drugset
drugset / Trial / NCT04427501

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

NCT04427501 ↗

Phase 2/3 Completed 3307 enrolled Eli Lilly and Company AbCellera Biologics Inc. · collabShanghai Junshi Bioscience Co., Ltd. · collab
RandomizedSequentialDouble-blindTreatment

Summary

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.

Timeline

Start
2020-06-17
Primary completion
2023-02-21
Completion
2023-02-21

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry Phase 3: Placebo For 2800 mg Bamlanivimab + 2800 mg Etesevimab vs Phase 3: 2800 mg Bamlanivimab + 2800 mg Etesevimab; Odds Ratio (OR) 0.30 reads as mixed primary results NCT04427501 ↗

registry Phase 3: Placebo For 350 mg Bamlanivimab + 700 mg Etesevimab vs Phase 3: 350 mg Bamlanivimab + 700 mg Etesevimab; Odds Ratio (OR) 0.23 reads as mixed primary results NCT04427501 ↗

registry Part A: Placebo vs Phase 2: 700 mg Bamlanivimab; p = 0.6921 reads as mixed primary results NCT04427501 ↗

registry Part A: Placebo vs Phase 2: 2800 mg Bamlanivimab + 2800 mg Etesevimab; p = 0.0099; Mean Difference (Net) -0.57 reads as mixed primary results NCT04427501 ↗

release “meeting the primary endpoint of the Phase 3 BLAZE-1 trial” reads as met primary endpoint lilly.com ↗

release “BLAZE-1 Phase 3 study, demonstrating bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together significantly reduced COVID-19 related hospitalizations and deaths” reads as met primary endpoint lilly.com ↗

release “BLAZE-1 Phase 2/3 study are as follows: The trial met its primary endpoint and key secondary endpoints with high statistical significance” reads as met primary endpoint abcellera.com ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Bamlanivimab Monoclonal antibody 15 mg/kg Intravenous
Subject Bamlanivimab Monoclonal antibody 175 mg Intravenous
Subject Bamlanivimab Monoclonal antibody 350 mg Intravenous
Subject Bamlanivimab Monoclonal antibody 700 mg Intravenous
Subject Bamlanivimab Monoclonal antibody 2800 mg Intravenous
Subject Bamlanivimab Monoclonal antibody 7000 mg Intravenous
Subject Bebtelovimab Monoclonal antibody 3 mg/kg Intravenous
Subject Bebtelovimab Monoclonal antibody 43.75 mg Intravenous
Subject Bebtelovimab Monoclonal antibody 87.5 mg Intravenous
Subject Bebtelovimab Monoclonal antibody 175 mg Intravenous
Subject Etesevimab Monoclonal antibody 30 mg/kg Intravenous
Subject Etesevimab Monoclonal antibody 350 mg Intravenous
Subject Etesevimab Monoclonal antibody 700 mg Intravenous
Subject Etesevimab Monoclonal antibody 1400 mg Intravenous
Subject Etesevimab Monoclonal antibody 2800 mg Intravenous

Indications

COVID-19