Overview

MP0420 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Status:
Active, not recruiting
Trial end date:
2023-05-15
Target enrollment:
0
Participant gender:
All
Summary
This study looks at the safety and effectiveness of MP0420 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either MP0420 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H5.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Minnesota
Collaborators:
AIDS Clinical Trials Group
Cardiothoracic Surgical Trials Network (CTSN)
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
Kirby Institute
Medical Research Council
Molecular Partners AG
National Heart, Lung, and Blood Institute (NHLBI)
Prevention and Early Treatment of Acute Lung Injury (PETAL)
University of Copenhagen
US Department of Veterans Affairs
Washington D.C. Veterans Affairs Medical Center
Treatments:
Remdesivir
Criteria
Inclusion Criteria: Refer to the master protocol (NCT04501978)

Exclusion Criteria: Refer to the master protocol (NCT04501978)

Additional Exclusion Criteria:

1. Pregnant women

2. Nursing mothers

3. 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
11 weeks after receiving MP0420/placebo

4. 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 11 weeks after receiving MP0420/placebo.