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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-002857-28 | EudraCT Number | ||
| EPIC-SR | Other Identifier | Alias Study Number |
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Enrollment ceased due to a very low rate of hospitalization or death observed in the standard-risk patient population
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07321332/ritonavir | Experimental | Orally administered PF-07321332+ritonavir |
|
| Placebo | Placebo Comparator | Orally administered Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07321332 | Drug | PF-07321332 (tablet) |
| |
| Ritonavir |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cahaba Research Inc | Pelham | Alabama | 35124 | United States | ||
| The Institute for Liver Health dba Arizona Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40788441 | Derived | Brown TM, Kanu C, Harrington M. Assessing participants' experiences with the COVID-19 symptom diary in a clinical trial. J Patient Rep Outcomes. 2025 Aug 11;9(1):99. doi: 10.1186/s41687-025-00901-5. | |
| 40592258 | Derived | Baniecki ML, Guan S, Rai DK, Yang Q, Lee JT, Hao L, Weinstein E, Hyde C, Cardin RD, Soares H, Hammond J. Integrated virologic analysis of resistance to nirmatrelvir/ritonavir in individuals across four phase 2/3 clinical studies for the treatment of COVID-19. EBioMedicine. 2025 Aug;118:105819. doi: 10.1016/j.ebiom.2025.105819. Epub 2025 Jun 30. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 1440 participants signed informed consent form. Out of which, 1296 subjects were randomized and assigned to study drug. 1288 participants were treated and remaining 8 participants were not treated.
Participants who had confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by reverse transcription polymerase chain reaction (RT-PCR) within 5 days prior to randomization were included in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nirmatrelvir 300 Milligram (mg) + Ritonavir 100 mg | Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5 |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 9, 2022 | Jul 20, 2023 |
Eligible participants with a confirmed diagnosis of SARS-CoV-2 infection will be randomized (1:1) to receive PF-07321332/ritonavir or placebo orally every 12 hours for 5 days (10 doses total).
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Double-blind
| Drug |
Ritonavir (capsule) |
|
| Placebo | Drug | Placebo (tablet) |
|
| Placebo | Drug | Placebo (capsule) |
|
| From start of study intervention (Day 1) up to Day 34 |
| 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 |
| 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 |
| 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 |
| Duration of Hospitalization and Intensive Care Unit (ICU) Stay Through Day 28 | From Day 1 to Day 28 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Plasma Concentration Versus Time Summary of PF-07321332 | Day 1: 1 hour post dose; Day 5: 0 minutes pre-dose |
| 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 |
| Mesa |
| Arizona |
| 85210 |
| United States |
| Matrix Mobile Health Clinic #49, #35, and #62 | Scottsdale | Arizona | 85258 | United States |
| The Institute for Liver Health dba Arizona Clinical Trials | Tucson | Arizona | 85712 | United States |
| Hope Clinical Research | Canoga Park | California | 91303 | United States |
| Lightship | El Segundo | California | 90245 | United States |
| Ascada Research | Fullerton | California | 92835 | United States |
| Atella Clinical Research LLC. | La Palma | California | 90623 | United States |
