A Post-Exposure Prophylaxis Study of PF-07321332/Ritonavir in Adult Household Contacts of an Individual With Symptomatic COVID-19

Sponsor
Pfizer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05047601
Collaborator
(none)
2,634
Enrollment
261
Locations
3
Arms
5.7
Anticipated Duration (Months)
10.1
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of PF-07321332/ritonavir as postexposure prophylaxis for adult household contacts of a patient with COVID-19

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2634 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
Anticipated Primary Completion Date :
Mar 2, 2022
Anticipated Study Completion Date :
Mar 2, 2022

Arms and Interventions

ArmIntervention/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

  1. Proportion of participants who have a negative reverse transcription polymerase chain reaction (RT-PCR) result at baseline who develop a symptomatic, RT-PCR confirmed SARS-CoV-2 infection. [Day 1 through Day 14]

Secondary Outcome Measures

  1. Percentage of participants who experience adverse events [Day 1 through Day 38]

  2. 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 confirmed SARS-CoV-2 infection through Day 14

  3. 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

  4. 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 confirmed SARS-CoV-2 infection.

  5. 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.

  6. 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]

  7. 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]

  8. Minimal Concentration (Ctrough) of PF-07321332 [Day 1 post dose, Day 5 pre dose]

  9. All cause mortality in participants who have a negative RT-PCR result at baseline [Day 1 through Day 38]

  10. Viral titers measured via RT-PCR in nasal swabs in participants who have a negative RT-PCR result at baseline [Day 1 through Day 14]

  11. 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]

  12. 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

  • 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, other than localized skin cancer

  • 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

  • Has received or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments during the study period

