Phase 3
N=485
MP0420 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT05780463 ↗Enrolled (actual)
485
Serious AEs
6.6%
Results posted
Feb 2024
Primary outcome: Primary: Number of Participants With Sustained Recovery — 203; 190 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MP0420 (Drug); Placebo (Drug); Remdesivir (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Sustained Recovery |
203; 190 | — |
| PRIMARY Number of Participants With an Ordinal Outcome on Day 5 |
1; 3; 16; 10; 46; 45 | — |
| SECONDARY Number of Participants Who Died From All Causes |
30; 35 | — |
| SECONDARY Number of Participants With a Safety Outcome Through Day 5 |
61; 70 | — |
| SECONDARY Number of Participants With a Safety Outcome Through Day 28 |
85; 97 | — |
| SECONDARY Number of Participants With a Safety Outcome Through Day 90 |
78; 70 | — |
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.
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 11 weeks after receiving MP0420/placebo
- 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.
Data sourced from ClinicalTrials.gov (NCT05780463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.