NCT04634409

A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness

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: Phase 2
• Study type: Interventional
• Enrollment: 1,755 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to measure how well monoclonal antibodies work, either alone or in combination, against the virus that causes COVID-19. Study drug(s) 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 or 24 weeks and includes at least 1 visit to the study site, with the remainder of assessments performed in the home, local clinic, or by phone.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Bamlanivimab	Administered IV.
DRUG	Etesevimab	Administered IV.
DRUG	Placebo	Administered IV.
DRUG	VIR-7831	Administered IV.
DRUG	Bebtelovimab	Administered IV.

Timeline

• Start date: 2020-10-29
• Primary completion: 2021-07-27
• Completion: 2021-10-18
• First posted: 2020-11-18
• Last updated: 2022-07-01
• Results posted: 2022-07-01

Locations

141 sites across 3 countries: United States, Argentina, Puerto Rico

Regulatory

• FDA-regulated drug study