  • 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

SiteCityStateCountryPostal Code
1Cahaba Research IncBirminghamAlabamaUnited States35235
2Cahaba Research IncBirminghamAlabamaUnited States35242
3Cahaba Research, Inc.PelhamAlabamaUnited States35124
4The Institute for Liver Health dba Arizona Clinical TrialsMesaArizonaUnited States85210
5The Institute for Liver Health dba Arizona Clinical TrialsTucsonArizonaUnited States85712
6KLR Business Group, Inc. dba Arkansas Clinical ResearchLittle RockArkansasUnited States72205
7Hope Clinical ResearchCanoga ParkCaliforniaUnited States91303
8LightshipEl SegundoCaliforniaUnited States90245
9Ascada Health PCFullertonCaliforniaUnited States92835
10Ark Clinical ResearchLong BeachCaliforniaUnited States90806
11American Institute of ResearchLos AngelesCaliforniaUnited States90017
12Providence Clinical ResearchNorth HollywoodCaliforniaUnited States91606
13FOMAT Medical ResearchOxnardCaliforniaUnited States93030
14Benchmark ResearchSacramentoCaliforniaUnited States95864
15Optimus Medical GroupSan FranciscoCaliforniaUnited States94102
16South Bay Clinical Research InstituteTorranceCaliforniaUnited States90503
17Hope Clinical Research (COVID Satellite Location)West HillsCaliforniaUnited States91304
18Future Innovative Treatments, LLCColorado SpringsColoradoUnited States80907
19BRB Health Group DBA Broward Research CenterAventuraFloridaUnited States33180
20Synergy HealthcareBradentonFloridaUnited States34208
21MOORE Clinical Research, Inc.BrandonFloridaUnited States33511
22Innovative Research of West Florida, Inc.ClearwaterFloridaUnited States33756
23Herco Medical and Research Center IncCoral GablesFloridaUnited States33134
24Advance Clinical Research GroupCutler BayFloridaUnited States33157
25Beautiful Minds Clinical Research CenterCutler BayFloridaUnited States33157
26Midland Florida Clinical Research Center, LLCDeLandFloridaUnited States32720
27Unlimited Medical Research Group, LLCHialeah GardensFloridaUnited States33018
28Qway Research, LLCHialeahFloridaUnited States33010
29Eastern Research IncHialeahFloridaUnited States33013
30Inpatient Research ClinicHialeahFloridaUnited States33013
31Doral Medical Research,LLCHialeahFloridaUnited States33016
32Advanced Pulmonary Research InstituteLoxahatchee GrovesFloridaUnited States33470
33Asclepes Research CentersLutzFloridaUnited States33549
34Pro-Care Research Center, Corp.Miami GardensFloridaUnited States33014
35Lakes Research, LLC.Miami LakesFloridaUnited States33014
36Savin Medical Group, LLCMiami LakesFloridaUnited States33014
37Angels Clinical Research InstituteMiamiFloridaUnited States33122
38Nova Life Med SpaMiamiFloridaUnited States33122
39LCC Medical Research Institute, LLCMiamiFloridaUnited States33126
40Premium Medical Research CorpMiamiFloridaUnited States33126
41Global Health Clinical Trials CorpMiamiFloridaUnited States33135
42South Florida Research Center, Inc.MiamiFloridaUnited States33135
43Suncoast Research Group, LLCMiamiFloridaUnited States33135
44University of Miami Health SystemMiamiFloridaUnited States33136
45I.V.A.M. Clinical & Investigational Center, LLCMiamiFloridaUnited States33144
46Entrust Clinical ResearchMiamiFloridaUnited States33156
47Medical Research of Westchester IncMiamiFloridaUnited States33165
48C'A ResearchMiamiFloridaUnited States33174
49ProLive Medical Research, Corp.MiamiFloridaUnited States33175
50Reed Medical ResearchMiamiFloridaUnited States33176
51Kendall South Medical Center, Inc.MiamiFloridaUnited States33185
52Clinical Site Partners, Inc dba CSP MiamiMiamiFloridaUnited States33186
53Coral Research Clinic CorpMiamiFloridaUnited States33186
54Omega Research OrlandoOrlandoFloridaUnited States32808
55NAPA Research LLCPompano BeachFloridaUnited States33064
56CDC Research Institute, LLCPort Saint LucieFloridaUnited States34952
57GCP, Global Clinical ProfessionalsSaint PetersburgFloridaUnited States33705
58Accel Research Sites - St. Petersburg Clinical Research UnitSaint PetersburgFloridaUnited States33709
59Professional Urgent Care ServicesSaint PetersburgFloridaUnited States33710
60USPA Advance Concept Medical Research Group LLCSouth MiamiFloridaUnited States33143
61Asclepes Research CentersSpring HillFloridaUnited States34609
62Sunrise Research InstituteSunriseFloridaUnited States33325
63Tampa General HospitalTampaFloridaUnited States33606
64Santos Research Center, CORPTampaFloridaUnited States33615
65Palm Beach Research CenterWest Palm BeachFloridaUnited States33409
