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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
4,568 Previous Clinical Trials
10,911,450 Total Patients Enrolled
67 Trials studying COVID-19
1,438,247 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,092,618 Total Patients Enrolled
49 Trials studying COVID-19
1,427,024 Patients Enrolled for COVID-19

Media Library

Nirmatrelvir (Protease Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05567952 — Phase 2
COVID-19 Research Study Groups: nirmatrelvir plus ritonavir for 5 days, placebo plus ritonavir for 5 days
COVID-19 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities for participants to join this trial?

"According to the clinicaltrials.gov database, this medical trial is actively recruiting participants. Since its inception on October 19th 2022, there has been one update made on November 8th of that same year."

Answered by AI

How many health care facilities are implementing this research endeavor?

"The present medical study is inviting participants from 11 different sites, among them Tampa, Wilmington and Redmond. To minimize the need for travel during your involvement in this trial, it's advisable to select a centre closest to you."

Answered by AI

Has the consumption of nirmatrelvir in tandem with ritonavir for a period of five days been legally sanctioned by the FDA?

"Our experts at Power estimated the safety of nirmatrelvir plus ritonavir for 5 days to be a 2 due to this being a Phase 2 clinical trial, with existing data indicating its safety but not yet any proof of efficacy."

Answered by AI

How many participants are included in the current trial?

"This trial mandates 411 participants who satisfy the predetermined inclusionary requirements. Said individuals can register for this clinical test from Innova Pharma Research in Tampa, North carolina and Santos Research Center based in Wilmington, Washington."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Smart Cures Clinical Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
A Study to Learn About a Repeat 5-Day Treatment With the Study Medicines (Called Nirmatrelvir/Ritonavir) in People 12 Years Old or Older With Return of COVID-19 Symptoms and SARS-CoV-2 Positivity After Finishing Treatment With Nirmatrelvir/Ritonavir
2022. "A Study to Learn About a Repeat 5-Day Treatment With the Study Medicines (Called Nirmatrelvir/Ritonavir) in People 12 Years Old or Older With Return of COVID-19 Symptoms and SARS-CoV-2 Positivity After Finishing Treatment With Nirmatrelvir/Ritonavir". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05567952.
~174 spots leftby Apr 2025
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