ACTIV-3: Therapeutics for Inpatients With COVID-19

Summary

This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.

Conditions

• Covid19

Interventions

BIOLOGICAL

LY3819253

Participants are no longer being randomized to this intervention.

DRUG

Placebo

Commercially available 0.9% sodium chloride solution. Administered by IV infusion

BIOLOGICAL

Remdesivir

Provided to all study participants as SOC unless contraindicated for an individual patient.

BIOLOGICAL

VIR-7831

Participants are no longer being randomized to this intervention.

BIOLOGICAL

BRII-196/BRII-198

Participants are no longer being randomized to this intervention.

BIOLOGICAL

AZD7442

Participants are no longer being randomized to this intervention.

DRUG

MP0420

Participants are no longer being randomized to this intervention.

DRUG

PF-07304814

250 mg per day for 5 days. Administered as a constant rate intravenous infusion. Suspended: Participants are not currently being randomized to this intervention.

Sponsors & Collaborators

• International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)

  collaborator NETWORK

• University of Copenhagen

  collaborator OTHER

• Medical Research Council

  collaborator OTHER_GOV

• Kirby Institute

  collaborator OTHER_GOV

• Washington D.C. Veterans Affairs Medical Center

  collaborator FED

• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

  collaborator NETWORK

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• US Department of Veterans Affairs

  collaborator FED

• Prevention and Early Treatment of Acute Lung Injury

  collaborator OTHER

• Cardiothoracic Surgical Trials Network

  collaborator OTHER

• Eli Lilly and Company

  collaborator INDUSTRY

• Vir Biotechnology, Inc.

  collaborator INDUSTRY

• GlaxoSmithKline

  collaborator INDUSTRY

• Brii Biosciences Limited

  collaborator INDUSTRY

• AstraZeneca

  collaborator INDUSTRY

• Molecular Partners AG

  collaborator INDUSTRY

• Pfizer

  collaborator INDUSTRY

• University of Minnesota

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Prof. Jens Lundgren · INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen

• Prof. James Neaton · INSIGHT Statistical and Coordinating Centre, University of Minnesota

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-04

Primary Completion

2022-04-06

Completion

2023-07-14

FDA Drug

Yes

Countries

• United States
• Denmark
• Greece
• Nigeria
• Poland
• Singapore
• Spain
• Switzerland
• Uganda
• United Kingdom

Study Locations