66Clinical Site Partners, IncWinter ParkFloridaUnited States32789
67Research by Design, LLCChicagoIllinoisUnited States60643
68The South Bend Clinic Center for ResearchSouth BendIndianaUnited States46617
69AccellacareAmesIowaUnited States50010
70McFarland Clinic, PCAmesIowaUnited States50010
71WKB Family Medicine AssociatesBossier CityLouisianaUnited States71111
72New Orleans Sinus Center (COVID-19 Testing)MarreroLouisianaUnited States70072
73Tandem Clinical Research GI, LLCMarreroLouisianaUnited States70072
74Southern Clinical Research Associates, LLCMetairieLouisianaUnited States70001
75MedPharmics LLCMetairieLouisianaUnited States70006
76Willis-Knighton Health SystemShreveportLouisianaUnited States71118
77Michigan Center of Medical ResearchFarmington HillsMichiganUnited States48334
78Jackson Medical MallJacksonMississippiUnited States39213
79Lakeland PharmacyBranson W.MissouriUnited States65737
80Price CutterSpringfieldMissouriUnited States65802
81Mercury Street Medical Group, PLLCButteMontanaUnited States59701
82Meridian Clinical Research, LLCGrand IslandNebraskaUnited States68803
83Quality Clinical Research IncOmahaNebraskaUnited States68112
84Quality Clinical ResearchOmahaNebraskaUnited States68114
85WalmartLas VegasNevadaUnited States89108
86Excel Clinical ResearchLas VegasNevadaUnited States89109
87WalgreensLas VegasNevadaUnited States89121
88AXCES Research GroupSanta FeNew MexicoUnited States87505
89Meridian Clinical Research, LLCEndwellNew YorkUnited States13760
90NYC Health + Hospitals/HarlemNew YorkNew YorkUnited States10037
91Monroe Biomedical ResearchMonroeNorth CarolinaUnited States28112
92AccellacareWilmingtonNorth CarolinaUnited States28401
93Innovo Research: Wilmington HealthWilmingtonNorth CarolinaUnited States28401
94Premier Medical GroupClarksvilleTennesseeUnited States37040
95PharmaTex Research, LLCAmarilloTexasUnited States79109
96ARC Clinical Research at William CannonAustinTexasUnited States78745
97St Hope FoundationBellaireTexasUnited States77401
98Conroe Willis Medical ResearchConroeTexasUnited States77304
99South Texas Clinical ResearchCorpus ChristiTexasUnited States78413
100SingnatureCare Emergency CenterHoustonTexasUnited States77008
101Trio Clinical Trials, LLCHoustonTexasUnited States77008
102C & R Research Services USAHoustonTexasUnited States77022
103Next Level Urgent CareHoustonTexasUnited States77057
104SMS Clinical Research, LLCMesquiteTexasUnited States75149
105LinQ Research, LLCPearlandTexasUnited States77584
106Epic Medical ResearchRed OakTexasUnited States75154
107Sun Research InstituteSan AntonioTexasUnited States78215
108Endeavor Clinical Trials, LLCSan AntonioTexasUnited States78229
109BFHC ResearchSan AntonioTexasUnited States78249
110Tranquility ResearchWebsterTexasUnited States77598
111University of Utah Medical CenterSalt Lake CityUtahUnited States84132
112TPMG Clinical ResearchNewport NewsVirginiaUnited States23606
113Centro Medico Viamonte SRLCabaBuenos AiresArgentinaC1120AAC
114Instituto de Investigaciones Clinicas ZarateZarateBuenos AiresArgentinaB2800DGH
115Hospital Cardio PulmonarSalvadorBahiaBrazil40170-130
116Chronos Pesquisa ClinicaBrasiliaDistrito FederalBrazil72145-450
117AMB3 Serviços Médicos LtdaCuiabáMATO GrossoBrazil78055-085
118Hospital Luxemburgo - Associacao Mario PennaBelo HorizonteMGBrazil30380-472
119Infection Control LtdaBelo HorizonteMinas GeraisBrazil30110-063
120School of Medicine Federal University of Minas GeraisBelo HorizonteMinas GeraisBrazil30130-100
121Hospital Agamenon MagalhaesRecifePernambucoBrazil52051-380
122Centro de Estudos e Pesquisas em Moléstias InfecciosasNatalRIO Grande DO NorteBrazil59025050
123Hospital De Clinicas De Porto AlegrePorto AlegreRIO Grande DO SULBrazil90035-903
124IBPClin- Instituto Brasil de Pesquisa ClinicaRio de JaneiroRJBrazil20241-180
125Instituto Nacional de Infectologia Evandro Chagas - INI/FIOCRUZRio de JaneiroRJBrazil21040-360
126CECOR - Centro Oncológico de RoraimaBoa VistaRoraima/rrBrazil69304-015
127Centro de Estudos Clinicos do Interior Paulista (CECIP)JauSAO PauloBrazil17201-130
128Hospital Dia do PulmaoBlumenauSCBrazil89030-101
129Hospital Regional Hans Dieter Schmidt (HRHDS)JoinvilleSCBrazil89227-680
130Hospital e Maternidade Celso Pierro - PUC Campinas / Sociedade Campineira de Educação e InstruçãCampinasSPBrazil13060-904
131Pesquisare Saude S/S LtdaSanto AndréSPBrazil09080-110
132Hospital HeliópolisSão PauloSPBrazil04231-030
