Phase 3
N=353
BRII-196/BRII-198 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT05780424 ↗Enrolled (actual)
353
Serious AEs
6.8%
Results posted
Feb 2024
Primary outcome: Primary: Number of Participants With an Ordinal Outcome on Day 5 — 1; 1; 4; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BRII-196 (Biological); BRII-198 (Biological); Placebo (Biological); Remdesivir (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Ordinal Outcome on Day 5 |
1; 1; 4; 3; 15; 14 | — |
| SECONDARY Number of Participants Who Died From All Causes |
15; 13 | — |
| SECONDARY Number of Participants With a Safety Outcome Through Day 5 |
46; 43 | — |
| SECONDARY Number of Participants With a Safety Outcome Through Day 28 |
58; 57 | — |
| SECONDARY Number of Participants With a Safety Outcome Through Day 90 |
45; 47 | — |
Summary
This study looks at the safety and effectiveness of BRII-196/BRII-198 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either BRII-196/BRII-198 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H3.
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
- In addition, prior to the initial futility assessment which is performed when approximately 150 participants have been enrolled on BRII-196/BRII-198 and 150 on placebo, patients on high-flow oxygen or non-invasive ventilation (category 5 of the pulmonary ordinal outcome) will be excluded. These patients may be eligible for the trial if the initial futility assessment is passed by this agent.
Data sourced from ClinicalTrials.gov (NCT05780424). 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.