drugset / Trial / NCT06729606
Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)
Phase 3
Completed
471 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · collabInternational Network for Strategic Initiatives in Global HIV Trials (INSIGHT) · collabKirby Institute · collabMedical Research Council · collabNeuroRx, Inc. · collabPrevention and Early Treatment of Acute Lung Injury (PETAL) Network · collabUS Department of Veterans Affairs · collabUniversity of Copenhagen · collabWashington D.C. Veterans Affairs Medical Center · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2021-04-20
- Primary completion
- 2022-08-22
- Completion
- 2022-11-20
Outcome
Missed primary endpoint
registry analysis (superiority test); Aviptadil + SOC vs Placebo + SOC; p = 0.54; Odds Ratio (OR) 1.11 (95% CI 0.80 to 1.55) NCT06729606 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aviptadil | Peptide | — | Intravenous |
| Background | Dexamethasone | Small molecule | — | — |
| Background | Hydrocortisone | Other / unclassified | — | — |
| Background | Methylprednisolone | Other / unclassified | — | — |
| Background | Prednisone | Other / unclassified | — | — |