133Instituto D'Or de Pesquisa e Ensino / Hospital São Luiz JabaquaraSão PauloSPBrazil04321-120
134Scentryphar - Pesquisa ClínicaCampinasSÃO PauloBrazil13020-431
135Associação Evangélica de Campinas - Hospital SamaritanoCampinasSÃO PauloBrazil13041-304
136Instituto de Pesquisa Clínica de CampinasCampinasSÃO PauloBrazil13060-080
137Centro de Referência e Treinamento DST/AIDSSao PauloSÃO PauloBrazil04121-000
138Clinica de Alergia Martti AntilaSorocabaSÃO PauloBrazil18040-425
139CPCLIN - Centro de Pesquisas Clinicas LtdaSão PauloBrazil01228-200
140Instituto de Infectologia Emilio RibasSão PauloBrazil01246-900
141Doktor Brno s.r.o.BrnoCzechia602 00
142Fakultni nemocnice Hradec KraloveHradec KraloveCzechia500 05
143MEDITRIAL s.r.o.Jindrichuv Hradec IIICzechia377 01
144Zdraví-Fit, s.r.o.ProtivínCzechia398 11
145Nemocnice SlanySlanyCzechia274 01
146Trial Pharma Kft.BekescsabaHungary5600
147Debreceni Egyetem Klinikai Kozpont Infektologiai KlinikaDebrecenHungary4031
148Agria-Study Kft.EgerHungary3300
149Trial Pharma Kft.GyulaHungary5700
150Medifarma-98 Kft.NyiregyhazaHungary4400
151International University of Health and Welfare Narita HospitalNaritaChibaJapan286-8520
152Rakuwakai Otowa HospitalKyoto-shiKyotoJapan607-8062
153Rinku General Medical CenterIzumisanoOsakaJapan598-8577
154Denenchofu Family ClinicOtaTokyoJapan145-0071
155Tokyo Shinagawa HospitalShinagawa-kuTokyoJapan140-8522
156Sekino HospitalToshimakuTokyoJapan171-0014
157Kyushu Medical CenterFukuokaJapan810-8563
158Kyungpook National University Chilgok HospitalDaeguKorea, Republic of41404
159Hospital Raja Perempuan Zainab IIKota BharuKelantanMalaysia15586
160Klinik Kesihatan GreentownIpohPerakMalaysia30450
161Hospital Seberang JayaSeberang JayaPulau PinangMalaysia13700
162Hospital MiriMiriSarawakMalaysia98000
163Klinik Kesihatan KuangSungai BulohSelangorMalaysia48050
164InfectoLab Consultorios de Especialidad en InfectologiaTijuanaBAJA CaliforniaMexico22010
165Clinical Research Institute Saltillo S.A. de C.V.SaltilloCoahuilaMexico25020
166Centro de Investigacion Clinica Del Pacifico SA de CVAcapulco de JuarezGuerreroMexico39670
167Asociacion Mexicana para la Investigacion Clinica, A. C.Pachuca de SotoHidalgoMexico42070
168Instituto Jalisciense de Metabolismo, S.C.GuadalajaraJaliscoMexico44670
169JM ResearchCuernavacaMorelosMexico62290
170Hospital Universitario Dr. Jose Eleuterio GonzalezMonterreyNuevo LEONMexico64460
171Eukarya Pharmasite S.C.MonterreyNuevo LEONMexico64718
172Christus- Latam Hub Center of Excellence and Innovation Center S.C.MonterreyNuevo LEÓNMexico64060
173Oaxaca site management organization s.cOaxaca de JuarezOaxacaMexico68000
174Hospital General de Culiacán "Bernardo J. Gastélum"CulíacanSinaloaMexico80230
175Kohler & Milstein Research S.A. de C.V.MeridaYucatanMexico97070
176Eme Red HospitalariaMéridaYucatánMexico97000
177Hospital Cardiologica AguascalientesAguascalientesMexico20230
178Instituto de Investigaciones Clínicas para la SaludDurangoMexico34000
179FAICIC Clinical ResearchVeracruzMexico91900
180Sociedad de Metabolismo y Corazon S.C.VeracruzMexico91900
181Arke SMO S.A. de C.VVeracruzMexico91910
182KLIMED Marek KlimkiewiczBialystokPoland15-704
183Krakowskie Centrum MedyczneKrakowPoland31-501
184Przychodnia Valeo MedicalLodzPoland94-004
185IRMED Ośrodek Badań KlinicznychPiotrkow TrybunalskiPoland97-300
186Tomasz Blicharski Lubelskie Centrum DiagnostyczneSwidnikPoland21-040
187WIP Warsaw IBD Point Profesor KierkusWarszawaPoland00-728
188Centrum Badań Klinicznych Piotr Napora Lekarze Spółka PartnerskaWroclawPoland51-162
189Ponce Medical School Foundation, Inc. CAIMED CenterPoncePuerto Rico00716
190Clinical Research Management Group IncPoncePuerto Rico00780
191Advance Medical Research CenterSan JuanPuerto Rico00926
192Global Clinical TrialsGqeberhaEastern CAPESouth Africa6014
193MERC WelkomWelkomFREE StateSouth Africa9460
194Worthwhile Clinical TrialsBenoniGautengSouth Africa1500
195REIMED VosloorusBoksburgGautengSouth Africa1475
196Lenasia Clinical Trial CentreJohannesburgGautengSouth Africa1820
197Peermed CTC (Pty) Ltd T/A MERC KemptonKempton ParkGautengSouth Africa1619
198Midrand Medical CentreMidrandGautengSouth Africa1685
199About Allergy (PTY) LtdPretoria NorthGautengSouth Africa0009
200Global Clinical TrialsPretoriaGautengSouth Africa0001
201Botho ke Bontle Health ServicesPretoriaGautengSouth Africa0122
202Emmed ResearchPretoriaGautengSouth Africa0181
203Into ResearchPretoriaGautengSouth Africa0181
