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NCT06679140 · ClinicalTrials.gov registry record · Phase 3
A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease
A Phase 3 study of COVID-19, SARS-CoV-2 Infection, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 2,330
- Enrollment target
- 20
- Study locations
NCT06679140: Recruiting Phase 3 study of COVID-19, SARS-CoV-2 Infection, sponsored by Pfizer.
NCT06679140 is a Phase 3 study of COVID-19, SARS-CoV-2 Infection that is actively recruiting participants, run by Pfizer. The registered enrollment target is 2,330 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (202% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06679140, a Phase 3 study of COVID-19, SARS-CoV-2 Infection, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 2,330 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.
Primary Outcome
The difference in proportions of patients requiring COVID 19 related emergency department visits with administration of supplemental oxygen, COVID-19 antiviral or IV treatment (eg hydration, antibiotics, or corticosteroids), all-cause hospitalization, or all-cause death through Day 28 between ibuzatrelvir and placebo, among patients who were treated ≤5 days after COVID-19 symptom onset and who were not receiving background SoC treatment for their COVID-19 infection at baseline.
Conditions Studied
Interventions
- DRUG placebo
- DRUG ibuzatrelvir
Study Locations (20)
California
- National Institute of Clinical Research - Bakersfield - Bakersfield
- 310 Clinical Research - Inglewood
- Long Beach Research Institute - Long Beach
- Long Beach Clinical Trials - Long Beach
- Downtown L.A. Research Center, Inc. - Los Angeles
- Clinica mi Salud by Focil Med - Oxnard
- FOMAT Medical Research - Oxnard
- Paradigm Clinical Research, LLC - Redding
- Acclaim Clinical Research - San Diego
- Tweedy Medical Group - Charity Health - South Gate
- Breathe Clear Institute for Sinus and Allergy Relief - Torrance
Florida
- Innovative Research of West Florida - Clearwater
- Invictus Clinical Research Group - Coconut Creek
- Hillcrest Medical Research LLC - DeLand
- Hillcrest Medical Research - DeLand
- Universal Axon Clinical Research, LLC - Doral
District of Columbia
- Georgetown University Medical Center - Washington D.C.
- Emerson Clinical Research Institute - Washington D.C.
Arkansas
- Applied Research Center of Arkansas - Little Rock
Colorado
- Paradigm Clinical Research, LLC - Wheat Ridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,330 participants |
| Start Date | 2024-12-08 |
| Est. Completion | 2028-03-02 |
| Phase | Phase 3 |
What NCT06679140 shows while recruiting
NCT06679140 is an interventional study that assigns participants to a tested intervention. Its 2,330 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (202% higher).
The record links to 1 condition, with COVID-19, SARS-CoV-2 Infection appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT06679140 names 20 study sites across 5 states, led by California, Florida, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT06679140 about?
NCT06679140 is a clinical study titled "A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease". The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatre...
What is the current status of trial NCT06679140?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 2,330 participants. The study started on 2024-12-08. Estimated completion is 2028-03-02.
What conditions does trial NCT06679140 study?
This clinical trial studies the following conditions: COVID-19, SARS-CoV-2 Infection.
What interventions are being tested in trial NCT06679140?
The interventions under investigation include: placebo (DRUG), ibuzatrelvir (DRUG).
Who is sponsoring clinical trial NCT06679140?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06679140 being conducted?
This trial has 20 study locations across Arkansas, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for COVID-19, SARS-CoV-2 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 NCT06679140's enrollment target sits among peer trials
2,330 92nd of 2000 higher than 1,909 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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