| Ark Clinical Research | Long Beach | California | 90806 | United States |
| South Bay Clinical Research Institute | Redondo Beach | California | 90277 | United States |
| Benchmark Research | Sacramento | California | 95864 | United States |
| Optimus Medical Group | San Francisco | California | 94102 | United States |
| Hope Clinical Research (COVID Satellite Site) | West Hills | California | 91304 | United States |
| Future Innovative Treatments, LLC | Colorado Springs | Colorado | 80907 | United States |
| Synergy Healthcare | Bradenton | Florida | 34208 | United States |
| MOORE Clinical Research, Inc. | Brandon | Florida | 33511 | United States |
| TrueBlue Clinical Research | Brandon | Florida | 33511 | United States |
| Herco Medical and Research Center Inc | Coral Gables | Florida | 33134 | United States |
| Advance Clinical Research Group | Cutler Bay | Florida | 33157 | United States |
| Beautiful Minds Clinical Research Center | Cutler Bay | Florida | 33157 | United States |
| Omega Research Orlando, LLC | DeBary | Florida | 32713 | United States |
| Eastern Research Inc | Hialeah | Florida | 33013 | United States |
| Inpatient Research Clinic | Hialeah | Florida | 33013 | United States |
| Doral Medical Research, LLC | Hialeah | Florida | 33016 | United States |
| Unlimited Medical Research Group, LLC | Hialeah Gardens | Florida | 33018 | United States |
| ASCLEPES Research Centers | Lutz | Florida | 33549 | United States |
| Angels Clinical Research Institute | Miami | Florida | 33122 | United States |
| LCC Medical Research Institute, LLC | Miami | Florida | 33126 | United States |
| Premium Medical Research Corp | Miami | Florida | 33126 | United States |
| Global Health Clinical Trials Corp | Miami | Florida | 33135 | United States |
| South Florida Research Center, Inc. | Miami | Florida | 33135 | United States |
| I.V.A.M. Clinical & Investigational Center, LLC | Miami | Florida | 33144 | United States |
| C'A Research | Miami | Florida | 33174 | United States |
| ProLive Medical Research, Corp. | Miami | Florida | 33175 | United States |
| Entrust Clinical Research | Miami | Florida | 33176 | United States |
| Reed Medical Research | Miami | Florida | 33176 | United States |
| Kendall South Medical Center, Inc. | Miami | Florida | 33185 | United States |
| Clinical Site Partners, Inc d/b/a CSP Miami | Miami | Florida | 33186 | United States |
| Coral Research Clinic Corp | Miami | Florida | 33186 | United States |
| Pro-Care Research Center, Corp. | Miami Gardens | Florida | 33014 | United States |
| Savin Medical Group, LLC | Miami Lakes | Florida | 33014 | United States |
| Omega Research Orlando, LLC | Orlando | Florida | 32808 | United States |
| CDC Research Institute | Port Saint Lucie | Florida | 34952 | United States |
| USPA Advance Concept Medical Research Group LLC | South Miami | Florida | 33143 | United States |
| ASCLEPES Research Centers | Spring Hill | Florida | 34609 | United States |
| GCP, Global Clinical Professionals | St. Petersburg | Florida | 33705 | United States |
| Sunrise Research Institute | Sunrise | Florida | 33325 | United States |
| Santos Research Center, CORP | Tampa | Florida | 33615 | United States |
| Clinical Site Partners, Inc. dba CSP Orlando | Winter Park | Florida | 32789 | United States |
| Accellacare | Ames | Iowa | 50010 | United States |
| McFarland Clinic, PC | Ames | Iowa | 50010 | United States |
| New Orleans Sinus Center (COVID-19 Testing) | Marrero | Louisiana | 70072 | United States |
| Tandem Clinical Research GI, LLC | Marrero | Louisiana | 70072 | United States |
| Southern Clinical Research Associates, LLC | Metairie | Louisiana | 70001 | United States |