204Clinical Trial Systems (Pty) LtdPretoriaGautengSouth Africa0186
205Sandton Medical ClinicSandtonGautengSouth Africa2196
206FCRN Clinical Trial CentreVereenigingGautengSouth Africa1935
207Dr PJ Sebastian Clinical Research CentreDurbanKwa-zulu NatalSouth Africa4092
208Synapta Clinical Research CenterDurbanKwazulu NatalSouth Africa4001
209Ahmed Al-Kadi Private HospitalMayville, DurbanKwazulu-natalSouth Africa4091
210Private Practice - Dr. Jeevren ReddyStangerKwazulu-natalSouth Africa4449
211Limpopo Clinical Research InitiativeThabazimbiLimpopoSouth Africa0380
212NHC Thohoyandou CRSThohoyandouLimpopoSouth Africa0950
213MERC MiddelburgMiddelburgMpumalangaSouth Africa1055
214Madibeng Centre for ResearchBritsNorth WESTSouth Africa0250
215TASK EdenGeorgeWestern CAPESouth Africa6530
216Be Part Research Pty (Ltd)PaarlWestern CAPESouth Africa7626
217Clinical Projects ResearchWorcesterWestern CAPESouth Africa6850
218Synopsis ResearchClaremontSouth Africa7708
219Dr JM Engelbrecht Trial SiteSomerset WestSouth Africa7130
220Far Eastern Memorial HospitalNew Taipei CityTaiwan220
221China Medical University HospitalTaichungTaiwan40447
222National Taiwan University HospitalTaipeiTaiwan100229
223National Taiwan University HospitalTaipeiTaiwan100
224Bangkok Centre HotelBangrakBangkokThailand10500
225Chula Filed hospital, Chulalongkorn University Sport center (Chantanayingyong Gymnasium),Pathum Wan District,BangkokThailand10330
226Thai Red Cross Emerging Infectious Diseases (EDI) ClinicPathumwan,BangkokThailand10330
227The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),PathumwanBangkokThailand10330
228Faculty of Medicine - Khon Kaen UniversityMuangKhon KaenThailand40002
229Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University,Hat YaiSongkhlaThailand90110
230King Chulalongkorn Memorial HospitalBangkokThailand10330
231Faculty of Tropical Medicine, Mahidol UniversityBangkokThailand10400
232Tropical Medicine HospitalBangkokThailand10400
233Ankara University Medical Faculty, Ibni-Sina HospitalAnkaraTurkey06230
234Hacettepe University Medical Faculty HospitalAnkaraTurkey06230
235Akdeniz Universitesi HastanesiAntalyaTurkey07059
236Istanbul University Istanbul Medical FacultyFatih / IstanbulTurkey34093
237Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma HastanesiGaziantepTurkey27310
238Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma HastanesiIstanbulTurkey34020
239Medipol Mega University HospitalIstanbulTurkey34214
240Acibadem University Atakent HospitalIstanbulTurkey34303
241Basaksehir Cam ve Sakura Sehir HastanesiIstanbulTurkey34480
242Izmir Suat Seren Chest Disease and Surgery Training and Research HospitalIzmirTurkey35110
243Kocaeli University Medical FacultyKocaeliTurkey41380
244Mersin University Medical FacultyMersinTurkey33110
245Sakarya University Training and Research HospitalSakaryaTurkey54100
246Karadeniz Teknik Universitesi Farabi HastanesiTrabzonTurkey61080
247Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital"ChernivtsiUkraine58001
248Communal non-commercial Enterprise "City Central Clinical Hospital" of Chernivtsi City CouncilChernivtsiUkraine58002
249Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital ofIvano-FrankivskUkraine76007
250Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council"Ivano-FrankivskUkraine76018
251Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City CouncilKharkivUkraine61002
252Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious DiseasesKharkivUkraine61096
253Municipal Nonprofit Enterprise "City Clinic Hospital # 13" of Kharkiv City CouncilKharkivUkraine61124
254Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the KyivKyivUkraine02091
255Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding CompanyKyivUkraine04050
256Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and AnalyticalLvivUkraine79008
257Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"LvivUkraine79011
258Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional CouncilTarasove VillageUkraine45625
259Medical Center of Private Enterprise "Medical center INTERSONO"UzhhorodUkraine88000
260Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital №1"VinnytsiaUkraine21029
261Communal Enterprise "Hospital #1" of Zhytomyr City CouncilZhytomyrUkraine10002

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:
Nov 18, 2021
Last Verified:
Nov 1, 2021
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:

Study Results

No Results Posted as of Nov 18, 2021