NCT05064800
|
PF-07321332/Ritonavir and Ritonavir on Dabigatran Study in Healthy Participants |
Completed |
Phase 1 |
Sep/21/2021 |
Dec/06/2021 |
- Alternative id - C4671012
- Interventions - Drug: Dabigatran|Drug: PF-07321332/ritonavir + Dabigatran|Drug: Ritonavir + Dabigatran
- Study type - Interventional
- Study results - No Results Available
- Locations - Research Centers of America ( Hollywood ), Hollywood, Florida, United States
- Study designs - Allocation: Non-Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 24
- Age - 18 Years to 60 Years (Adult)
- Outcome measures - Area under the curve from time zero to infinity (AUCinf) of dabigatran when administer with PF-07321332/ritonavir|Maximum Observed Plasma Concentration (Cmax) of dabigatran when administered with PF-07321332/ritonavir|AUCinf of dabigatran when administered with multiple doses of ritonavir|Cmax of dabigatran when administered with multiple doses of ritonavir|Number of Participants With Treatment-Emergent Adverse Events (TEAEs)|Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities|Number of Participants With Clinically Significant Change From Baseline in Vital Signs|Number of Participants With Abnormalities in Physical Examination|Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings|Time to Reach Maximum Observed Plasma Concentration (Tmax) of dabigatran|Plasma Decay Half-Life (t1/2) of dabigatran|Cmax of PF-07321332|AUCtau (area under the curve of the dosing interval) of PF-0321332|Tmax of PF-0321332|T1/2 of PF-0321332|Apparent Oral Clearance (CL/F) of PF-0321332|Apparent Volume of Distribution (Vz/F) of PF-0321332
|
NCT05047601
|
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection |
Recruiting |
Phase 3 |
Sep/09/2021 |
Apr/18/2022 |
- Alternative id - C4671006|2021-002894-24|EPIC-PEP
- Interventions - Drug: PF-07321332|Drug: Placebo for PF-07321332|Drug: Placebo for Ritonavir|Drug: Ritonavir
- Study type - Interventional
- Study results - No Results Available
- Locations - Cahaba Research, Inc., Pelham, Alabama, United States|The Institute for Liver Health dba Arizona Clinical Trials, Mesa, Arizona, United States|The Institute for Liver Health dba Arizona Clinical Trials, Tucson, Arizona, United States|KLR Business Group, Inc. dba Arkansas Clinical Research, Little Rock, Arkansas, United States|Hope Clinical Research, Canoga Park, California, United States|Lightship, El Segundo, California, United States|Ascada Health PC, Fullerton, California, United States|Ark Clinical Research, Long Beach, California, United States|American Institute of Research, Los Angeles, California, United States|FOMAT Medical Research, Oxnard, California, United States|Optimus Medical Group, San Francisco, California, United States|South Bay Clinical Research Institute, Torrance, California, United States|Hope Clinical Research (COVID Satellite Location), West Hills, California, United States|Future Innovative Treatments, LLC, Colorado Springs, Colorado, United States|BRB Health Group DBA Broward Research Center, Aventura, Florida, United States|Synergy Healthcare, Bradenton, Florida, United States|MOORE Clinical Research, Inc., Brandon, Florida, United States|Innovative Research of West Florida, Inc., Clearwater, Florida, United States|Herco Medical and Research Center Inc, Coral Gables, Florida, United States|Advance Clinical Research Group, Cutler Bay, Florida, United States|Beautiful Minds Clinical Research Center, Cutler Bay, Florida, United States|Midland Florida Clinical Research Center, LLC, DeLand, Florida, United States|Unlimited Medical Research Group, LLC, Hialeah Gardens, Florida, United States|Qway Research, LLC, Hialeah, Florida, United States|Eastern Research Inc, Hialeah, Florida, United States|Inpatient Research Clinic, Hialeah, Florida, United States|Doral Medical Research,LLC, Hialeah, Florida, United States|Advanced Pulmonary Research Institute, Loxahatchee Groves, Florida, United States|Asclepes Research Centers, Lutz, Florida, United States|Pro-Care Research Center, Corp., Miami Gardens, Florida, United States|Lakes Research, LLC., Miami Lakes, Florida, United States|Savin Medical Group, LLC, Miami Lakes, Florida, United States|Angels Clinical Research Institute, Miami, Florida, United States|Nova Life Med Spa, Miami, Florida, United States|LCC Medical Research Institute, LLC, Miami, Florida, United States|Premium Medical Research Corp, Miami, Florida, United States|Global Health Clinical Trials Corp, Miami, Florida, United States|South Florida Research Center, Inc., Miami, Florida, United States|Suncoast Research Group, LLC, Miami, Florida, United States|University of Miami Health System, Miami, Florida, United States|I.V.A.M. Clinical & Investigational Center, LLC, Miami, Florida, United States|Medical Research of Westchester Inc, Miami, Florida, United States|C'A Research, Miami, Florida, United States|ProLive Medical Research, Corp., Miami, Florida, United States|Entrust Clinical Research, Miami, Florida, United States|Reed Medical Research, Miami, Florida, United States|Kendall South Medical Center, Inc., Miami, Florida, United States|Clinical Site Partners, Inc dba CSP Miami, Miami, Florida, United States|Coral Research Clinic Corp, Miami, Florida, United States|Omega Research Orlando, Orlando, Florida, United States|NAPA Research LLC, Pompano Beach, Florida, United States|CDC Research Institute, LLC, Port Saint Lucie, Florida, United States|GCP, Global Clinical Professionals, Saint Petersburg, Florida, United States|GCP, Global Clinical Professionals, Saint Petersburg, Florida, United States|Accel Research Sites - St. Petersburg Clinical Research Unit, Saint Petersburg, Florida, United States|Professional Urgent Care Services, Saint Petersburg, Florida, United States|USPA Advance Concept Medical Research Group LLC, South Miami, Florida, United States|Asclepes Research Centers, Spring Hill, Florida, United States|Sunrise Research Institute, Sunrise, Florida, United States|Tampa General Hospital, Tampa, Florida, United States|Santos Research Center, CORP, Tampa, Florida, United States|Palm Beach Research Center, West Palm Beach, Florida, United States|Clinical Site Partners, Inc, Winter Park, Florida, United States|Research by Design, LLC, Chicago, Illinois, United States|The South Bend Clinic Center for Research, South Bend, Indiana, United States|Accellacare, Ames, Iowa, United States|McFarland Clinic, PC, Ames, Iowa, United States|WKB Family Medicine Associates, Bossier City, Louisiana, United States|New Orleans Sinus Center (COVID-19 Testing), Marrero, Louisiana, United States|Tandem Clinical Research GI, LLC, Marrero, Louisiana, United States|Southern Clinical Research Associates, LLC, Metairie, Louisiana, United States|MedPharmics LLC, Metairie, Louisiana, United States|Willis-Knighton Health System, Shreveport, Louisiana, United States|Michigan Center of Medical Research, Farmington Hills, Michigan, United States|Jackson Medical Mall, Jackson, Mississippi, United States|Lakeland Pharmacy, Branson W., Missouri, United States|Price Cutter, Springfield, Missouri, United States|Mercury Street Medical Group, PLLC, Butte, Montana, United States|Meridian Clinical Research, LLC, Grand Island, Nebraska, United States|Quality Clinical Research Inc, Omaha, Nebraska, United States|Quality Clinical Research, Omaha, Nebraska, United States|Walmart, Las Vegas, Nevada, United States|Excel Clinical Research, Las Vegas, Nevada, United States|Walgreens, Las Vegas, Nevada, United States|Meridian Clinical Research, LLC, Endwell, New York, United States|NYC Health + Hospitals/Harlem, New York, New York, United States|Monroe Biomedical Research, Monroe, North Carolina, United States|Accellacare, Wilmington, North Carolina, United States|Innovo Research: Wilmington Health, Wilmington, North Carolina, United States|Premier Medical Group, Clarksville, Tennessee, United States|PharmaTex Research, LLC, Amarillo, Texas, United States|ARC Clinical Research at William Cannon, Austin, Texas, United States|St Hope Foundation, Bellaire, Texas, United States|Conroe Willis Medical Research, Conroe, Texas, United States|South Texas Clinical Research, Corpus Christi, Texas, United States|Brooke Army Medical Center, Fort Sam Houston, Texas, United States|SingnatureCare Emergency Center, Houston, Texas, United States|Trio Clinical Trials, LLC, Houston, Texas, United States|C & R Research Services USA, Houston, Texas, United States|Next Level Urgent Care, Houston, Texas, United States|SMS Clinical Research, LLC, Mesquite, Texas, United States|LinQ Research, LLC, Pearland, Texas, United States|Epic Medical Research, Red Oak, Texas, United States|Sun Research Institute, San Antonio, Texas, United States|Endeavor Clinical Trials, LLC, San Antonio, Texas, United States|BFHC Research, San Antonio, Texas, United States|Tranquility Research, Webster, Texas, United States|University of Utah Medical Center, Salt Lake City, Utah, United States|TPMG Clinical Research, Newport News, Virginia, United States|Centro Medico Viamonte SRL, Caba, Buenos Aires, Argentina|DIM Clinica Privada, Ramos Mejia. La Matanza, Buenos Aires, Argentina|Instituto de Investigaciones Clinicas Zarate, Zarate, Buenos Aires, Argentina|Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos), Rosario, Santa FE, Argentina|Sanatorio Britanico, Rosario, Santa FE, Argentina|Instituto CAICI, Rosario, Santa FE, Argentina|Hospital de Clinicas Presidente Nicolas Avellaneda, San Miguel de Tucuman, Tucuman, Argentina|Clinica Mayo de UMCB SRL, San Miguel de Tucuman, Tucuman, Argentina|Sanatorio Britanico S.A., Rosario, Argentina|Fundação de Medicina Tropical Doutor Heitor Vieira Dourado, Manaus, Amazonas, Brazil|Hospital Universitario Prof. Edgard Santos/ Universidade Federal da Bahia, Salvador, Bahia, Brazil|Hospital Cardio