EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT04960202
Collaborator
(none)
2,245
201
2
9.3
11.2
1.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
2245 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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).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).
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date
:
Jul 16, 2021
Actual Primary Completion Date
:
Dec 9, 2021
Actual Study Completion Date
:
Apr 26, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PF-07321332/ritonavir Orally administered PF-07321332+ritonavir |
Drug: PF-07321332
PF-07321332 (tablet)
Drug: Ritonavir
Ritonavir (capsule)
|
| Placebo Comparator: Placebo Orally administered placebo |
Drug: Placebo
Placebo (tablet or capsule)
|
Outcome Measures
Primary Outcome Measures
- Proportion of participants with COVID-19 related hospitalization or death from any cause [Day 1 through Day 28]
Secondary Outcome Measures
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)of PF-07321332/ritonavir relative to placebo [Day 1 through Day 34]
- Incidence of Treatment-emergent Adverse Events (TEAEs) of PF-07321332/ritonavir relative to placebo of PF-07321332/ritonavir relative to placebo [Day 1 through Day 34]
- Duration of each targeted COVID-19 sign/symptom [Day 1 through Day 28]
- Severity of each targeted COVID-19 sign/symptom [Day 1 through Day 28]
- Proportion of participants with death (all cause) [Day 1 through Week 24]
- 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 [Day 1 through Day 5]
- Viral titers measured by Reverse Transcription Polymerase Chain Reaction (RT-PCR) in nasal swabs [Day 1 through Day 14]
- Number of COVID-19 related medical visits other than hospitalization [Day 1 through Day 34]
- Number of days in hospital and intensive care unit for the treatment of COVID-19 [Day 1 through Day 34]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cahaba Research, Inc. | Pelham | Alabama | United States | 35124 |
| 2 | The Institute for Liver Health dba Arizona Clinical Trials | Mesa | Arizona | United States | 85210 |
| 3 | The Institute for Liver Health dba Arizona Clinical Trials | Tucson | Arizona | United States | 85712 |
| 4 | Hope Clinical Research | Canoga Park | California | United States | 91303 |
| 5 | Ascada Research | Fullerton | California | United States | 92835 |
| 6 | Atella Clinical Research LLC. | La Palma | California | United States | 90623 |
| 7 | Ark Clinical Research | Long Beach | California | United States | 90806 |
| 8 | American Institute of Research | Los Angeles | California | United States | 90017 |
| 9 | South Bay Clinical Research Institute | Redondo Beach | California | United States | 90277 |
| 10 | Hope Clinical Research (COVID Satellite Site) | West Hills | California | United States | 91304 |
| 11 | Future Innovative Treatments, LLC | Colorado Springs | Colorado | United States | 80907 |
| 12 | Xera Med Research | Boca Raton | Florida | United States | 33487 |
| 13 | MOORE Clinical Research, Inc. | Brandon | Florida | United States | 33511 |
| 14 | Innovative Research of West Florida, Inc. | Clearwater | Florida | United States | 33756 |
| 15 | Herco Medical and Research Center Inc | Coral Gables | Florida | United States | 33134 |
| 16 | Advance Clinical Research Group | Cutler Bay | Florida | United States | 33157 |
| 17 | Beautiful Minds Clinical Research Center | Cutler Bay | Florida | United States | 33157 |
| 18 | Unlimited Medical Research Group, LLC | Hialeah Gardens | Florida | United States | 33018 |
| 19 | Qway Research | Hialeah | Florida | United States | 33010 |
| 20 | Eastern Research Inc | Hialeah | Florida | United States | 33013 |
| 21 | Inpatient Research Clinic | Hialeah | Florida | United States | 33013 |
| 22 | Doral Medical Research LLC. | Hialeah | Florida | United States | 33016 |
| 23 | Doral Medical Research,LLC | Hialeah | Florida | United States | 33016 |
