The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe inadults and adolescents with COVID-19 who do not need to be in the hospital but who are athigh risk for progression to severe disease. Eligible participants will be randomlyassigned (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 ofthe study is around 6 months.
Not Provided
Drug: ibuzatrelvir
ibuzatrelvir tablets
Other Name: PF-07817883
Drug: placebo
placebo tablets
Inclusion Criteria:
1. 12 to <18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight
at screening.
2. Presence of risk factors for progression to severe COVID-19 at the time of screening
based on age:
1. 12 to 49 years of age with at least two risk factors, where one must be
moderate immunocompromise;
2. 50 to 64 years of age with at least two risk factors;
3. 65 to 74 years of age with at least one risk factor;
4. For participants 75 years of age or older, there are no requirements related to
risk factors.
The list of risk factors includes:
BMI ≥30 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.
3. Confirmed SARS-CoV-2 infection as determined by RAT in nasal 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.
4. Participants must be unable or unwilling to take nirmatrelvir/ritonavir.
Exclusion Criteria:
1. 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.
2. Receiving dialysis or have known severe renal impairment [ie, eGFR <30 mL/min/1.73
m2 for adults or CrCl <30 mL/min for adolescents] within 6 months of the screening
visit, using the serum creatinine-based CKD-EPI formula or the Cockroft Gault,
respectively.
3. Active liver disease with AST or ALT >3 ULN, Total bilirubin ≥2 × ULN (for Gilbert's
syndrome, direct bilirubin >ULN is exclusionary) within the past 3 months, or liver
function impairment with Class C per Child Pugh classification.
4. Suspected or confirmed concurrent active systemic infection other than COVID-19 that
may interfere with the evaluation of response to the study intervention.
5. Ongoing Long COVID or Post Acute Sequelae of COVID-19 diagnosis.
6. Severely immunocompromised.
7. 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.
8. 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.
9. Current use of any prohibited concomitant medication(s).
10. 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.
11. Received any dose of a COVID-19 vaccine within 4 months of randomization or expected
to receive one through Day 34.
12. 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).
13. Prior participation in this clinical trial or any other clinical trial of
ibuzatrelvir.
14. 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.
Applied Research Center of Arkansas
Little Rock 4119403, Arkansas 4099753, United States
National Institute of Clinical Research - Bakersfield
Bakersfield 5325738, California 5332921, United States
310 Clinical Research
Inglewood 5359488, California 5332921, United States
Long Beach Research Institute
Long Beach 5367929, California 5332921, United States
Long Beach Clinical Trials
Long Beach 5367929, California 5332921, United States
Downtown L.A. Research Center, Inc.
Los Angeles 5368361, California 5332921, United States
Clinica mi Salud by Focil Med
Oxnard 5380184, California 5332921, United States
FOMAT Medical Research
Oxnard 5380184, California 5332921, United States
Acclaim Clinical Research
San Diego 5391811, California 5332921, United States
Tweedy Medical Group - Charity Health
South Gate 5397603, California 5332921, United States
Breathe Clear Institute for Sinus and Allergy Relief
Torrance 5403022, California 5332921, United States
Clinical Research of California
Walnut Creek 5406990, California 5332921, United States
Clinical Research of California
West Hills 8030162, California 5332921, United States
Paradigm Clinical Research, LLC
Wheat Ridge 5443948, Colorado 5417618, United States
Georgetown University Medical Center
Washington D.C. 4140963, District of Columbia 4138106, United States
Emerson Clinical Research Institute
Washington D.C. 4140963, District of Columbia 4138106, United States
Innovative Research of West Florida
Clearwater 4151316, Florida 4155751, United States
Invictus Clinical Research Group
Coconut Creek 4151455, Florida 4155751, United States
Hillcrest Medical Research LLC
DeLand 4152890, Florida 4155751, United States
Hillcrest Medical Research
DeLand 4152890, Florida 4155751, United States
Universal Axon Clinical Research, LLC
Doral 4153471, Florida 4155751, United States
Herco Medical and Research Center Inc
Flagami 4155529, Florida 4155751, United States
Proactive Clinical Research,LLC
Fort Lauderdale 4155966, Florida 4155751, United States
Qway Research LLC
Hialeah 4158476, Florida 4155751, United States
Sunbright Health Medical Centers
Homestead 4159050, Florida 4155751, United States
Bio-Medical Research LLC
Miami 4164138, Florida 4155751, United States
Kendall South Medical Center
Miami 4164138, Florida 4155751, United States
Nuovida Research Center
Miami 4164138, Florida 4155751, United States
Global Health Research Center, Inc.
