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NCT05567952 Clinical Trial

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

COVID-19 Clinical Trial

Official title:
AN INTERVENTIONAL, EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE A REPEAT 5-DAY COURSE OF NIRMATRELVIR/RITONAVIR COMPARED TO PLACEBO/RITONAVIR IN PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH REBOUND OF COVID-19 SYMPTOMS AND RAPID ANTIGEN TEST POSITIVITY

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05567952
Other study ID # C4671042
Secondary ID 2022-002827-36
Status Completed
Phase Phase 2
First received
Last updated
Start date October 19, 2022
Est. completion date February 9, 2024

Study information
Verified date March 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 436
Est. completion date February 9, 2024
Est. primary completion date September 27, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - Documentation of nirmatrelvir/ritonavir treatment with patient-reported 100% compliance. Symptom alleviation or resolution in COVID-19 signs/symptoms followed by a worsening (rebound) of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir - 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: - 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 - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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.

Locations
Country Name City State
Canada 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
Greece Alexandra General Hospital of Athens Athens Attikí
Greece Evangelismos General Hospital of Athens Athens Attikí
Greece General Hospital of Athens "Laiko" Athens
Greece Thoracic General Hospital of Athens "I Sotiria" Athens Attica
Greece AHEPA University General Hospital of Thessaloniki Thessaloniki
Italy ASST Fatebenefratelli Sacco Milan Milano
Italy Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Milano Lombardia
Italy A.O.U. Policlinico Paolo Giaccone Palermo Sicilia
Italy Fondazione IRCCS Policlinico San Matteo Pavia
Taiwan 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
United States Smart Cures Clinical Research Anaheim California
United States Nayak Research, LLC Andrews Texas
United States Great Lakes Research Group, Inc. Bay City Michigan
United States Heritage Valley Multispecialty Group, Inc Beaver Pennsylvania
United States Bingham Memorial Hospital Blackfoot Idaho
United States Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research Brandon Florida
United States Montefiore Medical Center Bronx New York
United States Headlands Research - Brownsville Brownsville Texas
United States Mercury Street Medical Group, PLLC Butte Montana
United States Hope Clinical Research, Inc. Canoga Park California
United States OnSite Clinical Solutions Charlotte North Carolina
United States Onsite Clinical Solutions (secondary location) Charlotte North Carolina
United States University of Chicago Medical Center Chicago Illinois
United States WellNow Urgent Care and Research - Columbus Columbus Ohio
United States Herco Medical and Research Center Inc Coral Gables Florida
United States Southwest Family Medicine Associates Dallas Texas
United States C.S. Mott Clinical Research Center (CRC) Detroit Michigan
United States CVS Health - Site 02815 East Brunswick East Brunswick New Jersey
United States Centennial Medical Group Elkridge Maryland
United States Willamette Valley Clinical Studies Eugene Oregon
United States Ascada Health PC dba Ascada Research Fullerton California
United States Ascada Research Fullerton California
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 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 Paradigm Clinical Research Centers, Inc La Mesa California
United States Excel Clinical Research, LLC Las Vegas Nevada
United States CVS Health - 8876 - Long Beach Long Beach California
United States Asclepes Research Center - Spring Hill Lutz Florida
United States The Institute for Liver Health dba Arizona Clinical Trials Mesa Arizona
United States Entrust Clinical Research Miami Florida
United States Global Health Clinical Trials Miami Florida
United States Innova Pharma Research Miami Florida
United States Kendall South Medical Center Miami Florida
United States LCC Medical Research Institute Miami Florida
United States Premium Medical Research Corp Miami Florida
United States Reed Medical Research Miami Florida
United States Reliant Medical Research Miami Florida
United States South Florida Research Center Miami Florida
United States Pro-Care Research Center, Corp. Miami Gardens Florida
United States Hackensack Meridian Jersey Shore University Medical Center Neptune New Jersey
United States Carbon Health - North Hollywood - NoHo West North Hollywood California
United States Olive Branch Family Medical Center Olive Branch Mississippi
United States Omega Research Orlando Orlando Florida
United States Abby's Research institute Phoenix Arizona
United States NAPA Research Pompano Beach Florida
United States Eastside Research Associates Redmond Washington
United States Beaumont Infectious Diseases Research Royal Oak Michigan
United States GCP Research, Global Clinical professionals Saint Petersburg Florida
United States Theia Clinical Research - 5th Avenue North Saint Petersburg Florida
United States Sun Research Institute San Antonio Texas
United States Asclepes Research Center - Spring Hill Spring Hill Florida
United States Epic Medical Research - Surprise Surprise Arizona
United States Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research Tampa Florida
United States Santos Research Center Tampa Florida
United States Premier Primary Care Union City Tennessee
United States Emerson Clinical Research Institute Washington District of Columbia
United States Emerson Clinical Research Institute - Washington - Connecticut Avenue Washington District of Columbia
United States Paradigm Clinical Research Centers, Inc Wheat Ridge Colorado
United States Accellacare - Wilmington Wilmington North Carolina
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 University of Massachusetts Chan Medical School Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Greece,  Italy,  Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The change in viral SARS-CoV-2 RNA level as measured in nasopharyngeal (NP) swabs To compare the effect of nirmatrelvir/ritonavir to placebo/ritonavir on viral RNA level in NP swabs in participants with mild-to-moderate COVID-19. Baseline to Day 5
Secondary Time to 2 consecutive negative rapid antigen test results obtained at least 24 hours apart through Day 28 To compare the effect of nirmatrelvir/ritonavir to placebo/ritonavir on the duration of viral shedding. Day 1 through Day 28
Secondary 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. To compare the effect of nirmatrelvir/ritonavir to placebo/ritonavir on the duration and severity of signs and symptoms in participants with mild-to-moderate COVID-19. Day 1 through Day 28
Secondary Incidence of treatment emergent adverse events. To describe the safety and tolerability of nirmatrelvir/ritonavir in participants with mild-to-moderate COVID-19. Day 1 through Week 24
Secondary Incidence of serious adverse events and adverse events leading to discontinuation. To describe the safety and tolerability of nirmatrelvir/ritonavir in participants with mild-to-moderate COVID-19. Day 1 through Week 24
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