Study Stopped
Enrollment ceased due to a very low rate of hospitalization or death observed in the standard-risk patient population
Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).
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 LOW RISK OF PROGRESSING TO SEVERE ILLNESS
3 other identifiers
interventional
1,440
20 countries
225
Brief Summary
The primary hypothesis to be tested is whether or not there is a difference in time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28 between PF-07321332/ritonavir and placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started Aug 2021
Typical duration for phase_2 covid19
225 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2021
CompletedFirst Posted
Study publicly available on registry
August 18, 2021
CompletedStudy Start
First participant enrolled
August 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 25, 2022
CompletedResults Posted
Study results publicly available
August 14, 2023
CompletedAugust 14, 2023
July 1, 2023
11 months
July 30, 2021
July 20, 2023
July 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Sustained Alleviation of Overall COVID-19 Signs and Symptoms Through Day 28
Sustained alleviation of targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. Missing severity at baseline was considered as mild. Time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28, was calculated as time (days) from start of study intervention or placebo (Day 1) until sustained alleviation of all targeted COVID-19 associated signs and symptoms. In this outcome measure time to sustained alleviation is reported consolidated for overall COVID-19 signs and symptoms.
From Day 1 to Day 28
Secondary Outcomes (13)
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation
From start of study intervention (Day 1) up to Day 34
Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28
From Day 1 to Day 28
Percentage of Participants With Death Through Week 24
From Day 1 to Week 24
Number of COVID-19 Related Medical Visits Per Day Through Day 28
From Day 1 to Day 28
Duration of Hospitalization and Intensive Care Unit (ICU) Stay Through Day 28
From Day 1 to Day 28
- +8 more secondary outcomes
Study Arms (2)
PF-07321332/ritonavir
EXPERIMENTALOrally administered PF-07321332+ritonavir
Placebo
PLACEBO COMPARATOROrally administered Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed SARS-CoV-2 infection 5 days prior to randomization
- Initial onset of COVID-19 signs/symptoms within 5 days of randomization
- Fertile participants must agree to use a highly effective method of contraception
You may not qualify if:
- Has at least one underlying medical condition associated with an increased risk of developing severe illness from COVID-19
- History of or need for hospitalization for the medical treatment of COVID-19
- Prior diagnosis of SARS-CoV-2 infection (reinfection)
- Known medical history of liver disease
- Receiving dialysis or have known renal impairment
- Known Human Immunodeficiency Virus (HIV) infection with viral load \> 400 copies/ml or taking prohibited medications for HIV treatment
- Suspected or confirmed concurrent active systemic infection other than COVID-19
- Current or expected use of any medications or substances that are highly dependent on Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4
- Has received or is expected to receive monoclonal antibody treatment or convalescent COVID-19 plasma
- Has received any SARS-CoV-2 vaccine within 12 months of screening
- Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19
- Known prior participation in this trial or other trial involving PF-07321332
- Oxygen saturation of \< 92% on room air
- Females who are pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (225)
Cahaba Research Inc
Pelham, Alabama, 35124, United States
The Institute for Liver Health dba Arizona Clinical Trials
Mesa, Arizona, 85210, United States
Matrix Mobile Health Clinic #49, #35, and #62
Scottsdale, Arizona, 85258, United States
The Institute for Liver Health dba Arizona Clinical Trials
Tucson, Arizona, 85712, United States
Hope Clinical Research
Canoga Park, California, 91303, United States
Lightship
El Segundo, California, 90245, United States
Ascada Research
Fullerton, California, 92835, United States
Atella Clinical Research LLC.
La Palma, California, 90623, United States
Ark Clinical Research
Long Beach, California, 90806, United States
South Bay Clinical Research Institute
Redondo Beach, California, 90277, United States
Benchmark Research
Sacramento, California, 95864, United States
Optimus Medical Group
San Francisco, California, 94102, United States
Hope Clinical Research (COVID Satellite Site)
West Hills, California, 91304, United States
Future Innovative Treatments, LLC
Colorado Springs, Colorado, 80907, United States
Synergy Healthcare
Bradenton, Florida, 34208, United States
MOORE Clinical Research, Inc.
