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NCT05438602 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 158
- Enrollment target
NCT05438602 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 158 participants.
The verdict
NCT05438602, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 158 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Ritonavir
- DRUG Placebo for ritonavir
- DRUG Nirmatrelvir
- DRUG Placebo for nirmatrelvir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 158 participants |
| Start Date | 2022-08-03 |
| Est. Completion | 2023-11-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05438602
The ClinicalTrials.gov registry entry for NCT05438602 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 158 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Ritonavir is the first listed.
NCT05438602 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05438602 about?
NCT05438602 is a clinical study titled "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". 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 patie...
What is the current status of trial NCT05438602?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 158 participants. The study started on 2022-08-03. Estimated completion is 2023-11-13.
What interventions are being tested in trial NCT05438602?
The interventions under investigation include: Ritonavir (DRUG), Placebo for ritonavir (DRUG), Nirmatrelvir (DRUG), Placebo for nirmatrelvir (DRUG).
Who is sponsoring clinical trial NCT05438602?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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