Miami Lakes 4164186, Florida 4155751, United States
Adult Medicine of Lake County, Inc.
Mt. Dora 4165069, Florida 4155751, United States
Innovation Medical Research Center
Palmetto Bay 4167634, Florida 4155751, United States
DBC Research USA
Pembroke Pines 4168139, Florida 4155751, United States
GCP Research, Global Clinical professionals
St. Petersburg 4171563, Florida 4155751, United States
Global Health Research Center - Tampa
Tampa 4174757, Florida 4155751, United States
The Hope Clinic of Emory University
Decatur 4191124, Georgia 4197000, United States
Javara - Privia Medical Group Georgia - Fayetteville
Fayetteville 4194474, Georgia 4197000, United States
Coastal Heritage Clinical Research
Hinesville 4200671, Georgia 4197000, United States
Velocity Clinical Research, Savannah
Savannah 4221552, Georgia 4197000, United States
Koch Family Medicine
Morton 4902754, Illinois 4896861, United States
UL International Travel Clinic
Louisville 4299276, Kentucky 6254925, United States
University of Louisville Hospital
Louisville 4299276, Kentucky 6254925, United States
University of Louisville School of Medicine
Louisville 4299276, Kentucky 6254925, United States
Centennial Medical Group
Columbia 4352053, Maryland 4361885, United States
Jadestone Clinical Research
Silver Spring 4369596, Maryland 4361885, United States
Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926, United States
University of Massachusetts Chan Medical School
Worcester 4956184, Massachusetts 6254926, United States
Revival Research Institute, LLC
Dearborn 4990510, Michigan 5001836, United States
Henry Ford St. John Hospital
Grosse Pointe Woods 4994871, Michigan 5001836, United States
Mercury Street Medical Group, PLLC
Butte 5642934, Montana 5667009, United States
Velocity Clinical Research, Grand Island
Grand Island 5069297, Nebraska 5073708, United States
McGill Family Practice
Papillion 5074792, Nebraska 5073708, United States
Las Vegas Clinical Trials
North Las Vegas 5509403, Nevada 5509151, United States
Upstate Global Health Institute
East Syracuse 5116079, New York 5128638, United States
Upstate Connect Care
Syracuse 5140405, New York 5128638, United States
Prime Global Research
The Bronx 5110266, New York 5128638, United States
Montefiore Medical Center
The Bronx 5110266, New York 5128638, United States
Monroe Biomedical Research
Monroe 4479946, North Carolina 4482348, United States
Remington-Davis, Inc
Columbus 4509177, Ohio 5165418, United States
Preferred Primary Care Physicians
Uniontown 4561859, Pennsylvania 6254927, United States
WR-Clinsearch, LLC
Chattanooga 4612862, Tennessee 4662168, United States
AMR Clinical
Nashville 4644585, Tennessee 4662168, United States
Zenos Clinical Research
Dallas 4684888, Texas 4736286, United States
Southwest Family Medicine Associates
Dallas 4684888, Texas 4736286, United States
Southwest Mind and Body Care
Dallas 4684888, Texas 4736286, United States
Next Level Urgent Care
Houston 4699066, Texas 4736286, United States
Gulf Coast Clinical Research - Houston
Houston 4699066, Texas 4736286, United States
Mercury Clinical Research - Santa Clara Family Clinic
Houston 4699066, Texas 4736286, United States
The Crofoot Research Center
Houston 4699066, Texas 4736286, United States
Epic Clinical Research
Lewisville 4706057, Texas 4736286, United States
Javara - Privia Medical Group North Texas - Stephenville
Stephenville 4734350, Texas 4736286, United States
Javara - Privia Medical Group Gulf Coast - Sugarland
Sugar Land 4734825, Texas 4736286, United States
Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic
Tomball 4737094, Texas 4736286, United States
Alpine Research Organization
Clinton 5773001, Utah 5549030, United States
