Your session is about to expire
← Back to Search
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
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 Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through day 85
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through day 85
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 2/3, PK: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) for Bebtelovimab [Arm 23]
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)
+4 moreSecondary 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 2/3: Change From Baseline to Day 7 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load [Arm 22]
+16 moreSide effects data
From 2023 Phase 2 & 3 trial • 3307 Patients • NCT0442750118%
Influenza
6%
Constipation
6%
Blood creatine phosphokinase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2/3: Bebtelovimab (Pediatric Addendum, Arm 23)
Phase 2/3: Bamlanivimab + Etesevimab (Pediatric Addendum, Arm 22)
Phase 2: 700 mg Bamlanivimab
Phase 2: 2800 mg Bamlanivimab
Phase 2: 7000 mg Bamlanivimab
Phase 3: Placebo
Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab
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
5Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3853113 (Pediatric Addendum, Arm 23)Experimental Treatment1 Intervention
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.
Group II: LY3819253 + LY3832479 (Pediatric Addendum, Arm 22)Experimental Treatment2 Interventions
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.
Group III: LY3819253 + LY3832479Experimental Treatment2 Interventions
350 mg, 700 mg, 2800 mg LY3819253 + 700 mg, 1400 mg, 2800 mg LY3832479 administered IV or subcutaneously (SQ)
Group IV: LY3819253Experimental Treatment1 Intervention
700 mg, 2800 mg, 7000 mg, LY3819253 administered intravenously (IV)
Group V: 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
2,622 Previous Clinical Trials
3,213,468 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
23,936 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
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger