Clinical trial NCT04960202: EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19
Official title: AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT INCREASED RISK OF PROGRESSING TO SEVERE ILLNESS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: COVID-19
Keywords: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-07-13
Enrollment: 2246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants with a confirmed diagnosis of SARS-CoV-2 infection will be randomized (1:1) to receive PF-07321332/ritonavir or placebo orally every 12 hours for 5 days (10 doses total).
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether PF-07321332/ritonavir is safe and effective for the treatment of adults who are ill with COVID-19 and do not need to be in the hospital, but are at an increased risk of developing severe illness. Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or another non-clinic location if available. The total study duration is up to 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Confirmed SARS-CoV-2 infection within 5 days prior to randomization
* Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of randomization and at least 1 of the specified COVID-19 signs/symptoms present on the day of randomization
* Fertile participants must agree to use a highly effective method of contraception
* Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19

Exclusion Criteria:

* History of or need for hospitalization for the medical treatment of COVID-19
* Prior to current disease episode, any confirmed SARS-CoV-2 infection
* Known medical history of active liver disease
* Receiving dialysis or have known moderate to severe renal impairment
* Known human immunodeficiency virus (HIV) infection with a viral load greater than 400 copies/mL or taking prohibited medications for HIV treatment
* Suspected or confirmed concurrent active systemic infection other than COVID-19
* History of hypersensitivity or other contraindication to any of the components of the study intervention
* Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or are strong inducers of CYP3A4
* Has received or is expected to receive convalescent COVID-19 plasma
* Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 34 visit
* Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the long-term follow-up visit
* Known prior participation in this trial or other trial involving PF-07321332
* Oxygen saturation of \<92% on room air, or on their standard home oxygen supplementation for those who regularly receive chronic supplementary oxygen for an underlying lung condition
* Females who are pregnant or breastfeeding

Primary outcomes:
measure: Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population
timeFrame: From Day 1 to Day 28
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From start of study intervention (Day 1) up to end of safety follow-up (Day 34)
measure: Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs)
timeFrame: From start of study intervention (Day 1) up to end of safety follow-up (Day 34)
measure: Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population
timeFrame: From Day 1 to Day 28
measure: Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population
timeFrame: From Day 1 (baseline) to Day 28
measure: Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population
timeFrame: From Day 1 (baseline) to Day 28
measure: Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population
timeFrame: From Day 1 (baseline) to Day 28
measure: Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population
timeFrame: From Day 1 to Day 28
measure: Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population
timeFrame: From Day 1 to Day 28
measure: Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population
timeFrame: From Day 1 to Day 28
measure: Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population
timeFrame: From Day 1 (baseline) to Day 28
measure: Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population
timeFrame: From Day 1 (baseline) to Day 28
measure: Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population
timeFrame: From Day 1 (baseline) to Day 28
measure: Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population
timeFrame: From Day 1 (baseline) to Day 28
measure: Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population
timeFrame: From Day 1 (baseline) to Day 28
measure: Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population
timeFrame: From Day 1 (baseline) to Day 28
measure: Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population
timeFrame: From Day 1 (baseline) to Day 28
measure: Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population
timeFrame: From Day 1 (baseline) to Day 28
measure: Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population
timeFrame: From Day 1 (baseline) to Day 28
measure: Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population
timeFrame: From Day 1 (baseline) to Day 28
measure: Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population
timeFrame: From Day 1 (baseline) to Day 28
measure: Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population
timeFrame: From Day 1 (baseline) to Day 28
measure: Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population
timeFrame: Day 1, 5
measure: Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population
timeFrame: Day 1, 5
measure: Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population
timeFrame: Day 1, 5
measure: Percentage of Participants Who Died Through Week 24- mITT Population
timeFrame: From Day 1 up to Week 24
measure: Percentage of Participants Who Died Through Week 24- mITT1 Population
timeFrame: From Day 1 up to Week 24
measure: Percentage of Participants Who Died Through Week 24- mITT2 Population
timeFrame: From Day 1 up to Week 24
measure: Plasma Concentration Versus Time Summary of PF-07321332
timeFrame: 1 Hour post-dose on Day 1 and pre-dose on Day 5
measure: Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population
timeFrame: Baseline, Day 3, 5, 10 and 14
measure: Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population
timeFrame: Baseline, Day 3, 5, 10 and 14
measure: Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population
timeFrame: Baseline, Day 3, 5, 10 and 14
measure: Number of COVID-19 Related Medical Visits- mITT Population
timeFrame: From Day 1 up to Day 34
measure: Number of COVID-19 Related Medical Visits- mITT1 Population
timeFrame: From Day 1 up to Day 34
measure: Number of COVID-19 Related Medical Visits- mITT2 Population
timeFrame: From Day 1 up to Day 34
measure: Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population
timeFrame: From Day 1 up to Day 34
measure: Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population
timeFrame: From Day 1 up to Day 34
measure: Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population
timeFrame: From Day 1 up to Day 34
Other outcomes:
Locations:
city: Pelham
country: United States
facility: Cahaba Research Inc
state: Alabama
city: Mesa
country: United States
facility: The Institute for Liver Health dba Arizona Clinical Trials
state: Arizona
city: Tucson
country: United States
facility: The Institute for Liver Health dba Arizona Clinical Trials
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Fullerton
country: United States
facility: Ascada Research
state: California
city: La Palma
country: United States
facility: Atella Clinical Research LLC.
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: Los Angeles
country: United States
facility: American Institute of Research
state: California
city: Redondo Beach
country: United States
facility: South Bay Clinical Research Institute
state: California
city: West Hills
country: United States
facility: Hope Clinical Research (COVID Satellite Site)
state: California
city: Colorado Springs
country: United States
facility: Future Innovative Treatments, LLC
state: Colorado
city: Boca Raton
country: United States
facility: Xera Med Research
state: Florida
city: Brandon
country: United States
facility: MOORE Clinical Research, Inc.
state: Florida
city: Clearwater
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Coral Gables
country: United States
facility: Herco Medical and Research Center Inc
state: Florida
city: Cutler Bay
country: United States
facility: Advance Clinical Research Group
state: Florida
city: Cutler Bay
country: United States
facility: Beautiful Minds Clinical Research Center
state: Florida
city: Hialeah Gardens
country: United States
facility: Unlimited Medical Research Group, LLC
state: Florida
city: Hialeah
country: United States
facility: Qway Research
state: Florida
city: Hialeah
country: United States
facility: Eastern Research Inc
state: Florida
city: Hialeah
country: United States
facility: Inpatient Research Clinic
state: Florida
city: Hialeah
country: United States
facility: Doral Medical Research LLC.
state: Florida
city: Hialeah
country: United States
facility: Doral Medical Research,LLC
state: Florida
city: Loxahatchee Groves
country: United States
facility: Advanced Pulmonary Research Institute
state: Florida
city: Miami Lakes
country: United States
facility: Savin Medical Group, LLC
state: Florida
city: Miami
country: United States
facility: Angels Clinical Research Institute
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: Premium Medical Research Corp
state: Florida
city: Miami
country: United States
facility: Global Health Clinical Trials Corp
state: Florida
city: Miami
country: United States
facility: South Florida Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: Miami
country: United States
facility: I.V.A.M. Clinical & Investigational Center, LLC
state: Florida
city: Miami
country: United States
facility: C'A Research
state: Florida
city: Miami
country: United States
facility: ProLive Medical Research, Corp.
state: Florida
city: Miami
country: United States
facility: Entrust Clinical Research
state: Florida
city: Miami
country: United States
facility: Reed Medical Research
state: Florida
city: Miami
country: United States
facility: Kendall South Medical Center
state: Florida
city: Miami
country: United States
facility: Clinical Site Partners, Inc d/b/a CSP Miami
state: Florida
city: Miami
country: United States
facility: Coral Research Clinic Corp
state: Florida
city: Orlando
country: United States
facility: Omega Research Orlando, LLC
state: Florida
city: Pompano Beach
country: United States
facility: NAPA Research LLC
state: Florida
city: Port Saint Lucie
country: United States
facility: CDC Research Institute
state: Florida
city: Saint Petersburg
country: United States
facility: GCP, Global Clinical Professionals
state: Florida
city: South Miami
country: United States
facility: USPA Advance Concept Medical Research Group LLC
state: Florida
city: Sunrise
country: United States
facility: Sunrise Research Institute
state: Florida
city: Tampa
country: United States
facility: Santos Research Center, CORP
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, Inc. dba CSP Orlando
state: Florida
city: Chicago
country: United States
facility: Research by Design, LLC
state: Illinois
city: Marrero
country: United States
facility: New Orleans Sinus Center (COVID-19 Testing)
state: Louisiana
city: Marrero
country: United States
facility: Tandem Clinical Research GI, LLC
state: Louisiana
city: Butte
country: United States
facility: Mercury Street Medical Group, PLLC
state: Montana
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Endwell
country: United States
facility: Meridian Clinical Research, LLC
state: New York
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Clarksville
country: United States
facility: Premier Medical Group
state: Tennessee
city: Amarillo
country: United States
facility: PharmaTex Research, LLC
state: Texas
city: Austin
country: United States
facility: ARC Clinical Research at William Cannon
state: Texas
city: Bellaire
country: United States
facility: St Hope Foundation
state: Texas
city: Conroe
country: United States
facility: Conroe Willis Medical Research
state: Texas
city: Corpus Christi
country: United States
facility: South Texas Clinical Research
state: Texas
city: Houston
country: United States
facility: SignatureCare Emergency Center
state: Texas
city: Houston
country: United States
facility: Trio Clinical Trials, LLC
state: Texas
city: Houston
country: United States
facility: C & R Research Services USA
state: Texas
city: Houston
country: United States
facility: Next Level Urgent Care
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research, LLC
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research
state: Texas
city: Pearland
country: United States
facility: LinQ Research, LLC
state: Texas
city: Red Oak
country: United States
facility: Epic Medical Research
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: San Antonio
country: United States
facility: BFHC Research
state: Texas
city: Webster
country: United States
facility: Tranquility Research
state: Texas
city: Newport News
country: United States
facility: TPMG (Tidewater Physicians Multispecialty Group) Clinical Research
state: Virginia
city: Zarate
country: Argentina
facility: Instituto de Investigaciones Clinicas Zarate
state: Buenos Aires
city: San Miguel de Tucuman
country: Argentina
facility: Hospital De Clínicas Presidente Dr.Nicolas Avellaneda
state: Tucuman
city: Brasilia
country: Brazil
facility: Chronos Pesquisa Clinica
state: Distrito Federal
city: Recife
country: Brazil
facility: Hospital Agamenon Magalhaes
state: Pernambuco
city: Jau
country: Brazil
facility: CECIP JAÚ - Centro de Estudos Clínicos do Interior Paulista - LTDA
state: SAO Paulo
city: Burgas
country: Bulgaria
facility: Individual Practice for Primary Medical Care - IPPMC - Dr. P. Panayotov EOOD
city: Haskovo
country: Bulgaria
facility: "Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd
city: Kozloduy
country: Bulgaria
facility: MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD
city: Lom
country: Bulgaria
facility: Diagnostic-Consultative Center I Lom EOOD
city: Lom
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD
city: Lovech
country: Bulgaria
facility: Medical centre Leo Clinic EOOD
city: Pleven
country: Bulgaria
facility: MHAT Heart and Brain EAD
city: Plovdiv
country: Bulgaria
facility: DCC Sveti Georgi EOOD
city: Plovdiv
country: Bulgaria
facility: MHAT "St. Panteleimon "- Plovdiv
city: Razgrad
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD
city: Ruse
country: Bulgaria
facility: "Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -
city: Ruse
country: Bulgaria
facility: UMHAT Medica Ruse OOD
city: Samokov
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Samokov EOOD
city: Sevlievo
country: Bulgaria
facility: Medical Center-1-Sevlievo EOOD
city: Shumen
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment Shumen AD
city: Sliven
country: Bulgaria
facility: Multiprofile hospital for active treatment - Sliven to Military Medical Academy
city: Sliven
country: Bulgaria
facility: MHAT "Dr. Ivan Seliminski" AD, Sliven
city: Sofia
country: Bulgaria
facility: Diagnostic-Consultative Center XXII- Sofia ЕООD
city: Sofia
country: Bulgaria
facility: MHAT "St. Sofia" EOOD
city: Stara Zagora
country: Bulgaria
facility: Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD
city: Targovishte
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Targovishte AD
city: Tsarevo
country: Bulgaria
facility: Outpatient Clinic for Primary Outpatient Medical Care "Puls" - Dr. Mladen Buchvarov EOOD
city: Varna
country: Bulgaria
facility: Medical center Leo Clinic EOOD
city: Vratsa
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD
city: Armenia
country: Colombia
facility: Fundacion Cardiomet Cequin
state: Quindio
city: Protivín
country: Czechia
facility: Zdraví-Fit, s.r.o.
city: Slany
country: Czechia
facility: Nemocnice Slany
city: Bekescsaba
country: Hungary
facility: Trial Pharma Kft.
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika
city: Eger
country: Hungary
facility: Agria-Study Kft.
city: Gyula
country: Hungary
facility: Trial Pharma Kft.
city: Nyiregyhaza
country: Hungary
facility: Medifarma-98 Kft.
city: Raipur
country: India
facility: AIIMS Raipur
state: Chhattisgarh
city: Vadodara
country: India
facility: Jupiter Hospital
state: Gujarat
city: Bangalore
country: India
facility: BGS Global Institute of Medical Sciences and Hospital
state: Karnataka
city: Kochi
country: India
facility: Lisie Hospital
state: Kerala
city: Pune
country: India
facility: Jehangir Clinical Development Centre Pvt. Ltd
state: Maharashtra
city: Pune
country: India
facility: Lifepoint Research LLP
state: Maharashtra
city: Ajmer
country: India
facility: Jawahar Lal Nehru Medical College
state: Rajasthan
city: Jaipur
country: India
facility: Apex Hospitals Pvt Ltd
state: Rajasthan
city: Jaipur
country: India
facility: Maharaja Agrasen Superspeciality Hospital
state: Rajasthan
city: Kolkata
country: India
facility: Nil Ratan Sircar Medical College and Hospital
state: WEST Bengal
city: New Delhi
country: India
facility: Aakash Healthcare Private Limited
city: Pavan PURI Bikaner, Rajasthan
country: India
facility: Sardar Patel Medical College
city: Narita
country: Japan
facility: International University of Health and Welfare Narita Hospital
state: Chiba
city: Sapporo
country: Japan
facility: National Hokkaido Medical Center
state: Hokkaido
city: Izumisano
country: Japan
facility: Rinku General Medical Center
state: Osaka
city: Hachioji
country: Japan
facility: Tokyo Medical University Hachioji Medical Center
state: Tokyo
city: Shinjuku City
country: Japan
facility: National Center for Global Health and Medicine
state: Tokyo
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Incheon
country: Korea, Republic of
facility: Incheon Medical Center
city: Nam-gu
country: Korea, Republic of
facility: Chonnam National University Bitgoeul Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
state: Sarawak
city: Miri
country: Malaysia
facility: Hospital Miri
state: Sarawak
city: Saltillo
country: Mexico
facility: Clinical Research Institute Saltillo S.A. de C.V.
state: Coahuila
city: Pachuca de Soto
country: Mexico
facility: Asociacion Mexicana para la Investigacion Clinica A.C. (AMIC)
state: Hidalgo
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Metabolismo, S.C.
state: Jalisco
city: Cuernavaca
country: Mexico
facility: JM Research SC
state: Morelos
city: Monterrey
country: Mexico
facility: Christus - Latam Hub Center of Excellence and Innovation Center S.C.
state: Nuevo LEON
city: Monterrey
country: Mexico
facility: Eukarya Pharmasite S.C.
state: Nuevo LEON
city: Oaxaca de Juarez
country: Mexico
facility: Oaxaca Site Management Organization
state: Oaxaca
city: Baja California
country: Mexico
facility: InfectoLab Consultorios de Especialidad en Infectologia
state: Tijuana
city: Merida
country: Mexico
facility: Kohler & Milstein Research S.A. de C.V.
state: Yucatan
city: Mérida
country: Mexico
facility: EME RED Hospitalaria
state: Yucatán
city: Acapulco
country: Mexico
facility: Centro de Investigacion Clinica Del Pacifico SA de CV
city: Aguascalientes
country: Mexico
facility: Hospital Cardiologica Aguascalientes
city: Durango
country: Mexico
facility: Instituto de Investigaciones Clínicas para la Salud
city: Veracruz
country: Mexico
facility: FAICIC S. de R.L. de C.V.
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazon S.C.
city: Veracruz
country: Mexico
facility: Arké SMO S.A de C.V
city: Bialystok
country: Poland
facility: KLIMED Marek Klimkiewicz
city: Wroclaw
country: Poland
facility: Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska
city: Ponce
country: Puerto Rico
facility: Clinical Research Management Group Inc
city: San Juan
country: Puerto Rico
facility: Advance Medical Research Center
city: Odintsovo
country: Russian Federation
facility: LLC Trekhgorka Medicine
state: Moscow Region
city: Barnaul
country: Russian Federation
facility: Barnaul City Hospital Number 5
city: Moscow
country: Russian Federation
facility: KDC "Evromedservis", OJSC
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical University
city: Welkom
country: South Africa
facility: MERC Welkom
state: FREE State
city: Benoni
country: South Africa
facility: East Rand Research Centre T/A Worthwhile Clinical Trials
state: Gauteng
city: Pretoria
country: South Africa
facility: Botho Ke Bontle Health Services
state: Gauteng
city: Durban
country: South Africa
facility: Synapta Clinical Research Center
state: Kwazulu Natal
city: Thabazimbi
country: South Africa
facility: Limpopo Clinical Research Initiative
state: Limpopo
city: Middelburg
country: South Africa
facility: MERC Middelburg
state: Mpumalanga
city: Centelles
country: Spain
facility: Eba Centelles
state: Barcelona [barcelona]
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario da Coruna
city: Bangrak
country: Thailand
facility: Bangkok Centre Hotel
state: Bangkok
city: Pathum Wan District,
country: Thailand
facility: Chula Field Hospital, Chulalongkorn University Sport center (Chantanayingyong Gymnasium)
state: Bangkok
city: Pathumwan,
country: Thailand
facility: Thai Red Cross Emerging Infectious Diseases (EDI) Clinic
state: Bangkok
city: Pathumwan
country: Thailand
facility: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),
state: Bangkok
city: Muang
country: Thailand
facility: Faculty of Medicine - Khon Kaen University
state: Khon Kaen
city: Hat Yai
country: Thailand
facility: Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University,
state: Songkhla
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty, Ibni-Sina Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty Hospital
city: Antalya
country: Turkey
facility: Akdeniz Universitesi Hastanesi
city: Beykoz / Istanbul
country: Turkey
facility: Istanbul Medipol University Clinical Research Ethics Committee
city: Gaziantep
country: Turkey
facility: Gaziantep University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty
city: Istanbul
country: Turkey
facility: Acibadem Saglik Hizmetleri ve Tic.A.S, Acibadem Atakent Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Klinik Arastirmalar Mukemmeliyet Uygulama ve Arastirma Merkezi
city: Istanbul
country: Turkey
facility: Basaksehir Cam ve Sakura Sehir Hastanesi
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
city: Konak/Izmir
country: Turkey
facility: Sbü Dr. Suat Seren Göğüs Hastaliklari Ve Cerrahisi Eğitim Ve Araştirma Hastanesi
city: Mersin
country: Turkey
facility: Mersin University Health Research and Application Hospital
city: Sakarya
country: Turkey
facility: Sakarya University Training and Research Hospital
city: Trabzon
country: Turkey
facility: Karadeniz Teknik Universitesi Farabi Hastanesi
city: Dnipro
country: Ukraine
facility: Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council
city: Ivano-Frankivsk
country: Ukraine
facility: Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of
city: Ivano-Frankivsk
country: Ukraine
facility: Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council"
city: Kharkiv
country: Ukraine
facility: Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council
city: Kharkiv
country: Ukraine
facility: Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases
city: Kyiv
country: Ukraine
facility: "Municipal Non-Profit Enterprise "Alexander Clinical Hospital of Kyiv" of the Kyiv City Council
city: Kyiv
country: Ukraine
facility: Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the Kyiv
city: Kyiv
country: Ukraine
facility: Kyiv Railway Clinical Hospital No.2 of Branch "Health Center of the Public Joint Stock Company
city: Kyiv
country: Ukraine
facility: Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company
city: Lviv
country: Ukraine
facility: Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analitical
city: Lviv
country: Ukraine
facility: Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"
city: Poltava
country: Ukraine
facility: Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional
city: Tarasove Village
country: Ukraine
facility: Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council
city: Vinnytsia
country: Ukraine
facility: Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital №1"
city: Zhytomyr
country: Ukraine
facility: Communal Enterprise "Hospital #1" of Zhytomyr City Council
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Hammond J, Leister-Tebbe H, Gardner A, Abreu P, Bao W, Wisemandle W, Baniecki M, Hendrick VM, Damle B, Simon-Campos A, Pypstra R, Rusnak JM; EPIC-HR Investigators. Oral Nirmatrelvir for High-Risk, Nonhospitalized Adults with Covid-19. N Engl J Med. 2022 Apr 14;386(15):1397-1408. doi: 10.1056/NEJMoa2118542. Epub 2022 Feb 16.