Clinical trial

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

Name

014/ACTIV-3/H4

Description

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.

Trial arms

Trial start

2021-02-05

Estimated PCD

2022-01-28

Trial end

2023-03-31

Status

Active (not recruiting)

Phase

Early phase I

Treatment

AZD7442

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.

Arms:

AZD7442 plus SOC

Other names:

AZD8895 + AZD1061

Placebo

Commercially available 0.9% sodium chloride solution

Arms:

Placebo plus SOC

Remdesivir

Antiviral agent

Arms:

AZD7442 plus SOC, Placebo plus SOC

Other names:

Veklury

Size

1455

Primary endpoint

Time from randomization to sustained recovery

Up to Day 90

Eligibility criteria

Inclusion Criteria: * Refer to the master protocol (NCT04501978) Exclusion Criteria: * Refer to the master protocol (NCT04501978) * Additional Exclusion Criteria: * Pregnant women * Nursing mothers * Women of child-bearing potential who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with men or practice appropriate contraception through the entire 18 months of the study * Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through the entire 18 months of the study. * In addition, prior to the initial futility assessment which is performed when approximately 150 participants have been enrolled on AZD7442 and 150 on placebo, patients on highflow oxygen or non-invasive ventilation (category 5 of the pulmonary ordinal outcome) will be excluded. These patients may be eligible for the trial if the initial futility assessment is passed by this agent.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 1455, 'type': 'ACTUAL'}}

Updated at

2023-03-27

1 organization

2 products

1 drug

1 indication

Organization

National Institute of Allergy and Infectious Diseases

Product

Indication

Drug

Product