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New pill combo aims to protect vulnerable from severe COVID

NCT ID NCT07013474

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 26, 2026 · Updated 13 times

Summary

This phase 3 trial tests a new antiviral pill, ibuzatrelvir, alone or with an IV drug (remdesivir) in 300 adults with weak immune systems who have mild-to-moderate COVID-19. The goal is to see if the combination prevents hospitalizations or worsening symptoms better than remdesivir alone. Participants are not severely ill at the start but are at high risk due to their immune status.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ibuzatrelvir (tablet) and remdesivir (injection)
What this could lead to
If successful, this could provide a new treatment option for severely immunocompromised people with COVID-19, potentially reducing hospitalizations and severe outcomes.
What could go wrong
This is still an experimental drug combination. The trial is relatively small (300 participants) and may not show a clear benefit over existing treatments. Side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 18 years of age or older at screening who are non-hospitalized or hospitalized with mild to moderate COVID-19 2. 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. 3. 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. Exclusion Criteria: 1. Severe or critical COVID-19, or current need for supplemental oxygen. 2. Receiving dialysis or have current kidney failure (ie, eGFR consistently \<15 mL/min) 3. Active liver disease 4. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator 5. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention. 6. Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator. 7. 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. 8. Has received any other antiviral for the treatment of the current COVID-19 infection 9. Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s). 10. 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. 11. Prior participation in this trial or any clinical trial of ibuzatrelvir. 12. Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study. 13. 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.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease COVID-19 Infections lung disorder pneumonia respiratory tract infectious disorder RNA Virus Infections viral infectious disease viral pneumonia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19 infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    152 sites in 18 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AZ Sint-Jan Brugge-Oostende AV

    RECRUITING

    Bruges, West-vlaanderen, 8000, Belgium

  • Aalborg Universitetshospital, Syd

    RECRUITING

    Gistrup, 9260, Denmark

  • Aarhus Universitetshospital, Skejby

    RECRUITING

    Aarhus, Central Jutland, 8200, Denmark

  • Acibadem Universitesi Atakent Hastanesi

    RECRUITING

    Istanbul, İ̇stanbul, 34303, Turkey (Türkiye)

  • Alexandra General Hospital of Athens

    RECRUITING

    Athens, Attikí, 115 28, Greece

  • Amicis Research Center - Granada Hills

    RECRUITING

    Granada Hills, California, 91344, United States

  • Asan Medical Center

    RECRUITING

    Seoul, Seoul-teukbyeolsi [seoul], 05505, South Korea

  • Aso Iizuka Hospital

    RECRUITING

    Iizuka, Fukuoka, 820-8505, Japan

  • BRCR Global Puerto Rico

    NOT_YET_RECRUITING

    San Juan, 00907-1509, Puerto Rico

  • BRCR Medical Center - Ponce

    NOT_YET_RECRUITING

    Ponce, 00717, Puerto Rico

  • BRP- Hialeah Hospital

    RECRUITING

    Hialeah, Florida, 33013, United States

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

    RECRUITING

    Dallas, Texas, 75246, United States

  • Baylor Scott & White Research Institute - Clinical Trials Office

    RECRUITING

    Dallas, Texas, 75246, United States

  • Baylor University Medical Center

    RECRUITING

    Dallas, Texas, 75246, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • CECIP - Centro de Estudos do Interior Paulista

    NOT_YET_RECRUITING

    Jaú, São Paulo, 17201130, Brazil

  • CHUAC-Complejo Hospitalario Universitario A Coruña

    RECRUITING

    A Coruña, A Coruña [LA Coruña], 15006, Spain

  • CHUVI- Hospital Alvaro Cunqueiro

    RECRUITING

    Vigo, Pontevedra [pontevedra], 36212, Spain

  • Canas Medical Center

    NOT_YET_RECRUITING

    Ponce, 00728, Puerto Rico

  • Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand

    RECRUITING

    Dijon, 21000, France

  • Centro Médico São Francisco

    RECRUITING

    Curitiba, Paraná, 80810-050, Brazil

  • Chonnam National University Hospital

    RECRUITING

    Gwangju, Kwangju-kwangyǒkshi, 61469, South Korea

  • Clinical Trials Center

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Clinical Trials Hub

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • D&H Cancer Research Center LLC

    RECRUITING

    Margate, Florida, 33063, United States

  • Duke University - Main Hospital and Clinics

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Duke Vaccine and Trials Unit

    RECRUITING

    Durham, North Carolina, 27703, United States

  • Duke Vaccine and Trials Unit

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Erasmus MC

    RECRUITING

    Rotterdam, 3015GD, Netherlands

  • Evangelismos General Hospital of Athens

    RECRUITING

    Athens, Attikí, 106 76, Greece

  • FAICIC S. de R.L. de C.V.

    RECRUITING

    Veracruz, Veracruz Ignacio de LA Llave, 91900, Mexico

  • Fakultna nemocnica Trnava

    RECRUITING

    Trnava, Trnava Region, 917 02, Slovakia

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

    RECRUITING

    Banská Bystrica, Banská Bystrica Region, 974 01, Slovakia

  • Far Eastern Memorial Hospital

    RECRUITING

    New Taipei City, NEW Taipei, 220, Taiwan

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Fred Hutchinson South Lake Union Clinic

    RECRUITING

    Seattle, Washington, 98109, United States

  • Fujita Health University Hospital

    RECRUITING

    Toyoake, Aichi-ken, 470-1192, Japan

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

    NOT_YET_RECRUITING

    San Pedro Garza García, Nuevo León, 66278, Mexico

  • Gachon University Gil Medical Center

    RECRUITING

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

  • Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi

    RECRUITING

    Gaziantep, 27310, Turkey (Türkiye)

  • General Hospital of Athens "Laiko"

    RECRUITING

    Athens, Attikí, 11527, Greece

  • Georgetown University Medical Center

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Hacettepe Universite Hastaneleri

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Henry Ford Hospital

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Holy Name Medical Center

    RECRUITING

    Teaneck, New Jersey, 07666, United States

  • Hope Clinical Research, Inc.

    RECRUITING

    Canoga Park, California, 91303, United States

  • Hopital Claude Huriez - CHU de Lille

    RECRUITING

    Lille, NORD, 59037, France

  • Hospital General Universitario Dr. Balmis

    RECRUITING

    Alicante, 03010, Spain

  • Hospital Germans Trias i Pujol

    RECRUITING

    Badalona, Barcelona [barcelona], 08916, Spain

  • Hospital Italiano de Buenos Aires

    RECRUITING

    ABB, Buenos Aires F.D., C1199ABB, Argentina

  • Hospital Italiano de La Plata

    RECRUITING

    La Plata, Buenos Aires, B1900XI, Argentina

  • Hospital Nossa Senhora das Graças

    RECRUITING

    Curitiba, Paraná, 80810-040, Brazil

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, Barcelona [barcelona], 08035, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, Madrid, Comunidad de, 28046, Spain

  • Hospital Universitario Reina Sofia

    RECRUITING

    Córdoba, Andalusia, 14004, Spain

  • Hospital Universitario Virgen de Valme

    RECRUITING

    Seville, 41014, Spain

  • Hospital de Clinicas de Porto Alegre

    RECRUITING

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

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, Catalunya [cataluña], 08041, Spain

  • Hospital e Maternidade Celso Pierro

    NOT_YET_RECRUITING

    Campinas, São Paulo, 13060-803, Brazil

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Humphreys Diabetes Center

    RECRUITING

    Boise, Idaho, 83702, United States

  • Hôpital Bichat - Claude-Bernard

    RECRUITING

    Paris, 75018, France

  • Hôpital Saint Antoine

    RECRUITING

    Paris, 75012, France

  • Hôpital Saint-Louis

    RECRUITING

    Paris, Île-de-France Region, 75010, France

  • Ibni Sina Hospital

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    RECRUITING

    São Paulo, 01246-000, Brazil

  • Instituto Médico Río Cuarto

    RECRUITING

    Río Cuarto, Córdoba Province, X5800AEV, Argentina

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    RECRUITING

    Mexico City, 14080, Mexico

  • Instituto Nacional de Infectologia Evandro Chagas

    NOT_YET_RECRUITING

    Rio de Janeiro, 21040-360, Brazil

  • International University of Health and Welfare Narita Hospital

    RECRUITING

    Narita, Chiba, 286-8520, Japan

  • Ippokrateio General Hospital of Thessaloniki

    RECRUITING

    Thessaloniki, 546 42, Greece

  • Jacobs Medical Center at UC San Diego Health

    RECRUITING

    La Jolla, California, 92037, United States

  • Jadestone Clinical Research

    RECRUITING

    Silver Spring, Maryland, 20904, United States

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Jules Bordet Institute

    RECRUITING

    Anderlecht, 1070, Belgium

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, 807, Taiwan

  • Karadeniz Technical University

    RECRUITING

    Trabzon, 61080, Turkey (Türkiye)

  • Karolinska Universitetssjukhuset Huddinge

    RECRUITING

    Huddinge, 141 86, Sweden

  • Kendall South Medical Center

    RECRUITING

    Miami, Florida, 33185, United States

  • Klinikum Mutterhaus der Borromaerinnen gGmbH

    NOT_YET_RECRUITING

    Trier, 54290, Germany

  • Kocaeli Üniversitesi

    RECRUITING

    Kocaeli, 41380, Turkey (Türkiye)

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medical University of South Carolina Infectious Disease Clinic

    RECRUITING

    Charleston, South Carolina, 29425, United States

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

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medical University of South Carolina Investigational Drug Services Pharmacy

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Medical University of South Carolina Research Nexus Clinic

    RECRUITING

    Charleston, South Carolina, 29425, United States

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

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Memorial Hermann Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Nagasaki University Hospital

