CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,455 enrolled
Drug / intervention
AZD7442 +2 morebiological
Likely dose
Not stated in 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/NCT05780437
NCT05780437Phase 3Completed

A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19 (Trial H4: AZD7442)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Mar 22, 2023·Updated Feb 4, 2025

In Brief

A Phase 3 clinical trial evaluating AZD7442, Placebo, and 1 other intervention for COVID-19. Completed, enrolled 1,455 participants across 124 sites in 9 countries.

Detailed Summary

This study looks at the safety and effectiveness of AZD7442 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a AZD7442 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H4.

Study Details

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedMar 22, 2023
Enrollment StartFeb 10, 2021
Primary CompletionJan 28, 2022
Study CompletionJun 9, 2023
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 3.3 years ago

Interventions

AZD7442biological

AZD8895 and AZD1061, known collectively as AZD7442, are two fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibodies (mAb) that target two distinct epitopes on the receptor-binding domain of the spike protein of SARS-CoV- 2.

Placebobiological

Commercially available 0.9% sodium chloride solution

Remdesivirbiological

Antiviral agent