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Protease Inhibitor

Nirmatrelvir/Ritonavir for COVID-19 Rebound

Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 28
Awards & highlights

Study Summary

This trial is to study the safety and effects of nirmatrelvir/ritonavir as a potential treatment for COVID-19 rebound. Patients will come to clinic 8 times to take the medicine for 5 days.

Who is the study for?
This trial is for people aged 12 and older who've had COVID-19 symptoms return after completing a course of Nirmatrelvir/Ritonavir. They must have documented compliance with the initial treatment, be at risk for severe illness from COVID-19, and test positive again within two weeks of their first treatment.Check my eligibility
What is being tested?
The study tests if a second 5-day course of Nirmatrelvir/Ritonavir can treat 'COVID-19 rebound', where symptoms return after initial recovery. Participants will take the medication twice daily, comparing its safety and effectiveness against a placebo.See study design
What are the potential side effects?
Possible side effects include digestive issues like diarrhea or nausea, changes in taste, muscle pain, elevated blood pressure, allergic reactions, liver problems. Not everyone will experience these side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Weight Changes
Secondary outcome measures
Incidence of serious adverse events and adverse events leading to discontinuation.
Therapeutic procedure
Time to 2 consecutive negative rapid antigen test results obtained at least 24 hours apart through Day 28
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: placebo plus ritonavir for 5 daysExperimental Treatment2 Interventions
placebo (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days
Group II: nirmatrelvir plus ritonavir for 5 daysExperimental Treatment2 Interventions
Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
nirmatrelvir
2022
Completed Phase 2
~450
ritonavir
2011
Completed Phase 4
~2000
placebo for nirmatrelvir
2022
Completed Phase 2
~440

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,587 Previous Clinical Trials
14,637,426 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,491 Previous Clinical Trials
11,814,178 Total Patients Enrolled

Media Library

Nirmatrelvir (Protease Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05567952 — Phase 2
Coronavirus Research Study Groups: nirmatrelvir plus ritonavir for 5 days, placebo plus ritonavir for 5 days
Coronavirus Clinical Trial 2023: Nirmatrelvir Highlights & Side Effects. Trial Name: NCT05567952 — Phase 2
Nirmatrelvir (Protease Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05567952 — Phase 2
~163 spots leftby Jun 2025