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A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System

Primary Purpose

COVID-19

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nirmatrelvir
Ritonavir
Placebo for nirmatrelvir
Placebo for ritonavir
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), Paxlovid, Nirmatrelvir, Immunocompromised

Eligibility Criteria

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

Inclusion Criteria:

  • Confirmed SARS-CoV-2 infection
  • Immunocompromised
  • Onset of signs/symptoms attributable to the current COVID-19 infection within 5 days prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization.

Exclusion Criteria:

  • Current need for hospitalization or anticipated need for hospitalization within 24 h after randomization
  • Known medical history of active liver disease
  • Known HIV infection with a viral load >400 copies/mL or taking prohibited medications for human immunodeficiency virus (HIV)
  • 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
  • Current use of any prohibited concomitant medication(s)
  • Females who are pregnant and <14 weeks gestation

Sites / Locations

  • CRS Outpatient Services UCSF
  • UCSF Helen Diller Medical Center at Parnassus Heights
  • UCSf infectious disease Lab
  • Georgetown University Medical Center
  • I.V.A.M. Clinical & Investigational Center
  • Qway Research LLC
  • Premium Medical Research Corp
  • Global Health Clinical Trials
  • I.V.A.M. Clinical & Investigational Center
  • NAPA Research
  • Santos Research Center
  • Emory University Hospital-Georgia Clinical Research Center
  • Emory University School of Medicine
  • The Emory Clinic
  • National Institute of Health
  • University of Michigan
  • Beaumont Infectious Diseases Research
  • Revival Research Institute
  • MediSearch Clinical Trials
  • Icahn School of Medicine at Mount Sinai
  • South Texas Clinical Research
  • Baylor University Medical Center
  • North Texas Infectious Diseases Consultants, P.A
  • Texas Centers for Infectious Disease Associates
  • Fred Hutchinson Cancer Center - COVID Clinical Research Center
  • Peter MacCallum Cancer Centre
  • The Royal Melbourne Hospital
  • Royal Melbourne Hospital - Royal Park Campus
  • Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCLIN/RN
  • CECIP - Centro de Estudos do Interior Paulista
  • Fundação Faculdade Regional de Medicina de São José do Rio Preto
  • IBPClin - Instituto Brasil de Pesquisa Clínica
  • Instituto Nacional de Infectologia Evandro Chagas
  • Diagnostic Consultative Center - 1 Lom EOOD
  • Military Medical Academy
  • MHAT Samokov
  • Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Haskovo EOOD
  • MHAT - Heart and Brain
  • Medical Center Artmed
  • MHAT Sveta Karidad EAD
  • Vancouver Infectious Diseases Centre
  • Dawson Clinical Research
  • St. Joseph's Healthcare Hamilton
  • Dr. Anil K. Gupta Medicine Professional Corporation
  • Winchester District Memorial Hospital
  • INTERMED Groupe Sante
  • Clinique Medicale lActuel
  • Diex Recherche Sherbrooke Inc.
  • Diex Recherche Trois-Rivieres Inc.
  • Medifarma 98 Kft
  • Dél-Pesti Centrumkórház Országos Hematológiai és infektológiai intézet, Szent László telep
  • Semmelweis Egyetem
  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • EME RED Hospitalaria
  • Instituto de Investigaciones Clínicas para la Salud
  • Oaxaca Site Management Organization S.C.
  • Instituto Veracruzano en Investigación Clínica S.C.
  • FAICIC S. de R.L. de C.V.
  • REUMEX s.r.o.
  • Narodny onkologicky ustav
  • ALERGIA s.r.o.
  • MUDr. Viliam Cibik, PhD., s.r.o.
  • Univerzitna nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda
  • Univerzitná nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda
  • ARTROMAC n. o.
  • MEDIKOMP, s.r.o
  • Plucna ambulancia Hrebenar s.r.o.
  • Plucna ambulancia Hrebenar, s.r.o.
  • SANARE spol.s.r.o.
  • ALERGIA s.r.o.
  • CHUAC-Complejo Hospitalario Universitario A Coruña
  • Hospital Germans Trias i Pujol
  • Hospital Clínic de Barcelona
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitario Ramón y Cajal
  • CHUVI- Hospital Alvaro Cunqueiro
  • Hospital Clinico de Valencia
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario La Paz
  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
  • Hospital Universitario Virgen de Valme
  • Hospital Clinico Universitario Valencia
  • Hospital Universitari i Politecnic La Fe

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Nirmatrelvir plus ritonavir for 5 days

Nirmatrelvir plus ritonavir for 10 days

Nirmatrelvir plus ritonavir for 15 days

Arm Description

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

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

Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 15 days.