Pulmonar, Salvador, Bahia, Brazil|Chronos Pesquisa Clinica, Brasilia, Distrito Federal, Brazil|AMB3 Serviços Médicos Ltda, Cuiabá, MATO Grosso, Brazil|Hospital Luxemburgo - Associacao Mario Penna, Belo Horizonte, MG, Brazil|Infection Control Ltda, Belo Horizonte, Minas Gerais, Brazil|School of Medicine Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil|Hospital Agamenon Magalhaes, Recife, Pernambuco, Brazil|Centro de Estudos e Pesquisas em Moléstias Infecciosas, Natal, RIO Grande DO Norte, Brazil|Hospital De Clinicas De Porto Alegre, Porto Alegre, RIO Grande DO SUL, Brazil|IBPClin- Instituto Brasil de Pesquisa Clinica, Rio de Janeiro, RJ, Brazil|Instituto Nacional de Infectologia Evandro Chagas - INI/FIOCRUZ, Rio de Janeiro, RJ, Brazil|CECOR - Centro Oncológico de Roraima, Boa Vista, Roraima/rr, Brazil|Centro de Estudos Clinicos do Interior Paulista (CECIP), Jau, SAO Paulo, Brazil|Hospital Dia do Pulmao, Blumenau, SC, Brazil|Hospital Regional Hans Dieter Schmidt (HRHDS), Joinville, SC, Brazil|Hospital e Maternidade Celso Pierro - PUC Campinas / Sociedade Campineira de Educação e Instruçã, Campinas, SP, Brazil|Pesquisare Saude S/S Ltda, Santo André, SP, Brazil|Hospital Alemao Oswaldo Cruz, São Paulo, SP, Brazil|Unidade Referenciada Oswaldo Cruz Vergueiro, São Paulo, SP, Brazil|Hospital Heliópolis, São Paulo, SP, Brazil|Instituto D'Or de Pesquisa e Ensino / Hospital São Luiz Jabaquara, São Paulo, SP, Brazil|Scentryphar - Pesquisa Clínica, Campinas, SÃO Paulo, Brazil|Associação Evangélica de Campinas - Hospital Samaritano, Campinas, SÃO Paulo, Brazil|Instituto de Pesquisa Clínica de Campinas, Campinas, SÃO Paulo, Brazil|Centro de Referência e Treinamento DST/AIDS, Sao Paulo, SÃO Paulo, Brazil|Clinica de Alergia Martti Antila, Sorocaba, SÃO Paulo, Brazil|CEMEC - Centro Multidisciplinar de Estudos Clínicos, São Bernardo do Campo, SÃO Paulo, Brazil|Hospital Anchieta, São Bernardo do Campo, SÃO Paulo, Brazil|CPCLIN - Centro de Pesquisas Clinicas Ltda, São Paulo, Brazil|Instituto de Infectologia Emilio Ribas, São Paulo, Brazil|Conjunto Hospitalar do Mandaqui, São Paulo, Brazil|Individual Practice for Primary Medical Care - IPPMC - Dr. P. Panayotov EOOD, Burgas, Bulgaria|MHAT St. Ekaterina, Dimitrovgrad EOOD, Dimitrovgrad, Bulgaria|"Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd, Haskovo, Bulgaria|MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD, Kozloduy, Bulgaria|Diagnostic-Consultative Center I Lom EOOD, Lom, Bulgaria|Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD, Lom, Bulgaria|Medical centre Leo Clinic EOOD, Lovech, Bulgaria|MHAT Heart and Brain EAD, Pleven, Bulgaria|UMHAT Sveta Marina - Pleven, Pleven, Bulgaria|DCC Sveti Georgi EOOD, Plovdiv, Bulgaria|MHAT "St. Panteleimon "- Plovdiv, Plovdiv, Bulgaria|Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD, Razgrad, Bulgaria|"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -, Ruse, Bulgaria|UMHAT Medica Ruse OOD, Ruse, Bulgaria|Multiprofile Hospital for Active Treatment - Samokov EOOD, Samokov, Bulgaria|Medical Center-1-Sevlievo EOOD, Sevlievo, Bulgaria|Multiprofile Hospital For Active Treatment Shumen AD, Shumen, Bulgaria|Multiprofile hospital for active treatment - Sliven to Military Medical Academy, Sliven, Bulgaria|MHAT "Dr. Ivan Seliminski" AD, Sliven, Sliven, Bulgaria|Diagnostic-Consultative Center XXII- Sofia ЕООD, Sofia, Bulgaria|University First MHAT "St. Yoan Krastitel"-Sofia EAD, Sofia, Bulgaria|UMHATEM N. I. Pirogov EAD, Sofia, Bulgaria|MHAT "St. Sofia" EOOD, Sofia, Bulgaria|Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD, Stara Zagora, Bulgaria|Multiprofile Hospital for Active Treatment Targovishte AD, Targovishte, Bulgaria|Outpatient Clinic for Primary Outpatient Medical Care "Puls" - Dr. Mladen Buchvarov EOOD, Tsarevo, Bulgaria|Medical center Leo Clinic EOOD, Varna, Bulgaria|MOBAL "D-r Stefan Cherkezov" AD, Veliko Tarnovo, Bulgaria|Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD, Vratsa, Bulgaria|Fundacion Centro de Investigacion Clinica CIC, Medellin, Antioquia, Colombia|Centro Cardivascular Colombiano-Clinica Santa Maria, Medellin, Antioquia, Colombia|Clinica de la Costa LTDA., Barranquilla, Atlantico, Colombia|Hospital Universidad Del Norte, Soledad, Atlantico, Colombia|IPS Medicos Internistas de Caldas, Manizales, Caldas, Colombia|Caimed S.A.S., Yopal, Casanare, Colombia|Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S, Bogota, Cundinamarca, Colombia|Bluecare Salud S A S, Bogota, D.C, Colombia|Fundacion Cardiomet CEQUIN, Armenia, Quindio, Colombia|Instituto de investigaciones Centro Medico Imbanaco, Cali, Valle DEL Cauca, Colombia|Doktor Brno s.r.o., Brno, Czechia|Fakultni nemocnice Hradec Kralove, Hradec Kralove, Czechia|MEDITRIAL s.r.o., Jindrichuv Hradec III, Czechia|Zdraví-Fit, s.r.o., Protivín, Czechia|Nemocnice Slany, Slany, Czechia|Trial Pharma Kft., Bekescsaba, Hungary|Semmelweis University Varosmajori Sziv Es Ergyogyaszati Klinika, Budapest, Hungary|Varosmajori Sziv- es Ergyogyaszati Klinika, Budapest, Hungary|Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika, Debrecen, Hungary|Agria-Study Kft., Eger, Hungary|Trial Pharma Kft., Gyula, Hungary|Medifarma-98 Kft., Nyiregyhaza, Hungary|International University of Health and Welfare Narita Hospital, Narita, Chiba, Japan|Rakuwakai Otowa Hospital, Kyoto-shi, Kyoto, Japan|Rinku General Medical Center, Izumisano, Osaka, Japan|Denenchofu Family Clinic, Ota, Tokyo, Japan|Tokyo Shinagawa Hospital, Shinagawa-ku, Tokyo, Japan|Sekino Hospital, Toshimaku, Tokyo, Japan|Kyushu Medical Center, Fukuoka, Japan|Kyungpook National University Chilgok Hospital, Daegu, Korea, Republic of|Hospital Raja Perempuan Zainab II, Kota Bharu, Kelantan, Malaysia|Klinik Kesihatan Greentown, Ipoh, Perak, Malaysia|Hospital Seberang Jaya, Seberang Jaya, Pulau Pinang, Malaysia|Hospital Miri, Miri, Sarawak, Malaysia|Klinik Kesihatan Kuang, Sungai Buloh, Selangor, Malaysia|InfectoLab Consultorios de Especialidad en Infectologia, Tijuana, BAJA California, Mexico|Clinical Research Institute Saltillo S.A. de C.V., Saltillo, Coahuila, Mexico|Centro de Investigacion Clinica Del Pacifico SA de CV, Acapulco de Juarez, Guerrero, Mexico|Asociacion Mexicana para la Investigacion Clinica, A. C., Pachuca de Soto, Hidalgo, Mexico|Instituto Jalisciense de Metabolismo, S.C., Guadalajara, Jalisco, Mexico|JM Research, Cuernavaca, Morelos, Mexico|Centro Médico Jojutla (Hospital Regional Jojutla)., Jojutla, Morelos, Mexico|Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Nuevo LEON, Mexico|Eukarya Pharmasite S.C., Monterrey, Nuevo LEON, Mexico|Christus- Latam Hub Center of Excellence and Innovation Center S.C., Monterrey, Nuevo LEÓN, Mexico|Oaxaca site management organization s.c, Oaxaca de Juarez, Oaxaca, Mexico|Hospital General de Culiacán "Bernardo J. Gastélum", Culíacan, Sinaloa, Mexico|Kohler & Milstein Research S.A. de C.V., Merida, Yucatan, Mexico|Eme Red Hospitalaria, Mérida, Yucatán, Mexico|Hospital Cardiologica Aguascalientes, Aguascalientes, Mexico|Instituto de Investigaciones Clínicas para la Salud, Durango, Mexico|FAICIC Clinical Research, Veracruz, Mexico|Sociedad de Metabolismo y Corazon S.C., Veracruz, Mexico|Arke SMO S.A. de C.V, Veracruz, Mexico|KLIMED Marek Klimkiewicz, Bialystok, Poland|Krakowskie Centrum Medyczne, Krakow, Poland|Przychodnia Valeo Medical, Lodz, Poland|IRMED Ośrodek Badań Klinicznych, Piotrkow Trybunalski, Poland|Tomasz Blicharski Lubelskie Centrum Diagnostyczne, Swidnik, Poland|WIP Warsaw IBD Point Profesor Kierkus, Warszawa, Poland|Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska, Wroclaw, Poland|Ponce Medical School Foundation, Inc. CAIMED Center, Ponce, Puerto Rico|Clinical Research Management Group Inc, Ponce, Puerto Rico|Advance Medical Research Center, San Juan, Puerto Rico|Kirovsk Interdistrict Hospital, Kirovsk, Leningrad Region, Russian Federation|LLC Trekhgorka Medicine, Odintsovo, Moscow Region, Russian Federation|Private Medical Institution "Euromedservice", Pushkin, Saint-petersburg, Russian Federation|Clinica UZI 4D, Pyatigorsk, Stavropol Region, Russian Federation|Barnaul City Hospital Number 5, Barnaul, Russian Federation|Korolev Medicine, Korolev, Russian Federation|KDC "Evromedservis", OJSC, Moscow, Russian Federation|City Polyclinic #44, Saint Petersburg, Russian Federation|LLC Strategic Medical Systems, Saint Petersburg, Russian Federation|Medical Research Institute, LLC, Saint Petersburg, Russian Federation|City Polyclinic No. 109, Saint-Petersburg, Russian Federation|Limited Liability Company "Center for Diagnostics and Rehabilitation "Praximed", Saint-Petersburg, Russian Federation|City Out-patient clinic #112, Saint-Petersburg, Russian Federation|"Research Center Eco-safety" LLC, Saint-Petersburg, Russian Federation|LLC Kurator, Saint-Petersburg, Russian Federation|Saint-Petersburg State Budgetary Healthcare Institution "City Pokrovskaya hospital", Saint-Petersburg, Russian Federation|Astarta LLC, Saint-Petersburg, Russian Federation|City Out-patient clinic #4, Saint-Petersburg, Russian Federation|Smolensk State Medical University, Smolensk, Russian Federation|LLC Family clinic, Yekaterinburg, Russian Federation|Global Clinical Trials, Gqeberha, Eastern CAPE, South Africa|Nelson Mandela Academic Clinical Research Unit (NeMACRU), Mthatha, Eastern CAPE, South Africa|MERC Welkom, Welkom, FREE State, South Africa|Worthwhile Clinical Trials, Benoni, Gauteng, South Africa|REIMED Vosloorus, Boksburg, Gauteng, South Africa|Lenasia Clinical Trial Centre, Johannesburg, Gauteng, South Africa|LCS Clinical Research, Johannesburg, Gauteng, South Africa|Peermed CTC (Pty) Ltd T/A MERC Kempton, Kempton Park, Gauteng, South Africa|Midrand Medical Centre, Midrand, Gauteng, South Africa|About Allergy (PTY) Ltd, Pretoria North, Gauteng, South Africa|Global Clinical Trials, Pretoria, Gauteng, South