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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
Must not have
Current need for hospitalization, hospitalized for the COVID-19 infection or anticipated need for hospitalization within 24 hours after randomization
History of severe chronic liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 28
Awards & highlights
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not need to be in the hospital now, haven't been for COVID-19, and don't expect to be within 24 hours.
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I have a history of severe liver disease.
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My kidney function is severely reduced.
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My immune system is weak.
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I am not taking any medications that are not allowed in this study.
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I am pregnant and less than 14 weeks along.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through day 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 28
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 moreTrial 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
4,595 Previous Clinical Trials
12,868,334 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,496 Previous Clinical Trials
10,044,943 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My immune system is weak.My COVID-19 symptoms returned or worsened in the last 48 hours and I still have symptoms today.I have fully completed a treatment course with nirmatrelvir/ritonavir.My COVID-19 symptoms got better then worsened after finishing a 5-day nirmatrelvir/ritonavir course.Your oxygen level is less than 92% when you are not active and not using extra oxygen.I am not taking any medications that are not allowed in this study.I am pregnant and less than 14 weeks along.I have a history of severe liver disease.I do not need to be in the hospital now, haven't been for COVID-19, and don't expect to be within 24 hours.My kidney function is severely reduced.You have a health condition that makes you more likely to get very sick from COVID-19.You tested positive for COVID-19 within 24 hours before the study starts.My COVID-19 symptoms returned within 2 weeks after finishing nirmatrelvir/ritonavir treatment.
Research Study Groups:
This trial has the following groups:- Group 1: nirmatrelvir plus ritonavir for 5 days
- Group 2: placebo plus ritonavir for 5 days
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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