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

NCT07013474 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: C50910182024-517671-21-00
• Study Type: interventional
• Target: 300
• Locations: 14 countries
• Sites: 54

Brief 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 who are non-hospitalized or are hospitalized for observation or study intervention administration but do not require supplemental oxygen for COVID-19.

Conditions

COVID-19 Infection

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

Outcome Measures

Primary Outcomes (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) COVID-19-related ED visits with administration of supplemental oxygen, COVID-19 antiviral, or IV treatment; COVID-19-related hospitalization; or all-cause mortality, and b) Evidence of recurrent or persistent SARS-CoV-2 infection

  38 days

Secondary Outcomes (8)

• Time to sustained alleviation of all targeted COVID-19 symptoms

  38 days

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

  38 days

• Proportion of participants with COVID-19-related ED visits with administration of supplemental oxygen, COVID-19 antiviral, or IV treatment, COVID-19-related hospitalization, or all-cause mortality.

  38 days

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

  38 days

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

  38 days

Study Arms (3)

Ibuzatrelvir

EXPERIMENTAL

Participants will receive ibuzatrelvir orally twice a day + IV placebo for remdesivir

Drug: ibuzatrelvir; Drug: placebo for remdesivir

Ibuzatrelvir + Remdesivir

EXPERIMENTAL

Participants will receive ibuzatrelvir orally twice a day + IV remdesivir

Drug: ibuzatrelvir; Drug: remdesivir

Remdesivir

EXPERIMENTAL

Participants will receive placebo for ibuzatrelvir orally twice a day + IV remdesivir

Drug: remdesivir; Drug: placebo for ibuzatrelvir

Interventions

ibuzatrelvir DRUG

tablet

Ibuzatrelvir; Ibuzatrelvir + Remdesivir

remdesivir DRUG

injection, for intravenous use

Also known as: veklury

Ibuzatrelvir + Remdesivir; Remdesivir

placebo for ibuzatrelvir DRUG

tablet

Remdesivir

placebo for remdesivir DRUG

injection, for intravenous use

Ibuzatrelvir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older at screening who are non-hospitalized or hospitalized for observation or with the intent of administering the study intervention.
• 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.

You may not qualify if:

• Severe COVID-19, or current need for supplemental oxygen for treatment of COVID-19.
• Receiving dialysis or have current kidney failure (ie, eGFR consistently \<15 mL/min/1.73 m2)
• 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.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (54)

UC Davis CTSC Clinical Research Center

Sacramento, California, 95817, United States

RECRUITING

University of California Davis Health

Sacramento, California, 95817, United States

RECRUITING

UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

D&H Cancer Research Center LLC

Margate, Florida, 33063, United States

RECRUITING

Velocity Clinical Research, Savannah

Savannah, Georgia, 31406, United States

RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Clinical Trials Center

Boston, Massachusetts, 02115, United States

RECRUITING

Clinical Trials Hub

Boston, Massachusetts, 02115, United States

RECRUITING

Skylight Health Research, - Burlington

Burlington, Massachusetts, 01803, United States

RECRUITING

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

RECRUITING

Revive Research Institute, Inc.

Farmington Hills, Michigan, 48334, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

TRC

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

UPMC Division of Infectious Disease Clinic

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

UPMC Presbyterian IDS

Pittsburgh, Pennsylvania, 15213, United States

NOT YET RECRUITING

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

NOT YET RECRUITING

UPMC Shadyside IDS

Pittsburgh, Pennsylvania, 15232, United States

NOT YET RECRUITING

Baylor University Medical Center

Dallas, Texas, 75246, United States

NOT YET RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Swedish Ambulatory Infusion Center- First Hill

Seattle, Washington, 98104, United States

RECRUITING

Swedish Cancer Institute Treatment Center

Seattle, Washington, 98104, United States

RECRUITING

AZ Sint-Jan Brugge-Oostende AV

Bruges, West-vlaanderen, 8000, Belgium

RECRUITING

School of Medicine Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

RECRUITING

Centro Médico São Francisco

Curitiba, Paraná, 80810-050, Brazil

RECRUITING

CECIP - Centro de Estudos do Interior Paulista

Jaú, São Paulo, 17201130, Brazil

NOT YET RECRUITING

Instituto Nacional de Infectologia Evandro Chagas

Rio de Janeiro, 21040-360, Brazil

NOT YET RECRUITING

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

Aalborg Universitetshospital, Syd

Aalborg, North Denmark, 9000, Denmark

RECRUITING

Hopital Claude Huriez - CHU de Lille

Lille, NORD, 59037, France

RECRUITING

Hôpital Bichat - Claude-Bernard

Paris, 75018, France

RECRUITING

TUM Klinikum

München, Bavaria, 81675, Germany

RECRUITING

Alexandra General Hospital of Athens

Athens, Attikí, 115 28, Greece

RECRUITING

General Hospital of Athens "Laiko"

Athens, Attikí, 11527, Greece

RECRUITING

Fujita Health University Hospital

Toyoake, Aichi-ken, 470-1192, Japan

RECRUITING

Rinku General Medical Center

Izumisano, Osaka, 598-8577, Japan

RECRUITING

Tachikawa Hospital

Tachikawa, Tokyo, 190-8531, Japan

RECRUITING

National Hospital Organization Kyushu Medical Center

Fukuoka, 810-8563, Japan

RECRUITING

Saga University Hospital

Saga, 849-8501, Japan

RECRUITING

Canas Medical Center

Ponce, 00728, Puerto Rico

NOT YET RECRUITING

Narodny ustav detskych chorob

Bratislava, Bratislava Region, 833 40, Slovakia

RECRUITING

Narodny onkologicky ustav

Bratislava, 833 10, Slovakia

RECRUITING

Chonnam National University Hospital

Gwangju, Kwangju-kwangyǒkshi, 61469, South Korea

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, Andalusia, 14004, Spain

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona], 08035, Spain

RECRUITING

Hospital General Universitario Dr. Balmis

Alicante, 03010, Spain

RECRUITING

Hospital Universitario Virgen de Valme

Seville, 41014, Spain

RECRUITING

Far Eastern Memorial Hospital

New Taipei City, NEW Taipei, 220, Taiwan

RECRUITING

Sakarya Training and Research Hospital

Sakarya, 54100, Turkey (Türkiye)

RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.
• Pfizer Clinical Trials website

MeSH Terms

Conditions

COVID-19; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; RNA Virus Infections; Lung Diseases; Pneumonia, Viral; Infections; Virus Diseases

Interventions

remdesivir

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; Respiratory Tract Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study, with required dedicated unblinded staff for dose preparation for remdesivir and placebo for remdesivir.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: June 10, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): December 6, 2026
• Study Completion (Estimated): May 6, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

BR (4); BE (1); FR (2); KR (1); GR (2); TW (1); DE (1); US (27); PR (1); ES (4); DK (2); SL (2); TU (1); JP (5)