| 24 | Advanced Pulmonary Research Institute | Loxahatchee Groves | Florida | United States | 33470 |
| 25 | Savin Medical Group, LLC | Miami Lakes | Florida | United States | 33014 |
| 26 | Angels Clinical Research Institute | Miami | Florida | United States | 33122 |
| 27 | LCC Medical Research Institute, LLC | Miami | Florida | United States | 33126 |
| 28 | Premium Medical Research Corp | Miami | Florida | United States | 33126 |
| 29 | Global Health Clinical Trials Corp | Miami | Florida | United States | 33135 |
| 30 | South Florida Research Center, Inc. | Miami | Florida | United States | 33135 |
| 31 | Suncoast Research Group, LLC | Miami | Florida | United States | 33135 |
| 32 | I.V.A.M. Clinical & Investigational Center, LLC | Miami | Florida | United States | 33144 |
| 33 | C'A Research | Miami | Florida | United States | 33174 |
| 34 | ProLive Medical Research, Corp. | Miami | Florida | United States | 33175 |
| 35 | Entrust Clinical Research | Miami | Florida | United States | 33176 |
| 36 | Reed Medical Research | Miami | Florida | United States | 33176 |
| 37 | Kendall South Medical Center | Miami | Florida | United States | 33185 |
| 38 | Clinical Site Partners, Inc d/b/a CSP Miami | Miami | Florida | United States | 33186 |
| 39 | Coral Research Clinic Corp | Miami | Florida | United States | 33186 |
| 40 | Omega Research Orlando, LLC | Orlando | Florida | United States | 32808 |
| 41 | NAPA Research LLC | Pompano Beach | Florida | United States | 33064 |
| 42 | CDC Research Institute | Port Saint Lucie | Florida | United States | 34952 |
| 43 | GCP, Global Clinical Professionals | Saint Petersburg | Florida | United States | 33705 |
| 44 | USPA Advance Concept Medical Research Group LLC | South Miami | Florida | United States | 33143 |
| 45 | Sunrise Research Institute | Sunrise | Florida | United States | 33325 |
| 46 | Santos Research Center, CORP | Tampa | Florida | United States | 33615 |
| 47 | Clinical Site Partners, Inc. dba CSP Orlando | Winter Park | Florida | United States | 32789 |
| 48 | Research by Design, LLC | Chicago | Illinois | United States | 60643 |
| 49 | New Orleans Sinus Center (COVID-19 Testing) | Marrero | Louisiana | United States | 70072 |
| 50 | Tandem Clinical Research GI, LLC | Marrero | Louisiana | United States | 70072 |
| 51 | Mercury Street Medical Group, PLLC | Butte | Montana | United States | 59701 |
| 52 | Excel Clinical Research | Las Vegas | Nevada | United States | 89109 |
| 53 | Meridian Clinical Research, LLC | Endwell | New York | United States | 13760 |
| 54 | Monroe Biomedical Research | Monroe | North Carolina | United States | 28112 |
| 55 | Accellacare | Wilmington | North Carolina | United States | 28401 |
| 56 | Premier Medical Group | Clarksville | Tennessee | United States | 37040 |
| 57 | PharmaTex Research, LLC | Amarillo | Texas | United States | 79109 |
| 58 | ARC Clinical Research at William Cannon | Austin | Texas | United States | 78745 |
| 59 | St Hope Foundation | Bellaire | Texas | United States | 77401 |
| 60 | Conroe Willis Medical Research | Conroe | Texas | United States | 77304 |
| 61 | South Texas Clinical Research | Corpus Christi | Texas | United States | 78413 |
| 62 | SignatureCare Emergency Center | Houston | Texas | United States | 77008 |
| 63 | Trio Clinical Trials, LLC | Houston | Texas | United States | 77008 |
| 64 | C & R Research Services USA | Houston | Texas | United States | 77022 |
| 65 | Next Level Urgent Care | Houston | Texas | United States | 77057 |
| 66 | SMS Clinical Research, LLC | Mesquite | Texas | United States | 75149 |
| 67 | SMS Clinical Research | Mesquite | Texas | United States | 75149 |
| 68 | LinQ Research, LLC | Pearland | Texas | United States | 77584 |
| 69 | Epic Medical Research | Red Oak | Texas | United States | 75154 |
| 70 | Sun Research Institute | San Antonio | Texas | United States | 78215 |
| 71 | BFHC Research | San Antonio | Texas | United States | 78249 |
