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Monoclonal Antibodies

LY3819253 for COVID-19 (BLAZE-1 Trial)

Phase 2 & 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are currently receiving immunosuppressive treatment or
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.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through day 85
Awards & highlights

BLAZE-1 Trial Summary

This trial will test two drugs, LY3819253 and LY3832479, to see how effective they are against the virus that causes COVID-19. The drugs will be given to participants with early symptoms of COVID-19, and samples will be taken to determine how much virus is in the body at various times. Participation could last about 12 weeks.

Eligible Conditions
  • COVID-19
  • Coronavirus

BLAZE-1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are currently taking medication that lowers your immune system.
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You have mild or moderate symptoms of COVID-19 such as fever, cough, sore throat, headache, body aches, upset stomach, or difficulty breathing during physical activity. (This doesn't apply to participants in treatment arm 22.)
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You are currently pregnant.
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Your body mass index (BMI) is 35 or higher.
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You have a condition that weakens your immune system.
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You have heart problems.
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You have a long-term breathing problem, such as COPD or other chronic respiratory disease.
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You are currently pregnant.
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You have a higher than average body weight for your age and gender, according to CDC growth charts.
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You were born with a heart condition or have developed one over time.
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You have a condition that affects how your brain develops, such as cerebral palsy.
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You rely on certain medical technologies such as a tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19).
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You have a chronic respiratory condition like asthma that requires daily medication to manage.
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You have a disease that weakens your immune system.
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You are currently taking medication that lowers your immune system.
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You have conditions that affect your brain development such as cerebral palsy, autism, or Down syndrome.
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You have a chronic respiratory disease, like asthma or cystic fibrosis, that requires daily medication for management.
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You are currently taking medication to suppress your immune system.
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You are experiencing symptoms of COVID-19.
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You experience trouble breathing or shortness of breath.
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You have a painful throat.
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You feel sick to your stomach and may vomit.
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You are experiencing diarrhea.
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There is no specific exclusion criterion for tiredness.
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You have a headache.
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You are experiencing a stuffy or runny nose.
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You are experiencing chills.
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You are experiencing abdominal pain.
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You experience vomiting.
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You have a persistent cough.
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You are experiencing discomfort or soreness in your muscles or body.
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You are currently pregnant.
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Your body mass index (BMI) is 35 or higher.
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You have a disease that weakens your immune system.
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You have a heart condition.
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You are currently pregnant.
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You have a disorder that affects your brain development, such as cerebral palsy.
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You have a respiratory condition (like asthma) that requires daily medication to manage.
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You have a disease that weakens your immune system.
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You are currently taking medication that weakens your immune system.
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You are currently pregnant.
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You have heart problems that you were born with or that you developed later on.
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You are currently pregnant.
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You have trouble breathing or feel like you can't catch your breath.
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You have a painful throat.
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You experience nausea.
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You have diarrhea.
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There is no criterion related to tiredness in clinical trials. It is not a specific medical condition that can be measured or diagnosed.
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You have a headache.
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You have a stuffy or runny nose.
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You are experiencing shivering or shaking with cold.
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You are feeling generally unwell or fatigued.
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You are experiencing vomiting.
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You have a persistent cough.
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You have discomfort or pain in your muscles or body.
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You have little to no interest in eating or feeding (if you're a baby under 1 year old).
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You cannot have participated in another clinical trial involving an experimental treatment within the past month, or within the last five half-lives of a treatment that has a long-lasting effect.
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You rely on medical technology like a tracheostomy or gastrostomy for your daily needs.
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You have a heart condition that you were born with or developed over time.
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You have conditions that affect your brain development, such as cerebral palsy, autism, or Down syndrome.
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You rely on medical devices like a tracheostomy or positive pressure ventilation for daily living (not related to COVID-19).
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You have a medical condition that weakens your immune system.
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You or your baby have a low appetite or difficulty feeding.
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You have a long-term breathing problem such as COPD or another chronic respiratory disease.
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You are overweight, with a body mass index (BMI) above a certain percentile based on your age and gender.
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You were born with or have developed heart disease.
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You rely on medical technology like a tracheostomy, gastrostomy, or positive pressure ventilation (that is not related to COVID-19).
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You have a chronic respiratory disease like asthma or cystic fibrosis that requires daily medication to manage.
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You have a disease that weakens your immune system.
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You are currently taking medication that weakens your immune system.
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You are experiencing one or more symptoms of COVID-19.
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You have mild to moderate COVID-19 symptoms within the past 7 days.
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You are allergic to any of the ingredients in the treatment.
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You currently have a serious infection caused by bacteria, fungus, virus, or other sources, apart from COVID-19, that could be harmful if you take the study drug.