| Mercury Street Medical Group, PLLC | Butte | Montana | 59701 | United States |
| Excel Clinical research | Las Vegas | Nevada | 89109 | United States |
| AXCES Research Group | Santa Fe | New Mexico | 87505 | United States |
| NYC Health + Hospitals / Harlem | New York | New York | 10037 | United States |
| Monroe Biomedical Research | Monroe | North Carolina | 28112 | United States |
| Accellacare | Wilmington | North Carolina | 28401 | United States |
| Innovo Research: Wilmington Health | Wilmington | North Carolina | 28401 | United States |
| Avera McKennan Hospital & University Health Center | Sioux Falls | South Dakota | 57105 | United States |
| Avera Research Institute | Sioux Falls | South Dakota | 57108 | United States |
| PharmaTex Research, LLC | Amarillo | Texas | 79109 | United States |
| ARC Clinical Research at William Cannon | Austin | Texas | 78745 | United States |
| St Hope Foundation | Bellaire | Texas | 77401 | United States |
| Conroe Willis Medical Research | Conroe | Texas | 77304 | United States |
| South Texas Clinical Research | Corpus Christi | Texas | 78413 | United States |
| SignatureCare Emergency Center | Houston | Texas | 77008 | United States |
| Trio Clinical Trials, LLC | Houston | Texas | 77008 | United States |
| Next Level Urgent Care | Houston | Texas | 77057 | United States |
| LinQ Research, LLC | Pearland | Texas | 77584 | United States |
| Epic Medical Research | Red Oak | Texas | 75154 | United States |
| Endeavor Clinical Trials, LLC | San Antonio | Texas | 78229 | United States |
| BFHC Research | San Antonio | Texas | 78249 | United States |
| Tranquility Research | Webster | Texas | 77598 | United States |
| TMPG Clinical Research | Newport News | Virginia | 23606 | United States |
| TPMG Clinical Research | Newport News | Virginia | 23606 | United States |
| Instituto de Investigaciones Clinicas Zarate | Zárate | Buenos Aires | B2800DGH | Argentina |
| Instituto Médico de la Fundación Estudios Clínicos (Fundación Estudios Clínicos) | Rosario | Santa Fe Province | 2000 | Argentina |
| Hospital de Clinicas Presidente Nicolas Avellaneda | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Clinica Mayo Urgencias Medicas Cruz Blanca SRL | San Miguel de Tucumán | Tucumán Province | T4000IHE | Argentina |
| Hospital Privado Centro Médico de Córdoba | Córdoba | X5016KEH | Argentina |
| Chronos Pesquisa Clinica | Brasília | Federal District | 72145-450 | Brazil |
| Hospital Agamenon Magalhaes | Recife | Pernambuco | 52051-380 | Brazil |
| IBPClin - Instituto Brasil de Pesquisa Clínica | Rio de Janeiro | Rio de Janeiro | 20241-180 | Brazil |
| Instituto Nacional de Infectologia Evandro Chagas - INI/FIOCRUZ | Rio de Janeiro | Rio de Janeiro | 21040-360 | Brazil |
| Centro de Estudos e Pesquisas em Moléstias Infecciosas | Natal | Rio Grande do Norte | 59025-050 | Brazil |
| Hospital De Clinicas De Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| CECOR - Centro Oncológico de Roraima | Boa Vista | Roraima/rr | 69304-015 | Brazil |
| Hospital Dia do Pulmao | Blumenau | Santa Catarina | 89030-101 | Brazil |
| Hospital e Maternidade Celso Pierro - PUC Campinas / Sociedade Campineira de Educação e Instruçã | Campinas | São Paulo | 13060-904 | Brazil |
| CECIP JAÚ - Centro de Estudos Clínicos do Interior Paulista - LTDA | Jaú | São Paulo | 17201-130 | Brazil |
| CEMEC - Centro Multidisciplinar de Estudos Clínicos | São Bernardo do Campo | São Paulo | 09715-090 | Brazil |
| Hospital Alemão Oswaldo Cruz | São Paulo | São Paulo | 01327-001 | Brazil |
| Unidade Referenciada Oswaldo Cruz Vergueiro | São Paulo | São Paulo | 01508-000 | Brazil |
