drugset / Trial / NCT05780541
PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
Phase 3
Terminated
58 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · collabCardiothoracic Surgical Trials Network · collabInternational Network for Strategic Initiatives in Global HIV Trials (INSIGHT) · collabKirby Institute · collabMedical Research Council · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabPfizer · collabPrevention and Early Treatment of Acute Lung Injury · collabUS Department of Veterans Affairs · collabUniversity of Copenhagen · collabUniversity of Minnesota · collabWashington D.C. Veterans Affairs Medical Center · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This study looks at the safety and effectiveness of PF-07304814 in treating COVID-19 in people who have been hospitalized with the infection. Participants in the study will be treated with either PF-07304814 plus current standard of care (SOC), or with placebo plus current SOC. This is ACTIV-3/TICO Treatment Trial H6.
Timeline
- Start
- 2021-09-15
- Primary completion
- 2022-04-06
- Completion
- 2023-07-14
Outcome
Outcome not reported
Stopped: “The agent was withdrawn from development by the manufacturer after being placed on clinical hold by the US FDA.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | lufotrelvir | Small molecule | 250 mg | Intravenous |
| Background | Remdesivir | Small molecule | — | Intravenous |