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NCT07013474 · ClinicalTrials.gov registry record · Phase 3
A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised
A Phase 3 study of COVID-19 Infection, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT07013474: Recruiting Phase 3 study of COVID-19 Infection, sponsored by Pfizer.
NCT07013474 is a Phase 3 study of COVID-19 Infection that is actively recruiting participants, run by Pfizer. The registered enrollment target is 300 participants, below the 3,137-participant average among 21 other COVID-19 Infection trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07013474, a Phase 3 study of COVID-19 Infection, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone for the treatment of symptomatic COVID-19 in severely immunocompromised adult participants who are non-hospitalized or are hospitalized for observation or study intervention administration but do not require supplemental oxygen for COVID-19.
Primary Outcome
The difference in the proportion of participants with the composite endpoint of a) Progression to severe COVID-19 or all-cause mortality by Day 38, or b) Evidence of recurrent or persistent SARS-CoV-2 infection
Conditions Studied
Interventions
- DRUG ibuzatrelvir
- DRUG remdesivir
- DRUG placebo for ibuzatrelvir
- DRUG placebo for remdesivir
Study Locations (20)
California
- Hope Clinical Research, Inc. - Canoga Park
- Amicis Research Center - Granada Hills - Granada Hills
- UC Davis CTSC Clinical Research Center - Sacramento
- University of California Davis Health - Sacramento
Colorado
- UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus - Aurora
- University of Colorado Anschutz Medical Campus - Aurora
- University of Colorado Clinical and Translational Research Center - Aurora
- University of Colorado Hospital - Aurora
Florida
- BRP- Hialeah Hospital - Hialeah
- D&H Cancer Research Center LLC - Margate
- Kendall South Medical Center - Miami
Idaho
- Humphreys Diabetes Center - Boise
- St. Luke's Idaho Elks Children's Pavilion - Boise
Illinois
- Northwestern Memorial Hospital - Chicago
- Northwestern University Feinberg School of Medicine - Chicago
Maryland
- Johns Hopkins Hospital - Baltimore
- Jadestone Clinical Research - Silver Spring
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Georgia
- Velocity Clinical Research, Savannah - Savannah
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2025-07-14 |
| Est. Completion | 2027-05-06 |
| Phase | Phase 3 |
What NCT07013474 shows while recruiting
NCT07013474 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 3,137-participant average among 21 other COVID-19 Infection trials with a reported enrollment target (90% lower).
The record links to 1 condition, with COVID-19 Infection appearing as the primary indexed condition, and to 4 interventions - of which ibuzatrelvir is the first listed.
NCT07013474 names 20 study sites across 9 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT07013474 about?
NCT07013474 is a clinical study titled "A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised". This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone for the treatment of symptomatic COVID-19 in severely immunocompromised ...
What is the current status of trial NCT07013474?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2025-07-14. Estimated completion is 2027-05-06.
What conditions does trial NCT07013474 study?
This clinical trial studies the following conditions: COVID-19 Infection.
What interventions are being tested in trial NCT07013474?
The interventions under investigation include: ibuzatrelvir (DRUG), remdesivir (DRUG), placebo for ibuzatrelvir (DRUG), placebo for remdesivir (DRUG).
Who is sponsoring clinical trial NCT07013474?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07013474 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for COVID-19 Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07013474's enrollment target sits among peer trials
300 12th of 21 higher than 10 of 21 other COVID-19 Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other COVID-19 Infection trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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