Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR).

COVID-19 Clinical Trial

Official title:

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2 ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF 07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT LOW RISK OF PROGRESSING TO SEVERE ILLNESS

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05011513
• Other study ID #: C4671002
• Secondary ID: 2021-002857-28EP
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: August 25, 2021
• Est. completion date: July 25, 2022

Study information

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

Clinical Trial Summary

The primary hypothesis to be tested is whether or not there is a difference in time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28 between PF-07321332/ritonavir and placebo.

Description:

Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or at another non-clinic location, if available. The total study duration is up to 24 weeks.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1440
• Est. completion date: July 25, 2022
• Est. primary completion date: July 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed SARS-CoV-2 infection 5 days prior to randomization

• Initial onset of COVID-19 signs/symptoms within 5 days of randomization

• Fertile participants must agree to use a highly effective method of contraception

Exclusion Criteria:

• Has at least one underlying medical condition associated with an increased risk of developing severe illness from COVID-19

• History of or need for hospitalization for the medical treatment of COVID-19

• Prior diagnosis of SARS-CoV-2 infection (reinfection)

• Known medical history of liver disease

• Receiving dialysis or have known renal impairment

• Known Human Immunodeficiency Virus (HIV) infection with viral load > 400 copies/ml or taking prohibited medications for HIV treatment

• Suspected or confirmed concurrent active systemic infection other than COVID-19

• 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 or is expected to receive monoclonal antibody treatment or convalescent COVID-19 plasma

• Has received any SARS-CoV-2 vaccine within 12 months of screening

• Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19

• Known prior participation in this trial or other trial involving PF-07321332

• Oxygen saturation of < 92% on room air

• Females who are pregnant or breastfeeding

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• PF-07321332
PF-07321332 (tablet)
• Ritonavir
Ritonavir (capsule)
• Placebo
Placebo (tablet)
• Placebo
Placebo (capsule)

