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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05047601
• Other study ID #: C4671006
• Secondary ID: 2021-002894-24EP
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 9, 2021
• Est. completion date: April 12, 2022

Study information

• Verified date: April 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2954
• Est. completion date: April 12, 2022
• Est. primary completion date: April 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• PF-07321332
PF-07321332
• Placebo for PF-07321332
Placebo
• Placebo for Ritonavir
Placebo
• Ritonavir
Ritonavir

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  Colombia,  Czechia,  Hungary,  Japan,  Malaysia,  Mexico,  Poland,  Russian Federation,  South Africa,  Spain,  Thailand,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of participants who developed symptomatic Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) or Rapid Antigen Test (RAT) confirmed SARS-Cov-2 infection were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.	From Day 1 to Day 14
Secondary	Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious AEs and AEs Leading to Study and Study Drug Discontinuation	An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening ; required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity ; congenital anomaly/birth defect; or that was considered as an important medical event. TEAEs were defined as events that started on or after the study medication start date and time. AEs included both serious and all non-serious adverse events. AEs that led to study discontinuation and AEs that led to discontinuation of study intervention and then continued study were also reported in this outcome measure.	From start of study intervention (Day 1) up to end of safety follow-up (Day 38)
Secondary	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	Percentage of participants who had a symptomatic RT-PCR or RAT confirmed SARS-Cov-2 infection were reported in this outcome measure. The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities. Index case was defined as participants with symptomatic COVID-19.	From Day 1 to Day 14
Secondary	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	The risk factors associated with severe covid-19 illness included age greater than or equal to 60 years, body mass index greater than 25, social history of smoking and presence of comorbidities.	From Day 1 to Day 28
Secondary	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	Percentage of participants who had asymptomatic RT-PCR or RAT confirmed SARS-CoV-2 infection through day 14 among participants with negative RT-PCR at baseline were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.	From Day 1 to Day 14
Secondary	Time to RT-PCR or RAT Confirmed SARS-CoV-2 Infection Through Day 14: Among Participants With Negative RT-PCR at Baseline	Number of days between first dose and confirmation of the SARS-CoV-2 infection by RT-PCR or RAT was reported in this outcome measure.	From Day 1 to Day 14
Secondary	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	Percentage of participants with a positive RT-PCR result at baseline who had a symptomatic SARS-CoV-2 infection confirmed by RAT or RT-PCR through Day 14 were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.	From Day 1 to Day 14
Secondary	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	Percentage of participants with a negative, positive, or missing RT-PCR result at baseline, who had a symptomatic SARS-CoV-2 infection confirmed by RAT or RT-PCR through Day 14 were reported in this outcome measure. Index case was defined as participants with symptomatic COVID-19.	From Day 1 to Day 14
Secondary	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	Participants were categorized according to severity of signs and symptoms as no, mild, moderate, severe in this outcome measure. The 12 signs and symptoms included stuffy or runny nose, sore throat, shortness of breath or difficulty breathing, cough, low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, nausea, vomiting, diarrhea. Participants recorded their daily severity rating of their symptoms over the past 24 hours based on a 4-point scale in which 0 was reported if no symptoms were present; 1 if mild; 2 if moderate; and 3 if severe.	From Day 1 to Day 28
Secondary	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	This outcome measure has been reported in terms of number of participants according to days of symptomatic SARS-CoV-2 infection through Day 28.	From Day 1 to Day 28
Secondary	Plasma Concentration Versus Time Summary of Nirmatrelvir (PF-07321332)		Day 1: 1 hour post dose; Day 5: 2 hours pre-dose
Secondary	Percentage of Participants With Death Event Through Day 38: Among Participants With Negative RT-PCR at Baseline	Percentage of participants with death (all-cause) event were reported in this outcome measure.	From Day 1 to Day 38
Secondary	Viral Load in Nasal Samples Over Time: Among Participants With Negative RT-PCR at Baseline	Nasal samples were collected to estimate the viral load in terms of logarithm to base 10 (log10) copies per milliliter in participants with negative RT-PCR at baseline and were reported in this outcome measure.	From Day 1 to Day 14
Secondary	Viral Load in Nasal Samples Over Time: Among Participants With Positive RT-PCR at Baseline	Nasal samples were collected to estimate the viral load in terms of logarithm to base 10 (log10) copies per milliliter in participants with positive RT-PCR at baseline and were reported in this outcome measure.	From Day 1 to Day 14
Secondary	Number of Days of Hospitalization and Intensive Care Unit (ICU) Stay: Among Participants With Negative RT-PCR at Baseline	This outcome measure has been presented in terms of participants according to number of days of hospitalization and in ICU as 0 days and more than or equal to 1 day.	From Day 1 to Day 28
Secondary	Number of COVID-19 Related Medical Visits Through Day 28: Among Participants With Negative RT-PCR at Baseline	In this outcome measure number of COVID-19 related medical visits per day were reported. Number of medical visits per day = number of medical visits/number of days follow up through day 28 visit or the last collection date on or before day 28, if day 28 visit was missing.	From Day 1 to Day 28

External Links

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