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
AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED IBUZATRELVIR COMPARED WITH PLACEBO IN NON-HOSPITALIZED SYMPTOMATIC ADULT AND ADOLESCENT PARTICIPANTS WITH COVID-19 WHO ARE AT HIGH RISK OF PROGRESSING TO SEVERE ILLNESS
2 other identifiers
interventional
2,330
19 countries
253
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2024
Typical duration for phase_3
253 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2024
CompletedFirst Posted
Study publicly available on registry
November 7, 2024
CompletedStudy Start
First participant enrolled
December 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 3, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 2, 2028
July 31, 2026
July 1, 2026
2.8 years
November 5, 2024
July 30, 2026
Conditions
Keywords
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
- +14 more secondary outcomes
Study Arms (2)
ibuzatrelvir
EXPERIMENTALIbuzatrelvir administered orally every 12 hours (twice daily) for a total of 5 days.
placebo
PLACEBO COMPARATORplacebo administered orally every 12 hours (twice daily) for 5 days.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (253)
Applied Research Center of Arkansas
Little Rock, Arkansas, 72205, United States
National Institute of Clinical Research - Bakersfield
Bakersfield, California, 93309, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255, United States
310 Clinical Research
Inglewood, California, 90301, United States
Long Beach Research Institute
Long Beach, California, 90805, United States
Long Beach Clinical Trials
Long Beach, California, 90806, United States
Pacific Clinical Studies Inc.
Los Alamitos, California, 90720, United States
Downtown L.A. Research Center, Inc.
Los Angeles, California, 90017, United States
Clinica mi Salud by Focil Med
Oxnard, California, 93030, United States
FOMAT Medical Research
Oxnard, California, 93030, United States
Paradigm Clinical Research, LLC
Redding, California, 96001, United States
Acclaim Clinical Research
San Diego, California, 92120, United States
Tweedy Medical Group - Charity Health
South Gate, California, 90280, United States
Breathe Clear Institute for Sinus and Allergy Relief
Torrance, California, 90503, United States
Paradigm Clinical Research, LLC
Wheat Ridge, Colorado, 80033, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Emerson Clinical Research Institute
Washington D.C., District of Columbia, 20009, United States
Innovative Research of West Florida
Clearwater, Florida, 33756, United States
Invictus Clinical Research Group
Coconut Creek, Florida, 33073, United States
Hillcrest Medical Research LLC
DeLand, Florida, 32720, United States
Hillcrest Medical Research
DeLand, Florida, 32720, United States
Universal Axon Clinical Research, LLC
Doral, Florida, 33166, United States
Herco Medical and Research Center Inc
Flagami, Florida, 33126, United States
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, 33308, United States
C & R Research Services USA
Fort Myers, Florida, 33919, United States
Qway Research LLC
Hialeah, Florida, 33010, United States
Sunbright Health Medical Centers
Homestead, Florida, 33032, United States
Infinite Clinical Research
Miami, Florida, 33133, United States
Bio-Medical Research LLC
Miami, Florida, 33144, United States
Kendall South Medical Center
Miami, Florida, 33185, United States
Nuovida Research Center
Miami, Florida, 33186, United States
Global Health Research Center, Inc.
Miami Lakes, Florida, 33016, United States
Adult Medicine of Lake County, Inc.