Locations

Country	Name	City	State
Argentina	Hospital Privado Centro Médico de Córdoba	Córdoba
Argentina	Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos)	Rosario	Santa FE
Argentina	Clinica Mayo Urgencias Medicas Cruz Blanca SRL	San Miguel de Tucuman	Tucuman
Argentina	Hospital de Clinicas Presidente Nicolas Avellaneda	San Miguel de Tucuman	Tucuman
Argentina	Instituto de Investigaciones Clinicas Zarate	Zarate	Buenos Aires
Brazil	Hospital Dia do Pulmao	Blumenau	SC
Brazil	CECOR - Centro Oncológico de Roraima	Boa Vista	Roraima/rr
Brazil	Chronos Pesquisa Clinica	Brasilia	Distrito Federal
Brazil	Hospital e Maternidade Celso Pierro - PUC Campinas / Sociedade Campineira de Educação e Instruçã	Campinas	SP
Brazil	CECIP JAÚ - Centro de Estudos Clínicos do Interior Paulista - LTDA	Jau	SAO Paulo
Brazil	Centro de Estudos e Pesquisas em Moléstias Infecciosas	Natal	RIO Grande DO Norte
Brazil	Hospital De Clinicas De Porto Alegre	Porto Alegre	RIO Grande DO SUL
Brazil	Hospital Agamenon Magalhaes	Recife	Pernambuco
Brazil	IBPClin - Instituto Brasil de Pesquisa Clínica	Rio de Janeiro	RJ
Brazil	Instituto Nacional de Infectologia Evandro Chagas - INI/FIOCRUZ	Rio de Janeiro	RJ
Brazil	CEMEC - Centro Multidisciplinar de Estudos Clínicos	São Bernardo do Campo	SÃO Paulo
Brazil	Hospital Alemão Oswaldo Cruz	São Paulo	SP
Brazil	Instituto de Infectologia Emilio Ribas	São Paulo
Brazil	Unidade Referenciada Oswaldo Cruz Vergueiro	São Paulo	SP
Brazil	Clinica de Alergia Martti Antila	Sorocaba	SÃO Paulo
Bulgaria	Individual Practice for Primary Medical Care - IPPMC - Dr. P. Panayotov EOOD	Burgas
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	Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD	Razgrad
Bulgaria	"Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -	Ruse
Bulgaria	Multiprofile Hospital for Active Treatment - Samokov EOOD	Samokov
Bulgaria	Medical Center-1-Sevlievo EOOD	Sevlievo
Bulgaria	Multiprofile hospital for active treatment - Sliven to Military Medical Academy	Sliven
Bulgaria	Diagnostic-Consultative Center XXII- Sofia ???D	Sofia
Bulgaria	MHAT "St. Sofia" EOOD	Sofia
Bulgaria	UMHATEM N. I. Pirogov EAD	Sofia
Bulgaria	Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD	Stara Zagora
Bulgaria	Multiprofile Hospital for Active Treatment Targovishte AD	Targovishte
Bulgaria	Outpatient Clinic for Primary Outpatient Medical Care "Puls" - Dr. Mladen Buchvarov EOOD	Tsarevo
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	Fundacion Cardiomet Cequin	Armenia	Quindio
Colombia	Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S	Bogota	Cundinamarca
Colombia	Fundacion Centro de Investigacion Clinica CIC	Medellin	Antioquia
Czechia	Zdraví-Fit, s.r.o.	Protivín
Czechia	Nemocnice Slany	Slany
Hungary	Trial Pharma Kft.	Bekescsaba
Hungary	Semmelweis University Varosmajori Sziv Es Ergyogyaszati Klinika	Budapest
Hungary	Varosmajori Sziv- es Ergyogyaszati Klinika	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika	Debrecen
Hungary	Agria-Study Kft.	Eger
Hungary	Trial Pharma Kft.	Gyula
Hungary	Medifarma-98 Kft.	Nyiregyhaza
Japan	Kyushu Medical Center	Fukuoka
Japan	Rakuwakai Otowa Hospital	Kyoto-shi	Kyoto
Japan	International University of Health and Welfare Narita Hospital	Narita	Chiba
Japan	Tokyo Shinagawa Hospital	Shinagawa-ku	Tokyo
Japan	Sekino Hospital	Toshimaku	Tokyo
Korea, Republic of	Chonnam National University Bitgoeul Hospital	Gwangju
Korea, Republic of	Boramae Medical Center	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Malaysia	Hospital Raja Perempuan Zainab II	Kota Bharu	Kelantan
Malaysia	Hospital Miri	Miri	Sarawak
Malaysia	Klinik Kesihatan Kuang	Rawang	Selangor
Malaysia	Hospital Taiping	Taiping	Perak
Mexico	JM Research SC	Cuernavaca	Morelos
Mexico	Instituto de Investigaciones Clínicas para la Salud	Durango
Mexico	Kohler & Milstein Research S.A. De C.V.	Merida	Yucatan
Mexico	EME RED Hospitalaria	Mérida	Yucatán
Mexico	Christus - Latam Hub Center of Excellence and Innovation Center S.C.	Monterrey	Nuevo LEON
Mexico	Eukarya Pharmasite S.C.	Monterrey	Nuevo LEON
Mexico	Oaxaca Site Management Organization	Oaxaca de Juarez	Oaxaca
Mexico	Asociación Mexicana para la Investigación Clínica A.C.	Pachuca de Soto	Hidalgo
Mexico	Clinical Research Institute S.C.	Saltillo	Coahuila
Mexico	FAICIC Clinical Research	Veracruz
Mexico	Sociedad de Metabolismo y Corazon S.C.	Veracruz
Poland	KLIMED Marek Klimkiewicz	Bialystok
Poland	Tomasz Blicharski Lubelskie Centrum Diagnostyczne	Swidnik
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warszawa
Poland	Centrum Badan Klinicznych Piotr Napora Lekarze Spólka Partnerska	Wroclaw
Puerto Rico	Clinical Research Management Group Inc	Ponce
Puerto Rico	Advance Medical Research Center	San Juan
Romania	Delta Health Care srl	Bucuresti
Slovakia	HODOSI - MED, s.r.o.	Moldava nad Bodvou
Slovakia	MUDr. Viliam Cibik, PhD., s.r.o.	Pruske
Slovakia	Plucna ambulancia Hrebenar, s.r.o.	Spisska Nova Ves
Slovakia	ALERGIA s.r.o.	Topolcany
South Africa	Worthwhile Clinical Trials	Benoni	Gauteng
South Africa	Reimed Vosloorus	Boksburg	Gauteng
South Africa	Dr PJ Sebastian Clinical Research Centre	Durban	Kwa-zulu Natal
South Africa	Synapta Clinical Research Center	Durban	Kwazulu Natal
South Africa	TASK Eden	George	Western CAPE
South Africa	Global Clinical Trials	Gqeberha	Eastern CAPE
South Africa	Lenasia Clinical Trial Centre	Johannesburg	Gauteng
South Africa	Ahmed Al-Kadi Private Hospital	Mayville, Durban	Kwazulu-natal
South Africa	Be Part Research Pty (Ltd)	Paarl	Western CAPE
South Africa	Botho Ke Bontle Health Services	Pretoria	Gauteng
South Africa	Clinical Trial Systems (Pty) Ltd	Pretoria	Gauteng
South Africa	Sandton Medical Clinic	Sandton	Gauteng
South Africa	FCRN Clinical Trial Centre	Vereeniging	Gauteng
Spain	Complexo Hospitalario Universitario da Coruna	A Coruna
Spain	Complexo Hospitalario Universitario da Coruna	A Coruña
Spain	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona
Spain	IMED Valencia	Burjassot	Valencia
Spain	Eba Centelles	Centelles	Barcelona [barcelona]
Spain	Hospital Universitario de la Paz	Madrid
Spain	Hospital Universitario Virgen de Valme	Sevilla
Spain	Hospital Alvaro Cunqueiro	Vigo	Pontevedra
Thailand	Siriraj Hospital, Mahidol University	BangkokNoi	Bangkok
Thailand	Riverside Bangkok Hotel	Bangplud	Bangkok
Thailand	Bangkok Centre Hotel	Bangrak	Bangkok
Thailand	Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University,	Hat Yai	Songkhla
Thailand	Khon Kaen Univerisity Field Hospital, Student Dormitory 26, Khon Kaen University	Khon Kaen
Thailand	Srinagarind Hospital	Khon Kaen
Thailand	The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT),	Pathumwan	Bangkok
Thailand	Thai Red Cross Emerging Infectious Diseases (EDI) Clinic	Pathumwan,	Bangkok
Thailand	Baiyoke Suite Hotel	Ratchathewi	Bangkok
Turkey	Ankara University Medical Faculty, Ibni-Sina Hospital	Ankara
Turkey	Hacettepe University Medical Faculty Hospital	Ankara
Turkey	Akdeniz Universitesi Hastanesi	Antalya
Turkey	Cukurova University Medical Faculty	Balcali	Adana
Turkey	Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi	Gaziantep
Turkey	Acibadem University Atakent Hospital	Istanbul
Turkey	Basaksehir Cam ve Sakura Sehir Hastanesi	Istanbul
Turkey	Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty	Istanbul
Turkey	Istanbul University Istanbul Medical Faculty	Istanbul
Turkey	Medipol Mega University Hospital	Istanbul
Turkey	Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital	Izmir
Turkey	Kocaeli University Medical Faculty	Kocaeli
Turkey	Mersin University Medical Faculty	Mersin
Turkey	Sakarya University Training and Research Hospital	Sakarya
Turkey	Karadeniz Teknik Universitesi Farabi Hastanesi	Trabzon
Ukraine	Communal non-commercial Enterprise "City Clinical Hospital ?3" of Chernivtsi City Council	Chernivtsi
Ukraine	Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital"	Chernivtsi
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 "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of	Ivano-Frankivsk
Ukraine	Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases	Kharkiv
Ukraine	Kyiv Railway Clinical Hospital No.2 of Branch "Health Center of the Public Joint Stock Company	Kyiv
Ukraine	Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the Kyiv	Kyiv
Ukraine	Municipal Non-profit Enterprise "Oleksandrivska Kyiv City Clinical Hospital" Of Executive Body Of	Kyiv
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 Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional	Poltava
Ukraine	Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital ?1"	Vinnytsia