Outcomes

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).
To describe the effect of nirmatrelvir/ritonavir on viral RNA levels in nasopharyngeal swabs over time for the treatment of COVID-19 in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.

Secondary Outcome Measures

Time to first nasopharyngeal swab SARS-CoV-2 RNA<LLOQ (<2.0 log10 copies/mL) for participants with nasopharyngeal swab SARS-CoV-2 RNA ≥LLOQ at baseline.
To describe the effect of nirmatrelvir/ritonavir treatment duration on the rate of sustained virologic clearance in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Time to sustained nasopharyngeal swab SARS-CoV-2 RNA <LLOQ (<2.0 log10 copies/mL) for participants with nasopharyngeal swab SARS-CoV-2 RNA ≥LLOQ at baseline.
To describe the effect of nirmatrelvir/ritonavir treatment duration on the rate of sustained virologic clearance in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Proportion of participants with SARS-CoV-2 RNA <LLOQ in plasma over time.
To describe the effect of nirmatrelvir/ritonavir on viral clearance for the treatment of COVID-19 in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Proportion of participants with SARS-CoV-2 RNA level in nasopharyngeal swabs <2.0 log10 copies/mL at each study visit.
To describe the effect of nirmatrelvir/ritonavir on viral clearance for the treatment of COVID-19 in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Change from baseline in SARS-CoV-2 RNA level in nasopharyngeal swabs and in plasma over time.
To describe the effect of nirmatrelvir/ritonavir on viral clearance for the treatment of COVID-19 in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Rebound in SARS-CoV-2 RNA level in nasopharyngeal swabs at follow up, defined as a half (0.5) log10 copies/mL increase or greater in SARS-CoV-2 RNA level, with a follow-up viral RNA level ≥2.5 log10 copies/mL
To describe the effect of nirmatrelvir/ritonavir on viral clearance for the treatment of COVID-19 in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Incidence of treatment emergent adverse events.
To describe the safety and tolerability of nirmatrelvir/ritonavir for the treatment of COVID-19 in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Incidence of serious adverse events and adverse events leading to discontinuations.
To describe the safety and tolerability of nirmatrelvir/ritonavir for the treatment of COVID-19 in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Proportion of participants with COVID-19-related hospitalization >24 hours, or death from any cause.
To describe the effect of nirmatrelvir/ritonavir on hospitalization and all-cause mortality in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Proportion of participants with death (all cause).
To describe the effect of nirmatrelvir/ritonavir on hospitalization and all-cause mortality in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Proportion of participants with COVID-19-related hospitalization of any duration.
To describe COVID-19 related healthcare resource utilization in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised and treated with nirmatrelvir/ritonavir.
Proportion of participants with COVID-19-related intensive care unit (ICU) admission of any duration.
To describe COVID-19 related healthcare resource utilization in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised and treated with nirmatrelvir/ritonavir.
Proportion of participants requiring invasive mechanical ventilation or Extracorporeal membrane oxygenation.
To describe COVID-19 related healthcare resource utilization in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised and treated with nirmatrelvir/ritonavir.
Number of days in hospital and ICU stay in participants with COVID-19-related hospitalization.
To describe COVID-19 related healthcare resource utilization in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised and treated with nirmatrelvir/ritonavir.
Plasma concentration of nirmatrelvir
Plasma concentration of ritonavir
Number of COVID-19-related medical visits through Day 44 and through Week 24.
To describe COVID-19 related healthcare resource utilization in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised and treated with nirmatrelvir/ritonavir.
Duration of each targeted COVID-19 signs/symptoms.
To evaluate nirmatrelvir/ritonavir for the duration and severity of signs and symptoms in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Proportion of participants with severe signs/symptoms attributed to COVID-19.
To evaluate nirmatrelvir/ritonavir for the duration and severity of signs and symptoms in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.

Full Information

First Posted
June 28, 2022
Last Updated
September 8, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05438602
Brief Title
A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System
Official Title
AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE NIRMATRELVIR/RITONAVIR IN NONHOSPITALIZED PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH SYMPTOMATIC COVID-19 WHO ARE IMMUNOCOMPROMISED
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
July 17, 2023 (Actual)
Study Completion Date
November 20, 2023 (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

5. Study Description

Brief Summary
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Nirmatrelvir/Ritonavir) for the possible treatment of COVID-19. Patients with COVID-19 who have more difficulty in fighting against infections have a higher chance of severe illness. Such patients may benefit from longer treatment durations compared to the standard treatment regimen. The study is seeking participants who: Have a confirmed COVID-19 infection Are Immunocompromised Experience onset of signs/symptoms attributable to the current COVID-19 infection within 5 days prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. In addition, this study will also evaluate the efficacy and safety of a second treatment course of nirmatrelvir/ritonavir in people who experience that their COVID-19 is flaring up within 14 days of having taken a 5-day treatment course of nirmatrelvir/ritonavir. For this group, the study is seeking participants who: Have a confirmed COVID-19 infection Experience a worsening of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir The worsening of COVID-19 symptoms must occur within 14 days after completion of the initial 5-day course of nirmatrelvir/ritonavir Are Immunocompromised Experience onset of signs/symptoms attributable to the current COVID-19 infection within 48 hours prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. All participants will be taking the study medicine for either 5, 10, or 15 days. The study medication will be taken by mouth 2 times a day. Participants will take part in this study for about 24 weeks. The first dose of study medication is taken at the study site and the rest at home. Selected participants will need to visit the study site at least 10 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), Paxlovid, Nirmatrelvir, Immunocompromised

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
131 (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 followed by placebo for nirmatrelvir (2 tablets) plus placebo for ritonavir (1 capsule) every 12 hours for 10 days
Arm Title
Nirmatrelvir plus ritonavir for 10 days
Arm Type
Experimental
Arm Description
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
Arm Title
Nirmatrelvir plus ritonavir for 15 days
Arm Type
Experimental
Arm Description
Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 15 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.
Intervention Type
Drug
Intervention Name(s)
Placebo for ritonavir
Intervention Description
Participants will receive 1 capsule of placebo for ritonavir 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
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).
Description
To describe the effect of nirmatrelvir/ritonavir on viral RNA levels in nasopharyngeal swabs over time for the treatment of COVID-19 in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Time Frame
From Day 15 through Day 44
Secondary Outcome Measure Information:
Title
Time to first nasopharyngeal swab SARS-CoV-2 RNA<LLOQ (<2.0 log10 copies/mL) for participants with nasopharyngeal swab SARS-CoV-2 RNA ≥LLOQ at baseline.
Description
To describe the effect of nirmatrelvir/ritonavir treatment duration on the rate of sustained virologic clearance in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Time Frame
Day 1 through Week 24
Title
Time to sustained nasopharyngeal swab SARS-CoV-2 RNA <LLOQ (<2.0 log10 copies/mL) for participants with nasopharyngeal swab SARS-CoV-2 RNA ≥LLOQ at baseline.
Description
To describe the effect of nirmatrelvir/ritonavir treatment duration on the rate of sustained virologic clearance in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Time Frame
Day 1 through Day 44
Title
Proportion of participants with SARS-CoV-2 RNA <LLOQ in plasma over time.
Description
To describe the effect of nirmatrelvir/ritonavir on viral clearance for the treatment of COVID-19 in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Time Frame
Day 1 through Week 24
Title
Proportion of participants with SARS-CoV-2 RNA level in nasopharyngeal swabs <2.0 log10 copies/mL at each study visit.
Description
To describe the effect of nirmatrelvir/ritonavir on viral clearance for the treatment of COVID-19 in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Time Frame
Day 1 through Day 44
Title
Change from baseline in SARS-CoV-2 RNA level in nasopharyngeal swabs and in plasma over time.
Description
To describe the effect of nirmatrelvir/ritonavir on viral clearance for the treatment of COVID-19 in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Time Frame
Day 1 through Week 24
Title
Rebound in SARS-CoV-2 RNA level in nasopharyngeal swabs at follow up, defined as a half (0.5) log10 copies/mL increase or greater in SARS-CoV-2 RNA level, with a follow-up viral RNA level ≥2.5 log10 copies/mL
Description
To describe the effect of nirmatrelvir/ritonavir on viral clearance for the treatment of COVID-19 in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Time Frame
End of treatment through Day 44
Title
Incidence of treatment emergent adverse events.
Description
To describe the safety and tolerability of nirmatrelvir/ritonavir for the treatment of COVID-19 in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Time Frame
Day 1 through Week 24
Title
Incidence of serious adverse events and adverse events leading to discontinuations.
Description
To describe the safety and tolerability of nirmatrelvir/ritonavir for the treatment of COVID-19 in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Time Frame
Day 1 through Week 24
Title
Proportion of participants with COVID-19-related hospitalization >24 hours, or death from any cause.
Description
To describe the effect of nirmatrelvir/ritonavir on hospitalization and all-cause mortality in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Time Frame
Day 1 through Day 28
Title
Proportion of participants with death (all cause).
Description
To describe the effect of nirmatrelvir/ritonavir on hospitalization and all-cause mortality in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Time Frame
Day 1 through Week 24
Title
Proportion of participants with COVID-19-related hospitalization of any duration.
Description
To describe COVID-19 related healthcare resource utilization in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised and treated with nirmatrelvir/ritonavir.
Time Frame
Day 1 through Week 24
Title
Proportion of participants with COVID-19-related intensive care unit (ICU) admission of any duration.
Description
To describe COVID-19 related healthcare resource utilization in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised and treated with nirmatrelvir/ritonavir.
Time Frame
Day 1 through Week 24
Title
Proportion of participants requiring invasive mechanical ventilation or Extracorporeal membrane oxygenation.
Description
To describe COVID-19 related healthcare resource utilization in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised and treated with nirmatrelvir/ritonavir.
Time Frame
Day 1 through Week 24
Title
Number of days in hospital and ICU stay in participants with COVID-19-related hospitalization.
Description
To describe COVID-19 related healthcare resource utilization in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised and treated with nirmatrelvir/ritonavir.
Time Frame
Day 1 through Week 24
Title
Plasma concentration of nirmatrelvir
Time Frame
Day 1, Day 5, Day 10, and Day 15
Title
Plasma concentration of ritonavir
Time Frame
Day 1, Day 5, Day 10, and Day 15
Title
Number of COVID-19-related medical visits through Day 44 and through Week 24.
Description
To describe COVID-19 related healthcare resource utilization in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised and treated with nirmatrelvir/ritonavir.
Time Frame
Day 1 through Day 44 and Week 24
Title
Duration of each targeted COVID-19 signs/symptoms.
Description
To evaluate nirmatrelvir/ritonavir for the duration and severity of signs and symptoms in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Time Frame
Day 1 through Day 44
Title
Proportion of participants with severe signs/symptoms attributed to COVID-19.
Description
To evaluate nirmatrelvir/ritonavir for the duration and severity of signs and symptoms in nonhospitalized symptomatic participants ≥12 years of age with COVID-19 who are immunocompromised.
Time Frame
Day 1 through Day 44

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (applicable for both the main population and population with rebound): Participants aged 12 years or older and weighing ≥40 kg at screening. Immunocompromised ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. Participants for the main population 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. Participants form the rebound population must have: - 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. Exclusion Criteria: Current need for hospitalization or anticipated need for hospitalization within 24 h after randomization Known medical history of active liver disease Known HIV infection with a viral load >400 copies/mL or taking prohibited medications for human immunodeficiency virus (HIV) 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 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
CRS Outpatient Services UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
UCSF Helen Diller Medical Center at Parnassus Heights
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
UCSf infectious disease Lab
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
I.V.A.M. Clinical & Investigational Center
City
Doral
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Qway Research LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33010
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
I.V.A.M. Clinical & Investigational Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
NAPA Research
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Santos Research Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Emory University Hospital-Georgia Clinical Research Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
National Institute of Health
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Beaumont Infectious Diseases Research
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Revival Research Institute
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48312
Country
United States
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
South Texas Clinical Research
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
North Texas Infectious Diseases Consultants, P.A
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Centers for Infectious Disease Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Fred Hutchinson Cancer Center - COVID Clinical Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Royal Melbourne Hospital - Royal Park Campus
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCLIN/RN
City
Natal
State/Province
RIO Grande DO Norte
ZIP/Postal Code
59025050
Country
Brazil
Facility Name
CECIP - Centro de Estudos do Interior Paulista
City
Jau
State/Province
SÃO Paulo
ZIP/Postal Code
17201130
Country
Brazil
Facility Name
Fundação Faculdade Regional de Medicina de São José do Rio Preto
City
São José do Rio Preto
State/Province
SÃO Paulo
ZIP/Postal Code
15090000
Country
Brazil
Facility Name
IBPClin - Instituto Brasil de Pesquisa Clínica
City
Rio de Janeiro
ZIP/Postal Code
20241-180
Country
Brazil
Facility Name
Instituto Nacional de Infectologia Evandro Chagas
City
Rio de Janeiro
ZIP/Postal Code
21040-360
Country
Brazil
Facility Name
Diagnostic Consultative Center - 1 Lom EOOD
City
Lom
State/Province
Montana
ZIP/Postal Code
3600
Country
Bulgaria
Facility Name
Military Medical Academy
City
Sofia
State/Province
Sofia (stolitsa)
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
MHAT Samokov
City
Samokov
State/Province
Sofia
ZIP/Postal Code
2000
Country
Bulgaria
Facility Name
Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Haskovo EOOD
City
Haskovo
ZIP/Postal Code
6305
Country
Bulgaria
Facility Name
MHAT - Heart and Brain
City
Pleven
ZIP/Postal Code
5804
Country
Bulgaria
Facility Name
Medical Center Artmed
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
MHAT Sveta Karidad EAD
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Vancouver Infectious Diseases Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2C7
Country
Canada
Facility Name
Dawson Clinical Research
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1H 1B1
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Dr. Anil K. Gupta Medicine Professional Corporation
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
Facility Name
Winchester District Memorial Hospital
City
Winchester
State/Province
Ontario
ZIP/Postal Code
K0C 2K0
Country
Canada
Facility Name
INTERMED Groupe Sante
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7Y8
Country
Canada
Facility Name
Clinique Medicale lActuel
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4P9
Country
Canada
Facility Name
Diex Recherche Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
Diex Recherche Trois-Rivieres Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
Medifarma 98 Kft
City
Nyiregyhaza
State/Province
Szabolcs-szatmár-bereg
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Dél-Pesti Centrumkórház Országos Hematológiai és infektológiai intézet, Szent László telep
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
Nuevo LEÓN
ZIP/Postal Code
66460
Country
Mexico
Facility Name
EME RED Hospitalaria
City
Mérida
State/Province
Yucatán
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Instituto de Investigaciones Clínicas para la Salud
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Oaxaca Site Management Organization S.C.
City
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Facility Name
Instituto Veracruzano en Investigación Clínica S.C.
City
Veracruz
ZIP/Postal Code
91851
Country
Mexico
Facility Name
FAICIC S. de R.L. de C.V.
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
REUMEX s.r.o.
City
Rimavska Sobota
State/Province
Banskobystricky KRAJ
ZIP/Postal Code
979 01
Country
Slovakia
Facility Name
Narodny onkologicky ustav
City
Bratislava
State/Province
Bratislavský KRAJ
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
ALERGIA s.r.o.
City
Topolcany
State/Province
Nitriansky KRAJ
ZIP/Postal Code
955 01
Country
Slovakia
Facility Name
MUDr. Viliam Cibik, PhD., s.r.o.
City
Pruske
State/Province
Trenčiansky KRAJ
ZIP/Postal Code
01852
Country
Slovakia
Facility Name
Univerzitna nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda
City
Bratislava
ZIP/Postal Code
851 07
Country
Slovakia
Facility Name
Univerzitná nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda
City
Bratislava
ZIP/Postal Code
851 07
Country
Slovakia
Facility Name
ARTROMAC n. o.
City
Kosice
ZIP/Postal Code
04011
Country
Slovakia
Facility Name
MEDIKOMP, s.r.o
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Plucna ambulancia Hrebenar s.r.o.
City
Spisska Nova Ves
ZIP/Postal Code
052 01
Country
Slovakia
Facility Name
Plucna ambulancia Hrebenar, s.r.o.
City
Spisska Nova Ves
ZIP/Postal Code
052 01
Country
Slovakia
Facility Name
SANARE spol.s.r.o.
City
Svidnik
ZIP/Postal Code
089 01
Country
Slovakia
Facility Name
ALERGIA s.r.o.
City
Topolcany
ZIP/Postal Code
955 01
Country
Slovakia
Facility Name
CHUAC-Complejo Hospitalario Universitario A Coruña
City
A Coruña
State/Province
A Coruña [LA Coruña]
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
State/Province
Catalunya [cataluña]
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
State/Province
Catalunya [cataluña]
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
State/Province
Madrid, Comunidad DE
ZIP/Postal Code
28034
Country
Spain
Facility Name
CHUVI- Hospital Alvaro Cunqueiro
City
Vigo
State/Province
Pontevedra [pontevedra]
ZIP/Postal Code
36312
Country
Spain
Facility Name
Hospital Clinico de Valencia
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Clinico Universitario Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain

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=C4671034
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System

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