AzTrials
AzTrials

COVID-19 InfectionPhase 3NCT07013474

A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised

A Phase 3 study testing ibuzatrelvir and remdesivir in people with COVID-19 Infection, run by Pfizer at 159 sites in 18 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone for the treatment of symptomatic COVID-19 in severely immunocompromised adult participants… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19 Infection
What is being tested?
ibuzatrelvir and remdesivir
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
159 sitesin 18 countries
Study dates
14 Jul 2025to 5 Feb 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years of age or older at screening who are non-hospitalized or hospitalized with mild to moderate COVID-19
  • Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) collected within 2 days prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization.
  • Severely immunocompromised due to:
  • Solid organ or islet cell transplant recipient who is receiving immunosuppressive therapy;
  • Active hematologic malignancy (eg, chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia);
  • Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or who are receiving immunosuppressive therapy;
  • Currently receiving or recently received B-cell depleting therapies (eg, rituximab), where the immunosuppressive effect is still ongoing.

Who cannot join

  • Severe or critical COVID-19, or current need for supplemental oxygen.
  • Receiving dialysis or have current kidney failure (ie, eGFR consistently <15 mL/min)
  • Active liver disease
  • History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator
  • Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
  • Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.
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  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Has received any other antiviral for the treatment of the current COVID-19 infection
  • Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
  • Current or previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational.
  • Prior participation in this trial or any clinical trial of ibuzatrelvir.
  • Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study.
  • Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Trial locations and contacts

159 sites in 18 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

159 sites in 18 countries

United States70 sites, 70 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Recruiting

  • UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus

    Aurora, Colorado, 80045

    Recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

    Recruiting

  • University of Colorado Clinical and Translational Research Center

    Aurora, Colorado, 80045

    Recruiting

  • University of Colorado Hospital

    Aurora, Colorado, 80045

    Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

    Recruiting

  • Humphreys Diabetes Center

    Boise, Idaho, 83702

    Recruiting

  • St. Luke's Idaho Elks Children's Pavilion

    Boise, Idaho, 83712

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Recruiting

  • Clinical Trials Center

    Boston, Massachusetts, 02115

    Recruiting

  • Clinical Trials Hub

    Boston, Massachusetts, 02115

    Recruiting

  • Hope Clinical Research, Inc.

    Canoga Park, California, 91303

    Recruiting

  • Medical University of South Carolina Infectious Disease Clinic

    Charleston, South Carolina, 29425

    Recruiting

  • Medical University of South Carolina Investigational Drug Services (IDS)

    Charleston, South Carolina, 29425

    Recruiting

  • Medical University of South Carolina Investigational Drug Services Pharmacy

    Charleston, South Carolina, 29425

    Recruiting

  • Medical University of South Carolina Research Nexus Clinic

    Charleston, South Carolina, 29425

    Recruiting

  • Medical University of South Carolina Translational Research Nexus Clinic and Laboratory

    Charleston, South Carolina, 29425

    Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

    Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    Recruiting

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Recruiting

  • University of Cincinnati College of Medicine (UC Holmes)

    Cincinnati, Ohio, 45267

    Recruiting

  • Zenos Clinical Research

    Dallas, Texas, 75230

    Recruiting

  • Baylor Scott & White Health - Center for Advanced Heart and Lung Disease

    Dallas, Texas, 75246

    Recruiting

  • Baylor Scott & White Research Institute - Clinical Trials Office

    Dallas, Texas, 75246

    Recruiting

  • Baylor University Medical Center

    Dallas, Texas, 75246

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Recruiting

  • Duke Vaccine and Trials Unit

    Durham, North Carolina, 27703

    Recruiting

  • Duke Vaccine and Trials Unit

    Durham, North Carolina, 27705

    Recruiting

  • Duke University - Main Hospital and Clinics

    Durham, North Carolina, 27710

    Recruiting

  • Amicis Research Center - Granada Hills

    Granada Hills, California, 91344

    Recruiting

  • BRP- Hialeah Hospital

    Hialeah, Florida, 33013

    Recruiting

  • Cockrell Center for Advanced Therapeutics

    Houston, Texas, 77030

    Recruiting

  • Houston Methodist - Transplant Center

    Houston, Texas, 77030

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Recruiting

  • Memorial Hermann Hospital

    Houston, Texas, 77030

    Recruiting

  • Scurlock CCAT clinic

    Houston, Texas, 77030

    Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Recruiting

  • UT Physicians

    Houston, Texas, 77030

    Recruiting

  • West Tennessee Research Institute

    Jackson, Tennessee, 38305

    Recruiting

  • Jacobs Medical Center at UC San Diego Health

    La Jolla, California, 92037

    Recruiting

  • D&H Cancer Research Center LLC

    Margate, Florida, 33063

    Recruiting

  • Kendall South Medical Center

    Miami, Florida, 33185

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Recruiting

  • TRC

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • UPMC Division of Infectious Disease Clinic

