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
NCT ID: NCT05567952
Last Updated: 2024-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
436 participants
INTERVENTIONAL
2022-10-19
2024-02-09
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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nirmatrelvir plus ritonavir for 5 days
Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days
nirmatrelvir
Participants will receive 2 tablets of nirmatrelvir every 12 hours
ritonavir
Participants will receive 1 capsule of ritonavir every 12 hours
placebo plus ritonavir for 5 days
placebo (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days
ritonavir
Participants will receive 1 capsule of ritonavir every 12 hours
placebo for nirmatrelvir
Participants will receive 2 tablets of placebo for nirmatrelvir every 12 hours. A placebo does not have any medicine in it but looks just like the medicine being studied.
Interventions
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nirmatrelvir
Participants will receive 2 tablets of nirmatrelvir every 12 hours
ritonavir
Participants will receive 1 capsule of ritonavir every 12 hours
placebo for nirmatrelvir
Participants will receive 2 tablets of placebo for nirmatrelvir every 12 hours. A placebo does not have any medicine in it but looks just like the medicine being studied.
Eligibility Criteria
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Inclusion Criteria
* Onset of rebound in COVID-19 symptoms within 2 weeks (14 days) after the completion of the initial 5-day course of nirmatrelvir/ritonavir.
* Onset of rebound in signs/symptoms attributable to COVID-19 within 48 hours prior to randomization and ≥1 sign/symptom attributable to COVID-19 present on the day of randomization.
* SARS-CoV-2 infection 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.
Exclusion Criteria
* History of severe chronic liver disease
* Receiving dialysis or have known age-specific estimated glomerular filtration rate (eGFR) or estimated creatinine clearance (eCrCl) \<30 mL/min/1.73 m2 at screening as measured by a serum creatinine point of care device
* Oxygen saturation of \<92% on room air obtained at rest within 24 hours prior to randomization
* Immunocompromised.
* Current use of any prohibited concomitant medication(s)
* Females who are pregnant and \<14 weeks gestation
12 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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The Institute for Liver Health dba Arizona Clinical Trials
Mesa, Arizona, United States
Abby's Research institute
Phoenix, Arizona, United States
Epic Medical Research - Surprise
Surprise, Arizona, United States
Smart Cures Clinical Research
Anaheim, California, United States
Hope Clinical Research, Inc.
Canoga Park, California, United States
Ascada Health PC dba Ascada Research
Fullerton, California, United States
Ascada Research
Fullerton, California, United States
Paradigm Clinical Research Centers, Inc
La Mesa, California, United States
CVS Health - 8876 - Long Beach
Long Beach, California, United States
Carbon Health - North Hollywood - NoHo West
North Hollywood, California, United States
Paradigm Clinical Research Centers, Inc
Wheat Ridge, Colorado, United States
Emerson Clinical Research Institute - Washington - Connecticut Avenue
Washington D.C., District of Columbia, United States
Emerson Clinical Research Institute
Washington D.C., District of Columbia, United States
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
Brandon, Florida, United States
Herco Medical and Research Center Inc
Coral Gables, Florida, United States
NeoClinical Research
Hialeah, Florida, United States
Sweet Hope Research Specialty, Inc
Hialeah, Florida, United States
Unlimited Medical Research Group LLC
Hialeah Gardens, Florida, United States
Asclepes Research Center - Spring Hill
Lutz, Florida, United States
LCC Medical Research Institute
Miami, Florida, United States
Premium Medical Research Corp
Miami, Florida, United States
Global Health Clinical Trials
Miami, Florida, United States
South Florida Research Center
Miami, Florida, United States
Reliant Medical Research
Miami, Florida, United States
Innova Pharma Research
Miami, Florida, United States
Entrust Clinical Research
Miami, Florida, United States
Reed Medical Research
Miami, Florida, United States
Kendall South Medical Center
Miami, Florida, United States
Pro-Care Research Center, Corp.
