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
Condition(s) studied
Investigational drug(s) / intervention(s)
ibuzatrelvir: ibuzatrelvir tablets
placebo: placebo tablets
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.
Eligibility
Primary outcome measure(s)
- Proportion of participants with COVID-19 related emergency department visits, all cause hospitalization and all cause mortality — Day 1 through Day 28
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.
Trial sites (253)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham, Huntsville Regional Medical Campus (HRMC) | Huntsville | Alabama | Not Yet Recruiting |
| Applied Research Center of Arkansas | Little Rock | Arkansas | Recruiting |
| National Institute of Clinical Research - Bakersfield | Bakersfield | California | Recruiting |
| Velocity Clinical Research, Huntington Park | Huntington Park | California | Recruiting |
| 310 Clinical Research | Inglewood | California | Recruiting |
| Long Beach Research Institute | Long Beach | California | Recruiting |
| Long Beach Clinical Trials | Long Beach | California | Recruiting |
| Pacific Clinical Studies Inc. | Los Alamitos | California | Recruiting |
| Downtown L.A. Research Center, Inc. | Los Angeles | California | Recruiting |
| Clinica mi Salud by Focil Med | Oxnard | California | Recruiting |
| FOMAT Medical Research | Oxnard | California | Recruiting |
| Paradigm Clinical Research, LLC | Redding | California | Recruiting |
| Acclaim Clinical Research | San Diego | California | Active Not Recruiting |
| Tweedy Medical Group - Charity Health | South Gate | California | Recruiting |
| Breathe Clear Institute for Sinus and Allergy Relief | Torrance | California | Recruiting |
| Paradigm Clinical Research, LLC | Wheat Ridge | Colorado | Recruiting |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | Recruiting |
| Emerson Clinical Research Institute | Washington D.C. | District of Columbia | Recruiting |
| Innovative Research of West Florida | Clearwater | Florida | Recruiting |
| Invictus Clinical Research Group | Coconut Creek | Florida | Recruiting |
| Hillcrest Medical Research LLC | DeLand | Florida | Recruiting |
| Hillcrest Medical Research | DeLand | Florida | Recruiting |
| Universal Axon Clinical Research, LLC | Doral | Florida | Recruiting |
| Herco Medical and Research Center Inc | Flagami | Florida | Recruiting |
| Proactive Clinical Research,LLC | Fort Lauderdale | Florida | Recruiting |
| C & R Research Services USA | Fort Myers | Florida | Recruiting |
| Qway Research LLC | Hialeah | Florida | Recruiting |
| Sunbright Health Medical Centers | Homestead | Florida | Recruiting |
| Infinite Clinical Research | Miami | Florida | Recruiting |
| Bio-Medical Research LLC | Miami | Florida | Recruiting |
| Kendall South Medical Center | Miami | Florida | Recruiting |
| Global Health Research Center, Inc. | Miami Lakes | Florida | Recruiting |
| Adult Medicine of Lake County, Inc. | Mt. Dora | Florida | Recruiting |
| Innovation Medical Research Center | Palmetto Bay | Florida | Recruiting |
| DBC Research USA | Pembroke Pines | Florida | Recruiting |
| GCP , Global Clinical Professionals | St. Petersburg | Florida | Recruiting |
| Global Health Research Center - Tampa | Tampa | Florida | Recruiting |
| The Hope Clinic of Emory University | Decatur | Georgia | Recruiting |
| Javara - Privia Medical Group Georgia - Fayetteville | Fayetteville | Georgia | Recruiting |
| Coastal Heritage Clinical Research | Hinesville | Georgia | Recruiting |
+ 213 more sites — see the full list on the official registry below.
More Pfizer trials in Mexico
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06679140 on ClinicalTrials.gov ↗ ← All trials in Mexico