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • UPMC Presbyterian IDS

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • UPMC Presbyterian Shadyside

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • UPMC Shadyside IDS

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • UPMC Shadyside

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • UC Davis CTSC Clinical Research Center

    Sacramento, California, 95817

    Recruiting

  • University of California Davis Health

    Sacramento, California, 95817

    Recruiting

  • UC San Diego Medical Center - Hillcrest

    San Diego, California, 92103

    Recruiting

  • University of California San Diego Health

    San Diego, California, 92103

    Recruiting

  • Velocity Clinical Research, Savannah

    Savannah, Georgia, 31406

    Recruiting

  • Seattle Rheumatology Associates

    Seattle, Washington, 98104

    Recruiting

  • Swedish Ambulatory Infusion Center- First Hill

    Seattle, Washington, 98104

    Recruiting

  • Swedish Cancer Institute Treatment Center

    Seattle, Washington, 98104

    Recruiting

  • Swedish Medical Center- Innovative Therapeutics & Research Unit

    Seattle, Washington, 98104

    Recruiting

  • Swedish Organ Transplant and Liver Center

    Seattle, Washington, 98104

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Recruiting

  • Fred Hutchinson South Lake Union Clinic

    Seattle, Washington, 98109

    Recruiting

  • Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122

    Recruiting

  • University of Washington Medical Center

    Seattle, Washington, 98195

    Recruiting

  • Jadestone Clinical Research

    Silver Spring, Maryland, 20904

    Recruiting

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

    Recruiting

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

    Recruiting

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655

    Recruiting

Other trials in United States

Japan10 sites, 10 recruiting

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, 810-8563

    Recruiting

  • Tokyo Medical University Hachioji Medical Center

    Hachiōji, Tokyo, 1930998

    Recruiting

  • Aso Iizuka Hospital

    Iizuka, Fukuoka, 820-8505

    Recruiting

  • Rinku General Medical Center

    Izumisano, Osaka, 598-8577

    Recruiting

  • Nagasaki University Hospital

    Nagasaki, 852-8501

    Recruiting

  • International University of Health and Welfare Narita Hospital

    Narita, Chiba, 286-8520

    Recruiting

  • Saga University Hospital

    Saga, 849-8501

    Recruiting

  • National Center for Global Health and Medicine

    Shinjuku, Tokyo, 162-8655

    Recruiting

  • Tachikawa Hospital

    Tachikawa, Tokyo, 190-8531

    Recruiting

  • Fujita Health University Hospital

    Toyoake, Aichi-ken, 470-1192

    Recruiting

Other trials in Japan

Spain10 sites, 10 recruiting

  • CHUAC-Complejo Hospitalario Universitario A Coruña

    A Coruña, A Coruña [LA Coruña], 15006

    Recruiting

  • Hospital General Universitario Dr. Balmis

    Alicante, 03010

    Recruiting

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona [barcelona], 08916

    Recruiting

  • Parc de Salut Mar - Hospital del Mar

    Barcelona, Barcelona [barcelona], 08003

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona], 08035

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalunya [cataluña], 08041

    Recruiting

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, 14004

    Recruiting

  • Hospital Universitario La Paz

    Madrid, Madrid, Comunidad de, 28046

    Recruiting

  • Hospital Universitario Virgen de Valme

    Seville, 41014

    Recruiting

  • CHUVI- Hospital Alvaro Cunqueiro

    Vigo, Pontevedra [pontevedra], 36212