Mt. Dora, Florida, 32757, United States
Innovation Medical Research Center
Palmetto Bay, Florida, 33157, United States
DBC Research USA
Pembroke Pines, Florida, 33029, United States
GCP , Global Clinical Professionals
St. Petersburg, Florida, 33714, United States
Global Health Research Center - Tampa
Tampa, Florida, 33615, United States
The Hope Clinic of Emory University
Decatur, Georgia, 30030, United States
Javara - Privia Medical Group Georgia - Fayetteville
Fayetteville, Georgia, 30214, United States
Coastal Heritage Clinical Research
Hinesville, Georgia, 31313, United States
Velocity Clinical Research, Savannah
Savannah, Georgia, 31406, United States
St. Luke's Humphreys Diabetes Center
Boise, Idaho, 83702, United States
St. Luke's Children's
Boise, Idaho, 83712, United States
St. Luke's Elks Children's Pavilion
Boise, Idaho, 83712, United States
Koch Family Medicine
Morton, Illinois, 61550, United States
UL International Travel Clinic
Louisville, Kentucky, 40202, United States
University of Louisville Hospital
Louisville, Kentucky, 40202, United States
University of Louisville School of Medicine
Louisville, Kentucky, 40202, United States
Centennial Medical Group
Columbia, Maryland, 21045, United States
Jadestone Clinical Research
Silver Spring, Maryland, 20904, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655, United States
Revival Research Institute, LLC
Dearborn, Michigan, 48126, United States
Henry Ford St. John Hospital
Grosse Pointe Woods, Michigan, 48236, United States
Mercury Street Medical Group, PLLC
Butte, Montana, 59701, United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, 68803, United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, 68134, United States
McGill Family Practice
Papillion, Nebraska, 68046, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030, United States
Upstate Global Health Institute
East Syracuse, New York, 13057, United States
Upstate Connect Care
Syracuse, New York, 13210, United States
Prime Global Research
The Bronx, New York, 10456, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Remington-Davis, Inc
Columbus, Ohio, 43215, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401, United States
Medical University of South Carolina Ashley River Tower
Charleston, South Carolina, 29401, United States
Medical University of South Carolina - SCTR Research Nexus
Charleston, South Carolina, 29425, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
WR-Clinsearch, LLC
Chattanooga, Tennessee, 37421, United States
Zenos Clinical Research
Dallas, Texas, 75230, United States
Southwest Family Medicine Associates
Dallas, Texas, 75235, United States
Southwest Mind and Body Care
Dallas, Texas, 75235, United States
Memorial Hermann Hospital TMC
Houston, Texas, 77030, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
UT Physicians
Houston, Texas, 77030, United States
Next Level Urgent Care
Houston, Texas, 77057, United States
Gulf Coast Clinical Research - Houston
Houston, Texas, 77070, United States
Mercury Clinical Research - Santa Clara Family Clinic
Houston, Texas, 77087, United States
The Crofoot Research Center
Houston, Texas, 77098, United States
Epic Clinical Research
Lewisville, Texas, 75057, United States
Javara - Privia Medical Group North Texas - Stephenville
Stephenville, Texas, 76401, United States
Javara - Privia Medical Group Gulf Coast - Sugarland
Sugar Land, Texas, 77478, United States
Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic
Tomball, Texas, 77375, United States
Velocity Clinical Research, Waco
Waco, Texas, 76710, United States
Alpine Research Organization
Clinton, Utah, 84015, United States
Velocity Clinical Research, Suffolk
Suffolk, Virginia, 23435, United States
Eastside Research Associates
Redmond, Washington, 98052, United States
Sanatorio Guemes
Ciudad de Buenos Aires, Buenos Aires, 1180, Argentina
Instituto Médico Platense (IMP)
La Plata, Buenos Aires, B1900AVG, Argentina
Hospital Italiano de La Plata
