Clinical Trial for COVID-19 Infection.

Who may participate

Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.

Condition

COVID-19 Infection

Sex

Male or Female

Age

18+ years

Healthy participants

Visit ClinicalTrials.gov for more information

Eligibility criteria

Inclusion criteria

18 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.

Exclusion criteria

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.

Study overview

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.

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Miles

0500

Nearest Locations found

50 sites found

Amicis Research Center - Granada Hills

Granada Hills, California, United States, 91344

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BRP- Hialeah Hospital

Hialeah, Florida, United States, 33013

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

Dallas, Texas, United States, 75246

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Baylor Scott & White Research Institute - Clinical Trials Office

Dallas, Texas, United States, 75246

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Baylor University Medical Center

Dallas, Texas, United States, 75246

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Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

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Clinical Trials Center

Boston, Massachusetts, United States, 02115

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Clinical Trials Hub

Boston, Massachusetts, United States, 02115

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D&H Cancer Research Center LLC

Margate, Florida, United States, 33063

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Duke University - Main Hospital and Clinics

Durham, North Carolina, United States, 27710

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Duke Vaccine and Trials Unit

Durham, North Carolina, United States, 27703

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Duke Vaccine and Trials Unit

Durham, North Carolina, United States, 27705

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Georgetown University Medical Center

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

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Henry Ford Hospital

Detroit, Michigan, United States, 48202

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Holy Name Medical Center

Teaneck, New Jersey, United States, 07666

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Hope Clinical Research, Inc.

Canoga Park, California, United States, 91303

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Humphreys Diabetes Center

Boise, Idaho, United States, 83702

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Jacobs Medical Center at UC San Diego Health

La Jolla, California, United States, 92037

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Jadestone Clinical Research

Silver Spring, Maryland, United States, 20904

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Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

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Kendall South Medical Center

Miami, Florida, United States, 33185

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Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

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Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States, 60611

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Profound Research LLC

Farmington Hills, Michigan, United States, 48334

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Revive Research Institute, Inc.

Farmington Hills, Michigan, United States, 48334

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Skylight Health Research, - Burlington

Burlington, Massachusetts, United States, 01803

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St. Luke's Idaho Elks Children's Pavilion

Boise, Idaho, United States, 83712

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TRC

Pittsburgh, Pennsylvania, United States, 15213

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UC Davis CTSC Clinical Research Center

Sacramento, California, United States, 95817

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UC San Diego Medical Center - Hillcrest

San Diego, California, United States, 92103

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UCHealth Anschutz Inpatient Pavilion - Anschutz Medical Campus

Aurora, Colorado, United States, 80045

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UPMC Division of Infectious Disease Clinic

Pittsburgh, Pennsylvania, United States, 15213

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UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States, 15232

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UPMC Presbyterian IDS

Pittsburgh, Pennsylvania, United States, 15213

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UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania, United States, 15213

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UPMC Shadyside

Pittsburgh, Pennsylvania, United States, 15232

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UPMC Shadyside IDS

Pittsburgh, Pennsylvania, United States, 15232

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University of California Davis Health

Sacramento, California, United States, 95817

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University of California San Diego Health

San Diego, California, United States, 92103

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University of Cincinnati College of Medicine (UC Holmes)

Cincinnati, Ohio, United States, 45267

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University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States, 80045

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University of Colorado Clinical and Translational Research Center

Aurora, Colorado, United States, 80045

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University of Colorado Hospital

Aurora, Colorado, United States, 80045

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University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States, 01655

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University of Michigan

Ann Arbor, Michigan, United States, 48109

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University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

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Velocity Clinical Research, Savannah

Savannah, Georgia, United States, 31406

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West Tennessee Research Institute

Jackson, Tennessee, United States, 38305

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Zenos Clinical Research

Dallas, Texas, United States, 75230

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Join PfizerConnect

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

Who may participate

Eligibility criteria

Study overview

View locations for this study

Nearest Locations found

Join PfizerConnect

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

Who may participate

Eligibility criteria

Study overview

View locations for this study

Nearest Locations found

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