    RECRUITING

    Nagasaki, 852-8501, Japan

  • Narodny onkologicky ustav

    RECRUITING

    Bratislava, 833 10, Slovakia

  • Narodny ustav detskych chorob

    RECRUITING

    Bratislava, Bratislava Region, 833 40, Slovakia

  • National Center for Global Health and Medicine

    RECRUITING

    Shinjuku, Tokyo, 162-8655, Japan

  • National Hospital Organization Kyushu Medical Center

    RECRUITING

    Fukuoka, 810-8563, Japan

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

    RECRUITING

    Michalovce, 07101, Slovakia

  • Northwestern Memorial Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Northwestern University Feinberg School of Medicine

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Odense Universitetshospital

    RECRUITING

    Odense, Region Syddanmark, 5000, Denmark

  • Parc de Salut Mar - Hospital del Mar

    RECRUITING

    Barcelona, Barcelona [barcelona], 08003, Spain

  • Radboudumc

    NOT_YET_RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • Rigshospitalet

    RECRUITING

    Copenhagen, Capital Region, 2100, Denmark

  • Rinku General Medical Center

    RECRUITING

    Izumisano, Osaka, 598-8577, Japan

  • Saga University Hospital

    RECRUITING

    Saga, 849-8501, Japan

  • Sakarya Training and Research Hospital

    RECRUITING

    Sakarya, 54100, Turkey (Türkiye)

  • Sanatorio Sagrado Corazón

    RECRUITING

    Buenos Aires, 1039, Argentina

  • School of Medicine Federal University of Minas Gerais

    RECRUITING

    Belo Horizonte, Minas Gerais, 30130-100, Brazil

  • Seattle Rheumatology Associates

    RECRUITING

    Seattle, Washington, 98104, United States

  • Skånes Universitetssjukhus Malmö

    RECRUITING

    Malmö, Skåne LÄN [se-12], 205 02, Sweden

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    RECRUITING

    São Paulo, 05652-900, Brazil

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

    RECRUITING

    Boise, Idaho, 83712, United States

  • Swedish Ambulatory Infusion Center- First Hill

    RECRUITING

    Seattle, Washington, 98104, United States

  • Swedish Cancer Institute Treatment Center

    RECRUITING

    Seattle, Washington, 98104, United States

  • Swedish Medical Center - First Hill Campus

    RECRUITING

    Seattle, Washington, 98122, United States

  • Swedish Medical Center- Innovative Therapeutics & Research Unit

    RECRUITING

    Seattle, Washington, 98104, United States

  • Swedish Organ Transplant and Liver Center

    RECRUITING

    Seattle, Washington, 98104, United States

  • TRC

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • TUM Klinikum

    RECRUITING

    München, Bavaria, 81675, Germany

  • Tachikawa Hospital

    RECRUITING

    Tachikawa, Tokyo, 190-8531, Japan

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 407, Taiwan

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 11217, Taiwan

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

    RECRUITING

    Seoul, Seoul-teukbyeolsi [seoul], 03312, South Korea

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • Tokyo Medical University Hachioji Medical Center

    RECRUITING

    Hachiōji, Tokyo, 1930998, Japan

  • UC Davis CTSC Clinical Research Center

    RECRUITING

    Sacramento, California, 95817, United States

  • UC San Diego Medical Center - Hillcrest

    RECRUITING

    San Diego, California, 92103, United States

  • UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • UKE Hamburg

    RECRUITING

    Hamburg, 20246, Germany

  • UPMC Division of Infectious Disease Clinic

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • UPMC Presbyterian IDS

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • UPMC Presbyterian Shadyside

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • UPMC Shadyside

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • UPMC Shadyside IDS

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • UT Physicians

    RECRUITING

    Houston, Texas, 77030, United States

  • UZ Brussel

    RECRUITING

    Brussels, Brussels Capital, 1090, Belgium

  • Universitaetsklinikum Koeln

    RECRUITING

    Cologne, North Rhine-Westphalia, 50937, Germany

  • University General Hospital of Alexandroupoli

    RECRUITING

    Alexandroupoli, Anatolikí Makedonía KAI Thráki, 681 00, Greece

  • University General Hospital of Heraklion

    RECRUITING

    Irakleio, 715 00, Greece

  • University of California Davis Health

    RECRUITING

    Sacramento, California, 95817, United States

  • University of California San Diego Health

    RECRUITING

    San Diego, California, 92103, United States

  • University of Cincinnati College of Medicine (UC Holmes)

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Colorado Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Colorado Clinical and Translational Research Center

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Colorado Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Massachusetts Chan Medical School

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Washington Medical Center

    RECRUITING

    Seattle, Washington, 98195, United States

  • Université Libre de Bruxelles - Hôpital Erasme

    RECRUITING

    Brussels, Bruxelles-capitale, Région de, 1070, Belgium

  • Velocity Clinical Research, Savannah

    RECRUITING

    Savannah, Georgia, 31406, United States

  • West Tennessee Research Institute

    RECRUITING

    Jackson, Tennessee, 38305, United States

  • Zenos Clinical Research

    RECRUITING

    Dallas, Texas, 75230, United States

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