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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Ritonavir; Drug: Nirmatrelvir; Drug: Placebo for nirmatrelvir; Drug: Placebo for ritonavir

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Centre
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital
    • Parkville, Victoria, Australia, 3052
      • Royal Melbourne Hospital - Royal Park Campus
• Brazil
  • Rio de Janeiro, Brazil, 20241-180
    • IBPClin - Instituto Brasil de Pesquisa Clínica
  • Rio de Janeiro, Brazil, 21040-360
    • Instituto Nacional de Infectologia Evandro Chagas
  • RIO Grande DO Norte
    • Natal, RIO Grande DO Norte, Brazil, 59025050
      • Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCLIN/RN
  • SÃO Paulo
    • Jau, SÃO Paulo, Brazil, 17201130
      • CECIP - Centro de Estudos do Interior Paulista
    • São José do Rio Preto, SÃO Paulo, Brazil, 15090000
      • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
• Bulgaria
  • Haskovo, Bulgaria, 6305
    • Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Haskovo EOOD
  • Pleven, Bulgaria, 5804
    • MHAT - Heart and Brain
  • Plovdiv, Bulgaria, 4000
    • Medical Center Artmed
  • Plovdiv, Bulgaria, 4000
    • MHAT Sveta Karidad EAD
  • Montana
    • Lom, Montana, Bulgaria, 3600
      • Diagnostic Consultative Center - 1 Lom EOOD
  • Sofia
    • Samokov, Sofia, Bulgaria, 2000
      • MHAT Samokov
  • Sofia (stolitsa)
    • Sofia, Sofia (stolitsa), Bulgaria, 1606
      • Military Medical Academy
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2C7
      • Vancouver Infectious Diseases Centre
  • Ontario
    • Guelph, Ontario, Canada, N1H 1B1
      • Dawson Clinical Research
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton
    • Toronto, Ontario, Canada, M9V 4B4
      • Dr. Anil K. Gupta Medicine Professional Corporation
    • Winchester, Ontario, Canada, K0C 2K0
      • Winchester District Memorial Hospital
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7Y8
      • INTERMED Groupe Sante
    • Montreal, Quebec, Canada, H2L 4P9
      • Clinique Medicale lActuel
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Diex Recherche Sherbrooke Inc.
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Diex Recherche Trois-Rivieres Inc.
• Hungary
  • Budapest, Hungary, 1122
    • Semmelweis Egyetem
  • Budapest, Hungary, 1097
    • Dél-Pesti Centrumkórház Országos Hematológiai és infektológiai intézet, Szent László telep
  • Szabolcs-szatmár-bereg
    • Nyiregyhaza, Szabolcs-szatmár-bereg, Hungary, 4400
      • Medifarma 98 Kft
• Mexico
  • Durango, Mexico, 34000
    • Instituto de Investigaciones Clínicas para la Salud
  • Oaxaca, Mexico, 68000
    • Oaxaca Site Management Organization S.C.
  • Veracruz, Mexico, 91900
    • FAICIC S. de R.L. de C.V.
  • Veracruz, Mexico, 91851
    • Instituto Veracruzano en Investigación Clínica S.C.
  • Distrito Federal
    • Mexico City, Distrito Federal, Mexico, 14080
      • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Nuevo LEÓN
    • Monterrey, Nuevo LEÓN, Mexico, 66460
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Yucatán
    • Mérida, Yucatán, Mexico, 97000
      • Eme Red Hospitalaria
• Slovakia
  • Bratislava, Slovakia, 851 07
    • Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda
  • Bratislava, Slovakia, 851 07
    • Univerzitna nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda
  • Kosice, Slovakia, 04011
    • ARTROMAC n. o.
  • Presov, Slovakia, 080 01
    • MEDIKOMP, s.r.o
  • Spisska Nova Ves, Slovakia, 052 01
    • Plucna ambulancia Hrebenar s.r.o.
  • Spisska Nova Ves, Slovakia, 052 01
    • Plucna ambulancia Hrebenar, s.r.o.
  • Svidnik, Slovakia, 089 01
    • SANARE spol.s.r.o.