Africa|Botho ke Bontle Health Services, Pretoria, Gauteng, South Africa|Emmed Research, Pretoria, Gauteng, South Africa|Into Research, Pretoria, Gauteng, South Africa|Clinical Trial Systems (Pty) Ltd, Pretoria, Gauteng, South Africa|Sandton Medical Clinic, Sandton, Gauteng, South Africa|FCRN Clinical Trial Centre, Vereeniging, Gauteng, South Africa|Dr PJ Sebastian Clinical Research Centre, Durban, Kwa-zulu Natal, South Africa|Synapta Clinical Research Center, Durban, Kwazulu Natal, South Africa|Ahmed Al-Kadi Private Hospital, Mayville, Durban, Kwazulu-natal, South Africa|Private Practice - Dr. Jeevren Reddy, Stanger, Kwazulu-natal, South Africa|Limpopo Clinical Research Initiative, Thabazimbi, Limpopo, South Africa|NHC Thohoyandou CRS, Thohoyandou, Limpopo, South Africa|MERC Middelburg, Middelburg, Mpumalanga, South Africa|Madibeng Centre for Research, Brits, North WEST, South Africa|TASK Applied Science, Cape Town, Western CAPE, South Africa|Red Zone Clinic, Cape Town, Western CAPE, South Africa|Tiervlei Trial Centre, Cape Town, Western CAPE, South Africa|TASK Eden, George, Western CAPE, South Africa|Be Part Research Pty (Ltd), Paarl, Western CAPE, South Africa|Clinical Projects Research, Worcester, Western CAPE, South Africa|Synopsis Research, Claremont, South Africa|Dr JM Engelbrecht Trial Site, Somerset West, South Africa|Eba Centelles, Centelles, Barcelona [barcelona], Spain|CAP Vicenç Papaceit, La Roca del Valles, Barcelona, Spain|CAP La Mina, Sant Adria de Besos, Barcelona, Spain|Hospital Universitario Mutua de Terrassa, Terrassa, Barcelona, Spain|Hospital Alvaro Cunqueiro, Vigo, Pontevedra, Spain|IMED Valencia, Burjassot, Valencia, Spain|Complexo Hospitalario Universitario da Coruna, A Coruña, Spain|Hospital Universitario Virgen de las Nieves, Granada, Spain|Hospital Universitario de la Paz, Madrid, Spain|Hospital Universitario Virgen de Valme, Sevilla, Spain|Far Eastern Memorial Hospital, New Taipei City, Taiwan|China Medical University Hospital, Taichung, Taiwan|Taichung Veterans General Hospital, Taichung, Taiwan|National Taiwan University Hospital, Taipei, Taiwan|National Taiwan University Hospital, Taipei, Taiwan|Bangkok Centre Hotel, Bangrak, Bangkok, Thailand|Chula Filed hospital, Chulalongkorn University Sport center (Chantanayingyong Gymnasium),, Pathum Wan District,, Bangkok, Thailand|Thai Red Cross Emerging Infectious Diseases (EDI) Clinic, Pathumwan,, Bangkok, Thailand|The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),, Pathumwan, Bangkok, Thailand|Faculty of Medicine - Khon Kaen University, Muang, Khon Kaen, Thailand|Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University,, Hat Yai, Songkhla, Thailand|King Chulalongkorn Memorial Hospital, Bangkok, Thailand|Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand|Tropical Medicine Hospital, Bangkok, Thailand|Cukurova University Medical Faculty, Balcali, Adana, Turkey|Ankara University Medical Faculty, Ibni-Sina Hospital, Ankara, Turkey|Hacettepe University Medical Faculty Hospital, Ankara, Turkey|Akdeniz Universitesi Hastanesi, Antalya, Turkey|Istanbul University Istanbul Medical Faculty, Fatih / Istanbul, Turkey|Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi, Gaziantep, Turkey|Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi, Istanbul, Turkey|Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty, Istanbul, Turkey|Medipol Mega University Hospital, Istanbul, Turkey|Acibadem University Atakent Hospital, Istanbul, Turkey|Basaksehir Cam ve Sakura Sehir Hastanesi, Istanbul, Turkey|Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital, Izmir, Turkey|Kocaeli University Medical Faculty, Kocaeli, Turkey|Mersin University Medical Faculty, Mersin, Turkey|Sakarya University Training and Research Hospital, Sakarya, Turkey|Karadeniz Teknik Universitesi Farabi Hastanesi, Trabzon, Turkey|Communal Medical Enterprise "Likarnya Prydniprovska", Kremenchuk, Poltava Region, Ukraine|Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital", Chernivtsi, Ukraine|Communal non-commercial Enterprise "City Central Clinical Hospital" of Chernivtsi City Council, Chernivtsi, Ukraine|Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council, Dnipro, Ukraine|Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of, Ivano-Frankivsk, Ukraine|Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council", Ivano-Frankivsk, Ukraine|Municipal Non-profit Enterprise "Ivano-Frankivsk Regional Phthisiopulmonology Center of, Ivano-Frankivsk, Ukraine|Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council, Kharkiv, Ukraine|Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases, Kharkiv, Ukraine|Municipal Nonprofit Enterprise "City Clinic Hospital # 13" of Kharkiv City Council, Kharkiv, Ukraine|Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the Kyiv, Kyiv, Ukraine|Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company, Kyiv, Ukraine|Municipal non-profit enterprise of Lviv regional council "Lviv regional phthisiopulmonology clinical, Lviv, Ukraine|Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analytical, Lviv, Ukraine|Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4", Lviv, Ukraine|Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional, Poltava, Ukraine|University Hospital of Sumy State University, Sumy, Ukraine|Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council, Tarasove Village, Ukraine|Medical Center of Private Enterprise "Medical center INTERSONO", Uzhhorod, Ukraine|Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital №1", Vinnytsia, Ukraine|Communal Enterprise "Hospital #1" of Zhytomyr City Council, Zhytomyr, Ukraine
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Prevention
- Enrollment - 2880
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Proportion of participants who have a negative reverse transcription polymerase chain reaction (RT-PCR) result at baseline who develop a symptomatic, RT-PCR or rapid antigen test confirmed SARS-CoV-2 infection.|Percentage of participants who experience adverse events|Efficacy in preventing symptomatic COVID-19 in participants who have a negative RT-PCR result at baseline and are at increased risk of severe COVID-19 illness|Prevention of SARS CoV-2 infection in participants by RT-PCR status at enrolment|Prevention of SARS CoV-2 infection in participants who have a negative RT-PCR result at baseline|Compare the duration of COVID-19 related signs and symptoms in participants who have a negative RT-PCR result at baseline|Compare the severity of COVID-19 related signs and symptoms in participants who have a negative RT-PCR result at baseline|Minimal Concentration (Ctrough) of PF-07321332|All cause mortality in participants who have a negative RT-PCR result at baseline|Viral titers measured via RT-PCR in nasal swabs in participants who have a negative or positive RT-PCR result at baseline|Number of days of hospital and intensive care unit stay in participants with COVID-19 related hospitalization who have a negative RT-PCR result at baseline|Number of COVID-19 related medical visits in participants who have a negative RT-PCR result at baseline
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NCT05011513
|
Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR). |
Active, not recruiting |
Phase 2|Phase 3 |
Aug/25/2021 |
Apr/25/2022 |
- Alternative id - C4671002|2021-002857-28|EPIC-SR
- Interventions - Drug: PF-07321332|Drug: Ritonavir|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Cahaba Research Inc, Birmingham, Alabama, United States|Cahaba Research, Inc., Birmingham, Alabama, United States|Cahaba Research, Inc., Pelham, Alabama, United States|The Institute for Liver Health dba Arizona Clinical Trials, Mesa, Arizona, United States|The Institute for Liver Health dba Arizona Clinical Trials, Tucson, Arizona, United States|KLR Business Group, Inc. dba Arkansas Clinical Research, Little Rock, Arkansas, United States|Hope Clinical Research, Canoga Park, California, United States|Lightship, El Segundo, California, United States|Ascada Research, Fullerton, California, United States|eStudySite, La Mesa, California, United States|Atella Clinical Research LLC., La Palma, California, United States|Ark Clinical Research, Long Beach, California, United States|American Institute of Research, Los Angeles, California, United States|Providence Clinical Research, North Hollywood, California, United States|FOMAT Medical Research, Oxnard, California, United States|Stanford University, Palo Alto, California, United States|Benchmark Research, Sacramento, California, United States|Optimus Medical Group, San Francisco, California, United States|South Bay Clinical Research Institute, Torrance, California, United States|Hope Clinical Research (COVID Satellite Site), West Hills, California, United States|Future Innovative Treatments, LLC, Colorado Springs, Colorado, United States|BRB Health Group DBA Broward Research Center, Aventura, Florida, United States|Xera Med Research, Boca Raton, Florida, United States|Synergy Healthcare, Bradenton, Florida, United States|MOORE Clinical Research, Inc., Brandon, Florida, United States|Innovative Research of West Florida, Clearwater, Florida, United States|Herco Medical and Research Center Inc, Coral Gables, Florida, United States|Advance Clinical Research Group, Cutler Bay, Florida, United States|Beautiful Minds Clinical Research Center, Cutler Bay, Florida, United States|Midland Florida Clinical Research Center, LLC, DeLand, Florida, United States|Unlimited Medical Research Group, LLC, Hialeah Gardens, Florida, United States|Qway Research, LLC, Hialeah, Florida, United States|Eastern Research Inc, Hialeah, Florida, United States|Inpatient Research Clinic, Hialeah, Florida, United States|Doral Medical Research, LLC, Hialeah, Florida, United States|Advanced Pulmonary Research Institute, Loxahatchee Groves, Florida, United States|Asclepes Research Centers, Lutz, Florida, United States|Pro-Care Research Center, Corp., Miami Gardens, Florida, United States|Lakes Research, LLC., Miami Lakes, Florida, United States|Savin Medical Group, LLC, Miami Lakes, Florida, United States|Angels Clinical Research Institute, Miami, Florida, United States|Nova Life Med Spa, Miami, Florida, United States|LCC Medical Research Institute, LLC, Miami, Florida, United States|Premium Medical Research Corp, Miami, Florida, United States|Global Health Clinical Trials Corp, Miami, Florida, United States|South Florida Research Center, Inc., Miami, Florida, United States|Suncoast Research Group, LLC, Miami, Florida, United States|University of Miami Health System, Miami, Florida, United States|I.V.A.M. Clinical & Investigational Center, LLC, Miami, Florida, United States|Entrust Clinical Research, Miami, Florida, United States|Medical Research of Westchester Inc, Miami, Florida, United States|C'A Research, Miami, Florida, United States|ProLive Medical Research, Corp., Miami, Florida, United States|Reed Medical Research, Miami, Florida, United States|Kendall South Medical Center, Inc., Miami, Florida, United States|Clinical Site Partners, Inc d/b/a CSP Miami, Miami, Florida, United States|Coral Research Clinic Corp, Miami, Florida, United States|Omega Research Orlando, LLC, Orlando, Florida, United States|NAPA Research LLC, Pompano Beach, Florida, United States|CDC Research Institute, Port Saint Lucie, Florida, United States|GCP, Global Clinical Professionals, Saint Petersburg, Florida, United States|Accel Research Sites - St. Petersburg Clinical Research Unit, Saint Petersburg, Florida, United States|Professional Urgent Care Services, Saint Petersburg, Florida, United States|USPA Advance Concept Medical Research Group LLC, South Miami, Florida, United States|Asclepes Research Centers, Spring Hill, Florida, United States|Sunrise Research Institute, Sunrise, Florida, United States|Tampa General Hospital, Tampa, Florida, United States|Santos Research Center, CORP, Tampa, Florida, United States|Palm Beach Research Center, West Palm Beach, Florida, United States|Clinical Site Partners, Inc. dba CSP Orlando, Winter Park, Florida, United States|Emory Clinic Investigational Drug Services, Atlanta, Georgia, United States|The Hope Clinic at Emory University - Annex, Decatur, Georgia, United States|The Hope Clinic at Emory University, Decatur, Georgia, United States|The Hope Clinic Investigational Drug Services - Satellite Pharmacy, Decatur, Georgia, United States|The South Bend Clinic Center for Research, South Bend, Indiana, United States|Accellacare, Ames, Iowa, United States|McFarland Clinic, PC, Ames, Iowa, United States|WKB Family Medicine Associates, Bossier City, Louisiana, United States|New Orleans Sinus Center (COVID-19 Testing), Marrero, Louisiana, United States|Tandem Clinical Research GI, LLC, Marrero, Louisiana, United States|Southern Clinical Research Associates, LLC, Metairie, Louisiana, United States|MedPharmics LLC, Metairie, Louisiana, United States|Willis-Knighton Health System, Shreveport, Louisiana, United States|Michigan Center of Medical Research, Farmington Hills, Michigan, United States|Jackson Medical Mall, Jackson, Mississippi, United States|Lakeland Pharmacy, Branson W., Missouri, United States|CVS, Springfield, Missouri, United States|Mercury Street Medical Group, PLLC, Butte, Montana, United States|Meridian Clinical Research, LLC, Grand Island, Nebraska, United States|Quality Clinical Research Inc, Omaha, Nebraska, United States|Quality Clinical Research, Omaha, Nebraska, United States|Walmart, Las Vegas, Nevada, United States|Excel Clinical Research, Las Vegas, Nevada, United States|Walgreens, Las Vegas, Nevada, United States|AXCES Research Group, Santa Fe, New Mexico, United States|Meridian Clinical Research, LLC, Endwell, New York, United States|NYC Health + Hospitals/Harlem, New York, New York, United States|Monroe Biomedical Research, Monroe, North Carolina, United States|Accellacare, Wilmington, North Carolina, United States|Innovo Research: Wilmington Health, Wilmington, North Carolina, United States|Rhode Island Hospital, Providence, Rhode Island, United States|The Miriam Hospital, Providence, Rhode Island, United States|Avera McKennan Hospital & University Health Center, Sioux Falls, South Dakota, United States|Avera Research Institute, Sioux Falls, South Dakota, United States|Premier Medical Group, Clarksville, Tennessee, United States|PharmaTex Research, LLC, Amarillo, Texas, United States|ARC Clinical Research at William Cannon, Austin, Texas, United States|St Hope Foundation, Bellaire, Texas, United States|Conroe Willis Medical Research, Conroe, Texas, United States|South Texas Clinical Research, Corpus Christi, Texas, United States|Urgent Care Clinical Trials at City Doc McKinney, Dallas, Texas, United States|SignatureCare Emergency Center, Houston, Texas, United States|Trio Clinical Trials, LLC, Houston, Texas, United States|C & R Research Services USA, Houston, Texas, United States|Houston Methodist Hospital, Houston, Texas, United States|Next Level Urgent Care, Houston, Texas, United States|SMS Clinical Research, LLC, Mesquite, Texas, United States|LinQ Research, LLC, Pearland, Texas, United States|Epic Medical Research, Red Oak, Texas, United States|Sun Research Institute, San Antonio, Texas, United States|Endeavor Clinical Trials, LLC, San Antonio, Texas, United States|BFHC Research, San Antonio, Texas, United States|Tranquility Research, Webster, Texas, United States|University of Utah Medical Center, Salt Lake City, Utah, United States|TMPG Clinical Research, Newport News, Virginia, United States|TPMG Clinical Research, Newport News, Virginia, United States|Centro Médico Viamonte, Caba, Buenos Aires, Argentina|DIM Clinica Privada, Ramos Mejia, Buenos Aires, Argentina|Instituto de Investigaciones Clinicas Zarate, Zarate, Buenos Aires, Argentina|Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos), Rosario, Santa FE, Argentina|Sanatorio Britanico S.A., Rosario, Santa FE, Argentina|Instituto CAICI, Rosario, Santa FE, Argentina|Hospital de Clinicas Presidente Nicolas Avellaneda, San Miguel de Tucuman, Tucuman, Argentina|Clinica Mayo Urgencias Medicas Cruz Blanca SRL, San Miguel de Tucuman, Tucuman, Argentina|Hospital Privado Centro Médico de Córdoba, Córdoba, Argentina|Fundação de Medicina Tropical Doutor Heitor Vieira Dourado, Manaus, Amazonas, Brazil|Chronos Pesquisa Clinica, Brasilia, Distrito Federal, Brazil|AMB3 Serviços Médicos Ltda, Cuiabá, MATO Grosso, Brazil|Hospital Luxemburgo - Associacao Mario Penna, Belo Horizonte, MG, Brazil|School of Medicine Federal University of Minas Gerais, Belo Horizonte, Minas Gerais, Brazil|Hospital Agamenon Magalhaes, Recife, Pernambuco, Brazil|Centro de Estudos e Pesquisas em Moléstias Infecciosas, Natal, RIO Grande DO Norte, Brazil|Hospital De Clinicas De Porto Alegre, Porto Alegre, RIO Grande DO SUL, Brazil|IBPClin - Instituto Brasil de Pesquisa Clínica, Rio de Janeiro, RJ, Brazil|Instituto Nacional de Infectologia Evandro Chagas - INI/FIOCRUZ, Rio de Janeiro, RJ, Brazil|CECOR - Centro Oncológico de Roraima, Boa Vista, Roraima/rr, Brazil|Hospital Regional Hans Dieter Schmidt (HRHDS), Joinville, Santa Catarina/sc, Brazil|Scentryphar - Pesquisa ClInica, Campinas, SAO Paulo, Brazil|Centro de Estudos Clinicos do Interior Paulista (CECIP), Jau, SAO Paulo, Brazil|Hospital Dia do Pulmao, Blumenau, SC, Brazil|Hospital e Maternidade Celso Pierro - PUC Campinas / Sociedade Campineira de Educação e Instruçã, Campinas, SP, Brazil|Pesquisare Saude S/S Ltda, Santo André, SP, Brazil|Hospital Alemão Oswaldo Cruz, São Paulo, SP, Brazil|Unidade Referenciada Oswaldo Cruz Vergueiro, São Paulo, SP, Brazil|Hospital Heliópolis, São Paulo, SP, Brazil|Instituto D'Or de Pesquisa e Ensino / Hospital São Luiz Jabaquara, São Paulo, SP, Brazil|Scentryphar - Pesquisa ClInica, Campinas, SÃO Paulo, Brazil|Associação Evangélica de Campinas - Hospital Samaritano, Campinas, SÃO Paulo, Brazil|Instituto de Pesquisa Clínica de Campinas, Campinas, SÃO Paulo, Brazil|Centro de Referência e Treinamento DST/AIDS, Sao Paulo, SÃO Paulo, Brazil|Clinica de Alergia Martti Antila, Sorocaba, SÃO Paulo, Brazil|CEMEC - Centro Multidisciplinar de Estudos Clínicos, São Bernardo do Campo, SÃO Paulo, Brazil|CPCLIN - Centro de Pesquisas Clinicas Ltda, São Paulo, Brazil|Instituto de Infectologia Emilio Ribas, São Paulo, Brazil|Conjunto Hospitalar do Mandaqui, São Paulo, Brazil|Individual Practice for Primary Medical Care - IPPMC - Dr. P. Panayotov EOOD, Burgas, Bulgaria|MHAT St. Ekaterina, Dimitrovgrad EOOD, Dimitrovgrad, Bulgaria|"Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd, Haskovo, Bulgaria|MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD, Kozloduy, Bulgaria|Diagnostic-Consultative Center I Lom EOOD, Lom, Bulgaria|Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD, Lom, Bulgaria|Medical centre Leo Clinic EOOD, Lovech, Bulgaria|MHAT Heart and Brain EAD, Pleven, Bulgaria|UMHAT Sveta Marina - Pleven, Pleven, Bulgaria|DCC Sveti Georgi EOOD, Plovdiv, Bulgaria|MHAT "St. Panteleimon "- Plovdiv, Plovdiv, Bulgaria|Multi-Profile Hospital for Active treatment ''Plovdiv''AD, Plovdiv, Bulgaria|Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD, Razgrad, Bulgaria|"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -, Ruse, Bulgaria|UMHAT Medica Ruse OOD, Ruse, Bulgaria|Multiprofile Hospital for Active Treatment - Samokov EOOD, Samokov, Bulgaria|Medical Center-1-Sevlievo EOOD, Sevlievo, Bulgaria|Multiprofile Hospital For Active Treatment Shumen AD, Shumen, Bulgaria|Multiprofile hospital for active treatment - Sliven to Military Medical Academy, Sliven, Bulgaria|MHAT "Dr. Ivan Seliminski" AD, Sliven, Sliven, Bulgaria|Diagnostic-Consultative Center XXII- Sofia ЕООD, Sofia, Bulgaria|University First MHAT "St. Yoan Krastitel"-Sofia EAD, Sofia, Bulgaria|Diagnostic Consultative Center 18 - Sofia EOOD, Sofia, Bulgaria|MHAT "St. Sofia" EOOD, Sofia, Bulgaria|Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD, Stara Zagora, Bulgaria|Multiprofile Hospital for Active Treatment Targovishte AD, Targovishte, Bulgaria|Outpatient Clinic for Primary Outpatient Medical Care "Puls" - Dr. Mladen Buchvarov EOOD, Tsarevo, Bulgaria|Medical center Leo Clinic EOOD, Varna, Bulgaria|Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD, Vratsa, Bulgaria|Fundacion Centro de Investigacion Clinica CIC, Medellin, Antioquia, Colombia|Clinica de la Costa LTDA., Barranquilla, Atlantico, Colombia|Hospital Universidad Del Norte, Soledad, Atlantico, Colombia|IPS Medicos Internistas de Caldas, Manizales, Caldas, Colombia|Caimed S.A.S., Yopal, Casanare, Colombia|Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S, Bogota, Cundinamarca, Colombia|Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia, Bogotá D.C., Cundinamarca, Colombia|Bluecare Salud S A S, Bogota, D.c., Colombia|Fundacion Cardiomet CEQUIN, Armenia, Quindio, Colombia|Klinika infekcnich nemoci, Hradec Kralove, Czechia|MEDITRIAL s.r.o., Jindrichuv Hradec III, Czechia|Zdraví-Fit, s.r.o., Protivín, Czechia|Nemocnice Slany, Slany, Czechia|Trial Pharma Kft., Bekescsaba, Hungary|Semmelweis University Varosmajori Sziv Es Ergyogyaszati Klinika, Budapest, Hungary|Varosmajori Sziv- es Ergyogyaszati Klinika, Budapest, Hungary|Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika, Debrecen, Hungary|Agria-Study Kft., Eger, Hungary|Trial Pharma Kft., Gyula, Hungary|Medifarma-98 Kft., Nyiregyhaza, Hungary|Szent Borbala Korhaz, Tatabanya, Hungary|Fujita Health University Hospital, Toyoake-City, Aichi, Japan|Chiba Aoba Municipal Hospital, Chuo-ku, Chiba, Japan|International University of Health and Welfare Narita Hospital, Narita, Chiba, Japan|National Hokkaido Medical Center, Sapporo, Hokkaido, Japan|Rakuwakai Otowa Hospital, Kyoto-shi, Kyoto, Japan|Rinku General Medical Center, Izumisano, Osaka, Japan|Tokyo Medical University Hachioji Medical Center, Hachioji, Tokyo, Japan|Tokyo Shinagawa Hospital, Shinagawa-ku, Tokyo, Japan|National Center for Global Health and Medicine, Shinjuku City, Tokyo, Japan|Sekino Hospital, Toshimaku, Tokyo, Japan|Kyushu Medical Center, Fukuoka, Japan|Chonnam National University Hospital, Gwangju-si, Kwangju-kwangy?kshi, Korea, Republic of|Pusan National University Hospital, Busan, Korea, Republic of|Kyungpook National University Chilgok Hospital, Daegu, Korea, Republic of|Chonnam National University Bitgoeul Hospital, Gwangju, Korea, Republic of|Incheon Medical Center, Incheon, Korea, Republic of|Boramae Medical Center, Seoul, Korea, Republic of|Seoul Medical Center, Seoul, Korea, Republic of|Hospital Raja Perempuan Zainab II, Kota Bharu, Kelantan, Malaysia|Hospital Taiping, Taiping, Perak, Malaysia|Hospital Seberang Jaya, Perai, Pulau Pinang, Malaysia|Hospital Miri, Miri, Sarawak, Malaysia|Klinik Kesihatan Kuang, Rawang, Selangor, Malaysia|InfectoLab Consultorios de Especialidad en Infectologia, Tijuana, BAJA California, Mexico|Clinical Research Institute Saltillo S.A. de C.V., Saltillo, Coahuila, Mexico|Arke SMO S.A. de C.V, Veracruz, COL. Ignacio Zaragoza, Mexico|Centro de Investigacion Clinica Del Pacifico SA de CV, Acapulco de Juarez, Guerrero, Mexico|Asociación Mexicana para la Investigación Clínica A.C., Pachuca de Soto, Hidalgo, Mexico|Instituto Jalisciense de Metabolismo, S.C., Guadalajara, Jalisco, Mexico|JM Research, Cuernavaca, Morelos, Mexico|Christus - Latam Hub Center of Excellence and Innovation Center S.C., Monterrey, Nuevo LEON, Mexico|Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Nuevo LEON, Mexico|Eukarya Pharmasite S.C., Monterrey, Nuevo LEON, Mexico|Oaxaca Site Management Organization, Oaxaca de Juarez, Oaxaca, Mexico|Hospital General de Culiacán "Bernardo J. Gastélum", Culíacan, Sinaloa, Mexico|Köhler & Milstein Research, Merida, Yucatan, Mexico|Eme Red Hospitalaria, Mérida, Yucatán, Mexico|Hospital Cardiologica Aguascalientes, Aguascalientes, Mexico|Instituto de Investigaciones Clínicas para la Salud, Durango, Mexico|FAICIC Clinical Research, Veracruz, Mexico|Sociedad de Metabolismo y Corazon S.C., Veracruz, Mexico|KLIMED Marek Klimkiewicz, Bialystok, Poland|Krakowskie Centrum Medyczne, Krakow, Poland|Przychodnia Valeo Medical, Lodz, Poland|IRMED Ośrodek Badań Klinicznych, Piotrkow Trybunalski, Poland|Tomasz Blicharski Lubelskie Centrum Diagnostyczne, Swidnik, Poland|WIP Warsaw IBD Point Profesor Kierkus, Warszawa, Poland|Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska, Wroclaw, Poland|Ponce Medical School Foundation, Inc. CAIMED Center, Ponce, Puerto Rico|Clinical Research Management Group Inc, Ponce, Puerto Rico|Advance Medical Research Center, San Juan, Puerto Rico|MERC Welkom, Welkom, FREE State, South Africa|Worthwhile Clinical Trials, Benoni, Gauteng, South Africa|REIMED Vosloorus, Boksburg, Gauteng, South Africa|Peermed CTC (Pty) Ltd T/A MERC Kempton, Kempton Park, Gauteng, South Africa|Midrand Medical Centre, Midrand, Gauteng, South Africa|Global Clinical Trials, Pretoria, Gauteng, South Africa|The Aurum Institute: Pretoria Clinical Research Centre, Pretoria, Gauteng, South Africa|Botho ke Bontle Health Services, Pretoria, Gauteng, South Africa|Emmed Research, Pretoria, Gauteng, South Africa|Into Research, Pretoria, Gauteng, South Africa|Clinical Trial Systems (Pty) Ltd, Pretoria, Gauteng, South Africa|Sandton Medical Clinic, Sandton, Gauteng, South Africa|FCRN Clinical Trial Centre, Vereeniging, Gauteng, South Africa|Dr PJ Sebastian Clinical Research Centre, Durban, Kwa-zulu Natal, South Africa|Synapta Clinical Research Center, Durban, Kwazulu Natal, South Africa|Ahmed Al-Kadi Private Hospital, Mayville, Durban, Kwazulu-natal, South Africa|Limpopo Clinical Research Initiative, Thabazimbi, Limpopo, South Africa|NHC Thohoyandou CRS, Thohoyandou, Limpopo, South Africa|MERC Middelburg, Middelburg, Mpumalanga, South Africa|TASK Eden, George, Western CAPE, South Africa|Be Part Research Pty (Ltd), Paarl, Western CAPE, South Africa|Clinical Projects Research, Worcester, Western CAPE, South Africa|Dr JM Engelbrecht Trial Site, Somerset West, South Africa|Eba Centelles, Centelles, Barcelona [barcelona], Spain|Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain|CAP Vicenç Papaceit, La Roca del Valles, Barcelona, Spain|CAP La Mina, Sant Adria de Besos, Barcelona, Spain|Hospital Clinico San Carlos, Madrid, Madrid, Comunidad DE, Spain|Hospital Alvaro Cunqueiro, Vigo, Pontevedra, Spain|IMED Valencia, Burjassot, Valencia, Spain|Complexo Hospitalario Universitario da Coruna, A Coruna, Spain|Complexo Hospitalario Universitario da Coruna, A Coruña, Spain|Hospital Universitario Virgen de las Nieves, Granada, Spain|Hospital Universitario de la Paz, Madrid, Spain|Hospital Universitario de Salamanca, Salamanca, Spain|Hospital Universitario Virgen de Valme, Sevilla, Spain|Far Eastern Memorial Hospital, New Taipei City, Taiwan|China Medical University Hospital, Taichung City, Taiwan|Taichung Veterans General Hospital, Taichung, Taiwan|National Taiwan University Hospital, Taipei, Taiwan|Siriraj Hospital, Mahidol University, BangkokNoi, Bangkok, Thailand|Riverside Bangkok Hotel, Bangplud, Bangkok, Thailand|Bangkok Centre Hotel, Bangrak, Bangkok, Thailand|Chula Filed hospital, Chulalongkorn University Sport center (Chantanayingyong Gymnasium),, Pathum Wan District,, Bangkok, Thailand|Thai Red Cross Emerging Infectious Diseases (EDI) Clinic, Pathumwan,, Bangkok, Thailand|The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),, Pathumwan, Bangkok, Thailand|Baiyoke Suite Hotel, Ratchathewi, Bangkok, Thailand|Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University,, Hat Yai, Songkhla, Thailand|Khon Kaen Univerisity Field Hospital, Student Dormitory 26, Khon Kaen University, Khon Kaen, Thailand|Srinagarind Hospital, Khon Kaen, Thailand|Cukurova University Medical Faculty, Balcali, Adana, Turkey|Ankara University Medical Faculty, Ibni-Sina Hospital, Ankara, Turkey|Hacettepe University Medical Faculty Hospital, Ankara, Turkey|Akdeniz Universitesi Hastanesi, Antalya, Turkey|Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi, Gaziantep, Turkey|Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi, Istanbul, Turkey|Istanbul University Istanbul Medical Faculty, Istanbul, Turkey|Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty, Istanbul, Turkey|Medipol Mega University Hospital, Istanbul, Turkey|Acibadem University Atakent Hospital, Istanbul, Turkey|Basaksehir Cam ve Sakura Sehir Hastanesi, Istanbul, Turkey|Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital, Izmir, Turkey|Kocaeli University Medical Faculty, Kocaeli, Turkey|Mersin University Medical Faculty, Mersin, Turkey|Sakarya University Training and Research Hospital, Sakarya, Turkey|Karadeniz Teknik Universitesi Farabi Hastanesi, Trabzon, Turkey|Communal Medical Enterprise "Likarnya Prydniprovska", Kremenchuk, Poltava Region, Ukraine|Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital", Chernivtsi, Ukraine|Communal non-commercial Enterprise "City Clinical Hospital №3" of Chernivtsi City Council, Chernivtsi, Ukraine|Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council, Dnipro, Ukraine|Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of, Ivano-Frankivsk, Ukraine|Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council", Ivano-Frankivsk, Ukraine|Municipal Non-profit Enterprise "Ivano-Frankivsk Regional Phthisiopulmonology Center of, Ivano-Frankivsk, Ukraine|Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council, Kharkiv, Ukraine|Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases, Kharkiv, Ukraine|Municipal Nonprofit Enterprise "City Clinic Hospital # 13" of Kharkiv City Council, Kharkiv, Ukraine|Municipal Non-profit Enterprise "Oleksandrivska Kyiv City Clinical Hospital" Of Executive Body Of, Kyiv, Ukraine|Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the Kyiv, Kyiv, Ukraine|Kyiv Railway Clinical Hospital No.2 of Branch "Health Center of the Public Joint Stock Company, Kyiv, Ukraine|Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company, Kyiv, Ukraine|Municipal non-profit enterprise of Lviv regional council "Lviv regional phthisiopulmonology clinical, Lviv, Ukraine|Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4", Lviv, Ukraine|Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional, Poltava, Ukraine|Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council, Tarasove Village, Ukraine|Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital №1", Vinnytsia, Ukraine|Communal Enterprise "Hospital #1" of Zhytomyr City Council, Zhytomyr, Ukraine
