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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
Confirmed SARS-CoV-2 infection as determined by RT-PCR or other acceptable test method in any specimen collected within 5 days prior to randomization for the main study population
Confirmed SARS-CoV-2 infection as determined by RT-PCR or rapid antigen testing in any specimen collected within 24h prior to randomization and collected within 14 days after the completion of the initial 5-day treatment course of nirmatrelvir/ritonavir for the population with rebound
Must not have
Timeline
Screening 3 weeks
Treatment Varies
Follow Upday 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
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
If you have any signs or symptoms of COVID-19 on the day of enrollment, you will not be able to participate.
Select...
Your immune system is not working properly.
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
2005
Completed Phase 4
~2200
Placebo for ritonavir
2009
Completed Phase 1
~130
Nirmatrelvir
2022
Completed Phase 2
~170
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,513 Previous Clinical Trials
9,894,990 Total Patients Enrolled
61 Trials studying COVID-19
145,029 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,435 Previous Clinical Trials
7,123,946 Total Patients Enrolled
44 Trials studying COVID-19
134,550 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 15 days
- Group 2: Nirmatrelvir plus ritonavir for 10 days
- Group 3: Nirmatrelvir 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.
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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