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Protease Inhibitor
Nirmatrelvir + Ritonavir for COVID-19
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, day 5, day 10, and day 15
Awards & highlights
Study Summary
This trial is testing a medication to see if it can help treat people with COVID-19 who are immunocompromised and may benefit from a longer treatment duration.
Eligible Conditions
- COVID-19
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, day 5, day 10, and day 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, day 5, day 10, and day 15
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants with sustained nasopharyngeal swab SARS-CoV-2 ribonucleic acid (RNA) <lower limit of quantitation (LLOQ) (defined as <2.0 log10 copies/mL).
Secondary outcome measures
Change from baseline in SARS-CoV-2 RNA level in nasopharyngeal swabs and in plasma over time.
Duration of each targeted COVID-19 signs/symptoms.
Incidence of serious adverse events and adverse events leading to discontinuations.
+16 moreSide effects data
From 2011 Phase 4 trial • 25 Patients • NCT012321274%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)
Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI
Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)
Trial Design
3Treatment groups
Experimental Treatment
Group I: Nirmatrelvir plus ritonavir for 5 daysExperimental Treatment4 Interventions
Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days followed by placebo for nirmatrelvir (2 tablets) plus placebo for ritonavir (1 capsule) every 12 hours for 10 days
Group II: Nirmatrelvir plus ritonavir for 15 daysExperimental Treatment2 Interventions
Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 15 days.
Group III: Nirmatrelvir plus ritonavir for 10 daysExperimental Treatment4 Interventions
Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 10 days followed by placebo for nirmatrelvir (2 tablets) plus placebo for ritonavir (1 capsule) every 12 hours for 5 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ritonavir
FDA approved
Placebo for nirmatrelvir
2022
Completed Phase 2
~160
Placebo for ritonavir
2009
Completed Phase 2
~290
Nirmatrelvir
FDA approved
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,716 Total Patients Enrolled
67 Trials studying COVID-19
1,438,526 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,884 Total Patients Enrolled
49 Trials studying COVID-19
1,427,303 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your immune system is not working properly.If you have any signs or symptoms of COVID-19 on the day of enrollment, you will not be able to participate.
Research Study Groups:
This trial has the following groups:- Group 1: Nirmatrelvir plus ritonavir for 5 days
- Group 2: Nirmatrelvir plus ritonavir for 10 days
- Group 3: Nirmatrelvir plus ritonavir for 15 days
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many areas within the state are conducting this research endeavor?
"From San Francisco to Vancouver, the trial encompasses 23 clinics; CRS Outpatient Services UCSF and the Winchester District Memorial Hospital are two notable examples."
Answered by AI
What potential hazards come with taking Ritonavir?
"There is some evidence of safety found in Phase 2 data, so we have assigned Ritonavir a rating of 2."
Answered by AI
Is this project currently open to participants?
"Correct. Clinicaltrials.gov has indicated that this trial is actively looking for participants; the original post was published on August 3rd 2022, with an update made on November 16th 2022."
Answered by AI
What is the current enrollment number for this research endeavor?
"This clinical trial necessitates the participation of 200 qualified individuals. Locations enrolled in this program include CRS Outpatient Services UCSF in California and Vancouver Infectious Diseases Centre located in British Columbia."
Answered by AI
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