La Plata, Buenos Aires, B1900XI, Argentina
Centro de Investigaciones Médicas Mar del Plata
Mar del Plata, Buenos Aires, 7600, Argentina
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, X5800, Argentina
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB, Argentina
Equipo Ciencia
Buenos Aires, C1428BNF, Argentina
ANIMA Research
Alken, Limburg, 3570, Belgium
Pneumocare
Erpent, 5101, Belgium
Hospital Universitario Professor Edgard Santos
Salvador, Estado de Bahia, 40110-060, Brazil
Infection Control
Belo Horizonte, Minas Gerais, 30110-945, Brazil
Centro Avançado de Tratamento Oncológico - CENANTRON
Belo Horizonte, Minas Gerais, 30130-090, Brazil
School of Medicine Federal University of Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Complexo Hospital de Clínicas da Universidade Federal do Paraná
Curitiba, Paraná, 80.060-900, Brazil
Centro Médico São Francisco
Curitiba, Paraná, 80810-050, Brazil
Real Hospital Portugues
Recife, Pernambuco, 52010-075, Brazil
Instituto Atena de Pesquisa Clinica
Natal, Rio Grande do Norte, 59020-500, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610000, Brazil
Centro de Pesquisa Clínica - CPC/UFSM
Santa Maria, Rio Grande do Sul, 97060-360, Brazil
Hospital e Maternidade Celso Pierro
Campinas, São Paulo, 13060-803, Brazil
i9 Pesquisas Clínicas - Loema Instituto de Pesquisa Clínica e Consultores SS Ltda
Campinas, São Paulo, 13092-133, Brazil
CECIP - Centro de Estudos do Interior Paulista
Jaú, São Paulo, 17201130, Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-870, Brazil
Centro de Referência e Treinamento DST/AIDS
São Paulo, São Paulo, 04121-000, Brazil
Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro, 21040-360, Brazil
Instituto de Infectologia Emilio Ribas
São Paulo, 01246900, Brazil
Diagnostic Consultative Center - 1 - Sevlievo EOOD
Sevlievo, Gabrovo, 5400, Bulgaria
Medical Centre "Asklepiy"
Dupnitsa, Kyustendil, 2600, Bulgaria
SHATPD Troyan
Troyan Municipality, Lovech, 5600, Bulgaria
Diagnostic Consultative Center - 1 Lom EOOD
Lom, Montana, 3600, Bulgaria
MHAT Samokov
Samokov, Sofia, 2000, Bulgaria
Military Medical Academy
Sofia, Sofia (stolitsa), 1606, Bulgaria
Medical Center Pulmo - 2018 EOOD
Haskovo, 6300, Bulgaria
MHAT "Rahila Angelova" Pernik
Pernik, 2300, Bulgaria
Diagnostic Consultative Center "Sveti Georgi" Plovdiv
Plovdiv, 4000, Bulgaria
Medical Center Sveti Ivan Rilski Chudotvorets - 2010
Plovdiv, 4003, Bulgaria
Ambulatory for Individual Primary Medical Care - Dr. Pavlina Petrova - Poli ET
Sofia, 1142, Bulgaria
Medical Center Hera EOOD
Sofia, 1510, Bulgaria
Medical Center Diana Med 2001
Yambol, 8600, Bulgaria
Vancouver Infectious Diseases Centre
Vancouver, British Columbia, V6Z 2E9, Canada
Clinical Research of Ontario
Scarborough Village, Ontario, M1S 4T7, Canada
Community Care Building
Winchester, Ontario, K0C 2K0, Canada
Dundas Manor Nursing Home
Winchester, Ontario, K0C 2K0, Canada
Winchester District Memorial Hospital
Winchester, Ontario, K0C 2K0, Canada
The People's Hospital of Chizhou
Chizhou, Anhui, 247000, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Zhongshan Hospital Fudan University (Xiamen Branch)
Xiamen, Fujian, 361004, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004, China
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530007, China
The Third Hospital of Changsha
Changsha, Hunan, 410015, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330038, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, 200120, China
Shanghai Minhang District Central Hospital
Shanghai, Shanghai Municipality, 201199, China
First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300384, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650032, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016, China
Beijing Ditan Hospital Capital Medical
Beijing, 100015, China
Doktor Brno
Brno, Brno-město, 602 00, Czechia
Lékařský dům v Mezibranské
Prague, Praha 1, 110 00, Czechia
Ordinace Hradebni s.r.o.
České Budějovice, South Bohemian Region, 370 01, Czechia
Zdravi-fit
Protivín, South Bohemian Region, 398 11, Czechia
ORL MUDr Pavel Navratil
Olomouc, 779 00, Czechia
Rigshospitalet
Copenhagen, Capital Region, 2100, Denmark
Nordsjællands Hospital - Hillerød
Hilleroed, Capital Region, 3400, Denmark
Regionshospitalet Gødstrup
Herning, Central Jutland, 7400, Denmark
Roskilde Sygehus
Roskilde, Region Sjælland, 4000, Denmark
Aalborg Universitetshospital, Syd
Gistrup, 9260, Denmark
FVR, Oulun rokotetutkimusklinikka
Oulu, North Ostrobothnia, 90220, Finland
FVR, Tampereen rokotetutkimusklinikka
Tampere, Pirkanmaa, 33100, Finland
FVR, Etelä-Helsingin rokotetutkimusklinikka
Helsinki, Uusimaa, 00100, Finland
MeVac - Meilahti Vaccine Research Center
Helsinki, Uusimaa, 00290, Finland
LMU Klinikum München
Munich, Bavaria, 80336, Germany
Praxisgemeinschaft Heimeranplatz
Munich, Bavaria, 80339, Germany
IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardio
Frankfurt am Main, Hesse, 60596, Germany
Studien Rahman & Detho
Obertshausen, Hesse, 63179, Germany
Praxis am Ebertplatz
Cologne, North Rhine-Westphalia, 50668, Germany
Universitätsklinikum Augsburg
Augsburg, 86156, Germany
Novopraxis Berlin GbR
Berlin, 10117, Germany
zibp Zentrum für lnfektiologie Berlin Prenzlauer Berg GmbH
Berlin, 10439, Germany
Charité - Universitätsmedizin Berlin
Berlin, 13353, Germany
Universitätsklinik Freiburg
Freiburg im Breisgau, 79106, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
University of Rostock
Rostock, 18057, Germany
Kamezawa Clinic
Kasugai, Aichi-ken, 486-0817, Japan
International University of Health and Welfare Narita Hospital
Narita, Chiba, 286-8520, Japan
Tashiro Endocrinology Clinic
Fukuoka, Fukuoka, 814-0153, Japan
Medical Corporation Kouhoukai Takagi Hospital
Okawa-shi, Fukuoka, 831-0016, Japan
Nishioka Hospital
Sapporo, Hokkaido, 062-0034, Japan
Terada Clinic Respiratory Medicine & General Practice
Himeji, Hyōgo, 670-0849, Japan
Koga General Hospital
Koga-shi, Ibaraki, 306-0041, Japan
Tsuchiura Beryl Clinic
Tsuchiura, Ibaraki, 300-0062, Japan
Shonan Fujisawa Tokushukai Hospital
Fujisawa, Kanagawa, 251-0041, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, 247-8533, Japan
Rakuwakai Otowa Hospital
Kyoto, Kyoto, 607-8062, Japan
National Hospital Organization Okinawa Hospital
Ginowan, Okinawa, 901-2214, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, 104-0031, Japan
Musashino Emergency Hospital
Kodaira-shi, Tokyo, 187-0031, Japan
Swing Nozaki Clinic
Musashino-shi, Tokyo, 180-0022, Japan
Yoshijima Hospital
Hiroshima, 730-0822, Japan
Asociación Mexicana para la Investigación Clínica A.C.
Pachuca, Hidalgo, 42082, Mexico
JM Research SC
Cuernavaca, Morelos, 62290, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460, Mexico
Eukarya Pharmasite S.C.
Monterrey, Nuevo León, 64718, Mexico
Clinstile, S.A. de C.V.
Mexico City, 06700, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080, Mexico
Arké SMO S.A de C.V
Veracruz, 91900, Mexico
IRS - Medicinska cinnost s.r.o., Vseobecna ambulancia pre dospelych
Kosice-Juh, Košice Region, 040 01, Slovakia
Artromac n.o.