  • Topolcany, Slovakia, 955 01
    • ALERGIA s.r.o.
  • Banskobystricky KRAJ
    • Rimavska Sobota, Banskobystricky KRAJ, Slovakia, 979 01
      • Reumex S.R.O.
  • Bratislavský KRAJ
    • Bratislava, Bratislavský KRAJ, Slovakia, 833 10
      • Narodny Onkologicky Ustav
  • Nitriansky KRAJ
    • Topolcany, Nitriansky KRAJ, Slovakia, 955 01
      • ALERGIA s.r.o.
  • Trenčiansky KRAJ
    • Pruske, Trenčiansky KRAJ, Slovakia, 01852
      • MUDr. Viliam Cibik, PhD., s.r.o.
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
  • Sevilla, Spain, 41014
    • Hospital Universitario Virgen de Valme
  • Valencia, Spain, 46026
    • Hospital Universitari i Politècnic La Fe
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario Valencia
  • A Coruña [LA Coruña]
    • A Coruña, A Coruña [LA Coruña], Spain, 15006
      • CHUAC-Complejo Hospitalario Universitario A Coruña
  • Barcelona [barcelona]
    • Badalona, Barcelona [barcelona], Spain, 08916
      • Hospital Germans Trias i Pujol
  • Catalunya [cataluña]
    • Barcelona, Catalunya [cataluña], Spain, 08036
      • Hospital Clinic de Barcelona
    • Barcelona, Catalunya [cataluña], Spain, 08041
      • Hospital de la Santa Creu i Sant Pau
  • Madrid, Comunidad DE
    • Madrid, Madrid, Comunidad DE, Spain, 28034
      • Hospital Universitario Ramón y Cajal
  • Pontevedra [pontevedra]
    • Vigo, Pontevedra [pontevedra], Spain, 36312
      • CHUVI- Hospital Alvaro Cunqueiro
  • Valenciana, Comunitat
    • Valencia, Valenciana, Comunitat, Spain, 46010
      • Hospital Clinico de Valencia
• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF Helen Diller Medical Center at Parnassus Heights
    • San Francisco, California, United States, 94143
      • CRS Outpatient Services UCSF
    • San Francisco, California, United States, 94143
      • UCSf infectious disease Lab
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Georgetown University Medical Center
  • Florida
    • Doral, Florida, United States, 33126
      • I.V.A.M. Clinical & Investigational Center
    • Hialeah, Florida, United States, 33010
      • Qway Research LLC
    • Miami, Florida, United States, 33126
      • Premium Medical Research Corp
    • Miami, Florida, United States, 33144
      • I.V.A.M. Clinical & Investigational Center
    • Miami, Florida, United States, 33135
      • Global Health Clinical Trials
    • Pompano Beach, Florida, United States, 33064
      • NAPA Research
    • Tampa, Florida, United States, 33615
      • Santos Research Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • The Emory Clinic
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital-Georgia Clinical Research Center
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institute Of Health
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Infectious Diseases Research
    • Sterling Heights, Michigan, United States, 48312
      • Revival Research Institute
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • MediSearch Clinical Trials
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
  • Texas
    • Corpus Christi, Texas, United States, 78404
      • South Texas Clinical Research
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • Dallas, Texas, United States, 75246
      • North Texas Infectious Diseases Consultants, P.A
    • Fort Worth, Texas, United States, 76104
      • Texas Centers for Infectious Disease Associates
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Center - COVID Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nirmatrelvir plus ritonavir for 5 days; 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	Drug: Ritonavir; Participants will receive 1 capsule of ritonavir every 12 hours; Drug: Nirmatrelvir; Participants will receive 2 tablets of nirmatrelvir every 12 hours; Drug: 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.; Drug: Placebo for ritonavir; 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.
Experimental: Nirmatrelvir plus ritonavir 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	Drug: Ritonavir; Participants will receive 1 capsule of ritonavir every 12 hours; Drug: Nirmatrelvir; Participants will receive 2 tablets of nirmatrelvir every 12 hours; Drug: 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.; Drug: Placebo for ritonavir; 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.
Experimental: Nirmatrelvir plus ritonavir for 15 days; Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 15 days.	Drug: Ritonavir; Participants will receive 1 capsule of ritonavir every 12 hours; Drug: Nirmatrelvir; Participants will receive 2 tablets of nirmatrelvir every 12 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Sustained Nasopharyngeal (NP) Swab Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Ribonucleic Acid (RNA) < Lower Limit of Quantitation (LLOQ) From Day 15 to Day 44	NP swab was collected by healthcare professional (HCP) from participants and were sent to the central laboratory for viral RNA level testing real-time reverse transcriptase-polymerase chain reaction(RT-PCR). Sustained was defined as NP swab SARS-CoV-2 RNA level not >=2.0 log10 per milliliter (copies/mL) at any study visit (through Day 44) following the first study visit where the participant's NP swab SARS-CoV-2 RNA level <LLOQ (<2.0 log10 copies/mL).	From Day 15 to Day 44

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First NP Swab SARS-Cov-2 RNA <LLOQ for Participants With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline	An NP swab was collected by HCP from participants and were sent to the central laboratory for viral RNA level testing RT-PCR. The LLOQ is <2.0 log10 copies/mL. Kaplan-Meier method was used for analysis. Time (days) to first NP swab SARS-CoV-2 RNA<LLOQ (event) was calculated as (First Event Date) - (First Dose Date) +1.	Day 1 through Day 44
Time to First Sustained NP Swab SARS-CoV-2 RNA < LLOQ for Participants Through Day 44 With NP Swab SARS-CoV-2 RNA >= LLOQ at Baseline	An NP swab was collected by HCP from participants and were sent to the central laboratory for viral RNA level testing RT-PCR. Sustained was defined as NP swab SARS-CoV-2 RNA level not >=2.0 log10 copies/mL at any study visit (through Day 44) following the first study visit where the participant's NP swab SARS-CoV-2 RNA level < LLOQ. The LLOQ is <2.0 log10 copies/mL. Time (days) to first sustained NP swab SARS-CoV-2 RNA<LLOQ (event) was calculated as (First Event Date) - (First Dose Date) +1.	Day 1 through Day 44
Percentage of Participants With SARS-CoV-2 RNA < LLOQ in Plasma Over Time at Each Visit Through Week 24	A 6-mL blood sample was collected for adult and pediatric participants and was analyzed to measure SARS-CoV-2 RNA <LLOQ in Plasma by RT-PCR. The LLOQ is <2.0 log10 copies/mL.	Baseline; Days 5, 10, 15, 21, 28, 35, and 44; Weeks 12 and 24
Percentage of Participants With SARS-CoV-2 RNA <LLOQ in NP Swabs at Each Study Visit Through Day 44	An NP swab was collected by HCP from adult and pediatric participants and were sent to the central laboratory for viral RNA level testing RT-PCR. The LLOQ is <2.0 log10 copies/mL.	Baseline; Days 5, 10, 15, 21, 28, 35 and 44
Change From Baseline in SARS-CoV-2 RNA Level in NP Swabs at Days 5, 10, 15, 21, 28, 35 and 44	An NP swab was collected by HCP from adult and pediatric participants and were sent to the central laboratory for viral RNA level testing RT-PCR.	Baseline; Days 5, 10, 15, 21, 28, 35 and 44
Change From Baseline in SARS-CoV-2 RNA Level in Plasma at Days 5, 10, 15, 21, 28, 35 and 44	A 6-mL blood sample was collected for adult and pediatric participants and was analyzed to measure SARS-CoV-2 RNA by RT-PCR.	Baseline; Days 5, 10, 15, 21, 28, 35 and 44
Number of Participants With Rebound in SARS-CoV-2 RNA Level in NP Swabs at Follow up	Rebound in SARS-CoV-2 RNA level in NP swabs at follow up (ie, any study visit after end of treatment through Day 44) was defined as a half (0.5) log10 copies/mL increase or greater in SARS-CoV-2 RNA level relative to end of treatment SARS-CoV-2 RNA level based on treatment regimen, with a follow-up viral RNA level >= 2.5 log10 copies/mL.	Day 16 through Day 44
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events (AEs) Leading to Treatment Discontinuation	An adverse event (AE) was any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. TEAE was an AE that occurred after initiation of study treatment that was not present at the time of treatment start or an AE that increased in severity after the initiation of medication, if the event was present at the time of treatment start emerges. SAE was an AE resulting in any of the following outcomes or considered medically significant: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or birth defect.	Day 1 of dosing up to Week 24
Percentage of Participants With COVID-19-Related Hospitalization >24 Hours (h) or Death Through Day 28	Hospitalization >24 h is defined as >24h of acute care in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. This included specialized acute medical care unit within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution.	Day 1 through Day 28
Percentage of Participants With Death Through Week 24	Death due to any cause through week 24 was considered. Kaplan-Meier method was used for evaluation.	Day 1 through Week 24
Percentage of Participants With COVID-19-Related Hospitalization Through Day 44 and Week 24	COVID-19 related hospitalization is defined as >24h of acute care in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with severe COVID-19. This included specialized acute medical care unit within an assisted living facility or nursing home. This did not include hospitalization for the purposes of public health and/or clinical trial execution.	Day 1 through Day 44 and Day 1 through Week 24
Percentage of Participants With COVID-19-Related Intensive Care Unit (ICU) Admission Through Day 44 and Week 24		Day 1 through Day 44 and Day 1 through Week 24
Percentage of Participants With Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Through Day 44 and Week 24	Invasive mechanical ventilation or ECMO were types of oxygen support received in hospital.	Day 1 through Day 44 and Day 1 through Week 24
Mean Number of Days in Hospital and ICU Stay Through Day 44 and Through Week 24	Hospitalization >24 hours is defined as >24h of acute care in a hospital or similar acute care facility, including emergency rooms or temporary facilities instituted to address medical needs of those with severe COVID-19.	Day 1 through Day 44 and Day 1 through Week 24
Mean Number of COVID-19-Related Medical Visits Through Day 44 and Through Week 24		Day 1 through Day 44 and Day 1 through Week 24
Time to First Alleviation of Each Targeted Signs and Symptoms Through Day 44	Symptoms alleviation through day44 of each targeted COVID-19 sign/symptom was defined as first time when each targeted symptom scored as moderate/severe at study entry are scored as mild or absent and a targeted symptom scored mild or absent at study entry are scored as absent.COVID-19 targeted signs/symptoms were muscle or body aches,shortness of breath(SOB)or difficulty breathing,chills or shivering, cough,diarrhea,feeling hot or feverish,headache,nausea,stuffy or runny nose,sense of smell,sense of taste,sore throat,low energy or tiredness, vomit.	Day 1 through Day 44
Time to First Resolution of Each Targeted Signs and Symptoms Through Day 44	Symptoms resolution through day 44 of each targeted COVID-19 sign/symptom was defined as the first time when each targeted symptom scored as mild, moderate or severe at study entry are scored as absent. COVID -19 targeted signs/symptoms were muscle or body aches, SOB or difficulty breathing, chills or shivering, cough, diarrhoea, feeling hot or feverish, headache, nausea, stuffy or runny nose, sense of smell, sense of taste, sore throat, low energy or tiredness, vomit.	Day 1 through Day 44
Percentage of Participants With Any Severe Targeted Signs and Symptoms Attributed to COVID-19 Through Day 44	COVID-19 targeted signs/symptoms were muscle or body aches, SOB or difficulty breathing, chills or shivering, cough, diarrhea, feeling hot or feverish, headache, nausea, stuffy or runny nose, sense of smell, sense of taste, sore throat, low energy or tiredness, vomit.	Day 1 through Day 44

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Actual): July 17, 2023
• Study Completion (Actual): November 13, 2023

Study Registration Dates

• First Submitted: June 28, 2022
• First Submitted That Met QC Criteria: June 28, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Paxlovid; Nirmatrelvir; Immunocompromised; Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); Coronavirus disease 2019 (COVID-19)
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir; Nirmatrelvir
• Other Study ID Numbers: C4671034; 2022-001362-35 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No