| 72 | Tranquility Research | Webster | Texas | United States | 77598 |
| 73 | TPMG (Tidewater Physicians Multispecialty Group) Clinical Research | Newport News | Virginia | United States | 23606 |
| 74 | Instituto de Investigaciones Clinicas Zarate | Zarate | Buenos Aires | Argentina | B2800DGH |
| 75 | Hospital De Clínicas Presidente Dr.Nicolas Avellaneda | San Miguel de Tucuman | Tucuman | Argentina | 4000 |
| 76 | Chronos Pesquisa Clinica | Brasilia | Distrito Federal | Brazil | 72145-450 |
| 77 | Hospital Agamenon Magalhaes | Recife | Pernambuco | Brazil | 52051-380 |
| 78 | Centro de Estudos Clinicos do Interior Paulista (CECIP) | Jau | SAO Paulo | Brazil | 17201-130 |
| 79 | Individual Practice for Primary Medical Care - IPPMC - Dr. P. Panayotov EOOD | Burgas | Bulgaria | 8001 | |
| 80 | "Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd | Haskovo | Bulgaria | 6300 | |
| 81 | MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD | Kozloduy | Bulgaria | 3320 | |
| 82 | Diagnostic-Consultative Center I Lom EOOD | Lom | Bulgaria | 3600 | |
| 83 | Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD | Lom | Bulgaria | 3600 | |
| 84 | Medical centre Leo Clinic EOOD | Lovech | Bulgaria | 5500 | |
| 85 | MHAT Heart and Brain EAD | Pleven | Bulgaria | 5800 | |
| 86 | DCC Sveti Georgi EOOD | Plovdiv | Bulgaria | 4000 | |
| 87 | MHAT "St. Panteleimon "- Plovdiv | Plovdiv | Bulgaria | 4004 | |
| 88 | Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD | Razgrad | Bulgaria | 7200 | |
| 89 | "Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov - | Ruse | Bulgaria | 7002 | |
| 90 | UMHAT Medica Ruse OOD | Ruse | Bulgaria | 7013 | |
| 91 | Multiprofile Hospital for Active Treatment - Samokov EOOD | Samokov | Bulgaria | 2000 | |
| 92 | Medical Center-1-Sevlievo EOOD | Sevlievo | Bulgaria | 5400 | |
| 93 | Multiprofile Hospital For Active Treatment Shumen AD | Shumen | Bulgaria | 9700 | |
| 94 | Multiprofile hospital for active treatment - Sliven to Military Medical Academy | Sliven | Bulgaria | 8800 | |
| 95 | MHAT "Dr. Ivan Seliminski" AD, Sliven | Sliven | Bulgaria | 8801 | |
| 96 | Diagnostic-Consultative Center XXII- Sofia ЕООD | Sofia | Bulgaria | 1113 | |
| 97 | MHAT "St. Sofia" EOOD | Sofia | Bulgaria | 1618 | |
| 98 | Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD | Stara Zagora | Bulgaria | 6000 | |
| 99 | Multiprofile Hospital for Active Treatment Targovishte AD | Targovishte | Bulgaria | 7700 | |
| 100 | Outpatient Clinic for Primary Outpatient Medical Care "Puls" - Dr. Mladen Buchvarov EOOD | Tsarevo | Bulgaria | 8260 | |
| 101 | Medical center Leo Clinic EOOD | Varna | Bulgaria | 9020 | |
| 102 | Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD | Vratsa | Bulgaria | 3000 | |
| 103 | Fundacion Cardiomet CEQUIN | Armenia | Quindio | Colombia | 630004 |
| 104 | Zdraví-Fit, s.r.o. | Protivín | Czechia | 398 11 | |
| 105 | Nemocnice Slany | Slany | Czechia | 274 01 | |
| 106 | Trial Pharma Kft. | Bekescsaba | Hungary | 5600 | |
| 107 | Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika | Debrecen | Hungary | 4031 | |
| 108 | Agria-Study Kft. | Eger | Hungary | 3300 | |
| 109 | Trial Pharma Kft. | Gyula | Hungary | 5700 | |
| 110 | Medifarma-98 Kft. | Nyiregyhaza | Hungary | 4400 | |
| 111 | AIIMS Raipur | Raipur | Chhattisgarh | India | 492099 |
| 112 | Jupiter Hospital | Vadodara | Gujarat | India | 390012 |
| 113 | BGS Global Institute of Medical Sciences and Hospital | Bangalore | Karnataka | India | 560060 |
| 114 | Lisie Hospital | Kochi | Kerala | India | 682018 |
| 115 | Jehangir Clinical Development Centre Pvt. Ltd | Pune | Maharashtra | India | 411001 |
| 116 | Lifepoint Research LLP | Pune | Maharashtra | India | 411057 |
| 117 | Jawahar Lal Nehru Medical College | Ajmer | Rajasthan | India | 305001 |
| 118 | Apex Hospitals Pvt Ltd | Jaipur | Rajasthan | India | 302017 |