| Clinica de Alergia Martti Antila | Sorocaba | São Paulo | 18040-425 | Brazil |
| Instituto de Infectologia Emilio Ribas | São Paulo | 01246-900 | Brazil |
| Individual Practice for Primary Medical Care - IPPMC - Dr. P. Panayotov EOOD | Burgas | 8001 | Bulgaria |
| "Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases-Haskovo" Ltd | Haskovo | 6300 | Bulgaria |
| MHAT "Sv.Ivan. Rilski'' Kozloduy EOOD | Kozloduy | 3320 | Bulgaria |
| Diagnostic-Consultative Center I Lom EOOD | Lom | 3600 | Bulgaria |
| Multiprofile Hospital for Active Treatment- Sveti Nikolay Chudotvoretz EOOD | Lom | 3600 | Bulgaria |
| Medical centre Leo Clinic EOOD | Lovech | 5500 | Bulgaria |
| MHAT Heart and Brain EAD | Pleven | 5800 | Bulgaria |
| DCC Sveti Georgi EOOD | Plovdiv | 4000 | Bulgaria |
| MHAT "St. Panteleimon "- Plovdiv | Plovdiv | 4004 | Bulgaria |
| Multiprofile Hospital for Active Treatment Sveti Ivan Rilski - Razgrad AD | Razgrad | 7200 | Bulgaria |
| "Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov - | Rousse | 7002 | Bulgaria |
| Multiprofile Hospital for Active Treatment - Samokov EOOD | Samokov | 2000 | Bulgaria |
| Medical Center-1-Sevlievo EOOD | Sevlievo | 5400 | Bulgaria |
| Multiprofile hospital for active treatment - Sliven to Military Medical Academy | Sliven | 8800 | Bulgaria |
| Diagnostic-Consultative Center XXII- Sofia ЕООD | Sofia | 1113 | Bulgaria |
| UMHATEM N. I. Pirogov EAD | Sofia | 1606 | Bulgaria |
| MHAT "St. Sofia" EOOD | Sofia | 1618 | Bulgaria |
| Specialized hospital for active treatment in pulmonology and phthisiology "Stara Zagora" EOOD | Stara Zagora | 6000 | Bulgaria |
| Multiprofile Hospital for Active Treatment Targovishte AD | Targovishte | 7700 | Bulgaria |
| Outpatient Clinic for Primary Outpatient Medical Care "Puls" - Dr. Mladen Buchvarov EOOD | Tsarevo | 8260 | Bulgaria |
| Medical center Leo Clinic EOOD | Varna | 9020 | Bulgaria |
| MOBAL "D-r Stefan Cherkezov" AD | Veliko Tarnovo | 5002 | Bulgaria |
| Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD | Vratsa | 3000 | Bulgaria |
| Fundacion Centro de Investigacion Clinica CIC | Medellín | Antioquia | 050021 | Colombia |
| Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S | Bogota | Cundinamarca | 110221 | Colombia |
| Fundacion Cardiomet Cequin | Armenia | Quindío Department | 630004 | Colombia |
| Zdraví-Fit, s.r.o. | Protivín | 398 11 | Czechia |
| Nemocnice Slany | Slaný | 274 01 | Czechia |
| Trial Pharma Kft. | Békéscsaba | 5600 | Hungary |
| Semmelweis University Varosmajori Sziv Es Ergyogyaszati Klinika | Budapest | 1122 | Hungary |
| Varosmajori Sziv- es Ergyogyaszati Klinika | Budapest | 1122 | Hungary |
| Debreceni Egyetem Klinikai Kozpont Infektologiai Klinika | Debrecen | 4031 | Hungary |
| Agria-Study Kft. | Eger | 3300 | Hungary |
| Trial Pharma Kft. | Gyula | 5700 | Hungary |
| Medifarma-98 Kft. | Nyíregyháza | 4400 | Hungary |
| International University of Health and Welfare Narita Hospital | Narita | Chiba | 286-8520 | Japan |
| Rakuwakai Otowa Hospital | Kyoto | Kyoto | 607-8062 | Japan |
| Tokyo Shinagawa Hospital | Shinagawa-ku | Tokyo | 140-8522 | Japan |
| Sekino Hospital | Toshimaku | Tokyo | 171-0014 | Japan |
| Kyushu Medical Center | Fukuoka | 810-8563 | Japan |
| Hospital Raja Perempuan Zainab II | Kota Bharu | Kelantan | 15586 | Malaysia |
| Hospital Taiping | Taiping | Perak | 34000 | Malaysia |
| Hospital Miri | Miri | Sarawak | 98000 | Malaysia |
| Klinik Kesihatan Kuang | Rawang | Selangor | 48050 | Malaysia |
| Clinical Research Institute S.C. | Saltillo | Coahuila | 25020 | Mexico |
| Asociación Mexicana para la Investigación Clínica A.C. | Pachuca | Hidalgo | 42070 | Mexico |
