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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04960202
Other study ID # C4671005
Secondary ID 2021-002895-38EP
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date July 16, 2021
Est. completion date April 25, 2022

Study information

Verified date January 2023
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether PF-07321332/ritonavir is safe and effective for the treatment of adults who are ill with COVID-19 and do not need to be in the hospital, but are at an increased risk of developing severe illness. Throughout the study period, provision will be made to allow study visits to be conducted at a participant's home or another non-clinic location if available. The total study duration is up to 24 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 2246
Est. completion date April 25, 2022
Est. primary completion date December 9, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Confirmed SARS-CoV-2 infection within 5 days prior to randomization - Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of randomization and at least 1 of the specified COVID-19 signs/symptoms present on the day of randomization - Fertile participants must agree to use a highly effective method of contraception - Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19 Exclusion Criteria: - History of or need for hospitalization for the medical treatment of COVID-19 - Prior to current disease episode, any confirmed SARS-CoV-2 infection - Known medical history of active liver disease - Receiving dialysis or have known moderate to severe renal impairment - Known human immunodeficiency virus (HIV) infection with a viral load greater than 400 copies/mL or taking prohibited medications for HIV treatment - Suspected or confirmed concurrent active systemic infection other than COVID-19 - History of hypersensitivity or other contraindication to any of the components of the study intervention - Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or are strong inducers of CYP3A4 - Has received or is expected to receive convalescent COVID-19 plasma - Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day 34 visit - Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the long-term follow-up visit - Known prior participation in this trial or other trial involving PF-07321332 - Oxygen saturation of <92% on room air, or on their standard home oxygen supplementation for those who regularly receive chronic supplementary oxygen for an underlying lung condition - Females who are pregnant or breastfeeding

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Argentina Hospital De Clínicas Presidente Dr.Nicolas Avellaneda San Miguel de Tucuman Tucuman
Argentina Instituto de Investigaciones Clinicas Zarate Zarate Buenos Aires
Brazil Chronos Pesquisa Clinica Brasilia Distrito Federal
Brazil CECIP JAÚ - Centro de Estudos Clínicos do Interior Paulista - LTDA Jau SAO Paulo
Brazil Hospital Agamenon Magalhaes Recife Pernambuco
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 UMHAT Medica Ruse OOD Ruse
Bulgaria Multiprofile Hospital for Active Treatment - Samokov EOOD Samokov
Bulgaria Medical Center-1-Sevlievo EOOD Sevlievo
Bulgaria Multiprofile Hospital For Active Treatment Shumen AD Shumen
Bulgaria MHAT "Dr. Ivan Seliminski" AD, Sliven Sliven
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 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 Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD Vratsa
Colombia Fundacion Cardiomet Cequin Armenia Quindio
Czechia Zdraví-Fit, s.r.o. Protivín
Czechia Nemocnice Slany Slany
Hungary Trial Pharma Kft. Bekescsaba
Hungary Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika Debrecen
Hungary Agria-Study Kft. Eger
Hungary Trial Pharma Kft. Gyula
Hungary Medifarma-98 Kft. Nyiregyhaza
India Jawahar Lal Nehru Medical College Ajmer Rajasthan
India BGS Global Institute of Medical Sciences and Hospital Bangalore Karnataka
India Apex Hospitals Pvt Ltd Jaipur Rajasthan
India Maharaja Agrasen Superspeciality Hospital Jaipur Rajasthan
India Lisie Hospital Kochi Kerala
India Nil Ratan Sircar Medical College and Hospital Kolkata WEST Bengal
India Aakash Healthcare Private Limited New Delhi
India Sardar Patel Medical College Pavan PURI Bikaner, Rajasthan
India Jehangir Clinical Development Centre Pvt. Ltd Pune Maharashtra
India Lifepoint Research LLP Pune Maharashtra
India AIIMS Raipur Raipur Chhattisgarh
India Jupiter Hospital Vadodara Gujarat
Japan Tokyo Medical University Hachioji Medical Center Hachioji Tokyo
Japan Rinku General Medical Center Izumisano Osaka
Japan International University of Health and Welfare Narita Hospital Narita Chiba
Japan National Hokkaido Medical Center Sapporo Hokkaido
Japan National Center for Global Health and Medicine Shinjuku City Tokyo
Korea, Republic of Kyungpook National University Chilgok Hospital Daegu
Korea, Republic of Incheon Medical Center Incheon
Korea, Republic of Chonnam National University Bitgoeul Hospital Nam-gu
Korea, Republic of SMG-SNU Boramae Medical Center Seoul
Malaysia Hospital Umum Sarawak Kuching Sarawak
Malaysia Hospital Miri Miri Sarawak
Mexico Centro de Investigacion Clinica Del Pacifico SA de CV Acapulco
Mexico Hospital Cardiologica Aguascalientes Aguascalientes
