A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease

NCT06679140 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: C50910172024-517727-39-00
• Study Type: interventional
• Target: 2,330
• Locations: 17 countries
• Sites: 103

Brief Summary

The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.

Conditions

COVID-19 SARS-CoV-2 Infection

Keywords

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; COVID-19; Viral Protease Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Anti-Infective Agents; ibuzatrelvir

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with COVID-19 related emergency department visits, all cause hospitalization and all cause mortality

  The difference in proportions of patients requiring COVID 19 related emergency department visits with administration of supplemental oxygen, COVID-19 antiviral or IV treatment (eg hydration, antibiotics, or corticosteroids), all-cause hospitalization, or all-cause death through Day 28 between ibuzatrelvir and placebo, among patients who were treated ≤5 days after COVID-19 symptom onset and who were not receiving background SoC treatment for their COVID-19 infection at baseline.

  Day 1 through Day 28

Secondary Outcomes (19)

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

  Day 1 to Day 28

• Proportion of participants with post acute COVID-19 medical events

  Day 29 to Week 24

• Proportion of participants with cardiovascular, renal and pulmonary events

  Day 1 to Week 24

• Proportion of participants with Long COVID symptoms

  Day 29 to Week 24

• Changes from baseline in SARS-CoV-2 RNA levels in nasopharyngeal/nasal swabs

  Day 1 through Day 34

Study Arms (2)

ibuzatrelvir

EXPERIMENTAL

Ibuzatrelvir administered orally every 12 hours (twice daily) for a total of 5 days.

Drug: ibuzatrelvir

placebo

PLACEBO COMPARATOR

placebo administered orally every 12 hours (twice daily) for 5 days.

Drug: placebo

Interventions

ibuzatrelvir DRUG

ibuzatrelvir tablets

Also known as: PF-07817883

ibuzatrelvir

placebo DRUG

placebo tablets

placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• to \<18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.
• Presence of risk factors for progression to severe COVID-19 at the time of screening based on age:
• to 49 years of age with at least two risk factors, where one must be moderate immunocompromise;
• to 64 years of age with at least two risk factors;
• to 74 years of age with at least one risk factor;
• For participants 75 years of age or older, there are no requirements related to risk factors.
• The list of risk factors includes:
• BMI ≥35 kg/m2; Current smoker; Chronic lung disease; Cardiovascular disease; Type 1 or Type 2 diabetes mellitus; Mild to moderate renal impairment; Neurodevelopmental disorders; Sickle cell disease; Moderate immunosuppression.
• Confirmed SARS-CoV-2 infection as determined by RAT in nasal or NP specimen collected within 1 day prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization. Randomization must occur no later than the 5th day, where the onset of symptoms is the first day.
• Participants must be unable or unwilling to take nirmatrelvir/ritonavir.

You may not qualify if:

• Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness (eg, SpO2 \<94% on room air, respiratory rate \>30 breaths/minute, or lung infiltrates \>50%) or due to other medical conditions requiring hospitalization in the opinion of the site investigator.
• Receiving dialysis or have known severe renal impairment \[ie, eGFR consistently \<30 mL/min/1.73 m2 for adults or CrCl \<30 mL/min for adolescents\], using the serum creatinine-based CKD-EPI formula or the Cockroft Gault, respectively.
• Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.
• Ongoing Long COVID or Post Acute Sequelae of COVID-19 diagnosis.
• Severely immunocompromised.
• Any comorbidity requiring hospitalization and/or surgery within 7 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator.
• History of hypersensitivity or other contraindication to any of the components of the study interventions.
• 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.
• Current use of any prohibited concomitant medication(s).
• Has received any other antiviral for the treatment of COVID-19, including remdesivir, nirmatrelvir/ritonavir, molnupiravir, or COVID-19 mAbs within 30 days or 5 half-lives \[whichever is longer\] prior to screening, or received convalescent COVID-19 plasma within 12 months.
• Received any dose of a COVID-19 vaccine within 4 months of randomization or expected to receive one through Day 34.
• Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
• Prior participation in this clinical trial or any other clinical trial of ibuzatrelvir.
• 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 (103)

National Institute of Clinical Research - Bakersfield

Bakersfield, California, 93309, United States

RECRUITING

Velocity Clinical Research, Huntington Park

Huntington Park, California, 90255, United States

NOT YET RECRUITING

310 Clinical Research

Inglewood, California, 90301, United States

RECRUITING

Long Beach Clinical Trials

Long Beach, California, 90806, United States

RECRUITING

Pacific Clinical Studies Inc.

Los Alamitos, California, 90720, United States

NOT YET RECRUITING

FOMAT Medical Research

Oxnard, California, 93030, United States

RECRUITING

Georgetown University Medical Center

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

RECRUITING

Emerson Clinical Research Institute

Washington D.C., District of Columbia, 20009, United States

RECRUITING

Innovative Research of West Florida

Clearwater, Florida, 33756, United States

RECRUITING

Proactive Clinical Research,LLC

Fort Lauderdale, Florida, 33308, United States

RECRUITING

Adult Medicine of Lake County, Inc.

Mt. Dora, Florida, 32757, United States

RECRUITING

GCP Research, Global Clinical professionals

St. Petersburg, Florida, 33705, United States

RECRUITING

Coastal Heritage Clinical Research

Hinesville, Georgia, 31313, United States

RECRUITING

Velocity Clinical Research, Savannah

Savannah, Georgia, 31406, United States

RECRUITING

St. Luke's Humphreys Diabetes Center

Boise, Idaho, 83702, United States

RECRUITING

UL International Travel Clinic

Louisville, Kentucky, 40202, United States

RECRUITING

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

University of Louisville School of Medicine

Louisville, Kentucky, 40202, United States

RECRUITING

Centennial Medical Group

Columbia, Maryland, 21045, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

RECRUITING

Revival Research Institute, LLC

Dearborn, Michigan, 48126, United States

RECRUITING

Henry Ford St. John Hospital

Grosse Pointe Woods, Michigan, 48236, United States

RECRUITING

Mercury Street Medical Group, PLLC

Butte, Montana, 59701, United States

RECRUITING

Velocity Clinical Research, Grand Island

Grand Island, Nebraska, 68803, United States

RECRUITING

McGill Family Practice

Papillion, Nebraska, 68046, United States

RECRUITING

Upstate Global Health Institute

East Syracuse, New York, 13057, United States

NOT YET RECRUITING

Prime Global Research

The Bronx, New York, 10456, United States

RECRUITING

Monroe Biomedical Research

Monroe, North Carolina, 28112, United States

RECRUITING

Remington-Davis, Inc

Columbus, Ohio, 43215, United States

RECRUITING

Preferred Primary Care Physicians

Uniontown, Pennsylvania, 15401, United States

RECRUITING

WR-Clinsearch, LLC

Chattanooga, Tennessee, 37421, United States

RECRUITING

Southwest Family Medicine Associates

Dallas, Texas, 75235, United States

RECRUITING

Memorial Hermann Hospital TMC

Houston, Texas, 77030, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Next Level Urgent Care

Houston, Texas, 77057, United States

RECRUITING

Gulf Coast Clinical Research - Houston

Houston, Texas, 77070, United States

RECRUITING

Mercury Clinical Research - Santa Clara Family Clinic

Houston, Texas, 77087, United States

RECRUITING

Alpine Research Organization

Clinton, Utah, 84015, United States

RECRUITING

Eastside Research Associates

Redmond, Washington, 98052, United States

RECRUITING

Instituto Médico Platense (IMP)

La Plata, Buenos Aires, B1900AVG, Argentina

NOT YET RECRUITING

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, X5800, Argentina

RECRUITING

Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

RECRUITING

ANIMA Research

Alken, Limburg, 3570, Belgium

RECRUITING

Hospital Universitario Professor Edgard Santos

Salvador, Estado de Bahia, 40110-060, Brazil

RECRUITING

Infection Control

Belo Horizonte, Minas Gerais, 30110-945, Brazil

RECRUITING

Complexo Hospital de Clínicas da Universidade Federal do Paraná

Curitiba, Paraná, 80.060-900, Brazil

RECRUITING

Centro Médico São Francisco

Curitiba, Paraná, 80810-050, Brazil

RECRUITING

Real Hospital Portugues

Recife, Pernambuco, 52010-075, Brazil

ACTIVE NOT RECRUITING

Instituto Atena de Pesquisa Clinica

Natal, Rio Grande do Norte, 59020-500, Brazil

RECRUITING

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, 90610000, Brazil

RECRUITING

i9 Pesquisas Clínicas - Loema Instituto de Pesquisa Clínica e Consultores SS Ltda

Campinas, São Paulo, 13092-133, Brazil

NOT YET RECRUITING

CECIP - Centro de Estudos do Interior Paulista

Jaú, São Paulo, 17201130, Brazil

RECRUITING

Instituto Nacional de Infectologia Evandro Chagas

Rio de Janeiro, 21040-360, Brazil

RECRUITING

Instituto de Infectologia Emilio Ribas

São Paulo, 01246900, Brazil

RECRUITING

Medical Centre "Asklepiy"