Košice, Košice Region, 040 11, Slovakia
ML MED, s.r.o., Vseobecna ambulancia pre dospelych
Moldava nad Bodvou, Košice Region, 045 01, Slovakia
Plucna ambulancia Hrebenar, s.r.o., Pneumologicko-ftizeologicka ambulancia
Spišská Nová Ves, Košice Region, 052 01, Slovakia
PULMO, s.r.o., Pneumologicko-ftizeologicka ambulancia
Prešov, Presov, 080 01, Slovakia
SALUBER SK s.r.o., Vseobecna ambulancia pre dospelych
Nové Mesto nad Váhom, Trenčín Region, 915 01, Slovakia
MUDr. Viliam Cibik, PhD., s.r.o.
Pruské, Trenčín Region, 018 52, Slovakia
AMB4YOU s.r.o.
Hlohovec, Trnava Region, 920 01, Slovakia
VL.AK s.r.o. Vseobecna ambulancia pre dospelych
Trnava, Trnava Region, 917 01, Slovakia
Newtown Clinical Research
Johannesburg, Gauteng, 2113, South Africa
Global Clinical Trials
Pretoria, Gauteng, 0157, South Africa
Jongaie Research
Pretoria West, Gauteng, 0183, South Africa
Sandton Medical Research Centre
Sandton, Gauteng, 2196, South Africa
Synapta Clinical Research Centre
Durban, KwaZulu-Natal, 4001, South Africa
Private Practice - Dr. Peter Sebastian
Silverglen Durban, KwaZulu-Natal, 4092, South Africa
Langeberg Clinical Trials
Cape Town, Western Cape, 7570, South Africa
Paarl Research Centre
Paarl, Western Cape, 7646, South Africa
TREAD Research
Parow, Western Cape, 7500, South Africa
Incheon Medical Center
Donggu, Incheon-gwangyeoksi [incheon], 22532, South Korea
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon], 21565, South Korea
Wonju Severance Christian Hospital
Wŏnju, Kang-won-do, 26426, South Korea
Chonnam National University Hospital
Gwangju, Kwangju-kwangyǒkshi, 61469, South Korea
Korea University Ansan Hospital
Ansan-si, Kyǒnggi-do, 15355, South Korea
Ajou University Hospital
Suwon, Kyǒnggi-do, 16499, South Korea
Chung-Ang University Hospital
Dongjak-gu, Seoul-teukbyeolsi [seoul], 06973, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Gangnam-gu, Seoul-teukbyeolsi [seoul], 06273, South Korea
Korea University Anam Hospital
Seoul, Seoul-teukbyeolsi [seoul], 02841, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul], 03312, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, Seoul-teukbyeolsi [seoul], 07441, South Korea
Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [seoul], 08308, South Korea
Keimyung University Dongsan Hospital
Daegu, Taegu-kwangyǒkshi, 42601, South Korea
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [LA Coruña], 15006, Spain
Hospital Vithas Xanit Internacional
Benalmádena, Andalusia, 29631, Spain
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 14004, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona [barcelona], 08916, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [barcelona], 08035, Spain
Hospital Universitario La Paz
Madrid, Madrid, Comunidad de, 28046, Spain
CHUVI- Hospital Alvaro Cunqueiro
Vigo, Pontevedra [pontevedra], 36312, Spain
Hospital General Universitario Dr. Balmis
Alicante, 03010, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
Hospital Universitario Virgen de Valme
Seville, 41014, Spain
Far Eastern Memorial Hospital
New Taipei City, NEW Taipei, 220, Taiwan
Taichung Veterans General Hospital
Taichung, 407, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Tri-Service General Hospital
Taipei, 114, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333, Taiwan
Acibadem Universitesi Atakent Hastanesi
Istanbul, İ̇stanbul, 34303, Turkey (Türkiye)
Ankara University Ibni Sina Hospital
Ankara, 06230, Turkey (Türkiye)
Hacettepe Universite Hastaneleri
Ankara, 06230, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Gaziantep, 27310, Turkey (Türkiye)
Kocaeli Üniversitesi
Kocaeli, 41380, Turkey (Türkiye)
Sakarya Training and Research Hospital
Sakarya, 54100, Turkey (Türkiye)
Karadeniz Technical University
Trabzon, 61080, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
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
July 31, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
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.