Mexico InfectoLab Consultorios de Especialidad en Infectologia Baja California Tijuana
Mexico JM Research SC Cuernavaca Morelos
Mexico Instituto de Investigaciones Clínicas para la Salud Durango
Mexico Instituto Jalisciense de Metabolismo, S.C. Guadalajara Jalisco
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 Asociacion Mexicana para la Investigacion Clinica A.C. (AMIC) Pachuca de Soto Hidalgo
Mexico Clinical Research Institute Saltillo S.A. de C.V. Saltillo Coahuila
Mexico Arké SMO S.A de C.V Veracruz
Mexico FAICIC S. de R.L. de C.V. Veracruz
Mexico Sociedad de Metabolismo y Corazon S.C. Veracruz
Poland KLIMED Marek Klimkiewicz Bialystok
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
Russian Federation Barnaul City Hospital Number 5 Barnaul
Russian Federation KDC "Evromedservis", OJSC Moscow
Russian Federation LLC Trekhgorka Medicine Odintsovo Moscow Region
Russian Federation Smolensk State Medical University Smolensk
South Africa East Rand Research Centre T/A Worthwhile Clinical Trials Benoni Gauteng
South Africa Synapta Clinical Research Center Durban Kwazulu Natal
South Africa MERC Middelburg Middelburg Mpumalanga
South Africa Botho Ke Bontle Health Services Pretoria Gauteng
South Africa Limpopo Clinical Research Initiative Thabazimbi Limpopo
South Africa MERC Welkom Welkom FREE State
Spain Complexo Hospitalario Universitario da Coruna A Coruña
Spain Eba Centelles Centelles Barcelona [barcelona]
Thailand Bangkok Centre Hotel Bangrak Bangkok
Thailand Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai Songkhla
Thailand Faculty of Medicine - Khon Kaen University Muang Khon Kaen
Thailand Chula Field Hospital, Chulalongkorn University Sport center (Chantanayingyong Gymnasium) Pathum Wan District, Bangkok
Thailand The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Pathumwan Bangkok
Thailand Thai Red Cross Emerging Infectious Diseases (EDI) Clinic Pathumwan, Bangkok
Turkey Ankara University Medical Faculty, Ibni-Sina Hospital Ankara
Turkey Hacettepe University Medical Faculty Hospital Ankara
Turkey Akdeniz Universitesi Hastanesi Antalya
Turkey Istanbul Medipol University Clinical Research Ethics Committee Beykoz / Istanbul
Turkey Gaziantep University Medical Faculty Gaziantep
Turkey Acibadem Saglik Hizmetleri ve Tic.A.S, Acibadem Atakent Hastanesi Istanbul
Turkey Basaksehir Cam ve Sakura Sehir Hastanesi Istanbul
Turkey Istanbul Universitesi Klinik Arastirmalar Mukemmeliyet Uygulama ve Arastirma Merkezi Istanbul
Turkey Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty Istanbul
Turkey Istanbul Yedikule Gogus Hastaliklari ve Gogus Cerrahisi Egitim Arastirma Hastanesi Istanbul
Turkey Kocaeli University Medical Faculty Kocaeli
Turkey Sbü Dr. Suat Seren Gögüs Hastaliklari Ve Cerrahisi Egitim Ve Arastirma Hastanesi Konak/Izmir
Turkey Mersin University Health Research and Application Hospital Mersin
Turkey Sakarya University Training and Research Hospital Sakarya
Turkey Karadeniz Teknik Universitesi Farabi Hastanesi Trabzon
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 Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of Ivano-Frankivsk
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 "Municipal Non-Profit Enterprise "Alexander Clinical Hospital of Kyiv" of the Kyiv City Council Kyiv
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 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 of the Lviv Regional Council Lviv Regional Information and Analitical 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 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 ARC Clinical Research at William Cannon Austin Texas
United States St Hope Foundation Bellaire Texas
United States Xera Med Research Boca Raton Florida
United States MOORE Clinical Research, Inc. Brandon Florida
United States Mercury Street Medical Group, PLLC Butte Montana
United States Hope Clinical Research Canoga Park California
United States Research by Design, LLC Chicago Illinois
United States Premier Medical Group Clarksville Tennessee
United States Innovative Research of West Florida, Inc. Clearwater Florida
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 Meridian Clinical Research, LLC Endwell New York
United States Ascada Research Fullerton California
United States Doral Medical Research LLC. Hialeah Florida
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 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 American Institute of Research Los Angeles California
United States Advanced Pulmonary Research Institute Loxahatchee Groves 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 SMS Clinical Research Mesquite Texas
United States SMS Clinical Research, LLC Mesquite Texas
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 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 Suncoast Research Group, LLC Miami Florida
United States Savin Medical Group, LLC Miami Lakes Florida
United States Monroe Biomedical Research Monroe North Carolina
United States TPMG (Tidewater Physicians Multispecialty Group) 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 NAPA Research LLC Pompano Beach Florida
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 GCP, Global Clinical Professionals Saint Petersburg Florida
United States BFHC Research San Antonio Texas
United States Sun Research Institute San Antonio Texas
United States USPA Advance Concept Medical Research Group LLC South Miami 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 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,  India,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Poland,  Puerto Rico,  Russian Federation,  South Africa,  Spain,  Thailand,  Turkey,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat (mITT) Population 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. Using KM method, survival probability for each time interval was calculated as the number of participants surviving divided by the number of participants at risk. Participants who had the event, dropped out, or moved out were not counted as "at risk" i.e., participants who were lost were considered "censored" and were not counted in the denominator. From Day 1 to Day 28
Secondary Number of Participants With Treatment Emergent Adverse Events (TEAEs) An adverse event (AE) was any untoward medical occurrence in a participant, temporarily associated with the use of study intervention, whether or not considered related to the study intervention. Serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events. AEs included both SAEs and all non-SAEs. An AE was considered as TEAE if the event started on or after start date of study intervention. From start of study intervention (Day 1) up to end of safety follow-up (Day 34)
Secondary Number of Participants With AEs Leading to Discontinuation and Serious Adverse Events (SAEs) An AE was any untoward medical occurrence in a participant, temporarily associated with the use of study treatment, whether or not considered related to the study treatment. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/ incapacity; congenital anomaly/birth defect; a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical events. From start of study intervention (Day 1) up to end of safety follow-up (Day 34)
Secondary Percentage of Participants With Covid-19 Related Hospitalization or Death From Any Cause Through Day 28- Modified Intent-To-Treat 1 (mITT1) Population 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 method. From Day 1 to Day 28
Secondary Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population Sustained alleviation of all 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. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. From Day 1 (baseline) to Day 28
Secondary Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population Sustained alleviation of all 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. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. From Day 1 (baseline) to Day 28
Secondary Time to Sustained Alleviation of All Targeted COVID-19 Signs and Symptoms Through Day 28- Modified Intent-to-Treat 2 (mITT2) Population Sustained alleviation of all 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. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. From Day 1 (baseline) to Day 28
Secondary Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT Population Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported. From Day 1 to Day 28
Secondary Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT1 Population Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported. From Day 1 to Day 28
Secondary Percentage of Participants With Severe Covid-19 Signs and Symptoms Through Day 28- mITT2 Population Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale ranging from 0 to 3, higher scores indicated more severity. The scale was reported as 0= no symptoms, 1=mild, 2=moderate and 3=severe. A participant with severe score for any targeted symptoms post-baseline was counted as severe. Percentage of participants with severe Covid-19 signs and symptoms were reported. From Day 1 to Day 28
Secondary Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT Population Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. From Day 1 (baseline) to Day 28
Secondary Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT1 Population Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. From Day 1 (baseline) to Day 28
Secondary Time to Sustained Resolution of All Targeted COVID-19 Signs and Symptoms Through Day 28- mITT2 Population Sustained resolution was defined as when all targeted symptoms were scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. From Day 1 (baseline) to Day 28
Secondary Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT Population Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom 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. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. From Day 1 (baseline) to Day 28
Secondary Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom 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. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. From Day 1 (baseline) to Day 28
Secondary Time to Sustained Alleviation of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Sustained alleviation of each targeted COVID-19 signs/symptoms was defined as the event occurring on the first 4 consecutive days when each symptom 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. The first day of the 4 consecutive-day period was considered date of first event. Time to sustained alleviation (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained alleviation (censored), time was calculated as censoring date (last date on which symptom alleviation was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. From Day 1 (baseline) to Day 28
Secondary Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT Population Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. From Day 1 (baseline) to Day 28
Secondary Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT1 Population Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. From Day 1 (baseline) to Day 28
Secondary Time to Sustained Resolution of Each Targeted COVID-19 Signs and Symptoms- mITT2 Population Sustained resolution was defined as when each targeted symptom was scored as absent for 4 consecutive days. Time to sustained resolution (event) was calculated as first event date minus first dose date plus 1, for participants with event. For participants who completed Day 28 or discontinued the study before Day 28 without sustained resolution (censored), time was calculated as censoring date (last date on which symptom resolution was assessed) minus first dose date plus 1 or Day 25 whichever occurred first. From Day 1 (baseline) to Day 28
Secondary Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT Population Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= 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 (baseline) to Day 28
Secondary Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT1 Population Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= 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 (baseline) to Day 28
Secondary Number of Participants With Progression to a Worsening Status in 1 or More Self-reported COVID-19 Associated Symptoms Through Day 28-mITT2 Population Participants were required to record the severity of their Covid-19 symptoms over the past 24 hours daily on a 4-point scale where 0 = no symptoms; 1= mild; 2= moderate; and 3= severe. Vomiting and diarrhea were each rated on a 4-point frequency scale where 0= 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 (baseline) to Day 28
Secondary Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT Population In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation >=95% were reported. Day 1, 5
Secondary Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT1 Population In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation >=95% were reported. Day 1, 5
Secondary Percentage of Participants With a Resting Peripheral Oxygen Saturation >=95% at Days 1 and 5- mITT2 Population In this outcome measure, the percentage of participants with a resting peripheral oxygen saturation >=95% were reported. Day 1, 5
Secondary Percentage of Participants Who Died Through Week 24- mITT Population In this outcome measure, percentage of participants with death due to any cause was presented. From Day 1 up to Week 24
Secondary Percentage of Participants Who Died Through Week 24- mITT1 Population In this outcome measure, percentage of participants with death due to any cause was presented. From Day 1 up to Week 24
Secondary Percentage of Participants Who Died Through Week 24- mITT2 Population In this outcome measure, percentage of participants with death due to any cause was presented. From Day 1 up to Week 24
Secondary Plasma Concentration Versus Time Summary of PF-07321332 1 Hour post-dose on Day 1 and pre-dose on Day 5
Secondary Change From Baseline in Logarithm to Base10 (Log10) Transformed Viral Load at Day 3, 5, 10 and 14- mITT Population The viral load was measured in nasal or nasopharyngeal samples using reverse transcription polymerase chain reaction (RT-PCR). Baseline, Day 3, 5, 10 and 14
Secondary Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT1 Population The viral load was measured in nasal or nasopharyngeal samples using RT-PCR. Baseline, Day 3, 5, 10 and 14
Secondary Change From Baseline in Log10 Transformed Viral Load at Day 3, 5, 10 and 14- mITT2 Population The viral load was measured in nasal or nasopharyngeal samples using RT-PCR. Baseline, Day 3, 5, 10 and 14
Secondary Number of COVID-19 Related Medical Visits- mITT Population Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (intensive care unit [ICU] and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported. From Day 1 up to Day 34
Secondary Number of COVID-19 Related Medical Visits- mITT1 Population Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported. From Day 1 up to Day 34
Secondary Number of COVID-19 Related Medical Visits- mITT2 Population Medical visits included emergency room, practitioner's office, home healthcare services, urgent care, telephone consultation, outpatient infusion center, other, COVID-19-related-hospitalization (ICU and non-ICU stays). In this outcome measure, COVID-19-related medical visits of participants were reported. From Day 1 up to Day 34
Secondary Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT Population From Day 1 up to Day 34
Secondary Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT1 Population From Day 1 up to Day 34
Secondary Number of Days in Hospital and ICU for the Treatment of COVID-19- mITT2 Population From Day 1 up to Day 34
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