| 119 | Maharaja Agrasen Superspeciality Hospital | Jaipur | Rajasthan | India | 302039 |
| 120 | Nil Ratan Sircar Medical College and Hospital | Kolkata | WEST Bengal | India | 700014 |
| 121 | Aakash Healthcare Private Limited | New Delhi | India | 110075 | |
| 122 | Sardar Patel Medical College | Pavan PURI Bikaner, Rajasthan | India | 334003 | |
| 123 | International University of Health and Welfare Narita Hospital | Narita | Chiba | Japan | 286-8520 |
| 124 | National Hokkaido Medical Center | Sapporo | Hokkaido | Japan | 063-0005 |
| 125 | Rinku General Medical Center | Izumisano | Osaka | Japan | 598-8577 |
| 126 | Tokyo Medical University Hachioji Medical Center | Hachioji | Tokyo | Japan | 1930998 |
| 127 | National Center for Global Health and Medicine | Shinjuku City | Tokyo | Japan | 162-8655 |
| 128 | Kyungpook National University Chilgok Hospital | Daegu | Korea, Republic of | 41404 | |
| 129 | Incheon Medical Center | Incheon | Korea, Republic of | 22532 | |
| 130 | Chonnam National University Bitgoeul Hospital | Nam-gu | Korea, Republic of | 61748 | |
| 131 | SMG-SNU Boramae Medical Center | Seoul | Korea, Republic of | 07061 | |
| 132 | Hospital Umum Sarawak | Kuching | Sarawak | Malaysia | 93586 |
| 133 | Hospital Miri | Miri | Sarawak | Malaysia | 98000 |
| 134 | Clinical Research Institute Saltillo S.A. de C.V. | Saltillo | Coahuila | Mexico | 25020 |
| 135 | Asociacion Mexicana para la Investigacion Clinica A.C. (AMIC) | Pachuca de Soto | Hidalgo | Mexico | 42070 |
| 136 | Instituto Jalisciense de Metabolismo, S.C. | Guadalajara | Jalisco | Mexico | 44670 |
| 137 | JM Research | Cuernavaca | Morelos | Mexico | 62290 |
| 138 | Christus - Latam Hub Center of Excellence and Innovation Center S.C. | Monterrey | Nuevo LEON | Mexico | 64060 |
| 139 | Eukarya Pharmasite S.C. | Monterrey | Nuevo LEON | Mexico | 64718 |
| 140 | Oaxaca Site Management Organization | Oaxaca de Juarez | Oaxaca | Mexico | 68000 |
| 141 | InfectoLab Consultorios de Especialidad en Infectologia | Baja California | Tijuana | Mexico | 22010 |
| 142 | Kohler & Milstein Research S.A. de C.V. | Merida | Yucatan | Mexico | 97070 |
| 143 | EME RED Hospitalaria | Mérida | Yucatán | Mexico | 97000 |
| 144 | Centro de Investigacion Clinica Del Pacifico SA de CV | Acapulco | Mexico | ||
| 145 | Hospital Cardiologica Aguascalientes | Aguascalientes | Mexico | CP 201230 | |
| 146 | Instituto de Investigaciones Clínicas para la Salud | Durango | Mexico | 34000 | |
| 147 | FAICIC S. de R.L. de C.V. | Veracruz | Mexico | 91900 | |
| 148 | Sociedad de Metabolismo y Corazon S.C. | Veracruz | Mexico | 91900 | |
| 149 | Arké SMO S.A de C.V | Veracruz | Mexico | 91910 | |
| 150 | KLIMED Marek Klimkiewicz | Bialystok | Poland | 15-704 | |
| 151 | Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska | Wroclaw | Poland | 51-162 | |
| 152 | Clinical Research Management Group Inc | Ponce | Puerto Rico | 00780 | |
| 153 | Advance Medical Research Center | San Juan | Puerto Rico | 00926 | |
| 154 | LLC Trekhgorka Medicine | Odintsovo | Moscow Region | Russian Federation | 143005 |
| 155 | Barnaul City Hospital Number 5 | Barnaul | Russian Federation | 656045 | |
| 156 | KDC "Evromedservis", OJSC | Moscow | Russian Federation | 115419 | |
| 157 | Smolensk State Medical University | Smolensk | Russian Federation | 214019 | |
| 158 | MERC Welkom | Welkom | FREE State | South Africa | 9460 |
| 159 | East Rand Research Centre T/A Worthwhile Clinical Trials | Benoni | Gauteng | South Africa | 1500 |
| 160 | Botho ke Bontle Health Services | Pretoria | Gauteng | South Africa | 0122 |
| 161 | Synapta Clinical Research Center | Durban | Kwazulu Natal | South Africa | 4001 |
| 162 | Limpopo Clinical Research Initiative | Thabazimbi | Limpopo | South Africa | 0380 |
| 163 | MERC Middelburg | Middelburg | Mpumalanga | South Africa | 1055 |
| 164 | Eba Centelles | Centelles | Barcelona [barcelona] | Spain | 08540 |
