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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)

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Trial Profile

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)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 21 Feb 2023

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At a glance

  • Drugs Bamlanivimab (Primary) ; Bebtelovimab (Primary) ; Bebtelovimab (Primary) ; Etesevimab (Primary) ; Sotrovimab (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms BLAZE-4
  • Sponsors Eli Lilly and Company

    • Most Recent Events

    • 11 Feb 2022 According to an Eli Lilly and Company media release, The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant .The data supporting this EUA are primarily based on analyses from the Phase 2 BLAZE-4 trial.
    • 12 Nov 2021 Status changed from active, no longer recruiting to completed.
    • 12 Sep 2021 Results (n=2970) pharmacokinetic-25 pharmacodynamic (PK/PD) model from 2 studies (NCT04427501 for BLAZE-1 and 72 NCT04634409 for BLAZE-4) evaluating the relationship between bamlanivimab and 64 etesevimab concentration on viral load reductionpublished in the Clinical Pharmacology and Therapeutics
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