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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

Primary Purpose

COVID-19

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
nirmatrelvir
ritonavir
placebo for nirmatrelvir
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Coronavirus disease 2019 (COVID-19), COVID-19 rebound, Paxlovid, Nirmatrelvir

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Institute for Liver Health dba Arizona Clinical Trials
  • Abby's Research institute
  • Epic Medical Research - Surprise
  • Smart Cures Clinical Research
  • Hope Clinical Research, Inc.
  • Ascada Health PC dba Ascada Research
  • Ascada Research
  • Paradigm Clinical Research Centers, Inc
  • CVS Health - 8876 - Long Beach
  • Carbon Health - North Hollywood - NoHo West
  • Paradigm Clinical Research Centers, Inc
  • Emerson Clinical Research Institute
  • Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
  • Herco Medical and Research Center Inc
  • Unlimited Medical Research Group
  • Sweet Hope Research Specialty, Inc
  • Pro-Care Research Center, Corp.
  • LCC Medical Research Institute
  • Premium Medical Research Corp
  • Global Health Clinical Trials
  • South Florida Research Center
  • Reliant Medical Research
  • Innova Pharma Research
  • Entrust Clinical Research
  • Reed Medical Research
  • Kendall South Medical Center
  • Omega Research Orlando
  • NAPA Research
  • GCP Research, Global Clinical professionals
  • Theia Clinical Research - 5th Avenue North
  • Asclepes Research Center - Spring Hill
  • Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
  • Santos Research Center
  • Clinical Site Partners, LLC dba Flourish Research
  • Bingham Memorial Hospital
  • University of Chicago Medical Center
  • Centennial Medical Group
  • University of Massachusetts Chan Medical School
  • Great Lakes Research Group, Inc.
  • C.S. Mott Clinical Research Center (CRC)
  • Beaumont Infectious Diseases Research
  • Olive Branch Family Medical Center
  • Mercury Street Medical Group, PLLC
  • Excel Clinical Research, LLC
  • CVS Health - Site 02815 East Brunswick
  • Hackensack Meridian Jersey Shore University Medical Center
  • Montefiore Medical Center
  • Onsite Clinical Solutions (secondary location)
  • OnSite Clinical Solutions
  • Accellacare - Wilmington
  • WellNow Urgent Care and Research - Columbus
  • Willamette Valley Clinical Studies
  • Heritage Valley Multispecialty Group, Inc
  • Premier Primary Care
  • Nayak Research, LLC
  • Headlands Research - Brownsville
  • Southwest Family Medicine Associates
  • Next Innovative Clinical Research
  • Next Level Urgent Care
  • Accurate Clinical Research - East Humble
  • Sun Research Institute
  • Eastside Research Associates
  • Dawson Clinical Research
  • Hamilton Medical Research Group
  • Medical Trust Clinics
  • Winchester District Memorial Hospital
  • Thoracic General Hospital of Athens "I Sotiria"
  • Evangelismos General Hospital of Athens
  • Alexandra General Hospital of Athens
  • General Hospital of Athens "Laiko"
  • AHEPA University General Hospital of Thessaloniki
  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
  • ASST Fatebenefratelli Sacco
  • A.O.U. Policlinico Paolo Giaccone
  • Fondazione IRCCS Policlinico San Matteo
  • Far Eastern Memorial Hospital
  • Taichung Veterans General Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

nirmatrelvir plus ritonavir for 5 days

placebo plus ritonavir for 5 days

Arm Description

Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days

placebo (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Incidence of treatment emergent adverse events.
To describe the safety and tolerability of nirmatrelvir/ritonavir in participants with mild-to-moderate COVID-19.
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.

Full Information

First Posted
October 3, 2022
Last Updated
October 13, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05567952
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
September 27, 2023 (Actual)
Study Completion Date
February 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Coronavirus disease 2019 (COVID-19), COVID-19 rebound, Paxlovid, Nirmatrelvir

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
436 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nirmatrelvir plus ritonavir for 5 days
Arm Type
Experimental
Arm Description
Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days
Arm Title
placebo plus ritonavir for 5 days
Arm Type
Other
Arm Description
placebo (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 5 days
Intervention Type
Drug
Intervention Name(s)
nirmatrelvir
Intervention Description
Participants will receive 2 tablets of nirmatrelvir every 12 hours
Intervention Type
Drug
Intervention Name(s)
ritonavir
Intervention Description
Participants will receive 1 capsule of ritonavir every 12 hours
Intervention Type
Drug
Intervention Name(s)
placebo for nirmatrelvir
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change in viral SARS-CoV-2 RNA level as measured in nasopharyngeal (NP) swabs
Description
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.
Time Frame
Baseline to Day 5
Secondary Outcome Measure Information:
Title
Time to 2 consecutive negative rapid antigen test results obtained at least 24 hours apart through Day 28
Description
To compare the effect of nirmatrelvir/ritonavir to placebo/ritonavir on the duration of viral shedding.
Time Frame
Day 1 through Day 28
Title
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.
Description
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.
Time Frame
Day 1 through Day 28
Title
Incidence of treatment emergent adverse events.
Description
To describe the safety and tolerability of nirmatrelvir/ritonavir in participants with mild-to-moderate COVID-19.
Time Frame
Day 1 through Week 24
Title
Incidence of serious adverse events and adverse events leading to discontinuation.
Description
To describe the safety and tolerability of nirmatrelvir/ritonavir in participants with mild-to-moderate COVID-19.
Time Frame
Day 1 through Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
The Institute for Liver Health dba Arizona Clinical Trials
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Abby's Research institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85031
Country
United States
Facility Name
Epic Medical Research - Surprise
City
Surprise
State/Province
Arizona
ZIP/Postal Code
85378
Country
United States
Facility Name
Smart Cures Clinical Research
City
Anaheim
State/Province
California
ZIP/Postal Code
92806
Country
United States
Facility Name
Hope Clinical Research, Inc.
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Ascada Health PC dba Ascada Research
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Ascada Research
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Paradigm Clinical Research Centers, Inc
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
CVS Health - 8876 - Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Carbon Health - North Hollywood - NoHo West
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Paradigm Clinical Research Centers, Inc
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Emerson Clinical Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Facility Name
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Herco Medical and Research Center Inc
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Unlimited Medical Research Group
City
Hialeah Gardens
State/Province
Florida
ZIP/Postal Code
33018
Country
United States
Facility Name
Sweet Hope Research Specialty, Inc
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Pro-Care Research Center, Corp.
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
LCC Medical Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Premium Medical Research Corp
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Global Health Clinical Trials
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
South Florida Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Reliant Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Innova Pharma Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Entrust Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Reed Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Kendall South Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Facility Name
Omega Research Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
NAPA Research
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
GCP Research, Global Clinical professionals
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Theia Clinical Research - 5th Avenue North
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Facility Name
Asclepes Research Center - Spring Hill
City
Spring Hill
State/Province
Florida
ZIP/Postal Code
34609
Country
United States
Facility Name
Palm Harbor Dermatology PA d/b/a TrueBlue Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Santos Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Clinical Site Partners, LLC dba Flourish Research
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Bingham Memorial Hospital
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Centennial Medical Group
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
University of Massachusetts Chan Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
C.S. Mott Clinical Research Center (CRC)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Beaumont Infectious Diseases Research
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Olive Branch Family Medical Center
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Mercury Street Medical Group, PLLC
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Excel Clinical Research, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
CVS Health - Site 02815 East Brunswick
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Facility Name
Hackensack Meridian Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Onsite Clinical Solutions (secondary location)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28208
Country
United States
Facility Name
OnSite Clinical Solutions
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28208
Country
United States
Facility Name
Accellacare - Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
WellNow Urgent Care and Research - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Willamette Valley Clinical Studies
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Heritage Valley Multispecialty Group, Inc
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Premier Primary Care
City
Union City
State/Province
Tennessee
ZIP/Postal Code
38261
Country
United States
Facility Name
Nayak Research, LLC
City
Andrews
State/Province
Texas
ZIP/Postal Code
79714
Country
United States
Facility Name
Headlands Research - Brownsville
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78526
Country
United States
Facility Name
Southwest Family Medicine Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Next Innovative Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77021
Country
United States
Facility Name
Next Level Urgent Care
City
Houston
State/Province
Texas
ZIP/Postal Code
77057
Country
United States
Facility Name
Accurate Clinical Research - East Humble
City
Humble
State/Province
Texas
ZIP/Postal Code
77338
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Eastside Research Associates
City
Redmond
State/Province
Washington
ZIP/Postal Code
98052
Country
United States
Facility Name
Dawson Clinical Research
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1H 1B1
Country
Canada
Facility Name
Hamilton Medical Research Group
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
Medical Trust Clinics
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 4T3
Country
Canada
Facility Name
Winchester District Memorial Hospital
City
Winchester
State/Province
Ontario
ZIP/Postal Code
K0C 2K0
Country
Canada
Facility Name
Thoracic General Hospital of Athens "I Sotiria"
City
Athens
State/Province
Attica
ZIP/Postal Code
11527
Country
Greece
Facility Name
Evangelismos General Hospital of Athens
City
Athens
State/Province
Attikí
ZIP/Postal Code
106 76
Country
Greece
Facility Name
Alexandra General Hospital of Athens
City
Athens
State/Province
Attikí
ZIP/Postal Code
115 28
Country
Greece
Facility Name
General Hospital of Athens "Laiko"
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
AHEPA University General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
ASST Fatebenefratelli Sacco
City
Milan
State/Province
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
A.O.U. Policlinico Paolo Giaccone
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90129
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Far Eastern Memorial Hospital
City
New Taipei City
State/Province
NEW Taipei
ZIP/Postal Code
220
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4671042
Description
To obtain contact information for a study center near you, click here.

Learn more about this 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

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