Clinical trial NCT05047601: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: COVID-19
Keywords: Severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-09-17
Enrollment: 2954
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants 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
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline
timeFrame: From Day 1 to Day 14
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation
timeFrame: From start of study intervention (Day 1) up to end of safety follow-up (Day 38)
measure: Percentage of Participants Who Developed Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness
timeFrame: From Day 1 to Day 14
measure: Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28: Among Participants With Negative RT-PCR at Baseline With Increased Risk of Severe COVID-19 Illness
timeFrame: From Day 1 to Day 28
measure: Percentage of Participants With Asymptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline
timeFrame: From Day 1 to Day 14
measure: Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline
timeFrame: From Day 1 to Day 14
measure: Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Positive RT-PCR at Baseline
timeFrame: From Day 1 to Day 14
measure: Percentage of Participants With Symptomatic RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative, Positive or Missing RT-PCR at Baseline
timeFrame: From Day 1 to Day 14
measure: Percentage of Participants With no, Mild, Moderate, or Severe Signs and Symptoms Attributed to COVID-19 Through Day 28: Among Participants With Negative RT-PCR at Baseline
timeFrame: From Day 1 to Day 28
measure: Number of Days of Symptomatic RT-PCR or RAT Confirmed SARS-CoV- 2 Infection Through Day 28: Among Participants With Negative RT-PCR at Baseline
timeFrame: From Day 1 to Day 28
measure: Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332)
timeFrame: Day 1: 1 hour post dose; Day 5: 2 hours pre-dose
measure: Percentage of Participants With Death Event Through Day 38: Among Participants With Negative RT-PCR at Baseline
timeFrame: From Day 1 to Day 38
measure: Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline
timeFrame: From Day 1 to Day 14
measure: Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline
timeFrame: From Day 1 to Day 14
measure: Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline
timeFrame: From Day 1 to Day 28
measure: Number of COVID-19 Related Medical Visits Through Day 28: Among Participants With Negative RT-PCR at Baseline
timeFrame: From Day 1 to Day 28
Other outcomes:
Locations:
city: Pelham
country: United States
facility: Cahaba Research Inc
state: Alabama
city: Tucson
country: United States
facility: The Institute for Liver Health dba Arizona Clinical Trials
state: Arizona
city: Fullerton
country: United States
facility: Ascada Health PC
state: California
city: San Francisco
country: United States
facility: Optimus Medical Group
state: California
city: Bradenton
country: United States
facility: Synergy Healthcare
state: Florida
city: Brandon
country: United States
facility: MOORE Clinical Research, Inc.
state: Florida
city: Brandon
country: United States
facility: TrueBlue Clinical Research
state: Florida
city: Coral Gables
country: United States
facility: Herco Medical and Research Center Inc
state: Florida
city: Cutler Bay
country: United States
facility: Advance Clinical Research Group
state: Florida
city: Cutler Bay
country: United States
facility: Beautiful Minds Clinical Research Center
state: Florida
city: Hialeah Gardens
country: United States
facility: Unlimited Medical Research Group, LLC
state: Florida
city: Hialeah
country: United States
facility: Qway Research
state: Florida
city: Hialeah
country: United States
facility: Eastern Research Inc
state: Florida
city: Hialeah
country: United States
facility: Inpatient Research Clinic
state: Florida
city: Hialeah
country: United States
facility: Doral Medical Research,LLC
state: Florida
city: Lutz
country: United States
facility: ASCLEPES Research Centers
state: Florida
city: Miami Gardens
country: United States
facility: Pro-Care Research Center, Corp.
state: Florida
city: Miami Lakes
country: United States
facility: Savin Medical Group, LLC
state: Florida
city: Miami
country: United States
facility: Angels Clinical Research Institute
state: Florida
city: Miami
country: United States
facility: LCC Medical Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: Premium Medical Research Corp
state: Florida
city: Miami
country: United States
facility: Global Health Clinical Trials Corp
state: Florida
city: Miami
country: United States
facility: South Florida Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: University of Miami Health System
state: Florida
city: Miami
country: United States
facility: I.V.A.M. Clinical & Investigational Center, LLC
state: Florida
city: Miami
country: United States
facility: Medical Research of Westchester Inc
state: Florida
city: Miami
country: United States
facility: C'A Research
state: Florida
city: Miami
country: United States
facility: ProLive Medical Research, Corp.
state: Florida
city: Miami
country: United States
facility: Entrust Clinical Research
state: Florida
city: Miami
country: United States
facility: Reed Medical Research
state: Florida
city: Miami
country: United States
facility: Kendall South Medical Center, Inc.
state: Florida
city: Miami
country: United States
facility: Clinical Site Partners, Inc dba CSP Miami
state: Florida
city: Miami
country: United States
facility: Coral Research Clinic Corp
state: Florida
city: Orlando
country: United States
facility: Omega Research Orlando
state: Florida
city: Pompano Beach
country: United States
facility: NAPA Research LLC
state: Florida
city: Port Saint Lucie
country: United States
facility: CDC Research Institute, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: GCP, Global Clinical Professionals
state: Florida
city: South Miami
country: United States
facility: USPA Advance Concept Medical Research Group LLC
state: Florida
city: Spring Hill
country: United States
facility: ASCLEPES Research Centers
state: Florida
city: Sunrise
country: United States
facility: Sunrise Research Institute
state: Florida
city: Tampa
country: United States
facility: Santos Research Center, CORP
state: Florida
city: Chicago
country: United States
facility: Research by Design, LLC
state: Illinois
city: Ames
country: United States
facility: Accellacare
state: Iowa
city: Ames
country: United States
facility: McFarland Clinic, PC
state: Iowa
city: Metairie
country: United States
facility: Southern Clinical Research Associates. LLC
state: Louisiana
city: Grand Island
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research Inc
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: Walmart
state: Nevada
city: Las Vegas
country: United States
facility: Excel Clinical research
state: Nevada
city: Las Vegas
country: United States
facility: Walgreens
state: Nevada
city: New York
country: United States
facility: NYC Health + Hospitals / Harlem
state: New York
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Wilmington
country: United States
facility: Innovo Research: Wilmington Health
state: North Carolina
city: Amarillo
country: United States
facility: PharmaTex Research, LLC
state: Texas
city: Conroe
country: United States
facility: Conroe Willis Medical Research
state: Texas
city: Corpus Christi
country: United States
facility: South Texas Clinical Research
state: Texas
city: Houston
country: United States
facility: SingnatureCare Emergency Center
state: Texas
city: Houston
country: United States
facility: Trio Clinical Trials, LLC
state: Texas
city: Houston
country: United States
facility: C & R Research Services USA
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research, LLC
state: Texas
city: Red Oak
country: United States
facility: Epic Medical Research
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute
state: Texas
city: Webster
country: United States
facility: Tranquility Research
state: Texas
city: Zarate
country: Argentina
facility: Instituto de Investigaciones Clinicas Zarate
state: Buenos Aires
city: Rosario
country: Argentina
facility: Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos)
state: Santa FE
city: Santo André
country: Brazil
facility: Pesquisare Saude S/S Ltda
state: SP
city: São Paulo
country: Brazil
facility: Conjunto Hospitalar do Mandaqui
city: Haskovo
country: Bulgaria
facility: "Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd
city: Kozloduy
country: Bulgaria
facility: MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD
city: Lom
country: Bulgaria
facility: Diagnostic-Consultative Center I Lom EOOD
city: Lom
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD
city: Lovech
country: Bulgaria
facility: Medical centre Leo Clinic EOOD
city: Pleven
country: Bulgaria
facility: MHAT Heart and Brain EAD
city: Plovdiv
country: Bulgaria
facility: DCC Sveti Georgi EOOD
city: Plovdiv
country: Bulgaria
facility: MHAT "St. Panteleimon "- Plovdiv
city: Ruse
country: Bulgaria
facility: UMHAT Medica Ruse OOD
city: Samokov
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Samokov EOOD
city: Sliven
country: Bulgaria
facility: Multiprofile hospital for active treatment - Sliven to Military Medical Academy
city: Sofia
country: Bulgaria
facility: Diagnostic-Consultative Center XXII- Sofia ЕООD
city: Sofia
country: Bulgaria
facility: UMHATEM N. I. Pirogov EAD
city: Stara Zagora
country: Bulgaria
facility: Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD
city: Varna
country: Bulgaria
facility: Medical center Leo Clinic EOOD
city: Veliko Tarnovo
country: Bulgaria
facility: MOBAL "D-r Stefan Cherkezov" AD
city: Vratsa
country: Bulgaria
facility: Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD
city: Barranquilla
country: Colombia
facility: Clinica de la Costa LTDA.
state: Atlantico
city: Yopal
country: Colombia
facility: Caimed S.A.S.
state: Casanare
city: Bogota
country: Colombia
facility: Cireem Sas
state: Cundinamarca
city: Brno
country: Czechia
facility: Doktor Brno s.r.o.
city: Protivín
country: Czechia
facility: Zdraví-Fit, s.r.o.
city: Slany
country: Czechia
facility: Nemocnice Slany
city: Nyiregyhaza
country: Hungary
facility: Medifarma-98 Kft.
city: Narita
country: Japan
facility: International University of Health and Welfare Narita Hospital
state: Chiba
city: Kyoto-shi
country: Japan
facility: Rakuwakai Otowa Hospital
state: Kyoto
city: Izumisano
country: Japan
facility: Rinku General Medical Center
state: Osaka
city: Ota
country: Japan
facility: Denenchofu Family Clinic
state: Tokyo
city: Toshimaku
country: Japan
facility: Sekino Hospital
state: Tokyo
city: Miri
country: Malaysia
facility: Hospital Miri
state: Sarawak
city: Tijuana
country: Mexico
facility: InfectoLab Consultorios de Especialidad en Infectologia
state: BAJA California
city: Saltillo
country: Mexico
facility: Clinical Research Institute Saltillo S.A. de C.V.
state: Coahuila
city: Guadalajara
country: Mexico
facility: Instituto Jalisciense de Metabolismo, S.C.
state: Jalisco
city: Monterrey
country: Mexico
facility: Eukarya Pharmasite S.C.
state: Nuevo LEON
city: Monterrey
country: Mexico
facility: Christus- Latam Hub Center of Excellence and Innovation Center S.C.
state: Nuevo LEÓN
city: Mérida
country: Mexico
facility: EME RED Hospitalaria
state: Yucatán
city: Durango
country: Mexico
facility: Instituto de Investigaciones Clinicas para la Salud A.C.
city: Veracruz
country: Mexico
facility: FAICIC Clinical Research
city: Veracruz
country: Mexico
facility: Sociedad de Metabolismo y Corazon S.C.
city: Wroclaw
country: Poland
facility: Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska
city: Kirovsk
country: Russian Federation
facility: Kirovsk Interdistrict Hospital
state: Leningrad Region
city: Odintsovo
country: Russian Federation
facility: LLC Trekhgorka Medicine
state: Moscow Region
city: Pyatigorsk
country: Russian Federation
facility: Clinica UZI 4D
state: Stavropol Region
city: Barnaul
country: Russian Federation
facility: Barnaul City Hospital Number 5
city: Korolev
country: Russian Federation
facility: Korolev Medicine
city: Moscow
country: Russian Federation
facility: KDC "Evromedservis", OJSC
city: Saint Petersburg
country: Russian Federation
facility: City Polyclinic #44
city: Saint Petersburg
country: Russian Federation
facility: LLC Strategic Medical Systems
city: Saint-Petersburg
country: Russian Federation
facility: City Polyclinic No. 109
city: Saint-Petersburg
country: Russian Federation
facility: City Out-patient clinic #112
city: Saint-Petersburg
country: Russian Federation
facility: "Research Center Eco-safety" LLC
city: Saint-Petersburg
country: Russian Federation
facility: LLC Kurator
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budgetary Healthcare Institution "City Pokrovskaya hospital"
city: Saint-Petersburg
country: Russian Federation
facility: City Out-patient clinic #4
city: Smolensk
country: Russian Federation
facility: Smolensk State Medical University
city: Yekaterinburg
country: Russian Federation
facility: LLC Family clinic
city: Welkom
country: South Africa
facility: MERC Welkom
state: FREE State
city: Benoni
country: South Africa
facility: Worthwhile Clinical Trials
state: Gauteng
city: Johannesburg
country: South Africa
facility: LCS Clinical Research
state: Gauteng
city: Kempton Park
country: South Africa
facility: Peermed CTC (Pty) Ltd T/A MERC Kempton
state: Gauteng
city: Pretoria
country: South Africa
facility: Global Clinical Trials
state: Gauteng
city: Pretoria
country: South Africa
facility: Botho Ke Bontle Health Services
state: Gauteng
city: Pretoria
country: South Africa