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	ARC Clinical Research at William Cannon	Austin	Texas
United States	St Hope Foundation	Bellaire	Texas
United States	Synergy Healthcare	Bradenton	Florida
United States	MOORE Clinical Research, Inc.	Brandon	Florida
United States	TrueBlue Clinical Research	Brandon	Florida
United States	Mercury Street Medical Group, PLLC	Butte	Montana
United States	Hope Clinical Research	Canoga Park	California
United States	Future Innovative Treatments, LLC	Colorado Springs	Colorado
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	Omega Research Orlando, LLC	DeBary	Florida
United States	Lightship	El Segundo	California
United States	Ascada Research	Fullerton	California
United States	Doral Medical Research, LLC	Hialeah	Florida
United States	Eastern Research Inc	Hialeah	Florida
United States	Inpatient Research Clinic	Hialeah	Florida
United States	Unlimited Medical Research Group, LLC	Hialeah Gardens	Florida
United States	Next Level Urgent Care	Houston	Texas
United States	SignatureCare Emergency Center	Houston	Texas
United States	Trio Clinical Trials, LLC	Houston	Texas
United States	Atella Clinical Research LLC.	La Palma	California
United States	Excel Clinical research	Las Vegas	Nevada
United States	Ark Clinical Research	Long Beach	California
United States	ASCLEPES Research Centers	Lutz	Florida
United States	New Orleans Sinus Center (COVID-19 Testing)	Marrero	Louisiana
United States	Tandem Clinical Research GI, LLC	Marrero	Louisiana
United States	The Institute for Liver Health dba Arizona Clinical Trials	Mesa	Arizona
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 d/b/a 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	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	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	TMPG Clinical Research	Newport News	Virginia
United States	TPMG Clinical Research	Newport News	Virginia
United States	Omega Research Orlando, LLC	Orlando	Florida
United States	LinQ Research, LLC	Pearland	Texas
United States	Cahaba Research Inc	Pelham	Alabama
United States	CDC Research Institute	Port Saint Lucie	Florida
United States	Epic Medical Research	Red Oak	Texas
United States	South Bay Clinical Research Institute	Redondo Beach	California
United States	Benchmark Research	Sacramento	California
United States	GCP, Global Clinical Professionals	Saint Petersburg	Florida
United States	BFHC Research	San Antonio	Texas
United States	Endeavor Clinical Trials, LLC	San Antonio	Texas
United States	Optimus Medical Group	San Francisco	California
United States	AXCES Research Group	Santa Fe	New Mexico
United States	Matrix Mobile Health Clinic #49, #35, and #62	Scottsdale	Arizona
United States	Avera McKennan Hospital & University Health Center	Sioux Falls	South Dakota
United States	Avera Research Institute	Sioux Falls	South Dakota
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	Hope Clinical Research (COVID Satellite Site)	West Hills	California
United States	Accellacare	Wilmington	North Carolina
United States	Innovo Research: Wilmington Health	Wilmington	North Carolina
United States	Clinical Site Partners, Inc. dba CSP Orlando	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Bulgaria,  Colombia,  Czechia,  Hungary,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Poland,  Puerto Rico,  Romania,  Slovakia,  South Africa,  Spain,  Thailand,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Sustained Alleviation of Overall COVID-19 Signs and Symptoms Through Day 28	Sustained alleviation of targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. Missing severity at baseline was considered as mild. Time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28, was calculated as time (days) from start of study intervention or placebo (Day 1) until sustained alleviation of all targeted COVID-19 associated signs and symptoms. In this outcome measure time to sustained alleviation is reported consolidated for overall COVID-19 signs and symptoms.	From Day 1 to Day 28
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 or clinical study 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 Day 34
Secondary	Percentage of Participants With COVID-19 Related Hospitalization or Death From Any Cause Through Day 28	Percentage of participants with COVID-19 related hospitalization or death from any cause during the first 28 days of the study was estimated using the Kaplan-Meier (KM) method.	From Day 1 to Day 28
Secondary	Percentage of Participants With Death Through Week 24	Percentage of participants with death (all-cause) event were reported in this outcome measure.	From Day 1 to Week 24
Secondary	Number of COVID-19 Related Medical Visits Per Day Through Day 28	Number of COVID-19 related medical visits per day were reported in this outcome measure.	From Day 1 to Day 28
Secondary	Duration of Hospitalization and Intensive Care Unit (ICU) Stay Through Day 28		From Day 1 to Day 28
Secondary	Percentage of Participants With Severe Signs and Symptoms of COVID-19 Through Day 28	Participants recorded a daily severity rating of their symptom severity 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. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Vomiting and diarrhea each was rated on a 4-point frequency scale where 0 was reported for no occurrence, 1 for 1 to 2 times, 2 for 3 to 4 times, and 3 for 5 or greater. Sense of smell and sense of taste each be rated on a 3-point Likert scale where 0 was reported if the sense of smell/taste was the same as usual, 1 if the sense of smell/taste was less than usual, and 2 for no sense of smell/taste.	From Day 1 to Day 28
Secondary	Time to Sustained Resolution of Overall COVID-19 Signs and Symptoms Through Day 28	Sustained resolution was defined as when targeted symptoms are scored as absent for 4 consecutive days. The first day of the 4 consecutive-day period was considered the first event date.	From Day 1 to Day 28
Secondary	Time to Sustained Alleviation of Each COVID-19 Signs and Symptoms Through Day 28	Sustained alleviation of targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when all symptoms scored as moderate or severe at the time of enrollment were scored as mild or absent and those scored mild or absent at the time of enrollment were scored as absent. Missing severity at baseline was treated as mild. Time to sustained alleviation of all targeted COVID-19 signs and symptoms through Day 28, was calculated as time (days) from start of study intervention or placebo (Day 1) until sustained alleviation of all targeted COVID-19 associated signs and symptoms. In this outcome measure time to sustained alleviation is reported for each COVID-19 signs and symptoms.	From Day 1 to Day 28
Secondary	Time to Sustained Resolution of Each COVID-19 Signs and Symptoms Through Day 28	Sustained resolution was defined as when targeted symptoms are scored as absent for 4 consecutive days. The first day of the 4 consecutive-day period was considered the first event date. In this outcome measure time to sustained resolution is reported consolidated for each COVID-19 signs and symptoms.	From Day 1 to Day 28
Secondary	Percentage of Participants With Progression to Worsening Status of COVID-19 Signs and Symptoms	Participants recorded a daily severity rating of their symptom severity 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. Vomiting and diarrhea was rated on a 4-point frequency scale where 0 is reported for no occurrence, 1 (mild) for 1 to 2 times, 2 (moderate) for 3 to 4 times, and 3 (severe) for 5 or greater. Progression to a worsening status for any targeted symptom was based up on increasing severity (i.e. the first time any targeted symptoms worsened after treatment relative to baseline).	From Day 1 to Day 28
Secondary	Percentage of Participants With Resting Peripheral Oxygen Saturation Greater Than or Equal to (>=) 95% at Day 1 and Day 5	Percentage of participants with a resting peripheral oxygen saturation >=95% were reported in this outcome measure.	Day 1 and Day 5
Secondary	Plasma Concentration Versus Time Summary of PF-07321332		Day 1: 1 hour post dose; Day 5: 0 minutes pre-dose
Secondary	Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Days 3, 5, 10 and 14	Nasal samples were collected to estimate the viral load in participants in terms of logarithm to base 10 (log10) copies per milliliter.	Baseline, Days 3, 5, 10 and 14

External Links

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