    Recruiting

Other trials in Spain

Brazil9 sites, 9 recruiting

  • Hospital de Clinicas de Porto Alegre

    Bairro Santa Cecília, Rio Grande do Sul, 90630-165

    Recruiting

  • School of Medicine Federal University of Minas Gerais

    Belo Horizonte, Minas Gerais, 30130-100

    Recruiting

  • Hospital e Maternidade Celso Pierro

    Campinas, São Paulo, 13060-803

    Not yet recruiting

  • Hospital Nossa Senhora das Graças

    Curitiba, Paraná, 80810-040

    Recruiting

  • Centro Médico São Francisco

    Curitiba, Paraná, 80810-050

    Recruiting

  • CECIP - Centro de Estudos do Interior Paulista

    Jaú, São Paulo, 17201130

    Not yet recruiting

  • Instituto Nacional de Infectologia Evandro Chagas

    Rio de Janeiro, 21040-360

    Not yet recruiting

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo, 01246-000

    Recruiting

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652-900

    Recruiting

Other trials in Brazil

Germany7 sites, 7 recruiting

  • Universitaetsklinikum Koeln

    Cologne, North Rhine-Westphalia, 50937

    Recruiting

  • UKE Hamburg

    Hamburg, 20246

    Recruiting

  • TUM Klinikum

    München, Bavaria, 81675

    Recruiting

  • Universitaetsmedizin Rostock

    Rostock, 18057

    Not yet recruiting

  • Klinikum Mutterhaus der Borromaerinnen gGmbH

    Trier, 54290

    Recruiting

  • Kliniken Villingen-Schwenningen

    Villingen-Schwenningen, 78052

    Not yet recruiting

  • HELIOS Klinikum Wuppertal

    Wuppertal, 42283

    Not yet recruiting

Other trials in Germany

Greece7 sites, 7 recruiting

  • University General Hospital of Alexandroupoli

    Alexandroupoli, Anatolikí Makedonía KAI Thráki, 681 00

    Recruiting

  • Evangelismos General Hospital of Athens

    Athens, Attikí, 106 76

    Recruiting

  • Alexandra General Hospital of Athens

    Athens, Attikí, 115 28

    Recruiting

  • General Hospital of Athens "Laiko"

    Athens, Attikí, 11527

    Recruiting

  • University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"

    Chaïdári, 124 62

    Not yet recruiting

  • University General Hospital of Heraklion

    Irakleio, 71500

    Recruiting

  • Ippokrateio General Hospital of Thessaloniki

    Thessaloniki, 546 42

    Recruiting

Other trials in Greece

Turkey (Türkiye)7 sites, 7 recruiting

  • Hacettepe Universite Hastaneleri

    Ankara, 06230

    Recruiting

  • Ibni Sina Hospital

    Ankara, 06230

    Recruiting

  • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

    Gaziantep, 27310

    Recruiting

  • Acibadem Universitesi Atakent Hastanesi

    Istanbul, İ̇stanbul, 34303

    Recruiting

  • Kocaeli Üniversitesi

    Kocaeli, 41380

    Recruiting

  • Sakarya Training and Research Hospital

    Sakarya, 54100

    Recruiting

  • Karadeniz Technical University

    Trabzon, 61080

    Recruiting

Other trials in Turkey (Türkiye)

France5 sites, 5 recruiting

  • Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand

    Dijon, 21000

    Recruiting

  • Hopital Claude Huriez - CHU de Lille

    Lille, NORD, 59037

    Recruiting

  • Hôpital Saint Antoine

    Paris, 75012

    Recruiting

  • Hôpital Bichat - Claude-Bernard

    Paris, 75018

    Recruiting

  • Hôpital Saint-Louis

    Paris, Île-de-France Region, 75010

    Recruiting

Other trials in France

Slovakia5 sites, 5 recruiting

  • Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica

    Banská Bystrica, Banská Bystrica Region, 974 01

    Recruiting

  • Narodny ustav detskych chorob

    Bratislava, Bratislava Region, 833 40

    Recruiting

  • Narodny onkologicky ustav

    Bratislava, 833 10

    Recruiting

  • Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s.