Dupnitsa, Kyustendil, 2600, Bulgaria

RECRUITING

Diagnostic Consultative Center - 1 Lom EOOD

Lom, Montana, 3600, Bulgaria

RECRUITING

MHAT Samokov

Samokov, Sofia, 2000, Bulgaria

RECRUITING

Military Medical Academy

Sofia, Sofia (stolitsa), 1606, Bulgaria

RECRUITING

Diagnostic Consultative Center "Sveti Georgi" Plovdiv

Plovdiv, 4000, Bulgaria

RECRUITING

Ambulatory for Individual Primary Medical Care - Dr. Pavlina Petrova - Poli ET

Sofia, 1142, Bulgaria

RECRUITING

Medical Center Diana Med 2001

Yambol, 8600, Bulgaria

RECRUITING

Clinical Research of Ontario

Scarborough Village, Ontario, M1S 4T7, Canada

RECRUITING

Dundas Manor Nursing Home

Winchester, Ontario, K0C 2K0, Canada

RECRUITING

Winchester District Memorial Hospital

Winchester, Ontario, K0C 2K0, Canada

RECRUITING

Diex Recherche Quebec

Québec, G1V 4T3, Canada

RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

The Third Hospital of Changsha

Changsha, Hunan, 410015, China

RECRUITING

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Shanghai Minhang District Central Hospital

Shanghai, Shanghai Municipality, 201199, China

NOT YET RECRUITING

First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

RECRUITING

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, 300384, China

RECRUITING

Beijing Ditan Hospital Capital Medical

Beijing, 100015, China

RECRUITING

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

Roskilde Sygehus

Roskilde, Region Sjælland, 4000, Denmark

RECRUITING

LMU Klinikum München

Munich, Bavaria, 80336, Germany

RECRUITING

IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardio

Frankfurt am Main, Hesse, 60596, Germany

RECRUITING

Studien Rahman & Detho

Obertshausen, Hesse, 63179, Germany

RECRUITING

Novopraxis Berlin GbR

Berlin, 10117, Germany

RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Kamezawa Clinic

Kasugai, Aichi-ken, 486-0817, Japan

RECRUITING

Rakuwakai Otowa Hospital

Kyoto, Kyoto, 607-8062, Japan

RECRUITING

National Hospital Organization Okinawa Hospital

Ginowan, Okinawa, 901-2214, Japan

RECRUITING

Fukuwa Clinic

Chuo-ku, Tokyo, 104-0031, Japan

RECRUITING

Musashino Emergency Hospital

Kodaira-shi, Tokyo, 187-0031, Japan

RECRUITING

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, 14080, Mexico

NOT YET RECRUITING

ML MED, s.r.o., Vseobecna ambulancia pre dospelych

Moldava nad Bodvou, Košice Region, 045 01, Slovakia

RECRUITING

Plucna ambulancia Hrebenar, s.r.o., Pneumologicko-ftizeologicka ambulancia

Spišská Nová Ves, Košice Region, 052 01, Slovakia

RECRUITING

PULMO, s.r.o., Pneumologicko-ftizeologicka ambulancia

Prešov, Presov, 080 01, Slovakia

RECRUITING

Newtown Clinical Research

Johannesburg, Gauteng, 2113, South Africa

RECRUITING

TREAD Research

Cape Town, Western Cape, 7530, South Africa

RECRUITING

Chonnam National University Hospital

Gwangju, Kwangju-kwangyǒkshi, 61469, South Korea

RECRUITING

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

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

RECRUITING

Hospital Vithas Xanit Internacional

Benalmádena, Andalusia, 29631, Spain

RECRUITING

Hospital Universitario Reina Sofia

Córdoba, Andalusia, 14004, Spain

NOT YET RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona], 08035, Spain

RECRUITING

Hospital Universitario Virgen de Valme

Seville, 41014, Spain

RECRUITING

Taichung Veterans General Hospital

Taichung, 407, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, 114, Taiwan

RECRUITING

Hacettepe Universite Hastaneleri

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Ankara Bilkent Şehir Hastanesi

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Related Links

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

MeSH Terms

Conditions

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

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double blind with matching placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: December 8, 2024
• Primary Completion (Estimated): October 3, 2027
• Study Completion (Estimated): March 2, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (8); TW (3); JP (5); AR (3); BR (11); ME (1); US (40); DE (5); TU (2); CA (4); KR (2); ZA (2); SL (3); BE (1); DK (2); ES (4); BU (7)