BLAZE-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2: Change From Baseline to Day 11 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load
Phase 2: Percentage of Participants Who Experience a Serious Adverse Event(s) SAE(s)
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
+1 more
Secondary outcome measures
Phase 2, PK: Mean Concentration of Etesevimab in the Presence of Bamlanivimab
Phase 2, Pharmacokinetics (PK): Mean Concentration of Bamlanivimab Alone and in the Presence of Etesevimab
Phase 2: Change From Baseline to Day 11 in SARS-CoV-2 Viral Load Among Participants Enrolled With Recent Symptoms Prior to Randomization
+10 more

Side effects data

From 2023 Phase 2 & 3 trial • 3307 Patients • NCT04427501
3%
Headache
3%
Nausea
3%
Dizziness
2%
Blood pressure increased
2%
Pruritus
2%
Gastrooesophageal reflux disease
2%
Nasal congestion
1%
Dyspepsia
1%
Pyrexia
1%
Photophobia
1%
Skin infection
1%
Deep vein thrombosis
1%
Presyncope
1%
Clear cell renal cell carcinoma
1%
Pleurisy
1%
Transaminases increased
1%
Ear pain
1%
Thrombocytosis
1%
Eye paraesthesia
1%
Vision blurred
1%
Abdominal discomfort
1%
Diarrhoea
1%
Hypersensitivity
1%
Chest pain
1%
Oedema peripheral
1%
Swelling face
1%
Joint injury
1%
Blood lactate dehydrogenase increased
1%
Back pain
1%
Hepatic enzyme increased
1%
Lipase increased
1%
Myalgia
1%
Hypoaesthesia
1%
Cough
1%
Dyspnoea
1%
Paranasal sinus discomfort
1%
Rhinorrhoea
1%
Throat irritation
1%
Diabetic ketoacidosis
1%
Vomiting
1%
Asthma
1%
Rash
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2: 700 mg Bamlanivimab
Phase 2: 2800 mg Bamlanivimab
Phase 2: 7000 mg Bamlanivimab
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Phase 3: Placebo
Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab
Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab
Phase 3: 700 mg Bamlanivimab + 1400 mg Etesevimab
Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab
Phase 2: Placebo

BLAZE-1 Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3853113 Open Label Addenda Arm 23Experimental Treatment1 Intervention
Administered IV
Group II: LY3819253 + LY3832479Experimental Treatment2 Interventions
350 mg, 700 mg, 2800 mg LY3819253 + 700 mg, 1400 mg, 2800 mg LY3832479 administered IV or subcutaneously (SQ)
Group III: LY3819253Experimental Treatment1 Intervention
700 mg, 2800 mg, 7000 mg, LY3819253 administered intravenously (IV)
Group IV: PlaceboPlacebo Group1 Intervention
Placebo administered IV
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3819253
2020
Completed Phase 3
~6430
LY3832479
2020
Completed Phase 3
~3360
LY3853113
2020
Completed Phase 3
~3310

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,603 Previous Clinical Trials
3,196,323 Total Patients Enrolled
13 Trials studying COVID-19
12,811 Patients Enrolled for COVID-19
AbCellera Biologics Inc.Industry Sponsor
5 Previous Clinical Trials
3,070 Total Patients Enrolled
5 Trials studying COVID-19
3,070 Patients Enrolled for COVID-19
Shanghai Junshi Bioscience Co., Ltd.OTHER
112 Previous Clinical Trials
24,026 Total Patients Enrolled
4 Trials studying COVID-19
3,045 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you give me the total figure of people who have signed up for this experiment?

"That is correct, the clinical trial is still actively recruiting patients. 3360 individuals are needed for the research study which is taking place at 100 different medical facilities."

Answered by AI

Why is LY3819253 prescribed to patients?

"LY3819253 is an effective treatment for covid-19 in patients that are high risk for progression to severe covid-19, weigh 40 kg or more, and have mild to moderate symptoms."

Answered by AI

What does the research say about LY3819253 thus far?

"Presently, there are five ongoing clinical trials researching LY3819253 with three of them in Phase 3. Many of the investigations are based out of Milwaukee, Wisconsin, but there are a total of 607 locations running trials for LY3819253."

Answered by AI

What other similar research exists for this topic?

"LY3819253 has 5 studies ongoing in 287 cities and 24 countries. The first clinical trial began in 2020 and completed its Phase 2 & 3 drug approval stage that same year. 3360 patients were involved in the trial, which was sponsored by AbCellera Biologics Inc. Since 2020, a total of 18268 clinical trials have been completed."

Answered by AI

Who else is applying?

What state do they live in?
Other
Florida
Maryland
Texas
How old are they?
18 - 65
What site did they apply to?
Applied Rsch Ctr - Arkansas Inc.
University of Maryland Medical Center
BioPharma Clinc Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

For the money. I'm healthy. Mid of February I got heavy flu, my employer took a covid test, she said the result not clear, she said I got covid and asked me to wear mask and rest. She gave some medicines, but I don't know what medicine they are. I had been coughing since that time till now. I went to Urgent Care, was given medicines but did not help.
PatientReceived 2+ prior treatments
Recent research and studies
~696 spots leftby Mar 2025