Phase 3
N=471
Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT06729606 ↗Enrolled (actual)
471
Serious AEs
10.4%
Results posted
Oct 2025
Primary outcome: Primary: Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90 — 36; 31; 37; 35 Participants — p=0.54
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aviptadil (Biological); Aviptadil Placebo (Biological); Corticosteroid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a 6-category Primary Ordinal Outcome (Recovery) at Day 90 |
36; 31; 37; 35; 43; 32 | 0.54 |
| SECONDARY Number of Participants Who Died Through Day 90 |
86; 83 | 0.78 |
| SECONDARY Number of Participants With a Safety Outcome Through Day 5 |
146; 129 | 0.10 |
| SECONDARY Number of Participants With a Safety Outcome Through Day 28 |
181; 172 | 0.15 |
| SECONDARY Number of Participants Who Died Through Day 180 |
90; 86 | 0.71 |
Summary
This study looks at the safety and effectiveness of Aviptadil in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with Aviptadil plus current standard of care (SOC), or with placebo plus current SOC.
Eligibility Criteria
Inclusion Criteria
Refer to the master protocol (NCT04843761)
Exclusion Criteria
Refer to the master protocol (NCT04843761)
Additional Exclusion Criteria:
- Refractory hypotension
- Severe diarrhea
- Current C. difficile infection
- Pregnancy or current breast-feeding
- End-stage liver disease
Data sourced from ClinicalTrials.gov (NCT06729606). 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.