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 1150
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Time to Sustained Alleviation of All Targeted COVID-19 Signs/Symptoms|Percentage of Participants Who Experience Adverse Events (AEs)|Percentage of Participants Who Experience an AE(s) or Serious Adverse Events (SAEs) that Leads to Study Discontinuation|Proportion of Participants With Severe Signs/Symptoms Attributed to COVID-19|Time to Sustained Resolution of All Targeted COVID-19 Signs/Symptoms|Duration of Each Targeted COVID-19 Sign/Symptom|Proportion of Participants Progressing to a Worsening Status In 1 or More COVID-19 Signs/Symptoms|Proportion of Participants With a Resting Peripheral Oxygen Saturation ≥95%|Number of COVID-19 Related Medical Visits|Number of Days in Hospital and Intensive Care Unit (ICU) Stay in Participants With COVID-19 Related Hospitalization|Proportion of Participants With COVID-19 Related Hospitalization or Death From Any Cause|Proportion of Participants With Death (all cause)|Minimal Concentration (Ctrough) of PF-07321332|Viral Titers Measured Via Reverse Transcription Polymerase Chain Reaction (RT-PCR) in Nasal Swabs
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NCT05261139
|
EPIC-Peds: Study of Oral PF-07321332 (Nirmatrelvir)/Ritonavir in Nonhospitalized COVID-19 Pediatric Patients at Risk for Severe Disease |
Not yet recruiting |
Phase 3 |
Mar/02/2022 |
Mar/04/2023 |
- Alternative id - C4671026
- Interventions - Drug: nirmatrelvir|Drug: ritonavir
- Study type - Interventional
- Study results - No Results Available
- Locations - SKY Clinical Research Network Group-Quinn, Ridgeland, Mississippi, United States|Coastal Pediatric Research, Summerville, South Carolina, United States|Consano Clinical Research, LLC, Shavano Park, Texas, United States
- Study designs - Allocation: Non-Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 140
- Age - up to 18 Years (Child, Adult)
- Outcome measures - Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir|Cohort 3-5: Cmax of nirmatrelvir and ritonavir|Cohort 1-2: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir|Cohort 3-5: AUC0-tau of nirmatrelvir and ritonavir|Incidence of TEAEs, SAEs, AEs leading to discontinuations, and vital sign measurements|Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasal swabs over time|Proportion of participants with COVID-19 related hospitalization or death from any cause|Patient assessment on palatability of nirmatrelvir (film-coated tablets and age-appropriate formulation)|Patient assessment on palatability of ritonavir (age-appropriate formulation)|Patient assessment on acceptability of nirmatrelvir (film-coated tablets and age-appropriate formulation)|Patient assessment on acceptability of ritonavir (age-appropriate formulation)
|
NCT05032950
|
Drug-Drug Interaction Study to Estimate the Effect of PF-07321332/Ritonavir and Ritonavir on Midazolam in Healthy Participants |
Completed |
Phase 1 |
Sep/17/2021 |
Dec/09/2021 |
- Alternative id - C4671013|2021-003590-62
- Interventions - Drug: Midazolam|Drug: PF-07321332/ritonavir + Midazolam|Drug: Ritonavir + Midazolam
- Study type - Interventional
- Study results - No Results Available
- Locations - Brussels Clinical Research Unit, Brussels, Bruxelles-capitale, Région DE, Belgium
- Study designs - Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 12
- Age - 18 Years to 60 Years (Adult)
- Outcome measures - Maximum Observed Plasma Concentration (Cmax) of midazolam when administered alone|Cmax of midazolam when administered with PF-07321332/ritonavir|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of midazolam when administered alone|AUCinf of midazolam when administered with PF-07321332/ritonavir|Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of midazolam when administered alone|AUClast of midazolam when administered with PF-07321332/ritonavir|Assessment of Participants With Treatment-Emergent Adverse Events (TEAEs) of PF-07321332/Ritonavir|Assessment of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities of PF-07321332/Ritonavir|Assessment of Participants With Clinically Significant Change From Baseline in Vital Signs of PF-07321332/Ritonavir|Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings of PF-07321332/Ritonavir|Cmax of midazolam when administered with ritonavir|AUCinf of midazolam when administered with ritonavir|AUClast of midazolam when administered with ritonavir|Apparent Oral Clearance (CL/F) of midazolam when administered alone|CL/F of midazolam when administered with PF-07321332/ritonavir|Apparent Oral Volume of Distribution (Vz/F)) of midazolam when administered alone|Vz/F of midazolam when administered with PF-07321332/ritonavir|Time to Cmax (Tmax) of midazolam when administered alone|Tmax of midazolam when administered with PF-07321332/ritonavir|Plasma Decay Half-Life (t1/2) of midazolam when administered alone|t1/2 of midazolam when administered with PF-07321332/ritonavir
|
NCT04909853
|
Renal Impairment Study of PF-07321332 Boosted With Ritonavir in Adult Participants With Renal Impairment and in Healthy Participants With Normal Renal Function. |
Completed |
Phase 1 |
Jun/15/2021 |
Oct/07/2021 |
- Alternative id - C4671011
- Interventions - Drug: PF-07321332/ritonavir
- Study type - Interventional
- Study results - No Results Available
- Locations - Orange County Research Center, Tustin, California, United States|Investigational Drug Services (IDS) University of Miami Hospitals and Clinics, Miami, Florida, United States|University of Miami Division of Clinical Pharmacology, Miami, Florida, United States|Genesis Clinical Research, Tampa, Florida, United States|Prism Research LLC dba Nucleus Network, Saint Paul, Minnesota, United States
- Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 35
- Age - 18 Years to 75 Years (Adult, Older Adult)
- Outcome measures - Maximum observed plasma concentration (Cmax) for PF-07321332.|Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-07321332|Amount of PF-07321332 excreted in urine unchanged|Time to maximum concentration (Tmax) of PF-07321332|Area Under the Plasma Concentration-time Profile from Time 0 to Last Measurable PF-07321332 Concentration (AUClast)|Number of Participants reporting Treatment-Emergent Adverse Events|Number of Participants With Clinical Laboratory Abnormalities|Number of Participants With Vital Signs Abnormalities|Number of Participants With Abnormalities in Physical Examination|Number of Participants With Abnormal Electrocardiogram (ECG)
|
NCT04960202
|
EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19 |
Active, not recruiting |
Phase 3 |
Jul/16/2021 |
Apr/23/2022 |
- Alternative id - C4671005|2021-002895-38|EPIC-HR
- Interventions - Drug: PF-07321332|Drug: Ritonavir|Drug: Placebo
- Study type - Interventional
- Study results - No Results Available
- Locations - Cahaba Research, Inc., Pelham, Alabama, United States|The Institute for Liver Health dba Arizona Clinical Trials, Mesa, Arizona, United States|The Institute for Liver Health dba Arizona Clinical Trials, Tucson, Arizona, United States|Hope Clinical Research, Canoga Park, California, United States|Ascada Research, Fullerton, California, United States|Atella Clinical Research LLC., La Palma, California, United States|Ark Clinical Research, Long Beach, California, United States|American Institute of Research, Los Angeles, California, United States|South Bay Clinical Research Institute, Torrance, California, United States|Hope Clinical Research (COVID Satellite Site), West Hills, California, United States|Future Innovative Treatments, LLC, Colorado Springs, Colorado, United States|Xera Med Research, Boca Raton, Florida, United States|MOORE Clinical Research, Inc., Brandon, Florida, United States|Innovative Research of West Florida, Inc., Clearwater, Florida, United States|Herco Medical and Research Center Inc, Coral Gables, Florida, United States|Advance Clinical Research Group, Cutler Bay, Florida, United States|Beautiful Minds Clinical Research Center, Cutler Bay, Florida, United States|Unlimited Medical Research Group, LLC, Hialeah Gardens, Florida, United States|Qway Research, LLC, Hialeah, Florida, United States|Eastern Research Inc, Hialeah, Florida, United States|Inpatient Research Clinic, Hialeah, Florida, United States|Doral Medical Research LLC., Hialeah, Florida, United States|Doral Medical Research,LLC, Hialeah, Florida, United States|Advanced Pulmonary Research Institute, Loxahatchee Groves, Florida, United States|Savin Medical Group, LLC, Miami Lakes, Florida, United States|Angels Clinical Research Institute, Miami, Florida, United States|LCC Medical Research Institute, LLC, Miami, Florida, United States|Premium Medical Research Corp, Miami, Florida, United States|Global Health Clinical Trials Corp, Miami, Florida, United States|South Florida Research Center, Inc., Miami, Florida, United States|Suncoast Research Group, LLC, Miami, Florida, United States|I.V.A.M. Clinical & Investigational Center, LLC, Miami, Florida, United States|C'A Research, Miami, Florida, United States|ProLive Medical Research, Corp., Miami, Florida, United States|Entrust Clinical Research, Miami, Florida, United States|Reed Medical Research, Miami, Florida, United States|Kendall South Medical Center, Miami, Florida, United States|Clinical Site Partners, Inc d/b/a CSP Miami, Miami, Florida, United States|Coral Research Clinic Corp, Miami, Florida, United States|Omega Research Orlando, LLC, Orlando, Florida, United States|NAPA Research LLC, Pompano Beach, Florida, United States|CDC Research Institute, Port Saint Lucie, Florida, United States|GCP, Global Clinical Professionals, Saint Petersburg, Florida, United States|GCP, Global Clinical Professionals, Saint Petersburg, Florida, United States|USPA Advance Concept Medical Research Group LLC, South Miami, Florida, United States|Sunrise Research Institute, Sunrise, Florida, United States|Santos Research Center, CORP, Tampa, Florida, United States|Clinical Site Partners, Inc. dba CSP Orlando, Winter Park, Florida, United States|Research by Design, LLC, Chicago, Illinois, United States|New Orleans Sinus Center (COVID-19 Testing), Marrero, Louisiana, United States|Tandem Clinical Research GI, LLC, Marrero, Louisiana, United States|Mercury Street Medical Group, PLLC, Butte, Montana, United States|Excel Clinical Research, Las Vegas, Nevada, United States|Meridian Clinical Research, LLC, Endwell, New York, United States|Monroe Biomedical Research, Monroe, North Carolina, United States|Accellacare, Wilmington, North Carolina, United States|Premier Medical Group, Clarksville, Tennessee, United States|PharmaTex Research, LLC, Amarillo, Texas, United States|ARC Clinical Research at William Cannon, Austin, Texas, United States|St Hope Foundation, Bellaire, Texas, United States|Conroe Willis Medical Research, Conroe, Texas, United States|South Texas Clinical Research, Corpus Christi, Texas, United States|SignatureCare Emergency Center, Houston, Texas, United States|Trio Clinical Trials, LLC, Houston, Texas, United States|C & R Research Services USA, Houston, Texas, United States|Next Level Urgent Care, Houston, Texas, United States|SMS Clinical Research, LLC, Mesquite, Texas, United States|SMS Clinical Research, Mesquite, Texas, United States|LinQ Research, LLC, Pearland, Texas, United States|Epic Medical Research, Red Oak, Texas, United States|Sun Research Institute, San Antonio, Texas, United States|BFHC Research, San Antonio, Texas, United States|Tranquility Research, Webster, Texas, United States|TPMG (Tidewater Physicians Multispecialty Group) Clinical Research, Newport News, Virginia, United States|Instituto de Investigaciones Clinicas Zarate, Zarate, Buenos Aires, Argentina|Hospital De Clínicas Presidente Dr.Nicolas Avellaneda, San Miguel de Tucuman, Tucuman, Argentina|Chronos Pesquisa Clinica, Brasilia, Distrito Federal, Brazil|Hospital Agamenon Magalhaes, Recife, Pernambuco, Brazil|Centro de Estudos Clinicos do Interior Paulista (CECIP), Jau, SAO Paulo, Brazil|Individual Practice for Primary Medical Care - IPPMC - Dr. P. Panayotov EOOD, Burgas, Bulgaria|"Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd, Haskovo, Bulgaria|MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD, Kozloduy, Bulgaria|Diagnostic-Consultative Center I Lom EOOD, Lom, Bulgaria|Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD, Lom, Bulgaria|Medical centre Leo Clinic EOOD, Lovech, Bulgaria|MHAT Heart and Brain EAD, Pleven, Bulgaria|DCC Sveti Georgi EOOD, Plovdiv, Bulgaria|MHAT "St. Panteleimon "- Plovdiv, Plovdiv, Bulgaria|Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD, Razgrad, Bulgaria|"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -, Ruse, Bulgaria|UMHAT Medica Ruse OOD, Ruse, Bulgaria|Multiprofile Hospital for Active Treatment - Samokov EOOD, Samokov, Bulgaria|Medical Center-1-Sevlievo EOOD, Sevlievo, Bulgaria|Multiprofile Hospital For Active Treatment Shumen AD, Shumen, Bulgaria|Multiprofile hospital for active treatment - Sliven to Military Medical Academy, Sliven, Bulgaria|MHAT "Dr. Ivan Seliminski" AD, Sliven, Sliven, Bulgaria|Diagnostic-Consultative Center XXII- Sofia ЕООD, Sofia, Bulgaria|MHAT "St. Sofia" EOOD, Sofia, Bulgaria|Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD, Stara Zagora, Bulgaria|Multiprofile Hospital for Active Treatment Targovishte AD, Targovishte, Bulgaria|Outpatient Clinic for Primary Outpatient Medical Care "Puls" - Dr. Mladen Buchvarov EOOD, Tsarevo, Bulgaria|Medical center Leo Clinic EOOD, Varna, Bulgaria|Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD, Vratsa, Bulgaria|Fundacion Cardiomet CEQUIN, Armenia, Quindio, Colombia|Zdraví-Fit, s.r.o., Protivín, Czechia|Nemocnice Slany, Slany, Czechia|Trial Pharma Kft., Bekescsaba, Hungary|Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika, Debrecen, Hungary|Agria-Study Kft., Eger, Hungary|Trial Pharma Kft., Gyula, Hungary|Medifarma-98 Kft., Nyiregyhaza, Hungary|AIIMS Raipur, Raipur, Chhattisgarh, India|Jupiter Hospital, Vadodara, Gujarat, India|BGS Global Institute of Medical Sciences and Hospital, Bangalore, Karnataka, India|Lisie Hospital, Kochi, Kerala, India|Jehangir Clinical Development Centre Pvt. Ltd, Pune, Maharashtra, India|Lifepoint Research LLP, Pune, Maharashtra, India|Jawahar Lal Nehru Medical College, Ajmer, Rajasthan, India|Apex Hospitals Pvt Ltd, Jaipur, Rajasthan, India|Maharaja Agrasen Superspeciality Hospital, Jaipur, Rajasthan, India|Nil Ratan Sircar Medical College and Hospital, Kolkata, WEST Bengal, India|Aakash Healthcare Private Limited, New Delhi, India|Sardar Patel Medical College, Pavan PURI Bikaner, Rajasthan, India|International University of Health and Welfare Narita Hospital, Narita, Chiba, Japan|National Hokkaido Medical Center, Sapporo, Hokkaido, Japan|Rinku General Medical Center, Izumisano, Osaka, Japan|Tokyo Medical University Hachioji Medical Center, Hachioji, Tokyo, Japan|National Center for Global Health and Medicine, Shinjuku City, Tokyo, Japan|Kyungpook National University Chilgok Hospital, Daegu, Korea, Republic of|Incheon Medical Center, Incheon, Korea, Republic of|Chonnam National University Bitgoeul Hospital, Nam-gu, Korea, Republic of|SMG-SNU Boramae Medical Center, Seoul, Korea, Republic of|Hospital Umum Sarawak, Kuching, Sarawak, Malaysia|Hospital Miri, Miri, Sarawak, Malaysia|Clinical Research Institute Saltillo S.A. de C.V., Saltillo, Coahuila, Mexico|Asociacion Mexicana para la Investigacion Clinica A.C. (AMIC), Pachuca de Soto, Hidalgo, Mexico|Instituto Jalisciense de Metabolismo, CS, Guadalajara, Jalisco, Mexico|JM Research, Cuernavaca, Morelos, Mexico|Christus - Latam Hub Center of Excellence and Innovation Center S.C., Monterrey, Nuevo LEON, Mexico|Eukarya Pharmasite S.C., Monterrey, Nuevo LEON, Mexico|Oaxaca Site Management Organization, Oaxaca de Juarez, Oaxaca, Mexico|InfectoLab Consultorios de Especialidad en Infectologia, Baja California, Tijuana, Mexico|Kohler & Milstein Research S.A. de C.V., Merida, Yucatan, Mexico|Eme Red Hospitalaria, Mérida, Yucatán, Mexico|Centro de Investigacion Clinica Del Pacifico SA de CV, Acapulco, Mexico|Hospital Cardiologica Aguascalientes, Aguascalientes, Mexico|Instituto de Investigaciones Clínicas para la Salud, Durango, Mexico|FAICIC S. de R.L. de C.V., Veracruz, Mexico|Sociedad de Metabolismo y Corazon S.C., Veracruz, Mexico|Arke SMO S.A. de C.V, Veracruz, Mexico|KLIMED Marek Klimkiewicz, Bialystok, Poland|Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska, Wroclaw, Poland|Clinical Research Management Group Inc, Ponce, Puerto Rico|Advance Medical Research Center, San Juan, Puerto Rico|LLC Trekhgorka Medicine, Odintsovo, Moscow Region, Russian Federation|Barnaul City Hospital Number 5, Barnaul, Russian Federation|KDC "Evromedservis", OJSC, Moscow, Russian Federation|Smolensk State Medical University, Smolensk, Russian Federation|MERC Welkom, Welkom, FREE State, South Africa|East Rand Research Centre T/A Worthwhile Clinical Trials, Benoni, Gauteng, South Africa|Botho ke Bontle Health Services, Pretoria, Gauteng, South Africa|Synapta Clinical Research Center, Durban, Kwazulu Natal, South Africa|Limpopo Clinical Research Initiative, Thabazimbi, Limpopo, South Africa|MERC Middelburg, Middelburg, Mpumalanga, South Africa|Eba Centelles, Centelles, Barcelona [barcelona], Spain|Complexo Hospitalario Universitario da Coruna, A Coruña, Spain|Bangkok Centre Hotel, Bangrak, Bangkok, Thailand|Chula Filed hospital, Chulalongkorn University Sport center (Chantanayingyong Gymnasium),, Pathum Wan District,, Bangkok, Thailand|Thai Red Cross Emerging Infectious Diseases (EDI) Clinic, Pathumwan,, Bangkok, Thailand|The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),, Pathumwan, Bangkok, Thailand|Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University,, Hat Yai, Songkhla, Thailand|Srinagarind Hospital, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand|Ankara University Medical Faculty, Ibni-Sina Hospital, Ankara, Turkey|Hacettepe University Medical Faculty Hospital, Ankara, Turkey|Akdeniz Universitesi Hastanesi, Antalya, Turkey|Istanbul Medipol University Clinical Research Ethics Committee, Beykoz / Istanbul, Turkey|Gaziantep University Medical Faculty, Gaziantep, Turkey|Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi, Istanbul, Turkey|Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty, Istanbul, Turkey|Acibadem Saglik Hizmetleri ve Tic.A.S, Acibadem Atakent Hastanesi, Istanbul, Turkey|Istanbul Universitesi Klinik Arastirmalar Mukemmeliyet Uygulama ve Arastirma Merkezi, Istanbul, Turkey|Basaksehir Cam ve Sakura Sehir Hastanesi, Istanbul, Turkey|Kocaeli University Medical Faculty, Kocaeli, Turkey|Sbü Dr. Suat Seren Göğüs Hastaliklari Ve Cerrahisi Eğitim Ve Araştirma Hastanesi, Konak/Izmir, Turkey|Mersin University Health Research and Application Hospital, Mersin, Turkey|Sakarya University Training and Research Hospital, Sakarya, Turkey|Karadeniz Teknik Universitesi Farabi Hastanesi, Trabzon, Turkey|Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council, Dnipro, Ukraine|Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of, Ivano-Frankivsk, Ukraine|Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council", Ivano-Frankivsk, Ukraine|Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council, Kharkiv, Ukraine|Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases, Kharkiv, Ukraine|"Municipal Non-Profit Enterprise "Alexander Clinical Hospital of Kyiv" of the Kyiv City Council, Kyiv, Ukraine|Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the Kyiv, Kyiv, Ukraine|Kyiv Railway Clinical Hospital No.2 of Branch "Health Center of the Public Joint Stock Company, Kyiv, Ukraine|Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company, Kyiv, Ukraine|Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analitical, Lviv, Ukraine|Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4", Lviv, Ukraine|Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional, Poltava, Ukraine|Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council, Tarasove Village, Ukraine|Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital №1", Vinnytsia, Ukraine|Communal Enterprise "Hospital #1" of Zhytomyr City Council, Zhytomyr, Ukraine
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
- Enrollment - 2246
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Proportion of participants with COVID-19 related hospitalization or death from any cause|Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)of PF-07321332/ritonavir relative to placebo|Incidence of Treatment-emergent Adverse Events (TEAEs) of PF-07321332/ritonavir relative to placebo of PF-07321332/ritonavir relative to placebo|Duration of each targeted COVID-19 sign/symptom|Severity of each targeted COVID-19 sign/symptom|Proportion of participants with death (all cause)|To determine the pharmacokinetics (PK) in plasma and whole blood of PF-07321332 in nonhospitalized symptomatic adult participants with COVID 19 who are at increased risk of progression to severe disease|Viral titers measured by Reverse Transcription Polymerase Chain Reaction (RT-PCR) in nasal swabs|Number of COVID-19 related medical visits other than hospitalization|Number of days in hospital and intensive care unit for the treatment of COVID-19
|
NCT05178654
|
Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]PF-07321332 in Healthy Male Participants. |
Withdrawn |
Phase 1 |
Feb/22/2022 |
Apr/01/2022 |
- Alternative id - C4671007
- Interventions - Drug: [14C]PF-07321332
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Single Group Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 0
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Cumulative amount of radioactivity Recovered in Urine (Ae)|Cumulative amount of radioactivity Recovered in Feces (Ae)|Metabolic Profiling in blood|Metabolic Profiling in Urine|Metabolic Profiling in Feces|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)|Number of Participants With Notable Electrocardiogram (ECG) Values|Number of Participants With Clinically Notable Vital Signs|Number of Participants With Clinically Notable Clinical Chemistry/Biochemistry Shifts Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade
|
NCT05005312
|
Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332 |
Completed |
Phase 1 |
Aug/31/2021 |
Dec/07/2021 |
- Alternative id - C4671010
- Interventions - Drug: PF-07321332|Drug: Ritonavir
- Study type - Interventional
- Study results - No Results Available
- Locations - Orange County Research Center, Tustin, California, United States|Prism Research LLC dba Nucleus Network, Saint Paul, Minnesota, United States
- Study designs - Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 17
- Age - 18 Years to 75 Years (Adult, Older Adult)
- Outcome measures - Maximum observed plasma concentration (Cmax) for PF-07321332|Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Last Measurable Time (AUClast) for PF-07321332|Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-07321332|Incidence of Treatment Emergent Adverse Events|Incidence of Abnormal ECGs|Incidence of Abnormal Vital Signs|Incidence of Abnormal Laboratory Values
|
NCT05263908
|
General Investigation for PAXLOVID PACK |
Not yet recruiting |
|
Mar/01/2022 |
Jul/10/2023 |
- Alternative id - C4671018
- Interventions - Drug: nirmatrelvir / ritonavir
- Study type - Observational
- Study results - No Results Available
- Locations - Pfizer Local County, Tokyo, Japan
- Study designs - Observational Model: Case-Only|Time Perspective: Prospective
- Enrollment - 3300
- Age - 12 Years and older (Child, Adult, Older Adult)
- Outcome measures - Incidence of adverse drug reactions|Ratio of subjects with worsening severity
|
NCT05263895
|
Relative Bioavailability Study of 4 Different Formulations of PF-07321332 Relative to the Commercial Tablet Formulation |
Not yet recruiting |
Phase 1 |
Mar/03/2022 |
May/14/2022 |
- Alternative id - C4671008
- Interventions - Drug: PF-07321332/ritonavir|Drug: PF-07321332
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 12
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Area under the Concentration-Time Curve (AUC)|Maximum Observed Plasma Concentration (Cmax)|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)|Number of Participants With Notable Electrocardiogram (ECG) Values|Number of Participants With Clinically Notable Vital Signs|Number of Participants With Clinically Notable Changes in Clinical laboratory|Number of Participants With Clinically Notable Abnormality in physical examination
|
NCT05263921
|
Relative Bioavailability Study of PF-07321332/Ritonavir Oral Powder Relative to the Commercial Tablets in Healthy Participants |
Not yet recruiting |
Phase 1 |
Mar/11/2022 |
May/18/2022 |
- Alternative id - C4671024
- Interventions - Drug: PF-07321332/ritonavir
- Study type - Interventional
- Study results - No Results Available
- Locations -
- Study designs - Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 12
- Age - 18 Years to 60 Years (Adult)
- Outcome measures - Area under curve from time zero to 72 hours post dose|Peak plasma concentration (Cmax)|Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)|Number of Participants With Notable Electrocardiogram (ECG) Values|Number of Participants With Clinically Notable Vital Signs|Number of Participants With Clinically Notable Changes in Clinical laboratory|Number of Participants With Clinically Notable Abnormality in physical examination|Palatability assessment of PF-07321332/ritonavir oral powder mixed with water/applesauce/vanilla pudding
|
NCT04962022
|
Drug-Drug Interaction Study Assessing Effect of Itraconazole on PF-07321332/Ritonavir in Healthy Participants |
Completed |
Phase 1 |
Jul/20/2021 |
Sep/30/2021 |
- Alternative id - C4671015|2021-003308-42
- Interventions - Drug: PF-07321332/ritonavir|Drug: Itraconazole
- Study type - Interventional
- Study results - No Results Available
- Locations - Brussels Clinical Research Unit, Brussels, Bruxelles-capitale, Région DE, Belgium
- Study designs - Allocation: Non-Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 12
- Age - 18 Years to 60 Years (Adult)
- Outcome measures - Maximum Observed Plasma Concentration (Cmax) of PF-07321332/ritonavir when administered alone|Cmax of PF-07321332/ritonavir when administered with itraconazole|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07321332/ritonavir when administered alone|AUCinf of PF-07321332/ritonavir when administered with itraconazole|Assessment of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)|Assessment of Participants With Laboratory Abnormalities|Assessment of Participants With Vital Signs Abnormalities of PF-07321332/ritonavir|Assessment of Participants With Vital Signs Abnormalities of PF-07321332/ritonavir with itraconazole|Assessment of Abnormalities in Physical Examination (PE)|Assessment of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings of PF-07321332/ritonavir|Assessment of Participants with Clinically Significant ECG findings of PF-07321332/ritonavir with itraconazole
|
NCT05129475
|
Food Effect Study to Evaluate the Effect of High-Fat Meal on the Relative Bioavailability of PF-07321332 Boosted With Ritonavir in Healthy Adult Participants |
Completed |
Phase 1 |
Nov/12/2021 |
Jan/12/2022 |
- Alternative id - C4671019
- Interventions - Drug: PF-07321332/ritonavir|Drug: Ritonavir
- Study type - Interventional
- Study results - No Results Available
- Locations - New Haven Clinical Research Unit, New Haven, Connecticut, United States
- Study designs - Allocation: Randomized|Intervention Model: Crossover Assignment|Masking: None (Open Label)|Primary Purpose: Basic Science
- Enrollment - 12
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Maximum Observed Plasma Concentration (Cmax) of PF-07321332|Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07321332|Area Under the Curve From Time Zero o Last quantifiable concentration (AUClast) of PF-07321332|Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07321332|Plasma Decay Half-Life (t1/2) of PF-07321332|Apparent Oral Clearance (CL/F) of PF-07321332|Apparent Volume of Distribution (Vz/F) of PF-07321332|Number of Participants With Laboratory Abnormalities|Number of participants with Treatment-Emergent Adverse Events (TEAEs)|Number of Participants With Clinically Significant Change From Baseline in Vital Sign|Number of Participants with Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings
|