    Michalovce, 07101

    Recruiting

  • Fakultna nemocnica Trnava

    Trnava, Trnava Region, 917 02

    Recruiting

Other trials in Slovakia

Argentina4 sites, 4 recruiting

  • Hospital Italiano de Buenos Aires

    ABB, Buenos Aires F.D., C1199ABB

    Recruiting

  • Sanatorio Sagrado Corazón

    Buenos Aires, 1039

    Recruiting

  • Hospital Italiano de La Plata

    La Plata, Buenos Aires, B1900XI

    Recruiting

  • Instituto Médico Río Cuarto

    Río Cuarto, Córdoba Province, X5800AEV

    Recruiting

Other trials in Argentina

Belgium4 sites, 4 recruiting

  • Jules Bordet Institute

    Anderlecht, 1070

    Recruiting

  • AZ Sint-Jan Brugge-Oostende AV

    Bruges, West-vlaanderen, 8000

    Recruiting

  • UZ Brussel

    Brussels, Brussels Capital, 1090

    Recruiting

  • Université Libre de Bruxelles - Hôpital Erasme

    Brussels, Bruxelles-capitale, Région de, 1070

    Recruiting

Other trials in Belgium

Denmark4 sites, 4 recruiting

  • Aarhus Universitetshospital, Skejby

    Aarhus, Central Jutland, 8200

    Recruiting

  • Rigshospitalet

    Copenhagen, Capital Region, 2100

    Recruiting

  • Aalborg Universitetshospital, Syd

    Gistrup, 9260

    Recruiting

  • Odense Universitetshospital

    Odense, Region Syddanmark, 5000

    Recruiting

Other trials in Denmark

South Korea4 sites, 4 recruiting

  • Chonnam National University Hospital

    Gwangju, Kwangju-kwangyǒkshi, 61469

    Recruiting

  • Gachon University Gil Medical Center

    Namdong-gu, Incheon-gwangyeoksi [incheon], 21565

    Recruiting

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 03312

    Recruiting

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 05505

    Recruiting

Other trials in South Korea

Taiwan4 sites, 4 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

    Recruiting

  • Far Eastern Memorial Hospital

    New Taipei City, NEW Taipei, 220

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

Other trials in Taiwan

Mexico3 sites, 3 recruiting

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, 14080

    Recruiting

  • Fundación Santos y de la Garza Evia I.B.P

    San Pedro Garza García, Nuevo León, 66278

    Not yet recruiting

  • FAICIC S. de R.L. de C.V.

    Veracruz, Veracruz Ignacio de LA Llave, 91900

    Recruiting

Other trials in Mexico

Netherlands2 sites, 2 recruiting

  • Radboudumc

    Nijmegen, 6525 GA

    Not yet recruiting

  • Erasmus MC

    Rotterdam, 3015GD

    Recruiting

Other trials in Netherlands

Puerto Rico2 sites, 2 recruiting

  • BRCR Global Puerto Rico

    Ponce, 00728

    Not yet recruiting

  • BRCR Global Puerto Rico

    San Juan, 00907-1509

    Not yet recruiting

Other trials in Puerto Rico

Sweden2 sites, 2 recruiting

  • Karolinska Universitetssjukhuset Huddinge

    Huddinge, 141 86

    Recruiting

  • Skånes Universitetssjukhus Malmö

    Malmö, Skåne LÄN [se-12], 205 02

    Recruiting

Other trials in Sweden

About this study

Official title: AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE IBUZATRELVIR IN ADULTS WITH SYMPTOMATIC COVID-19 WHO ARE SEVERELY IMMUNOCOMPROMISED

This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone for the treatment of symptomatic COVID-19 in severely immunocompromised adult participants who are non-hospitalized or are hospitalized at baseline with mild-to-moderate COVID-19.

Read the detailed description

The purpose of this clinical trial is to learn about a study medicine called Ibuzatrelvir for the possible treatment of COVID-19 in immunocompromised patients. Immunocompromised patients with COVID-19 have more difficulty fighting infections and are at risk for persistent infections and progression to severe illness. This patient population may benefit from extended antiviral treatment durations, or a combination of antiviral therapies. This study will evaluate the efficacy and safety of ibuzatrelvir with and without remdesivir compared with remdesivir alone for the treatment of symptomatic COVID-19 in adult participants who are severely immunocompromised.

The study is seeking adult male and female participants who:

  • Have a confirmed COVID-19 infection
  • Are severely immunocompromised due to blood cancers, organ transplant, certain medications or therapies
  • Have experienced the onset of signs or symptoms of COVID-19 within the past 5 days and are currently experiencing at least one of them.

All of the participants in this study will receive active treatment for COVID-19, and will be randomized to one of three treatment arms. One-third will received remdesivir, one-third will receive ibuzatrelvir, and one third will receive both remdesivir and ibuzatrelvir. Ibuzatrelvir will be taken by mouth twice daily, and remdesivir is given as an IV infusion daily. Placebos that look like the study medicines but do not have any medication will be given to make the 3 treatment arms appear to be the same. The study will compare the experiences of people receiving ibuzatrelvir with and without remdesivir to those of the people who only received remdesivir for COVID-19. This will help decide if ibuzatrelvir is safe and effective.