Eastside Research Associates
Redmond 5808079, Washington 5815135, United States
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán 3836873, Tucumán Province 3833578, Argentina
Equipo Ciencia
Buenos Aires 3435910, Argentina
ANIMA Research
Alken 2803285, Limburg, Belgium
Pneumocare
Erpent 2798674, Belgium
Hospital Universitario Professor Edgard Santos
Salvador 3450554, Estado de Bahia 3471168, Brazil
Infection Control
Belo Horizonte 3470127, Minas Gerais 3457153, Brazil
Centro Médico São Francisco
Curitiba 3464975, Paraná 3455077, Brazil
Instituto Atena de Pesquisa Clinica
Natal 3394023, Rio Grande do Norte 3390290, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre 3452925, Rio Grande do Sul 3451133, Brazil
Hospital São Lucas da PUCRS
Porto Alegre 3452925, Rio Grande do Sul 3451133, Brazil
CECIP - Centro de Estudos do Interior Paulista
Jaú 3460005, São Paulo 3448433, Brazil
Faculdade de Medicina do ABC
Santo André 3449701, São Paulo 3448433, Brazil
Centro de Referência e Treinamento DST/AIDS
São Paulo 3448439, São Paulo 3448433, Brazil
Instituto de Infectologia Emilio Ribas
São Paulo 3448439, Brazil
Diagnostic Consultative Center - 1 - Sevlievo EOOD
Sevlievo 727337, Gabrovo 864552, Bulgaria
Medical Centre "Asklepiy"
Dupnitsa 726872, Kyustendil 864554, Bulgaria
SHATPD Troyan
Troyan Municipality 726320, Lovech 729560, Bulgaria
Diagnostic Consultative Center - 1 Lom EOOD
Lom 729581, Montana 453753, Bulgaria
MHAT Samokov
Samokov 727462, Sofia 727012, Bulgaria
Military Medical Academy
Sofia 727011, Sofia (stolitsa), Bulgaria
Medical Center Pulmo - 2018 EOOD
Haskovo 730435, Bulgaria
MHAT "Rahila Angelova" Pernik
Pernik 728330, Bulgaria
Diagnostic Consultative Center "Sveti Georgi" Plovdiv
Plovdiv 728193, Bulgaria
Medical Center Sveti Ivan Rilski Chudotvorets - 2010
Plovdiv 728193, Bulgaria
Ambulatory for Individual Primary Medical Care - Dr. Pavlina Petrova - Poli ET
Sofia 727011, Bulgaria
Medical Center Hera EOOD
Sofia 727011, Bulgaria
Medical Center Diana Med 2001
Yambol 725578, Bulgaria
Vancouver Infectious Diseases Centre
Vancouver 6173331, British Columbia 5909050, Canada
Clinical Research of Ontario
Scarborough Village 6141900, Ontario 6093943, Canada
Community Care Building
Winchester 6182823, Ontario 6093943, Canada
Dundas Manor Nursing Home
Winchester 6182823, Ontario 6093943, Canada
Winchester District Memorial Hospital
Winchester 6182823, Ontario 6093943, Canada
Diex Recherche Quebec
Québec 6325494, Canada
The People's Hospital of Chizhou
Chizhou 1814934, Anhui 1818058, China
Peking University People's Hospital
Beijing 1816670, Beijing Municipality 2038349, China
Zhongshan Hospital Fudan University (Xiamen Branch)
Xiamen 1790645, Fujian 1811017, China
Zhongshan Hospital Xiamen University
Xiamen 1790645, Fujian 1811017, China
ZhuJiang Hospital of Southern Medical University
Guangzhou 1809858, Guangdong 1809935, China
The Third Hospital of Changsha
Changsha 1815577, Hunan 1806691, China
Jiangxi Provincial People's Hospital
Nanchang 1800163, Jiangxi 1806222, China
Huashan Hospital, Fudan University
Shanghai 1796236, Shanghai Municipality 1796231, China
Shanghai Children's Medical Center
Shanghai 1796236, Shanghai Municipality 1796231, China
Shanghai Minhang District Central Hospital
Shanghai 1796236, Shanghai Municipality 1796231, China
First Affiliated Hospital of Shanxi Medical University
Taiyuan 1793511, Shanxi 1795912, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou 1808926, Zhejiang 1784764, China
Beijing Ditan Hospital Capital Medical
Beijing 1816670, China
Doktor Brno
Brno 3078610, Brno-město, Czechia
Zdravi-fit
Protivín 3067395, Jihočeský kraj 3339537, Czechia
MUDr. Petra První s.r.o.
Radomyšl 3067162, Jihočeský kraj 3339537, Czechia
Praktický lékař Hořiněves
Hořiněves 3075484, Královéhradecký kraj 3339540, Czechia
Lékařský dům v Mezibranské
Prague 3067696, Praha 1, Czechia
Ordinace Hradebni s.r.o.
České Budějovice 3077916, Czechia
FVR, Oulun rokotetutkimusklinikka
Oulu 643492, North Ostrobothnia 830667, Finland
FVR, Tampereen rokotetutkimusklinikka
Tampere 634963, Pirkanmaa 830704, Finland
FVR, Etelä-Helsingin rokotetutkimusklinikka
Helsinki 658225, Uusimaa 830709, Finland
MeVac - Meilahti Vaccine Research Center
Helsinki 658225, Uusimaa 830709, Finland
Praxisgemeinschaft Heimeranplatz
Munich 2867714, Bavaria 2951839, Germany
IKF Pneumologie Frankfurt, Clinical Research Center, Departments: Pulmonology, Endocrinology, Cardio
Frankfurt am Main 2925533, Hesse 2905330, Germany
Studien Rahman & Detho
Obertshausen 2858763, Hesse 2905330, Germany
Praxis am Ebertplatz
Cologne 2886242, North Rhine-Westphalia 2861876, Germany
zibp GmbH
Berlin 2950159, Germany
Kamezawa Clinic
Kasugai 1859891, Aichi-ken 1865694, Japan
International University of Health and Welfare Narita Hospital
Narita 2111684, Chiba 2113014, Japan
Tashiro Endocrinology Clinic
Fukuoka 1863967, Fukuoka 1863958, Japan
Medical Corporation Kouhoukai Takagi Hospital
Okawa-shi, Fukuoka 1863958, Japan
Nishioka Hospital
Sapporo 2128295, Hokkaido 2130037, Japan
Terada Clinic Respiratory Medicine & General Practice
Himeji 1862627, Hyōgo 1862047, Japan
Koga General Hospital
Koga 1859093, Ibaraki 2112669, Japan
Tsuchiura Beryl Clinic
Tsuchiura 6822099, Ibaraki 2112669, Japan
Shonan Fujisawa Tokushukai Hospital
Fujisawa 1864092, Kanagawa 1860291, Japan
Shonan Kamakura General Hospital
Kamakura 1860672, Kanagawa 1860291, Japan
National Hospital Organization Okinawa Hospital
Ginowan 1863627, Okinawa 1854345, Japan
Fukuwa Clinic
Chuo-ku, Tokyo 1850144, Japan
Musashino Emergency Hospital
Kodaira-shi, Tokyo 1850144, Japan
Swing Nozaki Clinic
Musashino-shi, Tokyo 1850144, Japan
Yoshijima Hospital
Hiroshima 1862415, Japan
Rakuwakai Otowa Hospital
Kyoto 1857910, Japan
Asociación Mexicana para la Investigación Clínica A.C.
Pachuca 3522210, Hidalgo 3527115, Mexico
JM Research SC
Cuernavaca 3529947, Morelos 3522961, Mexico
Arké SMO S.A de C.V
Veracruz 3514783, Mexico
IRS - Medicinska cinnost s.r.o., Vseobecna ambulancia pre dospelych
Kosice-Juh, Košice Region 865084, Slovakia
Artromac n.o.
Košice 724443, Košice Region 865084, Slovakia
ML MED, s.r.o., Vseobecna ambulancia pre dospelych
Moldava nad Bodvou 724111, Košice Region 865084, Slovakia
Plucna ambulancia Hrebenar, s.r.o., Pneumologicko-ftizeologicka ambulancia
Spišská Nová Ves 723526, Košice Region 865084, Slovakia
PULMO, s.r.o., Pneumologicko-ftizeologicka ambulancia
Prešov 723819, Presov 865085, Slovakia
MUDr. Viliam Cibik, PhD., s.r.o.
Pruské 3057971, Trenčín Region 3343957, Slovakia
AMB4YOU s.r.o.
Hlohovec 3060095, Trnava Region 3343958, Slovakia
VL.AK s.r.o. Vseobecna ambulancia pre dospelych
Trnava 3057124, Trnava Region 3343958, Slovakia
SALUBER SK s.r.o., Vseobecna ambulancia pre dospelych
Nové Mesto nad Váhom 3058477, Slovakia
Newtown Clinical Research
Johannesburg 993800, Gauteng 1085594, South Africa
Global Clinical Trials
Pretoria 964137, Gauteng 1085594, South Africa
Jongaie Research
Pretoria West 7870453, Gauteng 1085594, South Africa
Sandton Medical Research Centre
Sandton 957654, Gauteng 1085594, South Africa
Dr P J Sebastian Clinical Research Centre
Chatsworth 1013675, KwaZulu-Natal 972062, South Africa
Synapta Clinical Research Centre
Durban 1007311, KwaZulu-Natal 972062, South Africa
TREAD Research
Cape Town 3369157, Western Cape 1085599, South Africa
Langeberg Clinical Trials
Cape Town 3369157, Western Cape 1085599, South Africa
Paarl Research Centre
Paarl 3363094, Western Cape 1085599, South Africa
Incheon Medical Center
Donggu 6813718, Incheon-gwangyeoksi [incheon], South Korea
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon], South Korea
Wonju Severance Christian Hospital
Wŏnju 1833105, Kang-won-do, South Korea
Chonnam National University Hospital
Gwangju 1841811, Kwangju-kwangyǒkshi, South Korea
Korea University Ansan Hospital
Ansan-si 1846918, Kyǒnggi-do, South Korea
Ajou University Hospital
Suwon 1835553, Kyǒnggi-do, South Korea
Chung-Ang University Hospital
Dongjak-gu, Seoul-teukbyeolsi [seoul], South Korea
Gangnam Severance Hospital, Yonsei University Health System
Gangnam-gu, Seoul-teukbyeolsi [seoul], South Korea
Korea University Anam Hospital
Seoul 1835848, Seoul-teukbyeolsi [seoul], South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul 1835848, Seoul-teukbyeolsi [seoul], South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul 1835848, Seoul-teukbyeolsi [seoul], South Korea
Korea University Guro Hospital
Seoul 1835848, Seoul-teukbyeolsi [seoul], South Korea
Keimyung University Dongsan Hospital
Daegu 1835329, Taegu-kwangyǒkshi, South Korea
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña 3119841, A Coruña [LA Coruña], Spain
Hospital Vithas Xanit Internacional
Benalmádena 2521139, Andalusia 2593109, Spain
Hospital Universitario Reina Sofia
Córdoba 2519240, Andalusia 2593109, Spain
Hospital Germans Trias i Pujol
Badalona 3129028, Barcelona [barcelona], Spain
Hospital Universitari Vall d'Hebron
Barcelona 3128760, Barcelona [barcelona], Spain
Hospital Universitario La Paz
Madrid 3117735, Madrid, Comunidad de, Spain
Hospital Vithas Xanit Internacional
Benalmádena 2521139, Málaga, Spain
CHUVI- Hospital Alvaro Cunqueiro
Vigo 3105976, Pontevedra [pontevedra], Spain
Hospital General Universitario Dr. Balmis
Alicante 2521978, Spain
Hospital Universitario Infanta Leonor
Madrid 3117735, Spain
Hospital Universitario Virgen de Valme
Seville 2510911, Spain
Far Eastern Memorial Hospital
New Taipei City 12908892, NEW Taipei, Taiwan
Tri-Service General Hospital
Taipei City, Taipei 7280290, Taiwan
Taichung Veterans General Hospital
Taichung 1668399, Taiwan
Taipei Veterans General Hospital
Taipei 1668341, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District 1667905, Taiwan
Acibadem Universitesi Atakent Hastanesi
Istanbul 745044, İ̇stanbul, Turkey (Türkiye)
Ankara University Ibni Sina Hospital
Ankara 323786, Turkey (Türkiye)
Hacettepe Universite Hastaneleri
Ankara 323786, Turkey (Türkiye)
Kocaeli Üniversitesi
Kocaeli 306970, Turkey (Türkiye)
Sakarya Training and Research Hospital
Sakarya 302114, Turkey (Türkiye)
Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
Pfizer CT.gov Call Center, Study Director
Pfizer