Study identifier:D8850C00003
ClinicalTrials.gov identifier:NCT04625972
EudraCT identifier:2020-004719-28
CTIS identifier:N/A
A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Post-exposure Prophylaxis of COVID-19
COVID-19
Phase 3
No
AZD7442, Placebo
All
1131
Interventional
18 Years - 120 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Prevention
Verified 01 Nov 2023 by AstraZeneca
AstraZeneca
IQVIA
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: AZD7442 Participants will be randomized in a 2:1 ratio to receive a single dose (× 2 IM injections) of either 300 mg of AZD7442 (n = approximately 750) or saline placebo (n = approximately 375) on Day 1. | Drug: AZD7442 Single dose (× 2 IM injections) of 300 mg of AZD7442 on Day 1. Other Name: A combination of 2 mAbs (AZD8895 and AZD1061) |
Placebo Comparator: Placebo Participants will be randomized in a 2:1 ratio to receive a single dose (× 2 IM injections) of either 300 mg of AZD7442 (n = approximately 750) or saline placebo (n = approximately 375) on Day 1. | Drug: Placebo Single dose (× 2 IM injections) of saline placebo on Day 1. |