facility: About Allergy (PTY) Ltd
state: Gauteng
city: Pretoria
country: South Africa
facility: Into Research
state: Gauteng
city: Pretoria
country: South Africa
facility: Clinical Trial Systems (Pty) Ltd
state: Gauteng
city: Sandton
country: South Africa
facility: Sandton Medical Clinic
state: Gauteng
city: Durban
country: South Africa
facility: Dr PJ Sebastian Clinical Research Centre
state: Kwa-zulu Natal
city: Durban
country: South Africa
facility: Synapta Clinical Research Center
state: Kwazulu Natal
city: Mayville, Durban
country: South Africa
facility: Ahmed Al-Kadi Private Hospital
state: Kwazulu-natal
city: Thabazimbi
country: South Africa
facility: Limpopo Clinical Research Initiative
state: Limpopo
city: Thohoyandou
country: South Africa
facility: NHC Thohoyandou CRS
state: Limpopo
city: Middelburg
country: South Africa
facility: MERC Middelburg
state: Mpumalanga
city: Brits
country: South Africa
facility: Madibeng Centre for Research
state: North WEST
city: Vereeniging
country: South Africa
facility: FCRN Clinical Trial Centre
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario da Coruna
city: Pathumwan
country: Thailand
facility: The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),
state: Bangkok
city: Muang
country: Thailand
facility: Faculty of Medicine - Khon Kaen University
state: Khon Kaen
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Bangkok
country: Thailand
facility: Faculty of Tropical Medicine, Mahidol University
city: Bangkok
country: Thailand
facility: Tropical Medicine Hospital
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty, Ibni-Sina Hospital
city: Fatih / Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty
city: Gaziantep
country: Turkey
facility: Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi
city: Istanbul
country: Turkey
facility: Acibadem University Atakent Hospital
city: Izmir
country: Turkey
facility: Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Trabzon
country: Turkey
facility: Karadeniz Teknik Universitesi Farabi Hastanesi
city: Chernivtsi
country: Ukraine
facility: Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital"
city: Chernivtsi
country: Ukraine
facility: Communal non-commercial Enterprise "City Central Clinical Hospital" of Chernivtsi City Council
city: Dnipro
country: Ukraine
facility: Communal non-profit enterprise "City Clinical Hospital #16" of Dnipro City Council
city: Ivano-Frankivsk
country: Ukraine
facility: Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council"
city: Ivano-Frankivsk
country: Ukraine
facility: Municipal Non-profit Enterprise "Ivano-Frankivsk Regional Phthisiopulmonology Center of
city: Kharkiv
country: Ukraine
facility: Municipal Nonprofit Enterprise "City Student Hospital" of Kharkiv City Council
city: Kharkiv
country: Ukraine
facility: Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases
city: Kharkiv
country: Ukraine
facility: Municipal Nonprofit Enterprise "City Clinic Hospital # 13" of Kharkiv City Council
city: Kyiv
country: Ukraine
facility: Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company
city: Lviv
country: Ukraine
facility: Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"
city: Lviv
country: Ukraine
facility: Municipal NonProfit Enterprise of the Lviv Regional Council Lviv Regional Information and Analytical
city: Lviv
country: Ukraine
facility: Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4"
city: Poltava
country: Ukraine
facility: Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional
city: Tarasove Village
country: Ukraine
facility: Municipal Enterprise "Volyn Regional Clinical Hospital" of Volyn Regional Council
city: Zhytomyr
country: Ukraine
facility: Communal Enterprise "Hospital #1" of Zhytomyr City Council
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: