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
Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT05047601
Collaborator
(none)
2,957
170
3
7.1
17.4
2.5
Study Details
Study Description
Brief Summary
The purpose of this clinical trial is to learn whether the study medicine prevent symptoms of COVID-19 in adults who have been exposed to household member(s) with a confirmed symptomatic COVID-19 infection.
All participants in the study will receive treatment for COVID-19 as needed, based on their regular doctor's recommendation. Two-thirds of participants will also receive two study medicines (PF-07321332 and ritonavir) by mouth twice a day for either five or ten days. We will compare the experiences of people receiving the study medicines to those of the people who do not. This will help us determine if the study medicines are safe and effective
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
2957 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Eligible participants who are asymptomatic household contacts of an individual with symptomatic COVID-19 will be randomized (1:1:1) to receive orally every 12 hours:
PF-07321332/ritonavir for 5 days followed by placebo for 5 days or PF-07321332/ritonavir for 10 days or Placebo for 10 daysEligible participants who are asymptomatic household contacts of an individual with symptomatic COVID-19 will be randomized (1:1:1) to receive orally every 12 hours:PF-07321332/ritonavir for 5 days followed by placebo for 5 days or PF-07321332/ritonavir for 10 days or Placebo for 10 days
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double Blind Double Dummy
Primary Purpose:
Prevention
Official Title:
A PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF 2 REGIMENS OF ORALLY ADMINISTERED PF 07321332/RITONAVIR IN PREVENTING SYMPTOMATIC SARS-COV-2 INFECTION IN ADULT HOUSEHOLD CONTACTS OF AN INDIVIDUAL WITH SYMPTOMATIC COVID-19
Actual Study Start Date
:
Sep 9, 2021
Actual Primary Completion Date
:
Apr 12, 2022
Actual Study Completion Date
:
Apr 12, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PF-07321332/ritonavir (5 days) Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 5 followed by Placebo every 12 hours from Day 6 through Day 10 |
Drug: PF-07321332
PF-07321332
Drug: Placebo for PF-07321332
Placebo
Drug: Placebo for Ritonavir
Placebo
Drug: Ritonavir
Ritonavir
|
| Experimental: PF-07321332/ritonavir (10-Day) Participants will receive PF-07321332/ritonavir every 12 hours from Day 1 through Day 10. |
Drug: PF-07321332
PF-07321332
Drug: Ritonavir
Ritonavir
|
| Placebo Comparator: Placebo Participants will receive placebo every 12 hours from Day 1 through Day 10. |
Drug: Placebo for PF-07321332
Placebo
Drug: Placebo for Ritonavir
Placebo
|
Outcome Measures
Primary 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. [Day 1 through Day 14]
Secondary Outcome Measures
- Percentage of participants who experience adverse events [Day 1 through Day 38]
- 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 [Day 1 through Day 14]
Proportion of participants with symptomatic, RT-PCR or Rapid Antigen Test confirmed SARS-CoV-2 infection through Day 14
- 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 [Day 1 through Day 28]
Proportion of participants with COVID-19 related hospitalization or death from any cause
- Prevention of SARS CoV-2 infection in participants by RT-PCR status at enrolment [Day 1 through Day 14]
Proportion of participants with symptomatic or asymptomatic, RT-PCR or Rapid Antigen Test confirmed SARS-CoV-2 infection.
- Prevention of SARS CoV-2 infection in participants who have a negative RT-PCR result at baseline [Day 1 through Day 14]
Time to SARS-CoV-2 infection.
- Compare the duration of COVID-19 related signs and symptoms in participants who have a negative RT-PCR result at baseline [Day 1 through Day 28]
- Compare the severity of COVID-19 related signs and symptoms in participants who have a negative RT-PCR result at baseline [Day 1 through Day 28]
- Minimal Concentration (Ctrough) of PF-07321332 [Day 1 post dose, Day 5 pre dose]
- All cause mortality in participants who have a negative RT-PCR result at baseline [Day 1 through Day 38]
- Viral titers measured via RT-PCR in nasal swabs in participants who have a negative or positive RT-PCR result at baseline [Day 1 through Day 14]
- 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 [Day 1 through Day 28]
- Number of COVID-19 related medical visits in participants who have a negative RT-PCR result at baseline [Day 1 through Day 28]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participants who have a negative screening SARS-CoV-2 rapid antigen test result and who are asymptomatic household contacts with exposure within 96 hours to an individual who is symptomatic and recently tested positive for SARS CoV-2.
-
Fertile participants must agree to use a highly effective method of contraception
Exclusion Criteria:
-
History of SARS-CoV-2 infection in the past 6 months
-
Experiencing measured fever (documented temperature >38˚C or 100.4˚F) or other signs or symptoms consistent with COVID-19
-
Known medical history of active liver disease
-
Chronic Kidney Disease or have known moderate to severe renal impairment.
-
Known Human Immunodeficiency Virus (HIV) infection with viral load > 400 copies/ml within the last 6 months or taking prohibited medications for HIV treatment
-
Suspected or confirmed concurrent active systemic infection
-
Active cancer requiring treatment with prohibited medication.
-
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 approved, authorized, or investigational anti-SARS-CoV-2 mAb, convalescent plasma, other drugs for treatment of COVID-19, or other anti-SARS-CoV-2 biologic products within 6 months of screening
-
Has received any SARS-CoV-2 vaccine within 6 months prior to screening or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments through Day 38.
-
Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19
-
Known or prior participation in this trial or another trial involving PF-07321332.
-
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 | Cahaba Research, Inc. | Pelham | Alabama | United States | 35124 |
| 3 | The Institute for Liver Health dba Arizona Clinical Trials | Tucson | Arizona | United States | 85712 |
| 4 | Ascada Health PC | Fullerton | California | United States | 92835 |
| 5 | Optimus Medical Group | San Francisco | California | United States | 94102 |
| 6 | Synergy Healthcare | Bradenton | Florida | United States | 34208 |
| 7 | MOORE Clinical Research, Inc. | Brandon | Florida | United States | 33511 |
| 8 | Herco Medical and Research Center Inc | Coral Gables | Florida | United States | 33134 |
| 9 | Advance Clinical Research Group | Cutler Bay | Florida | United States | 33157 |
| 10 | Beautiful Minds Clinical Research Center | Cutler Bay | Florida | United States | 33157 |
| 11 | Unlimited Medical Research Group, LLC | Hialeah Gardens | Florida | United States | 33018 |
| 12 | Qway Research | Hialeah | Florida | United States | 33010 |
| 13 | Eastern Research Inc | Hialeah | Florida | United States | 33013 |
| 14 | Inpatient Research Clinic | Hialeah | Florida | United States | 33013 |
| 15 | Doral Medical Research,LLC | Hialeah | Florida | United States | 33016 |
| 16 | Asclepes Research Centers | Lutz | Florida | United States | 33549 |
| 17 | Pro-Care Research Center, Corp. | Miami Gardens | Florida | United States | 33014 |
| 18 | Savin Medical Group, LLC | Miami Lakes | Florida | United States | 33014 |
| 19 | Angels Clinical Research Institute | Miami | Florida | United States | 33122 |
| 20 | LCC Medical Research Institute, LLC | Miami | Florida | United States | 33126 |
| 21 | Premium Medical Research Corp | Miami | Florida | United States | 33126 |
| 22 | Global Health Clinical Trials Corp | Miami | Florida | United States | 33135 |
| 23 | South Florida Research Center, Inc. | Miami | Florida | United States | 33135 |
| 24 | University of Miami Health System | Miami | Florida | United States | 33136 |
| 25 | I.V.A.M. Clinical & Investigational Center, LLC | Miami | Florida | United States | 33144 |
| 26 | Medical Research of Westchester Inc | Miami | Florida | United States | 33165 |
| 27 | C'A Research | Miami | Florida | United States | 33174 |
| 28 | ProLive Medical Research, Corp. | Miami | Florida | United States | 33175 |
| 29 | Entrust Clinical Research | Miami | Florida | United States | 33176 |
| 30 | Reed Medical Research | Miami | Florida | United States | 33176 |
| 31 | Kendall South Medical Center, Inc. | Miami | Florida | United States | 33185 |
| 32 | Clinical Site Partners, Inc dba CSP Miami | Miami | Florida | United States | 33186 |
| 33 | Coral Research Clinic Corp | Miami | Florida | United States | 33186 |
| 34 | Omega Research Orlando | Orlando | Florida | United States | 32808 |
| 35 | NAPA Research LLC | Pompano Beach | Florida | United States | 33064 |
| 36 | CDC Research Institute, LLC | Port Saint Lucie | Florida | United States | 34952 |
| 37 | GCP, Global Clinical Professionals | Saint Petersburg | Florida | United States | 33705 |
| 38 | USPA Advance Concept Medical Research Group LLC | South Miami | Florida | United States | 33143 |
| 39 | Asclepes Research Centers | Spring Hill | Florida | United States | 34609 |
| 40 | Sunrise Research Institute | Sunrise | Florida | United States | 33325 |
| 41 | Santos Research Center, CORP | Tampa | Florida | United States | 33615 |
| 42 | Research by Design, LLC | Chicago | Illinois | United States | 60643 |
| 43 | Accellacare | Ames | Iowa | United States | 50010 |
| 44 | McFarland Clinic, PC | Ames | Iowa | United States | 50010 |
| 45 | Southern Clinical Research Associates. LLC | Metairie | Louisiana | United States | 70001 |
| 46 | Meridian Clinical Research, LLC | Grand Island | Nebraska | United States | 68803 |
| 47 | Quality Clinical Research Inc | Omaha | Nebraska | United States | 68112 |
| 48 | Quality Clinical Research | Omaha | Nebraska | United States | 68114 |
| 49 | Walmart | Las Vegas | Nevada | United States | 89108 |
| 50 | Excel Clinical Research | Las Vegas | Nevada | United States | 89109 |
| 51 | Walgreens | Las Vegas | Nevada | United States | 89121 |
| 52 | NYC Health + Hospitals / Harlem | New York | New York | United States | 10037 |
| 53 | Monroe Biomedical Research | Monroe | North Carolina | United States | 28112 |
| 54 | Innovo Research: Wilmington Health | Wilmington | North Carolina | United States | 28401 |
| 55 | PharmaTex Research, LLC | Amarillo | Texas | United States | 79109 |
| 56 | Conroe Willis Medical Research | Conroe | Texas | United States | 77304 |
| 57 | South Texas Clinical Research | Corpus Christi | Texas | United States | 78413 |
| 58 | SingnatureCare Emergency Center | Houston | Texas | United States | 77008 |
| 59 | Trio Clinical Trials, LLC | Houston | Texas | United States | 77008 |
| 60 | C & R Research Services USA | Houston | Texas | United States | 77022 |
| 61 | SMS Clinical Research, LLC | Mesquite | Texas | United States | 75149 |
| 62 | Epic Medical Research | Red Oak | Texas | United States | 75154 |
| 63 | Sun Research Institute | San Antonio | Texas | United States | 78215 |
| 64 | Tranquility Research | Webster | Texas | United States | 77598 |
| 65 | Instituto de Investigaciones Clinicas Zarate | Zarate | Buenos Aires | Argentina | B2800DGH |
| 66 | Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos) | Rosario | Santa FE | Argentina | 2000 |
| 67 | Pesquisare Saude S/S Ltda | Santo André | SP | Brazil | 09080-110 |
| 68 | Conjunto Hospitalar do Mandaqui | São Paulo | Brazil | 02401-400 | |
| 69 | "Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd | Haskovo | Bulgaria | 6300 | |
| 70 | MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD | Kozloduy | Bulgaria | 3320 | |
| 71 | Diagnostic-Consultative Center I Lom EOOD | Lom | Bulgaria | 3600 | |
| 72 | Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD | Lom | Bulgaria | 3600 | |
| 73 | Medical centre Leo Clinic EOOD | Lovech | Bulgaria | 5500 | |
| 74 | MHAT Heart and Brain EAD | Pleven | Bulgaria | 5800 | |
| 75 | DCC Sveti Georgi EOOD | Plovdiv | Bulgaria | 4000 | |
| 76 | MHAT "St. Panteleimon "- Plovdiv | Plovdiv | Bulgaria | 4004 | |
| 77 | UMHAT Medica Ruse OOD | Ruse | Bulgaria | 7013 | |
| 78 | Multiprofile Hospital for Active Treatment - Samokov EOOD | Samokov | Bulgaria | 2000 | |
| 79 | Multiprofile hospital for active treatment - Sliven to Military Medical Academy | Sliven | Bulgaria | 8800 | |
| 80 | Diagnostic-Consultative Center XXII- Sofia ЕООD | Sofia | Bulgaria | 1113 | |
| 81 | UMHATEM N. I. Pirogov EAD | Sofia | Bulgaria | 1606 | |
| 82 | Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD | Stara Zagora | Bulgaria | 6000 | |
| 83 | Medical center Leo Clinic EOOD | Varna | Bulgaria | 9020 | |
| 84 | MOBAL "D-r Stefan Cherkezov" AD | Veliko Tarnovo | Bulgaria | 5002 | |
| 85 | Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD | Vratsa | Bulgaria | 3000 | |
| 86 | Clinica de la Costa LTDA. | Barranquilla | Atlantico | Colombia | 080020 |
| 87 | Caimed S.A.S. | Yopal | Casanare | Colombia | 850001 |
| 88 | Cireem Sas | Bogota | Cundinamarca | Colombia | 110221 |
| 89 | Doktor Brno s.r.o. | Brno | Czechia | 602 00 | |
| 90 | Zdraví-Fit, s.r.o. | Protivín | Czechia | 398 11 | |
| 91 | Nemocnice Slany | Slany | Czechia | 274 01 | |
| 92 | Medifarma-98 Kft. | Nyiregyhaza | Hungary | 4400 | |
| 93 | International University of Health and Welfare Narita Hospital | Narita | Chiba | Japan | 286-8520 |
| 94 | Rakuwakai Otowa Hospital | Kyoto-shi | Kyoto | Japan | 607-8062 |
| 95 | Rinku General Medical Center | Izumisano | Osaka | Japan | 598-8577 |
| 96 | Denenchofu Family Clinic | Ota | Tokyo | Japan | 145-0071 |
| 97 | Sekino Hospital | Toshimaku | Tokyo | Japan | 171-0014 |
| 98 | Hospital Miri | Miri | Sarawak | Malaysia | 98000 |
| 99 | InfectoLab Consultorios de Especialidad en Infectologia | Tijuana | BAJA California | Mexico | 22010 |
| 100 | Clinical Research Institute Saltillo S.A. de C.V. | Saltillo | Coahuila | Mexico | 25020 |
| 101 | Instituto Jalisciense de Metabolismo, S.C. | Guadalajara | Jalisco | Mexico | 44670 |
| 102 | Eukarya Pharmasite S.C. | Monterrey | Nuevo LEON | Mexico | 64718 |
| 103 | Christus- Latam Hub Center of Excellence and Innovation Center S.C. | Monterrey | Nuevo LEÓN | Mexico | 64060 |
| 104 | EME RED Hospitalaria | Mérida | Yucatán | Mexico | 97000 |
| 105 | Instituto de Investigaciones Clinicas para la Salud A.C. | Durango | Mexico | 34000 | |
| 106 | FAICIC Clinical Research | Veracruz | Mexico | 91900 | |
| 107 | Sociedad de Metabolismo y Corazon S.C. | Veracruz | Mexico | 91900 | |
| 108 | Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska | Wroclaw | Poland | 51-162 | |
| 109 | Kirovsk Interdistrict Hospital | Kirovsk | Leningrad Region | Russian Federation | 187342 |
| 110 | LLC Trekhgorka Medicine | Odintsovo | Moscow Region | Russian Federation | 143005 |
| 111 | Clinica UZI 4D | Pyatigorsk | Stavropol Region | Russian Federation | 357502 |
| 112 | Barnaul City Hospital Number 5 | Barnaul | Russian Federation | 656045 | |
| 113 | Korolev Medicine | Korolev | Russian Federation | 141070 | |
| 114 | KDC "Evromedservis", OJSC | Moscow | Russian Federation | 115419 | |
| 115 | City Polyclinic #44 | Saint Petersburg | Russian Federation | 192071 | |
| 116 | LLC Strategic Medical Systems | Saint Petersburg | Russian Federation | 194291 | |
| 117 | City Polyclinic No. 109 | Saint-Petersburg | Russian Federation | 192298 | |
| 118 | City Out-patient clinic #112 | Saint-Petersburg | Russian Federation | 195427 | |
| 119 | "Research Center Eco-safety" LLC | Saint-Petersburg | Russian Federation | 196143 | |
| 120 | LLC Kurator | Saint-Petersburg | Russian Federation | 196240 | |
| 121 | Saint-Petersburg State Budgetary Healthcare Institution "City Pokrovskaya hospital" | Saint-Petersburg | Russian Federation | 199106 | |
| 122 | City Out-patient clinic #4 | Saint-Petersburg | Russian Federation | 199406 | |
| 123 | Smolensk State Medical University | Smolensk | Russian Federation | 214019 | |
| 124 | LLC Family clinic | Yekaterinburg | Russian Federation | 620109 | |
| 125 | MERC Welkom | Welkom | FREE State | South Africa | 9460 |
| 126 | Worthwhile Clinical Trials | Benoni | Gauteng | South Africa | 1500 |
| 127 | LCS Clinical Research | Johannesburg | Gauteng | South Africa | 1868 |
| 128 | Peermed CTC (Pty) Ltd T/A MERC Kempton | Kempton Park | Gauteng | South Africa | 1619 |
| 129 | Global Clinical Trials | Pretoria | Gauteng | South Africa | 0001 |
| 130 | Botho ke Bontle Health Services | Pretoria | Gauteng | South Africa | 0122 |
| 131 | About Allergy (PTY) Ltd | Pretoria | Gauteng | South Africa | 0181 |
| 132 | Into Research | Pretoria | Gauteng | South Africa | 0181 |
| 133 | Clinical Trial Systems (Pty) Ltd | Pretoria | Gauteng | South Africa | 0186 |
| 134 | Sandton Medical Clinic | Sandton | Gauteng | South Africa | 2196 |
| 135 | Dr PJ Sebastian Clinical Research Centre | Durban | Kwa-zulu Natal | South Africa | 4092 |
| 136 | Synapta Clinical Research Center | Durban | Kwazulu Natal | South Africa | 4001 |
| 137 | Ahmed Al-Kadi Private Hospital | Mayville, Durban | Kwazulu-natal | South Africa | 4091 |
| 138 | Limpopo Clinical Research Initiative | Thabazimbi | Limpopo | South Africa | 0380 |
| 139 | NHC Thohoyandou CRS | Thohoyandou | Limpopo | South Africa | 0950 |
| 140 | MERC Middelburg | Middelburg | Mpumalanga | South Africa | 1055 |
| 141 | Madibeng Centre for Research | Brits | North WEST | South Africa | 0250 |
| 142 | FCRN Clinical Trial Centre | Vereeniging | South Africa | 1935 | |
| 143 | Complexo Hospitalario Universitario da Coruna | A Coruña | Spain | 15006 | |
| 144 | The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), | Pathumwan | Bangkok | Thailand | 10330 |
| 145 | Faculty of Medicine - Khon Kaen University | Muang | Khon Kaen | Thailand | 40002 |
| 146 | King Chulalongkorn Memorial Hospital | Bangkok | Thailand | 10330 | |
| 147 | Faculty of Tropical Medicine, Mahidol University | Bangkok | Thailand | 10400 | |
| 148 | Tropical Medicine Hospital | Bangkok | Thailand | 10400 | |
| 149 | Ankara University Medical Faculty, Ibni-Sina Hospital | Ankara | Turkey | 06230 | |
| 150 | Istanbul University Istanbul Medical Faculty | Fatih / Istanbul | Turkey | 34093 | |
| 151 | Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi | Gaziantep | Turkey | 27310 | |
| 152 | Acibadem University Atakent Hospital | Istanbul | Turkey | 34303 | |
| 153 | Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital | Izmir | Turkey | 35110 | |
| 154 | Mersin University Medical Faculty | Mersin | Turkey | 33110 | |
| 155 | Karadeniz Teknik Universitesi Farabi Hastanesi | Trabzon | Turkey | 61080 | |
| 156 | Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital" | Chernivtsi | Ukraine | 58001 | |
| 157 | Communal non-commercial Enterprise "City Central Clinical Hospital" of Chernivtsi City Council | Chernivtsi | Ukraine | 58002 | |
| 158 | Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council | Dnipro | Ukraine | 49069 | |
| 159 | Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council" | Ivano-Frankivsk | Ukraine | 76018 | |
| 160 | Municipal Non-profit Enterprise "Ivano-Frankivsk Regional Phthisiopulmonology Center of | Ivano-Frankivsk | Ukraine | 76018 | |
| 161 | Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council | Kharkiv | Ukraine | 61002 | |
| 162 | Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases | Kharkiv | Ukraine | 61096 | |
| 163 | Municipal Nonprofit Enterprise "City Clinic Hospital # 13" of Kharkiv City Council | Kharkiv | Ukraine | 61124 | |
| 164 | Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company | Kyiv | Ukraine | 04050 | |
| 165 | Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4" | Lviv | Ukraine | 79005 | |
| 166 | Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analytical | Lviv | Ukraine | 79008 | |
| 167 | Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4" | Lviv | Ukraine | 79011 | |
| 168 | Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional | Poltava | Ukraine | 36011 | |
| 169 | Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council | Tarasove Village | Ukraine | 45625 | |
| 170 | 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:
NCT05047601
Other Study ID Numbers:
- C4671006
- 2021-002894-24
- EPIC-PEP
First Posted:
Sep 17, 2021
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 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: