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
NCT ID: NCT05438602
Last Updated: 2024-09-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
158 participants
INTERVENTIONAL
2022-08-03
2023-11-13
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
Nirmatrelvir
Participants will receive 2 tablets of nirmatrelvir every 12 hours
Ritonavir
Participants will receive 1 capsule of ritonavir every 12 hours
Placebo for nirmatrelvir
Participants will receive 2 tablets of placebo for nirmatrelvir every 12 hours. A placebo does not have any medicine in it but looks just like the medicine being studied.
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.
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
Nirmatrelvir
Participants will receive 2 tablets of nirmatrelvir every 12 hours
Ritonavir
Participants will receive 1 capsule of ritonavir every 12 hours
Placebo for nirmatrelvir
Participants will receive 2 tablets of placebo for nirmatrelvir every 12 hours. A placebo does not have any medicine in it but looks just like the medicine being studied.
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.
Nirmatrelvir plus ritonavir for 15 days
Nirmatrelvir (2 tablets) plus ritonavir (1 capsule) will be given by mouth every 12 hours for 15 days.
Nirmatrelvir
Participants will receive 2 tablets of nirmatrelvir every 12 hours
Ritonavir
Participants will receive 1 capsule of ritonavir every 12 hours
Interventions
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Nirmatrelvir
Participants will receive 2 tablets of nirmatrelvir every 12 hours
Ritonavir
Participants will receive 1 capsule of ritonavir every 12 hours
Placebo for nirmatrelvir
Participants will receive 2 tablets of placebo for nirmatrelvir every 12 hours. A placebo does not have any medicine in it but looks just like the medicine being studied.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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CRS Outpatient Services UCSF
San Francisco, California, United States
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, United States
UCSf infectious disease Lab
San Francisco, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
I.V.A.M. Clinical & Investigational Center
Doral, Florida, United States
Qway Research LLC
Hialeah, Florida, United States
Premium Medical Research Corp
Miami, Florida, United States
Global Health Clinical Trials
Miami, Florida, United States
I.V.A.M. Clinical & Investigational Center
Miami, Florida, United States
NAPA Research
Pompano Beach, Florida, United States
Santos Research Center
Tampa, Florida, United States
Emory University Hospital-Georgia Clinical Research Center
Atlanta, Georgia, United States
Emory University School of Medicine
Atlanta, Georgia, United States
The Emory Clinic
Atlanta, Georgia, United States
National Institute of Health
Bethesda, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Beaumont Infectious Diseases Research
Royal Oak, Michigan, United States
Revival Research Institute
Sterling Heights, Michigan, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
South Texas Clinical Research
Corpus Christi, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
North Texas Infectious Diseases Consultants, P.A
Dallas, Texas, United States
Texas Centers for Infectious Disease Associates
Fort Worth, Texas, United States
Fred Hutchinson Cancer Center - COVID Clinical Research Center
Seattle, Washington, United States
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Royal Melbourne Hospital - Royal Park Campus
Parkville, Victoria, Australia
Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCLIN/RN
Natal, Rio Grande do Norte, Brazil
CECIP - Centro de Estudos do Interior Paulista
Jaú, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, , Brazil
Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro, , Brazil
Diagnostic Consultative Center - 1 Lom EOOD
Lom, Montana, Bulgaria
MHAT Samokov
Samokov, Sofia, Bulgaria
Military Medical Academy
Sofia, Sofia (stolitsa), Bulgaria
Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Haskovo EOOD
Haskovo, , Bulgaria
MHAT - Heart and Brain
Pleven, , Bulgaria
Medical Center Artmed
Plovdiv, , Bulgaria
MHAT Sveta Karidad EAD
Plovdiv, , Bulgaria
Vancouver Infectious Diseases Centre
Vancouver, British Columbia, Canada
Dawson Clinical Research
Guelph, Ontario, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, Ontario, Canada
Winchester District Memorial Hospital
Winchester, Ontario, Canada
INTERMED Groupe Sante
Chicoutimi, Quebec, Canada
Clinique Medicale lActuel
Montreal, Quebec, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Diex Recherche Trois-Rivieres Inc.
Sherbrooke, Quebec, Canada
Medifarma 98 Kft
Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary
Dél-Pesti Centrumkórház Országos Hematológiai és infektológiai intézet, Szent László telep
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
EME RED Hospitalaria
Mérida, Yucatán, Mexico
Instituto de Investigaciones Clínicas para la Salud
Durango, , Mexico
Oaxaca Site Management Organization S.C.
Oaxaca City, , Mexico
Instituto Veracruzano en Investigación Clínica S.C.
Veracruz, , Mexico
FAICIC S. de R.L. de C.V.
Veracruz, , Mexico
REUMEX s.r.o.
Rimavská Sobota, Banská Bystrica Region, Slovakia
Narodny onkologicky ustav
Bratislava, Bratislava Region, Slovakia
ALERGIA s.r.o.
Topoľčany, Nitra Region, Slovakia
MUDr. Viliam Cibik, PhD., s.r.o.
Pruské, Trenčín Region, Slovakia
Univerzitna nemocnica Bratislava - Nemocnica sv. Cyrila a Metoda
Bratislava, , Slovakia
Univerzitná nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda
Bratislava, , Slovakia
ARTROMAC n. o.
Košice, , Slovakia
MEDIKOMP, s.r.o
Prešov, , Slovakia
Plucna ambulancia Hrebenar s.r.o.
Spišská Nová Ves, , Slovakia
Plucna ambulancia Hrebenar, s.r.o.
Spišská Nová Ves, , Slovakia
SANARE spol.s.r.o.
Svidník, , Slovakia
ALERGIA s.r.o.
Topoľčany, , Slovakia
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [LA Coruña], Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona [barcelona], Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [cataluña], Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [cataluña], Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, Spain
CHUVI- Hospital Alvaro Cunqueiro
Vigo, Pontevedra [pontevedra], Spain
Hospital Clinico de Valencia
Valencia, Valenciana, Comunitat, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen de Valme
Seville, , Spain
Hospital Clinico Universitario Valencia
Valencia, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Countries
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References
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Mokgokong R, Cislo P, Tudone E, Weinstein E, Cappelleri JC. Symptom Alleviation/Resolution and Returns to Usual Health/Activities in Immunocompromised Adults with COVID-19 Treated with Nirmatrelvir-Ritonavir: Results from the EPIC-IC Trial. Infect Dis Ther. 2025 Oct 14. doi: 10.1007/s40121-025-01228-w. Online ahead of print.
Weinstein E, Paredes R, Gardner A, Almas M, Baniecki ML, Guan S, Tudone E, Antonucci S, Gregg K, Garcia-Vidal C, Camacho-Ortiz A, Wisemandle W, Terra SG, Liu S, Aberg JA, Rana MM, Corey L, Ford ES, Hammond J, Rusnak J. Extended nirmatrelvir-ritonavir treatment durations for immunocompromised patients with COVID-19 (EPIC-IC): a placebo-controlled, randomised, double-blind, phase 2 trial. Lancet Infect Dis. 2025 Jul 14:S1473-3099(25)00221-X. doi: 10.1016/S1473-3099(25)00221-X. Online ahead of print.
Baniecki ML, Guan S, Rai DK, Yang Q, Lee JT, Hao L, Weinstein E, Hyde C, Cardin RD, Soares H, Hammond J. Integrated virologic analysis of resistance to nirmatrelvir/ritonavir in individuals across four phase 2/3 clinical studies for the treatment of COVID-19. EBioMedicine. 2025 Aug;118:105819. doi: 10.1016/j.ebiom.2025.105819. Epub 2025 Jun 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2022-001362-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C4671034
Identifier Type: -
Identifier Source: org_study_id
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