Participants will attend about 10 study visits over 24 weeks. During this time, they will have:

  • visits at the study clinic
  • blood work
  • swabs of the nose that are collected in the clinic and also by participants at home
  • questionnaires
Being tested
ibuzatrelvir, remdesivir, placebo for ibuzatrelvir, placebo for remdesivir
Keywords
COVID-19 infection, pneumonia, respiratory tract infections, coronavirus infection, RNA virus infection, lung disease, pneumonia, viral, infections, virus, viral protease inhibitor, protease inhibitor, enzyme inhibitor, severe immunocompromise, anti-viral agents, anti-infectives, ibuzatrelvir, remdesivir, COVID-19
Medical subject headings
COVID-19, Pneumonia, Respiratory Tract Infections, Coronavirus Infections, RNA Virus Infections, Lung Diseases, Pneumonia, Viral, Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ibuzatrelvirDrug

    tablet

  • remdesivirDrug

    Also called veklury

    injection, for intravenous use

  • placebo for ibuzatrelvirDrug

    tablet

  • placebo for remdesivirDrug

    injection, for intravenous use

Study groups in NCT07013474
Study groupRoleWhat they receive
Ibuzatrelvir + RemdesivirExperimentalParticipants will receive ibuzatrelvir orally twice a day + IV remdesivir
Receives: Drug: ibuzatrelvir; Drug: remdesivir
IbuzatrelvirExperimentalParticipants will receive ibuzatrelvir orally twice a day + IV placebo for remdesivir
Receives: Drug: ibuzatrelvir; Drug: placebo for remdesivir
RemdesivirExperimentalParticipants will receive placebo for ibuzatrelvir orally twice a day + IV remdesivir
Receives: Drug: remdesivir; Drug: placebo for ibuzatrelvir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The difference in the proportion of patients meeting the primary composite endpoint, between ibuzatrelvir and remdesivir vs remdesivir groups in symptomatic adult participants with COVID-19 who are severely immunocompromised

    The difference in the proportion of participants with the composite endpoint of a) Progression to severe COVID-19 or all-cause mortality by Day 38, or b) Evidence of recurrent or persistent SARS-CoV-2 infection

    Measured: 38 days

Secondary outcomes (8)

  1. Time to sustained alleviation of all targeted COVID-19 symptoms

    The difference in median time to sustained alleviation of all targeted symptoms. Symptoms will be assessed through a daily electronic diary and include sore throat, cough, fever and diarrhea, among others.

    Measured: 38 days

  2. Proportion of participants with evidence of recurrent or persistent SARS-CoV-2 infection.

    The viral load is measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR)

    Measured: 38 days

  3. Proportion of participants with COVID-19-related ED visits with medical intervention, COVID-19-related hospitalization, or all-cause mortality.

    Proportion of participants with COVID-19-related ED visits with medical intervention, COVID-19-related hospitalization, or all-cause mortality.

    Measured: 38 days

  4. Change from baseline in SARS-CoV-2 RNA level in NP or nasal swabs over time

    The viral load is measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR)

    Measured: 38 days

  5. Proportion of participants with SARS-CoV-2 NP or nasal RNA <LLOQ at each time point

    Proportion of participants with a SARS-CoV-2 viral load below the lower limit of quantification (LLOQ) of the assay used to measure it.

    Measured: 38 days

  6. Proportion of participants with viral rebound in SARS-CoV-2 RNA level in NP or nasal swabs

    Virologic rebound is defined as:

    • Viral RNA is not detectable at the end of treatment, and later is detectable through Day 38
    • Viral RNA is detected at end of treatment, and viral RNA levels increase further through Day 38

    Measured: 38 days

  7. Time to sustained NP or nasal swab SARS-CoV-2 RNA <LLOQ

    The time it takes for the viral RNA to no longer be detectable in a sample

    Measured: 38 days

  8. Incidence of Treatment emergent adverse events, serious adverse events, and adverse events leading to discontinuation

    An adverse event (AE) is any untoward medical occurrence in a participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Serious adverse event (SAE) is any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events. AEs included both SAEs and all non-SAEs. An AE is considered as TEAE if the event started on or after start date of study intervention.

    Measured: 38 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2025
  2. Study start14 Jul 2025
  3. Primary completion28 Sep 2027 (estimated)
  4. Study completion5 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07013474
Sponsor's protocol ID
C5091018
Other IDs
2024-517671-21-00
Status last verified
Oct 2026
First submitted
5 May 2025
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ibuzatrelvir and remdesivir in people with COVID-19 Infection, run by Pfizer at 159 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 159 sites in United States, Japan, Spain, Brazil, Germany and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The difference in the proportion of patients meeting the primary composite endpoint, between ibuzatrelvir and remdesivir vs remdesivir groups in symptomatic adult participants with COVID-19 who are severely immunocompromised (time frame: 38 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07013474.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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