseline through Day 29
COVID-19 Related Deterioration (yes/no) was defined as a participant experiencing COVID-19-related hospitalization (defined as 24 hours of acute care) or death from any cause by Day 29.
Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo
Time frame: Day 7
SARS-CoV-2 persistent high viral load (yes/no) was defined as ribonuclease P(RP) normalized viral load >=5.27 vs otherwise.
Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load
Time frame: Baseline, Day 11
SARS-CoV-2 viral load was based on nasopharyngeal swab sampling for reverse transcription polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Least squares (LS) mean values were determined using a mixed-effects model repeated-measures (MMRM) that included log base 10 transformed baseline as a covariate, treatment, day, treatment-by-day interaction as fixed effects. If Day 11 SARS-CoV-2 viral load was missing, the earliest measurement closest to the Day 11 visit, but within 4 days (Day 7-Day 15), was used for the Day 11 value. If no measurements were available, the Day 11 viral load was treated as missing at random (MAR) in the analysis. Viral load is reported as normalized viral load and is unitless.
Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)
Time frame: Baseline through Day 85
An SAE was defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other different situations will have medical or scientific judgment to determine if they are SAE. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality are reported in the Adverse Events section.
Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3819253 (Bamlanivimab)
Time frame: Day 29 Post-dose
Mean Concentration of Bamlanivimab in the presence of Etesevimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary.
Phase 3 and Phase 2/3 [Arm 22], Pharmacokinetics (PK): Mean Concentrations of LY3832479 (Etesevimab)
Time frame: Day 29 Post-dose
Mean Concentration of Etesevimab in the presence of Bamlanivimab is reported. Due to the limited number of pediatric participants across all study arms in phase 3, PK concentration summary data was combined including phase 3 and phase 2/3 (Pediatric addendum, Arm 22) reporting arms. All pediatric participants from Phase 3 trial arms including Arm 22 who contributed data to the required outcome (PK concentration at Day 29) were included in the PK summary.
Phase 2/3, PK: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for Bebtelovimab [Arm 23]
Time frame: Day 60 Post-dose
AUC0-∞ for Bebtelovimab was reported.

19 secondary outcomes

Phase 3: Percentage of Participants Demonstrating Symptom Resolution
Time frame: Day 11
Phase 3: Percentage of Participants Demonstrating Symptom Improvement
Time frame: Day 11
Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
Time frame: Baseline through Day 85
Phase 3: Change From Baseline to Day 7 in SARS-CoV-2 Viral Load
Time frame: Baseline, Day 7
Phase 3: Time to Sustained Symptom Resolution
Time frame: Baseline through Day 29
Phase 3: Time to SARS-CoV-2 Viral Clearance
Time frame: Baseline through Day 29
Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization
Time frame: Baseline, Day 11
Phase 2: Percentage of Participants Demonstrating Symptom Resolution
Time frame: Day 11
Phase 2: Percentage of Participants Demonstrating Symptom Improvement
Time frame: Day 11
Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab
Time frame: Day 29 Post-dose
Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab
Time frame: Day 29 Post-dose
Phase 2: Percentage of Participants Who Experience COVID-Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause
Time frame: Baseline through Day 85
Phase 2: Time to SARS-CoV-2 Viral Clearance
Time frame: Baseline through Day 29
Phase 2/3: Percentage of Participants Who Experience COVID-19 Related Hospitalization, COVID-Related Emergency Room (ER) Visit, or Death From Any Cause [Arm 22]
Time frame: Baseline through Day 29
Phase 2/3: Change From Baseline to Day 7 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load [Arm 22]
Time frame: Baseline, Day 7
Phase 2/3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold [Arm 22]
Time frame: Day 7
Phase 2/3: Time to Complete Symptom Resolution [Arm 22]
Time frame: Baseline through Day 29
Phase 2/3: Time to Sustained Complete Symptom Resolution [Arm 22]
Time frame: Baseline through Day 29
Phase 2/3: Time to SARS-CoV-2 Viral Clearance [Arm 22]
Time frame: Baseline through Day 29

Results and safety

Results posted to the registry on 7 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 2: Placebo	156	141
Phase 2: 700 mg Bamlanivimab	101	95
Phase 2: 2800 mg Bamlanivimab	107	103
Phase 2: 7000 mg Bamlanivimab	101	98
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab	112	103
Phase 3: Placebo	776	719
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab	518	485
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab	513	496
Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab	141	135
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab	213	207
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)	94	88
Phase 2/3: Bebtelovimab (Pediatric Addendum, Arm 23)	17	16

Primary outcome: Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups

Time frame: Baseline through Day 29. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab n = 517	Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab n = 518	Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab n = 776	Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab n = 511
Value	7.0 (4.8 to 9.2)	2.1 (0.9 to 3.4)	6.8 (5.1 to 8.6)	0.8 (0.0 to 1.5)

Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab vs Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab: Odds Ratio (OR): 0.30 (95% CI 0.15 to 0.58)
Phase 3: Placebo For 700 mg Bamlanivimab + 1400 mg Etesevimab vs Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab: Odds Ratio (OR): 0.12 (95% CI 0.04 to 0.31)

Population analysed: Phase 3: All randomized participants who received at least one dose of study drug and had COVID-related hospitalization or death from any cause data available in arms Placebo, 2800 mg Bamlanivimab + 2800 mg Etesevimab and 700 mg Bamlanivimab + 1400 mg Etesevimab.

Primary outcome: Phase 3: Percentage of Participants With SARS-CoV-2 Viral Load Greater Than a Prespecified Threshold in Arms 350 mg Bamlanivimab/700 mg Etesevimab and Placebo

Time frame: Day 7. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab n = 141	Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab n = 213
Value	34.8 (26.9 to 42.6)	10.8 (6.6 to 15.0)

Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab vs Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab: Odds Ratio (OR): 0.23 (95% CI 0.13 to 0.40)

Population analysed: Phase 3: All randomized participants who received at least one dose of study drug and had non-missing viral load values in arms Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab and 350 mg Bamlanivimab + 700 mg Etesevimab

Primary outcome: Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load

Time frame: Baseline, Day 11. Least squares mean (Standard Error). Unit: unitless

Measure	Part A: Placebo n = 146	Phase 2: 700 mg Bamlanivimab n = 100	Phase 2: 2800 mg Bamlanivimab n = 103	Phase 2: 7000 mg Bamlanivimab n = 95	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab n = 102
Value	-3.80 (0.141)	-3.72 (0.170)	-4.08 (0.168)	-3.49 (0.175)	-4.37 (0.169)

Part A: Placebo vs Phase 2: 700 mg Bamlanivimab: Mean Difference (Net): 0.09 (95% CI -0.35 to 0.52), p = 0.6921, Mixed Models Analysis
Part A: Placebo vs Phase 2: 2800 mg Bamlanivimab: Mean Difference (Net): -0.27 (95% CI -0.71 to 0.16), p = 0.2110, Mixed Models Analysis
Part A: Placebo vs Phase 2: 7000 mg Bamlanivimab: Mean Difference (Net): 0.31 (95% CI -0.13 to 0.76), p = 0.1630, Mixed Models Analysis

Population analysed: Phase 2: All randomized participants who received at least one dose of study drug and had a baseline and day 11 viral load value.

Primary outcome: Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)

Time frame: Baseline through Day 85. Number. Unit: percentage of participants

Measure	Phase 2: Placebo n = 156	Phase 2: 700 mg Bamlanivimab n = 101	Phase 2: 2800 mg Bamlanivimab n = 107	Phase 2: 7000 mg Bamlanivimab n = 101	Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab n = 112
Value	0.6	0	0	0	0.9

Population analysed: Phase 2: All randomized participants who received at least one dose of study drug.