Brandon, Florida, 33511, United States
TrueBlue Clinical Research
Brandon, Florida, 33511, United States
Herco Medical and Research Center Inc
Coral Gables, Florida, 33134, United States
Advance Clinical Research Group
Cutler Bay, Florida, 33157, United States
Beautiful Minds Clinical Research Center
Cutler Bay, Florida, 33157, United States
Omega Research Orlando, LLC
DeBary, Florida, 32713, United States
Eastern Research Inc
Hialeah, Florida, 33013, United States
Inpatient Research Clinic
Hialeah, Florida, 33013, United States
Doral Medical Research, LLC
Hialeah, Florida, 33016, United States
Unlimited Medical Research Group, LLC
Hialeah Gardens, Florida, 33018, United States
ASCLEPES Research Centers
Lutz, Florida, 33549, United States
Angels Clinical Research Institute
Miami, Florida, 33122, United States
LCC Medical Research Institute, LLC
Miami, Florida, 33126, United States
Premium Medical Research Corp
Miami, Florida, 33126, United States
Global Health Clinical Trials Corp
Miami, Florida, 33135, United States
South Florida Research Center, Inc.
Miami, Florida, 33135, United States
I.V.A.M. Clinical & Investigational Center, LLC
Miami, Florida, 33144, United States
C'A Research
Miami, Florida, 33174, United States
ProLive Medical Research, Corp.
Miami, Florida, 33175, United States
Entrust Clinical Research
Miami, Florida, 33176, United States
Reed Medical Research
Miami, Florida, 33176, United States
Kendall South Medical Center, Inc.
Miami, Florida, 33185, United States
Clinical Site Partners, Inc d/b/a CSP Miami
Miami, Florida, 33186, United States
Coral Research Clinic Corp
Miami, Florida, 33186, United States
Pro-Care Research Center, Corp.
Miami Gardens, Florida, 33014, United States
Savin Medical Group, LLC
Miami Lakes, Florida, 33014, United States
Omega Research Orlando, LLC
Orlando, Florida, 32808, United States
CDC Research Institute
Port Saint Lucie, Florida, 34952, United States
USPA Advance Concept Medical Research Group LLC
South Miami, Florida, 33143, United States
ASCLEPES Research Centers
Spring Hill, Florida, 34609, United States
GCP, Global Clinical Professionals
St. Petersburg, Florida, 33705, United States
Sunrise Research Institute
Sunrise, Florida, 33325, United States
Santos Research Center, CORP
Tampa, Florida, 33615, United States
Clinical Site Partners, Inc. dba CSP Orlando
Winter Park, Florida, 32789, United States
Accellacare
Ames, Iowa, 50010, United States
McFarland Clinic, PC
Ames, Iowa, 50010, United States
New Orleans Sinus Center (COVID-19 Testing)
Marrero, Louisiana, 70072, United States
Tandem Clinical Research GI, LLC
Marrero, Louisiana, 70072, United States
Southern Clinical Research Associates, LLC
Metairie, Louisiana, 70001, United States
Mercury Street Medical Group, PLLC
Butte, Montana, 59701, United States
Excel Clinical research
Las Vegas, Nevada, 89109, United States
AXCES Research Group
Santa Fe, New Mexico, 87505, United States
NYC Health + Hospitals / Harlem
New York, New York, 10037, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Accellacare
Wilmington, North Carolina, 28401, United States
Innovo Research: Wilmington Health
Wilmington, North Carolina, 28401, United States
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, 57105, United States
Avera Research Institute
Sioux Falls, South Dakota, 57108, United States
PharmaTex Research, LLC
Amarillo, Texas, 79109, United States
ARC Clinical Research at William Cannon
Austin, Texas, 78745, United States
St Hope Foundation
Bellaire, Texas, 77401, United States
Conroe Willis Medical Research
Conroe, Texas, 77304, United States
South Texas Clinical Research
Corpus Christi, Texas, 78413, United States
SignatureCare Emergency Center
Houston, Texas, 77008, United States
Trio Clinical Trials, LLC
Houston, Texas, 77008, United States
Next Level Urgent Care
Houston, Texas, 77057, United States
LinQ Research, LLC
Pearland, Texas, 77584, United States
Epic Medical Research
Red Oak, Texas, 75154, United States
Endeavor Clinical Trials, LLC
San Antonio, Texas, 78229, United States
BFHC Research
San Antonio, Texas, 78249, United States
Tranquility Research
Webster, Texas, 77598, United States
TMPG Clinical Research
Newport News, Virginia, 23606, United States
TPMG Clinical Research
Newport News, Virginia, 23606, United States
Instituto de Investigaciones Clinicas Zarate
Zárate, Buenos Aires, B2800DGH, Argentina
Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos)
Rosario, Santa Fe Province, 2000, Argentina
Hospital de Clinicas Presidente Nicolas Avellaneda
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Clinica Mayo Urgencias Medicas Cruz Blanca SRL
San Miguel de Tucumán, Tucumán Province, T4000IHE, Argentina
Hospital Privado Centro Médico de Córdoba
Córdoba, X5016KEH, Argentina
Chronos Pesquisa Clinica
Brasília, Federal District, 72145-450, Brazil
Hospital Agamenon Magalhaes
Recife, Pernambuco, 52051-380, Brazil
IBPClin - Instituto Brasil de Pesquisa Clínica
Rio de Janeiro, Rio de Janeiro, 20241-180, Brazil
Instituto Nacional de Infectologia Evandro Chagas - INI/FIOCRUZ
Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil
Centro de Estudos e Pesquisas em Moléstias Infecciosas
Natal, Rio Grande do Norte, 59025-050, Brazil
Hospital De Clinicas De Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
CECOR - Centro Oncológico de Roraima
Boa Vista, Roraima/rr, 69304-015, Brazil
Hospital Dia do Pulmao
Blumenau, Santa Catarina, 89030-101, Brazil
Hospital e Maternidade Celso Pierro - PUC Campinas / Sociedade Campineira de Educação e Instruçã
Campinas, São Paulo, 13060-904, Brazil
CECIP JAÚ - Centro de Estudos Clínicos do Interior Paulista - LTDA
Jaú, São Paulo, 17201-130, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
São Bernardo do Campo, São Paulo, 09715-090, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, São Paulo, 01327-001, Brazil
Unidade Referenciada Oswaldo Cruz Vergueiro
São Paulo, São Paulo, 01508-000, Brazil
Clinica de Alergia Martti Antila
Sorocaba, São Paulo, 18040-425, Brazil
Instituto de Infectologia Emilio Ribas
São Paulo, 01246-900, Brazil
Individual Practice for Primary Medical Care - IPPMC - Dr. P. Panayotov EOOD
Burgas, 8001, Bulgaria
"Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd
Haskovo, 6300, Bulgaria
MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD
Kozloduy, 3320, Bulgaria
Diagnostic-Consultative Center I Lom EOOD
Lom, 3600, Bulgaria
Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD
Lom, 3600, Bulgaria
Medical centre Leo Clinic EOOD
Lovech, 5500, Bulgaria
MHAT Heart and Brain EAD
Pleven, 5800, Bulgaria
DCC Sveti Georgi EOOD
Plovdiv, 4000, Bulgaria
MHAT "St. Panteleimon "- Plovdiv
Plovdiv, 4004, Bulgaria
Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD
Razgrad, 7200, Bulgaria
"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -
Rousse, 7002, Bulgaria
Multiprofile Hospital for Active Treatment - Samokov EOOD
Samokov, 2000, Bulgaria
Medical Center-1-Sevlievo EOOD
Sevlievo, 5400, Bulgaria
Multiprofile hospital for active treatment - Sliven to Military Medical Academy
Sliven, 8800, Bulgaria
Diagnostic-Consultative Center XXII- Sofia ЕООD
Sofia, 1113, Bulgaria
UMHATEM N. I. Pirogov EAD
Sofia, 1606, Bulgaria
MHAT "St. Sofia" EOOD
Sofia, 1618, Bulgaria
Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD
Stara Zagora, 6000, Bulgaria
Multiprofile Hospital for Active Treatment Targovishte AD
Targovishte, 7700, Bulgaria
Outpatient Clinic for Primary Outpatient Medical Care "Puls" - Dr. Mladen Buchvarov EOOD
Tsarevo, 8260, Bulgaria
Medical center Leo Clinic EOOD
Varna, 9020, Bulgaria
MOBAL "D-r Stefan Cherkezov" AD
Veliko Tarnovo, 5002, Bulgaria
Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD
Vratsa, 3000, Bulgaria
Fundacion Centro de Investigacion Clinica CIC
Medellín, Antioquia, 050021, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S
Bogota, Cundinamarca, 110221, Colombia
Fundacion Cardiomet Cequin
Armenia, Quindío Department, 630004, Colombia
Zdraví-Fit, s.r.o.
Protivín, 398 11, Czechia
Nemocnice Slany
Slaný, 274 01, Czechia
Trial Pharma Kft.
Békéscsaba, 5600, Hungary
Semmelweis University Varosmajori Sziv Es Ergyogyaszati Klinika
Budapest, 1122, Hungary
Varosmajori Sziv- es Ergyogyaszati Klinika
Budapest, 1122, Hungary
Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika
Debrecen, 4031, Hungary
Agria-Study Kft.
Eger, 3300, Hungary
Trial Pharma Kft.
Gyula, 5700, Hungary
Medifarma-98 Kft.
Nyíregyháza, 4400, Hungary
International University of Health and Welfare Narita Hospital
Narita, Chiba, 286-8520, Japan
Rakuwakai Otowa Hospital
Kyoto, Kyoto, 607-8062, Japan
Tokyo Shinagawa Hospital
Shinagawa-ku, Tokyo, 140-8522, Japan
Sekino Hospital
Toshimaku, Tokyo, 171-0014, Japan
Kyushu Medical Center
Fukuoka, 810-8563, Japan
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, 15586, Malaysia
Hospital Taiping
Taiping, Perak, 34000, Malaysia
Hospital Miri
Miri, Sarawak, 98000, Malaysia
Klinik Kesihatan Kuang
Rawang, Selangor, 48050, Malaysia
Clinical Research Institute S.C.
Saltillo, Coahuila, 25020, Mexico
Asociación Mexicana para la Investigación Clínica A.C.
Pachuca, Hidalgo, 42070, Mexico
JM Research SC
Cuernavaca, Morelos, 62290, Mexico
Christus - Latam Hub Center of Excellence and Innovation Center S.C.
Monterrey, Nuevo León, 64060, Mexico
Eukarya Pharmasite S.C.
Monterrey, Nuevo León, 64718, Mexico
Oaxaca Site Management Organization
Oaxaca City, Oaxaca, 68000, Mexico
EME RED Hospitalaria
Mérida, Yucatán, 97000, Mexico
Kohler & Milstein Research S.A. De C.V.
Mérida, Yucatán, 97070, Mexico
Instituto de Investigaciones Clínicas para la Salud
Durango, 34000, Mexico
FAICIC Clinical Research
Veracruz, 91900, Mexico
Sociedad de Metabolismo y Corazon S.C.
Veracruz, 91900, Mexico
KLIMED Marek Klimkiewicz
Bialystok, 15-704, Poland
Tomasz Blicharski Lubelskie Centrum Diagnostyczne
Świdnik, 21-040, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728, Poland
Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska
Wroclaw, 51-162, Poland
Clinical Research Management Group Inc
Ponce, 00780, Puerto Rico
Advance Medical Research Center
San Juan, 00926, Puerto Rico
Delta Health Care srl
Bucharest, 014142, Romania
HODOSI - MED, s.r.o.
Moldava nad Bodvou, 04501, Slovakia
MUDr. Viliam Cibik, PhD., s.r.o.
Pruské, 018 52, Slovakia
Plucna ambulancia Hrebenar, s.r.o.
Spišská Nová Ves, 052 01, Slovakia
ALERGIA s.r.o.
Topoľčany, 955 01, Slovakia
Global Clinical Trials
Port Elizabeth, Eastern Cape, 6014, South Africa
Worthwhile Clinical Trials
Benoni, Gauteng, 1500, South Africa
Reimed Vosloorus
Boksburg, Gauteng, 1475, South Africa
Lenasia Clinical Trial Centre
Johannesburg, Gauteng, 1820, South Africa
Botho Ke Bontle Health Services
Pretoria, Gauteng, 0184, South Africa
Clinical Trial Systems (Pty) Ltd
Pretoria, Gauteng, 0186, South Africa
Sandton Medical Clinic
Sandton, Gauteng, 2196, South Africa
FCRN Clinical Trial Centre
Vereeniging, Gauteng, 1935, South Africa
Synapta Clinical Research Center
Durban, KwaZulu-Natal, 4001, South Africa
Dr PJ Sebastian Clinical Research Centre
Durban, KwaZulu-Natal, 4092, South Africa
Ahmed Al-Kadi Private Hospital
Mayville, Durban, KwaZulu-Natal, 4091, South Africa
TASK Eden
George, Western Cape, 6530, South Africa
Be Part Research Pty (Ltd)
Paarl, Western Cape, 7626, South Africa
Chonnam National University Bitgoeul Hospital
Gwangju, 61748, South Korea
Boramae Medical Center
Seoul, 07061, South Korea
SMG-SNU Boramae Medical Center
Seoul, 07061, South Korea
Eba Centelles
Centelles, Barcelona [barcelona], 08540, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, 36312, Spain
IMED Valencia
Burjassot, Valencia, 46100, Spain
Complexo Hospitalario Universitario da Coruna
A Coruña, 15006, Spain
Hospital Universitario de la Paz
Madrid, 28046, Spain
Hospital Universitario Virgen de Valme
Seville, 41014, Spain
Bangkok Centre Hotel
Bang Rak, Bangkok, 10500, Thailand
Siriraj Hospital, Mahidol University
BangkokNoi, Bangkok, 10700, Thailand
Riverside Bangkok Hotel
Bangplud, Bangkok, 10700, Thailand
Thai Red Cross Emerging Infectious Diseases (EDI) Clinic
Pathumwan,, Bangkok, 10330, Thailand
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),
Pathumwan, Bangkok, 10330, Thailand
Baiyoke Suite Hotel
Ratchathewi, Bangkok, 10400, Thailand
Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University,
Hat Yai, Changwat Songkhla, 90110, Thailand
Khon Kaen Univerisity Field Hospital, Student Dormitory 26, Khon Kaen University
Khon Kaen, 40002, Thailand
Srinagarind Hospital
Khon Kaen, 40002, Thailand
Cukurova University Medical Faculty
Balcali, Adana, 01330, Turkey (Türkiye)
Ankara University Medical Faculty, Ibni-Sina Hospital
Ankara, 06230, Turkey (Türkiye)
Hacettepe University Medical Faculty Hospital
Ankara, 06230, Turkey (Türkiye)
Akdeniz Universitesi Hastanesi
Antalya, 07059, Turkey (Türkiye)
Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi
Gaziantep, 27310, Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty
Istanbul, 34093, Turkey (Türkiye)
Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty
Istanbul, 34098, Turkey (Türkiye)
Medipol Mega University Hospital
Istanbul, 34214, Turkey (Türkiye)
Acibadem University Atakent Hospital
Istanbul, 34303, Turkey (Türkiye)
Basaksehir Cam ve Sakura Sehir Hastanesi
Istanbul, 34480, Turkey (Türkiye)
Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital
Izmir, 35110, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, 41380, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, 33110, Turkey (Türkiye)
Sakarya University Training and Research Hospital
Sakarya, 54100, Turkey (Türkiye)
Karadeniz Teknik Universitesi Farabi Hastanesi
Trabzon, 61080, Turkey (Türkiye)
Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital"
Chernivtsi, 58001, Ukraine
Communal non-commercial Enterprise "City Clinical Hospital №3" of Chernivtsi City Council
Chernivtsi, 58002, Ukraine
Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of
Ivano-Frankivsk, 76007, Ukraine
Municipal Non-profit Enterprise "Ivano-Frankivsk Regional Phthisiopulmonology Center of
Ivano-Frankivsk, 76018, Ukraine
Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council"
Ivano-Frankivsk, 76025, Ukraine
Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases
Kharkiv, 61096, Ukraine
Municipal Non-profit Enterprise "Oleksandrivska Kyiv City Clinical Hospital" Of Executive Body Of
Kyiv, 01601, Ukraine
Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the Kyiv
Kyiv, 02091, Ukraine
Kyiv Railway Clinical Hospital No.2 of Branch "Health Center of the Public Joint Stock Company
Kyiv, 03049, Ukraine
Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company
Kyiv, 04050, Ukraine
Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"
Lviv, 79011, Ukraine
Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional
Poltava, 36011, Ukraine
Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital №1"
Vinnytsia, 21029, Ukraine
Communal Enterprise "Hospital #1" of Zhytomyr City Council
Zhytomyr, 10002, Ukraine
Related Publications (3)
Brown TM, Kanu C, Harrington M. Assessing participants' experiences with the COVID-19 symptom diary in a clinical trial. J Patient Rep Outcomes. 2025 Aug 11;9(1):99. doi: 10.1186/s41687-025-00901-5.
PMID: 40788441DERIVEDBaniecki ML, Guan S, Rai DK, Yang Q, Lee JT, Hao L, Weinstein E, Hyde C, Cardin RD, Soares H, Hammond J. Integrated virologic analysis of resistance to nirmatrelvir/ritonavir in individuals across four phase 2/3 clinical studies for the treatment of COVID-19. EBioMedicine. 2025 Aug;118:105819. doi: 10.1016/j.ebiom.2025.105819. Epub 2025 Jun 30.
PMID: 40592258DERIVEDHammond J, Fountaine RJ, Yunis C, Fleishaker D, Almas M, Bao W, Wisemandle W, Baniecki ML, Hendrick VM, Kalfov V, Simon-Campos JA, Pypstra R, Rusnak JM. Nirmatrelvir for Vaccinated or Unvaccinated Adult Outpatients with Covid-19. N Engl J Med. 2024 Apr 4;390(13):1186-1195. doi: 10.1056/NEJMoa2309003.
PMID: 38598573DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
In participant flow, there was discontinuations due to AE, which was captured under "Death" as reason for discontinuation. Adverse event was COVID-19 pneumonia and the participant died due to that event and discontinued study.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2021
First Posted
August 18, 2021
Study Start
August 25, 2021
Primary Completion
July 25, 2022
Study Completion
July 25, 2022
Last Updated
August 14, 2023
Results First Posted
August 14, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.