for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study start
estimated completion



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.

Official Title

A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19 (Trial H5: MP0420)


This is a treatment trial of the ACTIV-3/TICO master protocol (NCT04501978) to evaluate the safety and efficacy of MP0420 in hospitalized patients infected with COVID-19.

This is a randomized, blinded, controlled sub-study of MP0420 plus current standard of care (SOC) against placebo plus current SOC. The placebo arm may be shared across other sub-studies of the ACTIV-3/TICO master protocol. When more than one drug is being tested at the same time, participants will be randomly allocated to treatments or placebo.

Randomization will be stratified by study site pharmacy and disease severity. There are 2 disease severity strata: Participants without organ failure (severity stratum 1) and participants with organ failure (severity stratum 2).

An independent Data and Safety Monitoring Board (DSMB) will regularly review interim analyses and summarize safety and efficacy outcomes. The pace of enrollment with be initially restricted, and there will be an early review of safety data by the DSMB. At the outset of the trial, only participants in disease severity stratum 1 will be enrolled. This will continue until approximately 300 participants are enrolled and followed for 5 days. The exact number will vary according to the speed of enrollment and the timing of DSMB meetings. Prior to expanding enrollment to also include patients in disease severity stratum 2, safety will be evaluated and a pre-specified futility assessment by the DSMB will be carried out using 2 ordinal outcomes assessed at Day 5.

If MP0420 passes the futility assessment, enrollment of participants will be expanded, seamlessly and without any data unblinding, to include participants in disease severity stratum 2 as well as those in disease severity stratum 1. Future interim analyses will be based on the primary endpoint of sustained recovery and will use pre-specified guidelines to determine early evidence of benefit, harm, or futility for the investigational agent. Participants will be followed for 18 months following randomization.

This trial will be conducted in several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs.


COVID-19, COVID 19, Coronaviridae Infections, Coronavirus Infections, RNA Virus Infections, Virus Diseases, Nidovirales Infections, SARS-CoV-2, SARS Coronavirus, ACTIV-3, ACTIV3, TICO, Remdesivir


You can join if…

Open to people ages 18 years and up

Refer to the master protocol (NCT04501978)

You CAN'T join if...

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.


  • VA San Diego Healthcare System (Site 074-016), 3350 La Jolla Village Drive
    San Diego California 92161 United States
  • Velocity San Diego (Site 080-035), 5565 Grossmont Center Drive, Building 2, Suite 1
    La Mesa California 91942 United States
  • Velocity Chula Vista (Site 080-034), 752 Medical Center Ct., Ste. 304
    Chula Vista California 91911 United States


in progress, not accepting new patients
Start Date
Completion Date
National Institute of Allergy and Infectious Diseases (NIAID)
Phase 3 COVID-19 Research Study
Study Type
About 496 people participating
Last Updated