A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System
Public ClinicalTrials.gov record NCT05438602. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE NIRMATRELVIR/RITONAVIR IN NONHOSPITALIZED PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH SYMPTOMATIC COVID-19 WHO ARE IMMUNOCOMPROMISED
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Nirmatrelvir/Ritonavir) for the possible treatment of COVID-19. Patients with COVID-19 who have more difficulty in fighting against infections have a higher chance of severe illness. Such patients may benefit from longer treatment durations compared to the standard treatment regimen. The study is seeking participants who: * Have a confirmed COVID-19 infection * Are Immunocompromised * Experience onset of signs/symptoms attributable to the current COVID-19 infection within 5 days prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. In addition, this study will also evaluate the efficacy and safety of a second treatment course of nirmatrelvir/ritonavir in people who experience that their COVID-19 is flaring up within 14 days of having taken a 5-day treatment course of nirmatrelvir/ritonavir. For this group, the study is seeking participants who: * Have a confirmed COVID-19 infection * Experience a worsening of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir * The worsening of COVID-19 symptoms must occur within 14 days after completion of the initial 5-day course of nirmatrelvir/ritonavir * Are Immunocompromised * Experience onset of signs/symptoms attributable to the current COVID-19 infection within 48 hours prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. All participants will be taking the study medicine for either 5, 10, or 15 days. The study medication will be taken by mouth 2 times a day. Participants will take part in this study for about 24 weeks. The first dose of study medication is taken at the study site and the rest at home. Selected participants will need to visit the study site at least 10 times during the study.
Study identification
- NCT ID
- NCT05438602
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 158 participants
Conditions and interventions
Conditions
Interventions
- Nirmatrelvir Drug
- Ritonavir Drug
- Placebo for nirmatrelvir Drug
- Placebo for ritonavir Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2, 2022
- Primary completion
- Jul 16, 2023
- Completion
- Nov 12, 2023
- Last update posted
- Sep 22, 2024
2022 – 2023
United States locations
- U.S. sites
- 25
- U.S. states
- 10
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CRS Outpatient Services UCSF | San Francisco | California | 94143 | — |
| UCSF Helen Diller Medical Center at Parnassus Heights | San Francisco | California | 94143 | — |
| UCSf infectious disease Lab | San Francisco | California | 94143 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| I.V.A.M. Clinical & Investigational Center | Doral | Florida | 33126 | — |
| Qway Research LLC | Hialeah | Florida | 33010 | — |
| Premium Medical Research Corp | Miami | Florida | 33126 | — |
| Global Health Clinical Trials | Miami | Florida | 33135 | — |
| I.V.A.M. Clinical & Investigational Center | Miami | Florida | 33144 | — |
| NAPA Research | Pompano Beach | Florida | 33064 | — |
| Santos Research Center | Tampa | Florida | 33615 | — |
| Emory University Hospital-Georgia Clinical Research Center | Atlanta | Georgia | 30322 | — |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| The Emory Clinic | Atlanta | Georgia | 30322 | — |
| National Institute of Health | Bethesda | Maryland | 20892 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Beaumont Infectious Diseases Research | Royal Oak | Michigan | 48073 | — |
| Revival Research Institute | Sterling Heights | Michigan | 48312 | — |
| MediSearch Clinical Trials | Saint Joseph | Missouri | 64506 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| South Texas Clinical Research | Corpus Christi | Texas | 78404 | — |
| Baylor University Medical Center | Dallas | Texas | 75246 | — |
| North Texas Infectious Diseases Consultants, P.A | Dallas | Texas | 75246 | — |
| Texas Centers for Infectious Disease Associates | Fort Worth | Texas | 76104 | — |
| Fred Hutchinson Cancer Center - COVID Clinical Research Center | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 59 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05438602, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 22, 2024 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05438602 live on ClinicalTrials.gov.