Miami Gardens, Florida, United States
Omega Research Orlando
Orlando, Florida, United States
NAPA Research
Pompano Beach, Florida, United States
Asclepes Research Center - Spring Hill
Spring Hill, Florida, United States
GCP Research, Global Clinical professionals
St. Petersburg, Florida, United States
Theia Clinical Research - 5th Avenue North
St. Petersburg, Florida, United States
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
Tampa, Florida, United States
Santos Research Center
Tampa, Florida, United States
Clinical Site Partners, LLC dba CSP Orlando
Winter Park, Florida, United States
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, United States
Bingham Memorial Hospital
Blackfoot, Idaho, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Centennial Medical Group
Elkridge, Maryland, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
C.S. Mott Clinical Research Center (CRC)
Detroit, Michigan, United States
Beaumont Infectious Diseases Research
Royal Oak, Michigan, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States
Mercury Street Medical Group, PLLC
Butte, Montana, United States
Excel Clinical Research, LLC
Las Vegas, Nevada, United States
CVS Health - Site 02815 East Brunswick
East Brunswick, New Jersey, United States
Hackensack Meridian Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Montefiore Medical Center
The Bronx, New York, United States
Onsite Clinical Solutions (secondary location)
Charlotte, North Carolina, United States
OnSite Clinical Solutions
Charlotte, North Carolina, United States
Accellacare - Wilmington
Wilmington, North Carolina, United States
WellNow Urgent Care and Research - Columbus
Columbus, Ohio, United States
Willamette Valley Clinical Studies
Eugene, Oregon, United States
Heritage Valley Multispecialty Group, Inc
Beaver, Pennsylvania, United States
Premier Primary Care
Union City, Tennessee, United States
Nayak Research, LLC
Andrews, Texas, United States
Headlands Research - Brownsville
Brownsville, Texas, United States
Southwest Family Medicine Associates
Dallas, Texas, United States
Next Innovative Clinical Research
Houston, Texas, United States
Next Level Urgent Care
Houston, Texas, United States
Accurate Clinical Research - East Humble
Humble, Texas, United States
Accurate Clinical Research, Inc
Humble, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Eastside Research Associates
Redmond, Washington, United States
Dawson Clinical Research
Guelph, Ontario, Canada
Hamilton Medical Research Group
Hamilton, Ontario, Canada
Medical Trust Clinics
Oshawa, Ontario, Canada
Winchester District Memorial Hospital
Winchester, Ontario, Canada
Thoracic General Hospital of Athens "I Sotiria"
Athens, Attica, Greece
Evangelismos General Hospital of Athens
Athens, Attikí, Greece
Alexandra General Hospital of Athens
Athens, Attikí, Greece
General Hospital of Athens "Laiko"
Athens, , Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki, , Greece
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
ASST Fatebenefratelli Sacco
Milan, Milano, Italy
A.O.U. Policlinico Paolo Giaccone
Palermo, Sicily, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Far Eastern Memorial Hospital
New Taipei City, NEW Taipei, Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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References
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Zhang W, Terra SG, Weinstein EA, Bramson C, Leister-Tebbe H, Baniecki ML, Guan S, Agyemang A, Antonucci S, Wisemandle W, Hammond J. Retreatment With Nirmatrelvir/Ritonavir Following Return of COVID-19 Symptoms and SARS-CoV-2 Positivity. Clin Infect Dis. 2025 Sep 30:ciaf548. doi: 10.1093/cid/ciaf548. Online ahead of print.
Baniecki ML, Guan S, Rai DK, Yang Q, Lee JT, Hao L, Weinstein E, Hyde C, Cardin RD, Soares H, Hammond J. Integrated virologic analysis of resistance to nirmatrelvir/ritonavir in individuals across four phase 2/3 clinical studies for the treatment of COVID-19. EBioMedicine. 2025 Aug;118:105819. doi: 10.1016/j.ebiom.2025.105819. Epub 2025 Jun 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2022-002827-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C4671042
Identifier Type: -
Identifier Source: org_study_id
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