| JM Research SC | Cuernavaca | Morelos | 62290 | Mexico |
| Christus - Latam Hub Center of Excellence and Innovation Center S.C. | Monterrey | Nuevo León | 64060 | Mexico |
| Eukarya Pharmasite S.C. | Monterrey | Nuevo León | 64718 | Mexico |
| Oaxaca Site Management Organization | Oaxaca City | Oaxaca | 68000 | Mexico |
| EME RED Hospitalaria | Mérida | Yucatán | 97000 | Mexico |
| Kohler & Milstein Research S.A. De C.V. | Mérida | Yucatán | 97070 | Mexico |
| Instituto de Investigaciones Clínicas para la Salud | Durango | 34000 | Mexico |
| FAICIC Clinical Research | Veracruz | 91900 | Mexico |
| Sociedad de Metabolismo y Corazon S.C. | Veracruz | 91900 | Mexico |
| KLIMED Marek Klimkiewicz | Bialystok | 15-704 | Poland |
| Tomasz Blicharski Lubelskie Centrum Diagnostyczne | Świdnik | 21-040 | Poland |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | 00-728 | Poland |
| Centrum Badań Klinicznych Piotr Napora Lekarze Spółka Partnerska | Wroclaw | 51-162 | Poland |
| Clinical Research Management Group Inc | Ponce | 00780 | Puerto Rico |
| Advance Medical Research Center | San Juan | 00926 | Puerto Rico |
| Delta Health Care srl | Bucharest | 014142 | Romania |
| HODOSI - MED, s.r.o. | Moldava nad Bodvou | 04501 | Slovakia |
| MUDr. Viliam Cibik, PhD., s.r.o. | Pruské | 018 52 | Slovakia |
| Plucna ambulancia Hrebenar, s.r.o. | Spišská Nová Ves | 052 01 | Slovakia |
| ALERGIA s.r.o. | Topoľčany | 955 01 | Slovakia |
| Global Clinical Trials | Port Elizabeth | Eastern Cape | 6014 | South Africa |
| Worthwhile Clinical Trials | Benoni | Gauteng | 1500 | South Africa |
| Reimed Vosloorus | Boksburg | Gauteng | 1475 | South Africa |
| Lenasia Clinical Trial Centre | Johannesburg | Gauteng | 1820 | South Africa |
| Botho Ke Bontle Health Services | Pretoria | Gauteng | 0184 | South Africa |
| Clinical Trial Systems (Pty) Ltd | Pretoria | Gauteng | 0186 | South Africa |
| Sandton Medical Clinic | Sandton | Gauteng | 2196 | South Africa |
| FCRN Clinical Trial Centre | Vereeniging | Gauteng | 1935 | South Africa |
| Synapta Clinical Research Center | Durban | KwaZulu-Natal | 4001 | South Africa |
| Dr PJ Sebastian Clinical Research Centre | Durban | KwaZulu-Natal | 4092 | South Africa |
| Ahmed Al-Kadi Private Hospital | Mayville, Durban | KwaZulu-Natal | 4091 | South Africa |
| TASK Eden | George | Western Cape | 6530 | South Africa |
| Be Part Research Pty (Ltd) | Paarl | Western Cape | 7626 | South Africa |
| Chonnam National University Bitgoeul Hospital | Gwangju | 61748 | South Korea |
| Boramae Medical Center | Seoul | 07061 | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | 07061 | South Korea |
| Eba Centelles | Centelles | Barcelona [barcelona] | 08540 | Spain |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Alvaro Cunqueiro | Vigo | Pontevedra | 36312 | Spain |
| IMED Valencia | Burjassot | Valencia | 46100 | Spain |
| Complexo Hospitalario Universitario da Coruna | A Coruña | 15006 | Spain |
| Hospital Universitario de la Paz | Madrid | 28046 | Spain |
| Hospital Universitario Virgen de Valme | Seville | 41014 | Spain |
| Bangkok Centre Hotel | Bang Rak | Bangkok | 10500 | Thailand |
| Siriraj Hospital, Mahidol University | BangkokNoi | Bangkok | 10700 | Thailand |
| Riverside Bangkok Hotel | Bangplud | Bangkok | 10700 | Thailand |
| Thai Red Cross Emerging Infectious Diseases (EDI) Clinic | Pathumwan, | Bangkok | 10330 | Thailand |
| The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), | Pathumwan | Bangkok | 10330 | Thailand |
| Baiyoke Suite Hotel | Ratchathewi | Bangkok | 10400 | Thailand |
| Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, | Hat Yai | Changwat Songkhla | 90110 | Thailand |
| Khon Kaen Univerisity Field Hospital, Student Dormitory 26, Khon Kaen University | Khon Kaen | 40002 | Thailand |
| Srinagarind Hospital | Khon Kaen | 40002 | Thailand |
| Cukurova University Medical Faculty | Balcali | Adana | 01330 | Turkey (Türkiye) |
| Ankara University Medical Faculty, Ibni-Sina Hospital | Ankara | 06230 | Turkey (Türkiye) |
| Hacettepe University Medical Faculty Hospital | Ankara | 06230 | Turkey (Türkiye) |
| Akdeniz Universitesi Hastanesi | Antalya | 07059 | Turkey (Türkiye) |
| Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi | Gaziantep | 27310 | Turkey (Türkiye) |
| Istanbul University Istanbul Medical Faculty | Istanbul | 34093 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa-Cerrahpasa Medical Faculty | Istanbul | 34098 | Turkey (Türkiye) |
| Medipol Mega University Hospital | Istanbul | 34214 | Turkey (Türkiye) |
| Acibadem University Atakent Hospital | Istanbul | 34303 | Turkey (Türkiye) |
| Basaksehir Cam ve Sakura Sehir Hastanesi | Istanbul | 34480 | Turkey (Türkiye) |
| Izmir Suat Seren Chest Disease and Surgery Training and Research Hospital | Izmir | 35110 | Turkey (Türkiye) |
| Kocaeli University Medical Faculty | Kocaeli | 41380 | Turkey (Türkiye) |
| Mersin University Medical Faculty | Mersin | 33110 | Turkey (Türkiye) |
| Sakarya University Training and Research Hospital | Sakarya | 54100 | Turkey (Türkiye) |
| Karadeniz Teknik Universitesi Farabi Hastanesi | Trabzon | 61080 | Turkey (Türkiye) |
| Regional Communal Nonprofit Institution "Chernivtsi Regional Clinical Hospital" | Chernivtsi | 58001 | Ukraine |
| Communal non-commercial Enterprise "City Clinical Hospital №3" of Chernivtsi City Council | Chernivtsi | 58002 | Ukraine |
| Municipal Nonprofit Enterprise "Ivano-Frankivsk Regional Clinical Infectious Diseases Hospital of | Ivano-Frankivsk | 76007 | Ukraine |
| Municipal Non-profit Enterprise "Ivano-Frankivsk Regional Phthisiopulmonology Center of | Ivano-Frankivsk | 76018 | Ukraine |
| Communal nonprofit enterprise "Central City Clinical Hospital of Ivano-Frankivsk City Council" | Ivano-Frankivsk | 76025 | Ukraine |
| Municipal Nonprofit Enterprise of Kharkiv Regional Council "Regional Clinical Infectious Diseases | Kharkiv | 61096 | Ukraine |
| Municipal Non-profit Enterprise "Oleksandrivska Kyiv City Clinical Hospital" Of Executive Body Of | Kyiv | 01601 | Ukraine |
| Municipal non-commercial enterprise "Kyiv City Clinical Hospital #1" Of Executive Body Of the Kyiv | Kyiv | 02091 | Ukraine |
| Kyiv Railway Clinical Hospital No.2 of Branch "Health Center of the Public Joint Stock Company | Kyiv | 03049 | Ukraine |
| Polyclinic of Center for Medical Services and Rehabilitation of State Joint-Stock Holding Company | Kyiv | 04050 | Ukraine |
| Municipal Nonprofit Enterprise "Lviv City Clinic Hospital #4" | Lviv | 79011 | Ukraine |
| Municipal Enterprise "Poltava Regional Clinical Infectious Diseases Hospital" of Poltava Regional | Poltava | 36011 | Ukraine |
| Municipal Non-commercial Enterprise "Vinnytsia City Clinical Hospital №1" | Vinnytsia | 21029 | Ukraine |
| Communal Enterprise "Hospital #1" of Zhytomyr City Council | Zhytomyr | 10002 | Ukraine |
| 38598573 | Derived | Hammond J, Fountaine RJ, Yunis C, Fleishaker D, Almas M, Bao W, Wisemandle W, Baniecki ML, Hendrick VM, Kalfov V, Simon-Campos JA, Pypstra R, Rusnak JM. Nirmatrelvir for Vaccinated or Unvaccinated Adult Outpatients with Covid-19. N Engl J Med. 2024 Apr 4;390(13):1186-1195. doi: 10.1056/NEJMoa2309003. |
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 doses from Day 1 through Day 5.
