Clinical trial NCT05567952: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Coronavirus disease 2019 (COVID-19)
COVID-19 rebound
Paxlovid
Nirmatrelvir
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-10-05
Enrollment: 436
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline to Day 5 in Viral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) Level in Nasopharyngeal (NP) Swabs: mITT Population
timeFrame: Baseline, Day 5
Secondary outcomes:
measure: Time to Two Consecutive Negative Rapid Antigen Test (RAT) Results At Least 24 Hours Apart Through Day 28: mITT Population
timeFrame: Day 1 of dosing maximum up to Day 28 or censoring date, whichever occurred first
measure: Time to Sustained Alleviation of All Targeted Signs and Symptoms Through Day 28: mITT Population
timeFrame: Day 1 of dosing maximum up to Day 28 or censoring date, whichever occurred first
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Discontinuation From Study
timeFrame: Day 1 of dosing up to maximum Week 24 follow-up
Other outcomes:
Locations:
city: Mesa
country: United States
facility: The Institute for Liver Health dba Arizona Clinical Trials
state: Arizona
city: Phoenix
country: United States
facility: Abby's Research institute
state: Arizona
city: Surprise
country: United States
facility: Epic Medical Research - Surprise
state: Arizona
city: Anaheim
country: United States
facility: Smart Cures Clinical Research
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research, Inc.
state: California
city: Fullerton
country: United States
facility: Ascada Health PC dba Ascada Research
state: California
city: Fullerton
country: United States
facility: Ascada Research
state: California
city: La Mesa
country: United States
facility: Paradigm Clinical Research Centers, Inc
state: California
city: Long Beach
country: United States
facility: CVS Health - 8876 - Long Beach
state: California
city: North Hollywood
country: United States
facility: Carbon Health - North Hollywood - NoHo West
state: California
city: Wheat Ridge
country: United States
facility: Paradigm Clinical Research Centers, Inc
state: Colorado
city: Washington
country: United States
facility: Emerson Clinical Research Institute - Washington - Connecticut Avenue
state: District of Columbia
city: Washington
country: United States
facility: Emerson Clinical Research Institute
state: District of Columbia
city: Brandon
country: United States
facility: Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
state: Florida
city: Coral Gables
country: United States
facility: Herco Medical and Research Center Inc
state: Florida
city: Hialeah Gardens
country: United States
facility: Unlimited Medical Research Group LLC
state: Florida
city: Hialeah
country: United States
facility: NeoClinical Research
state: Florida
city: Hialeah
country: United States
facility: Sweet Hope Research Specialty, Inc
state: Florida
city: Lutz
country: United States
facility: Asclepes Research Center - Spring Hill
state: Florida
city: Miami Gardens
country: United States
facility: Pro-Care Research Center, Corp.
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Institute
state: Florida
city: Miami
country: United States
facility: Premium Medical Research Corp
state: Florida
city: Miami
country: United States
facility: Global Health Clinical Trials
state: Florida
city: Miami
country: United States
facility: South Florida Research Center
state: Florida
city: Miami
country: United States
facility: Reliant Medical Research
state: Florida
city: Miami
country: United States
facility: Innova Pharma Research
state: Florida
city: Miami
country: United States
facility: Entrust Clinical Research
state: Florida
city: Miami
country: United States
facility: Reed Medical Research
state: Florida
city: Miami
country: United States
facility: Kendall South Medical Center
state: Florida
city: Orlando
country: United States
facility: Omega Research Orlando
state: Florida
city: Pompano Beach
country: United States
facility: NAPA Research
state: Florida
city: Saint Petersburg
country: United States
facility: GCP Research, Global Clinical professionals
state: Florida
city: Saint Petersburg
country: United States
facility: Theia Clinical Research - 5th Avenue North
state: Florida
city: Spring Hill
country: United States
facility: Asclepes Research Center - Spring Hill
state: Florida
city: Tampa
country: United States
facility: Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
state: Florida
city: Tampa
country: United States
facility: Santos Research Center
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, LLC dba CSP Orlando
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, LLC dba Flourish Research
state: Florida
city: Blackfoot
country: United States
facility: Bingham Memorial Hospital
state: Idaho
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Detroit
country: United States
facility: C.S. Mott Clinical Research Center (CRC)
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Infectious Diseases Research
state: Michigan
city: Olive Branch
country: United States
facility: Olive Branch Family Medical Center
state: Mississippi
city: Butte
country: United States
facility: Mercury Street Medical Group, PLLC
state: Montana
city: Las Vegas
country: United States
facility: Excel Clinical Research, LLC
state: Nevada
city: East Brunswick
country: United States
facility: CVS Health - Site 02815 East Brunswick
state: New Jersey
city: Neptune
country: United States
facility: Hackensack Meridian Jersey Shore University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Charlotte
country: United States
facility: Onsite Clinical Solutions (secondary location)
state: North Carolina
city: Charlotte
country: United States
facility: OnSite Clinical Solutions
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare - Wilmington
state: North Carolina
city: Columbus
country: United States
facility: WellNow Urgent Care and Research - Columbus
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Clinical Studies
state: Oregon
city: Beaver
country: United States
facility: Heritage Valley Multispecialty Group, Inc
state: Pennsylvania
city: Union City
country: United States
facility: Premier Primary Care
state: Tennessee
city: Andrews
country: United States
facility: Nayak Research, LLC
state: Texas
city: Brownsville
country: United States
facility: Headlands Research - Brownsville
state: Texas
city: Dallas
country: United States
facility: Southwest Family Medicine Associates
state: Texas
city: Houston
country: United States
facility: Next Innovative Clinical Research
state: Texas
city: Houston
country: United States
facility: Next Level Urgent Care
state: Texas
city: Humble
country: United States
facility: Accurate Clinical Research - East Humble
state: Texas
city: Humble
country: United States
facility: Accurate Clinical Research, Inc
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Redmond
country: United States
facility: Eastside Research Associates
state: Washington
city: Guelph
country: Canada
facility: Dawson Clinical Research
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Medical Research Group
state: Ontario
city: Oshawa
country: Canada
facility: Medical Trust Clinics
state: Ontario
city: Winchester
country: Canada
facility: Winchester District Memorial Hospital
state: Ontario
city: Athens
country: Greece
facility: Thoracic General Hospital of Athens "I Sotiria"
state: Attica
city: Athens
country: Greece
facility: Evangelismos General Hospital of Athens
state: Attikí
city: Athens
country: Greece
facility: Alexandra General Hospital of Athens
state: Attikí
city: Athens
country: Greece
facility: General Hospital of Athens "Laiko"
city: Thessaloniki
country: Greece
facility: AHEPA University General Hospital of Thessaloniki
city: Milano
country: Italy
facility: Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
state: Lombardia
city: Milan
country: Italy
facility: ASST Fatebenefratelli Sacco
state: Milano
city: Palermo
country: Italy
facility: A.O.U. Policlinico Paolo Giaccone
state: Sicilia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
state: NEW Taipei
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: