VIR-7831 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Summary

This study looks at the safety and effectiveness of VIR-7831 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either VIR-7831 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H2.

Conditions

• COVID-19

Interventions

BIOLOGICAL

VIR-7831

VIR-7831 is a fully human neutralizing immunoglobulin G (IgG)-1 kappa monoclonal antibody (mAb) derived from antibody S309 from a survivor of SARS-CoV-1.

BIOLOGICAL

Placebo

Commercially available 0.9% sodium chloride solution

BIOLOGICAL

Remdesivir

Antiviral agent

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

• Vir Biotechnology, Inc.

  collaborator INDUSTRY

• GlaxoSmithKline

  collaborator INDUSTRY

• University of Minnesota

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

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

• James Neaton, Prof. · INSIGHT Statistical and Data Management Center, 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

2020-12-16

Primary Completion

2021-06-09

Completion

2022-10-04

FDA Drug

Yes

Countries

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

Study Locations