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline Up to 85 Days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 2: Placebo	1 of 156 (0.6%)	44 of 156 (28.2%)	0 of 156
Phase 2: 700 mg Bamlanivimab	2 of 101 (2%)	29 of 101 (28.7%)	0 of 101
Phase 2: 2800 mg Bamlanivimab	0 of 107 (0%)	26 of 107 (24.3%)	0 of 107
Phase 2: 7000 mg Bamlanivimab	0 of 101 (0%)	24 of 101 (23.8%)	0 of 101
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab	1 of 112 (0.9%)	23 of 112 (20.5%)	0 of 112
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab	10 of 518 (1.9%)	72 of 518 (13.9%)	0 of 518
Phase 3: Placebo	8 of 776 (1%)	92 of 776 (11.9%)	15 of 776
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab	16 of 513 (3.1%)	61 of 513 (11.9%)	0 of 513
Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab	4 of 141 (2.8%)	17 of 141 (12.1%)	0 of 141
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab	1 of 213 (0.5%)	14 of 213 (6.6%)	0 of 213
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)	1 of 94 (1.1%)	16 of 94 (17%)	0 of 94
Phase 2/3: Bebtelovimab (Pediatric Addendum, Arm 23)	0 of 17 (0%)	4 of 17 (23.5%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39230829Patel DR, Macpherson L, Bohm M, Upadhyaya H, Deveau C, Nirula A, Klekotka P, Williams M, Hufford MM. Efficacy and Safety of Low-Dose, Rapidly Infused Bamlanivimab and Etesevimab: Phase 3 BLAZE-1 Trial for Mild-to-Moderate COVID-19. Infect Dis Ther. 2024 Oct;13(10):2123-2134. doi: 10.1007/s40121-024-01031-z. Epub 2024 Sep 4.
Derived from this study: PubMed 37329415Upadhyaya HP, Chien JY, Long AJ, Bohm MS, Kallewaard NL, Macpherson LF, Patel DR, Hufford MM, Krull CJ, Ang JY, Chen P, Muller WJ, Potts JA, Quinn T, Williams M; BLAZE-1 Investigators. Pharmacokinetics, Efficacy, and Safety of a SARS-CoV-2 Antibody Treatment in Pediatric Participants: An Open-Label Addendum of a Placebo-Controlled, Randomized Phase 2/3 Trial. Infect Dis Ther. 2023 Jul;12(7):1861-1873. doi: 10.1007/s40121-023-00832-y. Epub 2023 Jun 17.
Derived from this study: PubMed 35713300Hirsch 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.
Derived from this study: PubMed 35493124Chen P, Behre G, Hebert C, Kumar P, Farmer Macpherson L, Graham-Clarke PL, De La Torre I, Nichols RM, Hufford MM, Patel DR, Naegeli AN. Bamlanivimab and Etesevimab Improve Symptoms and Associated Outcomes in Ambulatory Patients at Increased Risk for Severe Coronavirus Disease 2019: Results From the Placebo-Controlled Double-Blind Phase 3 BLAZE-1 Trial. Open Forum Infect Dis. 2022 Apr 7;9(5):ofac172. doi: 10.1093/ofid/ofac172. eCollection 2022 May.
Derived from this study: PubMed 34718468Dougan M, Azizad M, Mocherla B, Gottlieb RL, Chen P, Hebert C, Perry R, Boscia J, Heller B, Morris J, Crystal C, Igbinadolor A, Huhn G, Cardona J, Shawa I, Kumar P, Blomkalns A, Adams AC, Van Naarden J, Custer KL, Knorr J, Oakley G, Schade AE, Holzer TR, Ebert PJ, Higgs RE, Sabo J, Patel DR, Dabora MC, Williams M, Klekotka P, Shen L, Skovronsky DM, Nirula A. A Randomized, Placebo-Controlled Clinical Trial of Bamlanivimab and Etesevimab Together in High-Risk Ambulatory Patients With COVID-19 and Validation of the Prognostic Value of Persistently High Viral Load. Clin Infect Dis. 2022 Aug 24;75(1):e440-e449. doi: 10.1093/cid/ciab912.
Derived from this study: PubMed 34473343Kreuzberger 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.
Derived from this study: PubMed 34374951Nathan 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.
Derived from this study: PubMed 34346827Meng X, Wang P, Xiong Y, Wu Y, Lin X, Lu S, Li R, Zhao B, Liu J, Zeng S, Zeng L, Wu Y, Lu Y, Zhang J, Liu D, Wang S, Lu H. Safety, tolerability, pharmacokinetic characteristics, and immunogenicity of MW33: a Phase 1 clinical study of the SARS-CoV-2 RBD-targeting monoclonal antibody. Emerg Microbes Infect. 2021 Dec;10(1):1638-1648. doi: 10.1080/22221751.2021.1960900.
Derived from this study: PubMed 34260849Dougan M, Nirula A, Azizad M, Mocherla B, Gottlieb RL, Chen P, Hebert C, Perry R, Boscia J, Heller B, Morris J, Crystal C, Igbinadolor A, Huhn G, Cardona J, Shawa I, Kumar P, Adams AC, Van Naarden J, Custer KL, Durante M, Oakley G, Schade AE, Holzer TR, Ebert PJ, Higgs RE, Kallewaard NL, Sabo J, Patel DR, Dabora MC, Klekotka P, Shen L, Skovronsky DM; BLAZE-1 Investigators. Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19. N Engl J Med. 2021 Oct 7;385(15):1382-1392. doi: 10.1056/NEJMoa2102685. Epub 2021 Jul 14.
Derived from this study: PubMed 33475701Gottlieb RL, Nirula A, Chen P, Boscia J, Heller B, Morris J, Huhn G, Cardona J, Mocherla B, Stosor V, Shawa I, Kumar P, Adams AC, Van Naarden J, Custer KL, Durante M, Oakley G, Schade AE, Holzer TR, Ebert PJ, Higgs RE, Kallewaard NL, Sabo J, Patel DR, Klekotka P, Shen L, Skovronsky DM. Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2021 Feb 16;325(7):632-644. doi: 10.1001/jama.2021.0202.
Derived from this study: PubMed 33113295Chen P, Nirula A, Heller B, Gottlieb RL, Boscia J, Morris J, Huhn G, Cardona J, Mocherla B, Stosor V, Shawa I, Adams AC, Van Naarden J, Custer KL, Shen L, Durante M, Oakley G, Schade AE, Sabo J, Patel DR, Klekotka P, Skovronsky DM; BLAZE-1 Investigators. SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19. N Engl J Med. 2021 Jan 21;384(3):229-237. doi: 10.1056/NEJMoa2029849. Epub 2020 Oct 28.
A Study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in Participants With Mild to Moderate COVID-19 Illness (BLAZE-1)Link provided by the sponsor.
Individual participant dataSharing planned: Yes

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COVID -19

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing LY3819253, LY3832479 and LY3853113 in people with COVID-19, run by Eli Lilly and Company at 12 sites in United States.

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 84 inclusion and 31 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 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 7 Mar 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?

Phase 3: Percentage of Participants Who Experience COVID-Related Hospitalization or Death From Any Cause in 2800 mg Bamlanivumab/2800 mg Etesevimab, 700 mg Bamlanivimab/1400mg Etesevimab and Their Placebo Groups (time frame: Baseline through Day 29). The study lists 7 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 NCT04427501, which also lists 11 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 11 Apr 2024.