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received. A randomized but not treated participant was excluded from the safety analyses.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Nirmatrelvir 300 mg + Ritonavir 100 mg | Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5. |
| BG001 | Placebo | Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 doses from Day 1 through Day 5. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | Modified intent-to-treat (mITT1) population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. | Posted | Median | 95% Confidence Interval | Days | From Day 1 to Day 28 |
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| 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. | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received. A randomized but not treated participant was excluded from the safety analyses. | Posted | Count of Participants | Participants | From start of study intervention (Day 1) up to Day 34 |
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| 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. | Modified Intent-To-Treat (mITT1) population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. | Posted | Number | Percentage of participants | From Day 1 to Day 28 |
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| Secondary | Percentage of Participants With Death Through Week 24 | Percentage of participants with death (all-cause) event were reported in this outcome measure. | Modified Intent-To-Treat (mITT1) population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. | Posted | Number | Percentage of participants | From Day 1 to Week 24 |
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| 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. | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. | Posted | Least Squares Mean | 95% Confidence Interval | Medical visits per day | From Day 1 to Day 28 |
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| Secondary | Duration of Hospitalization and Intensive Care Unit (ICU) Stay Through Day 28 | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. | Posted | Mean | Standard Deviation | Days | From Day 1 to Day 28 |
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| 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. | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | From Day 1 to Day 28 |
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| 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. | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. In this outcome measure time to sustained resolution is reported consolidated for overall COVID-19 signs and symptoms. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Days | From Day 1 to Day 28 |
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| 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. | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. Here, ''Number Analyzed'' signifies participants evaluable at specific rows. | Posted | Median | 95% Confidence Interval | Days | From Day 1 to Day 28 |
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| 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. | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. Here ''Overall Number of Participants Analyzed''=participants evaluable for this outcome measure and ''number analyzed''= participants evaluable at specified time points. | Posted | Median | 95% Confidence Interval | Days | From Day 1 to Day 28 |
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| 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). | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure. | Posted | Number | Percentage of participants | From Day 1 to Day 28 |
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| 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. | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. Here ''Overall Number of Participants Analyzed''=participants evaluable for this outcome measure and ''number analyzed''= participants evaluable at specified time points. | Posted | Number | Percentage of participants | Day 1 and Day 5 |
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| Secondary | Plasma Concentration Versus Time Summary of PF-07321332 | Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the intervention they actually received. A randomized but not treated participant was excluded from the safety analyses. Here ''Overall Number of Participants Analyzed''=participants evaluable for this outcome measure and ''number analyzed''= participants evaluable at specified time points. | Posted | Mean | Standard Deviation | Nanograms per milliliter | Day 1: 1 hour post dose; Day 5: 0 minutes pre-dose |
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| 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. | mITT1 population included all participants randomly assigned to study intervention, who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they were randomized. Here ''Overall Number of Participants Analyzed''=participants evaluable for this outcome measure and ''number analyzed''= participants evaluable at specified time points. | Posted | Least Squares Mean | Standard Error | Log 10 copies per milliliter | Baseline, Days 3, 5, 10 and 14 |
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SAEs and Non-SAEs: From Day 1 to Week 24; All-cause mortality: till Week 24
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population comprised of all participants who received at least 1 dose of study intervention during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nirmatrelvir 300 mg + Ritonavir 100 mg | Participants were randomized to receive nirmatrelvir 300 mg and ritonavir 100 mg orally every 12 hours from Day 1 to 5. | 0 | 654 | 8 | 654 | 120 | 654 |
| EG001 | Placebo | Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 doses from Day 1 through Day 5. | 1 | 634 | 13 | 634 | 71 | 634 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
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| Pneumonia aspiration | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA v25.0 | Non-systematic Assessment |
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| Creatinine renal clearance decreased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
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| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.0 | Non-systematic Assessment |
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| Multiple sclerosis relapse | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Osmotic demyelination syndrome | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Activated partial thromboplastin time prolonged | Investigations | MedDRA v25.0 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
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| Blood thyroid stimulating hormone increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
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| Fibrin D dimer increased | Investigations | MedDRA v25.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v25.0 | Non-systematic Assessment |
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In participant flow, there was discontinuations due to AE, which was captured under "Death" as reason for discontinuation. Adverse event was COVID-19 pneumonia and the participant died due to that event and discontinued study.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 14, 2022 | Jul 20, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718217 | nirmatrelvir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Placebo |
Participants were randomized to receive placebo matched to nirmatrelvir/ritonavir every 12 hours for 10 doses from Day 1 through Day 5. |
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