CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,197 enrolled
Drug / intervention
AZD7442 +1 moredrug
Likely dose
AZD7442 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04625725
NCT04625725Phase 3Completed
CompareCT.gov

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 Pre-exposure Prophylaxis of COVID-19.

AstraZeneca·interventional·Posted Nov 12, 2020·Updated Dec 31, 2024

In Brief

A Phase 3 clinical trial evaluating AZD7442 and Placebo for COVID-19. Completed, enrolled 5,197 participants across 89 sites in 5 countries.

Detailed Summary

This study will assess the safety and efficacy of a single dose of AZD7442(× 2 IM injections) compared to placebo for the prevention of COVID-19.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesBelgium, France, Spain, United Kingdom, United States
CollaboratorsIQVIA Pty Ltd

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedNov 12, 2020
Enrollment StartNov 21, 2020
Primary CompletionAug 16, 2022
Study CompletionDec 8, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.6 years ago

Interventions

AZD7442drug

* Single dose (× 2IM injections) of 300 mg of AZD7442 on parent study Day 1. * Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 1. * Single dose (× 2IM injections) of 300 mg of AZD7442 on sub-study Day 183. * Single dose (x 2IM injections) of 600mg of AZD7442 on sub-study Day 183 and Day 366

Placebodrug

Single dose (× 2IM injections) of saline placebo on parent study Day 1.