| 165 | Complexo Hospitalario Universitario da Coruna | A Coruña | Spain | 15006 | |
| 166 | Bangkok Centre Hotel | Bangrak | Bangkok | Thailand | 10500 |
| 167 | Chula Field Hospital, Chulalongkorn University Sport center (Chantanayingyong Gymnasium) | Pathum Wan District, | Bangkok | Thailand | 10330 |
| 168 | Thai Red Cross Emerging Infectious Diseases (EDI) Clinic | Pathumwan, | Bangkok | Thailand | 10330 |
| 169 | The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), | Pathumwan | Bangkok | Thailand | 10330 |
| 170 | Faculty of Medicine - Khon Kaen University | Muang | Khon Kaen | Thailand | 40002 |
| 171 | Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, | Hat Yai | Songkhla | Thailand | 90110 |
| 172 | Ankara University Medical Faculty, Ibni-Sina Hospital | Ankara | Turkey | 06230 | |
| 173 | Hacettepe University Medical Faculty Hospital | Ankara | Turkey | 06230 | |
| 174 | Akdeniz Universitesi Hastanesi | Antalya | Turkey | 07059 | |
| 175 | Istanbul Medipol University Clinical Research Ethics Committee | Beykoz / Istanbul | Turkey | 34810 | |
| 176 | Gaziantep University Medical Faculty | Gaziantep | Turkey | 27300 | |
| 177 | Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi | Istanbul | Turkey | 34020 | |
| 178 | Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty | Istanbul | Turkey | 34098 | |
| 179 | Acibadem Saglik Hizmetleri ve Tic.A.S, Acibadem Atakent Hastanesi | Istanbul | Turkey | 34303 | |
| 180 | Istanbul Universitesi Klinik Arastirmalar Mukemmeliyet Uygulama ve Arastirma Merkezi | Istanbul | Turkey | 34452 | |
| 181 | Basaksehir Cam ve Sakura Sehir Hastanesi | Istanbul | Turkey | 34480 | |
| 182 | Kocaeli University Medical Faculty | Kocaeli | Turkey | 41380 | |
| 183 | Sbü Dr. Suat Seren Göğüs Hastaliklari Ve Cerrahisi Eğitim Ve Araştirma Hastanesi | Konak/Izmir | Turkey | 35170 | |
| 184 | Mersin University Health Research and Application Hospital | Mersin | Turkey | 33110 | |
| 185 | Sakarya University Training and Research Hospital | Sakarya | Turkey | 54100 | |
| 186 | Karadeniz Teknik Universitesi Farabi Hastanesi | Trabzon | Turkey | 61080 | |
| 187 | Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council | Dnipro | Ukraine | 49069 | |
| 188 | Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of | Ivano-Frankivsk | Ukraine | 76007 | |
| 189 | Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council" | Ivano-Frankivsk | Ukraine | 76018 | |
| 190 | Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council | Kharkiv | Ukraine | 61002 | |
| 191 | Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases | Kharkiv | Ukraine | 61096 | |
| 192 | "Municipal Non-Profit Enterprise "Alexander Clinical Hospital of Kyiv" of the Kyiv City Council | Kyiv | Ukraine | 01601 | |
| 193 | Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the Kyiv | Kyiv | Ukraine | 02091 | |
| 194 | Kyiv Railway Clinical Hospital No.2 of Branch "Health Center of the Public Joint Stock Company | Kyiv | Ukraine | 03049 | |
| 195 | Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company | Kyiv | Ukraine | 04050 | |
| 196 | Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analitical | Lviv | Ukraine | 79008 | |
| 197 | Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4" | Lviv | Ukraine | 79011 | |
| 198 | Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional | Poltava | Ukraine | 36011 | |
| 199 | Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council | Tarasove Village | Ukraine | 45625 | |
| 200 | Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital №1" | Vinnytsia | Ukraine | 21029 | |
| 201 | Communal Enterprise "Hospital #1" of Zhytomyr City Council | Zhytomyr | Ukraine | 10002 |
Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04960202
Other Study ID Numbers:
- C4671005
- 2021-002895-38
- EPIC-HR
First Posted:
Jul 13, 2021
Last Update Posted:
Jul 22, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Pfizer
Additional relevant MeSH terms: