nirmatrelvir plus ritonavir for 5 days for COVID19 (disease)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
COVID19 (disease)+3 More
ritonavir - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to learn about the safety and effects of nirmatrelvir/ritonavir for the potential treatment of COVID-19 rebound. The study is seeking participants who: Have completed treatment with nirmatrelvir/ritonavir Have a rebound in COVID-19 symptoms Are SARS-CoV-2 (COVID-19) positive All study medications will be taken 2 times a day by mouth for 5 days. The first dose of study medication is taken at the study clinic and the rest at home. We will examine the experiences of people receiving the study medicines to those who do not. This will help us determine if the study medicines are safe and effective. People taking part will be in this study for about 24 weeks. Enrolled participants will need to visit the study clinic at least 8 times during the study.

Eligible Conditions
  • COVID19 (disease)
  • COVID-19

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Day 1 through Day 28

Baseline to Day 5
Body Weight Changes
Day 28
Time to 2 consecutive negative rapid antigen test results obtained at least 24 hours apart through Day 28
Time to sustained alleviation of all targeted signs and symptoms defined as the first of two consecutive days when symptoms scored moderate/severe at baseline are scored mild/absent and symptoms scored mild/absent at baseline are scored absent.
Week 24
Incidence of serious adverse events and adverse events leading to discontinuation.
Therapeutic procedure

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

nirmatrelvir plus ritonavir for 5 days
1 of 1

Experimental Treatment

411 Total Participants · 1 Treatment Group

Primary Treatment: nirmatrelvir plus ritonavir for 5 days · Has Placebo Group · Phase 2

nirmatrelvir plus ritonavir for 5 daysExperimental Group · 2 Interventions: ritonavir, nirmatrelvir · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ritonavir
2011
Completed Phase 4
~2020

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 through day 28

Who is running the clinical trial?

PfizerLead Sponsor
4,263 Previous Clinical Trials
7,107,732 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,251 Previous Clinical Trials
4,823,242 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patient-reported 100% compliance with nirmatrelvir/ritonavir treatment.
You are infected with SARS-CoV-2 as determined by rapid antigen testing within 24 hours prior to randomization.
At least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: November 26th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.