En studie för att jämföra S-217622 med placebo hos icke-sjukhushållna deltagare med covid-19 (SCORPIO-HR)
29 juli 2026 uppdaterad av: Shionogi
En fas 3, multicenter, randomiserad, dubbelblind, 24-veckors studie av den kliniska och antivirala effekten av S-217622 jämfört med placebo hos icke-hospitaliserade deltagare med covid-19
Huvudsyftet med denna studie är att utvärdera effekten av S-217622 kontra placebo bland deltagare som ingår i delpopulationen av deltagare som inte förväntades få standardbehandling med COVID-19 grupp A (definierad som monoklonal antikropp [mAb) ] behandling eller poliklinisk intravenös [IV] remdesivir).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
2093
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Buenos Aires, Argentina, 1602
- Clínica Olivos
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Córdoba, Argentina, X5000JHQ
- Sanatorio Allende, Av.
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San Juan, Argentina, 5400
- CER San Juan,
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Santa Fe, Argentina, S2000PBJ
- Mendoza 2612, Rosario
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Buenos Aires
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1027AAP
- CINME Centro Investigaciones Metabolicas, Pres. Jose Evaristo Uriburu 754, Piso 3 dpto 12
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1039AAO
- Sanatorio De La Trinidad, Mitre Bartolome Mitre
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1199
- Hospital Italiano sede Central, Tte. Gral. Juan Domingo Perón 4190
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1412
- Centro Privado de Medicina Familiar, Mindout Research
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Mar del Plata, Buenos Aires, Argentina, B7600FYK
- Centro De Investigaciones
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Ramos Mejía, Buenos Aires, Argentina, 1704
- DIM Clínica Privada, Belgrano 136 - 5to piso
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Ramos Mejía, Buenos Aires, Argentina, C1221ADC
- Hospital General Agudos Dr. J.M., Grl Justo José de Urquiza 609 2do piso, Pabellón Clínica Médica, Enf. Emergentes
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Zárate, Buenos Aires, Argentina, B2800DGH
- Clínicas Zárate, F. Andrade 332
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Córdoba Province
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Quiros, Córdoba Province, Argentina, 1948
- Sanatorio Privado ,Duarte Quiros
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Sante Fe
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Rosario, Sante Fe, Argentina, 2000
- Instituto Médico de la, Fundación Estudios Clínicos, Italia 428, Rosario
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentina, 4000
- Clinica Mayo UMCB
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Campinas, Brasilien, 13034-685
- Hospital da Puc Campinas, Centro de Pesquisa Sao Lucas
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Rio de Janeiro, Brasilien, 20241-180
- IBPClin, Rua da Gloria
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Rio de Janeiro, Brasilien, 21040-360
- INI/Fiocruz
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Volta Redonda, Brasilien, 27253-003
- Lóbus Cntr. de Pesquisa Cl.
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Estado de Bahia
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Salvador, Estado de Bahia, Brasilien, 41650-010
- SENAI CIMATEC Clinical Trial Research Center
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Mato Grosso
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Cuiabá, Mato Grosso, Brasilien, 78050-253
- AMB3 Servicos Medicos Ltda Rua Campinas
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasilien, 30130-100
- Faculdade de Medicina da univ., Federal, Av Alfredo Balena, 190, 1° andar - sala 161
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Paraná
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Curitiba, Paraná, Brasilien, 80810-040
- Hosp Nossa Senhora das Gracas, Rue Alcides Munhoz
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brasilien, 59020-500
- Instituto Atena de Psequisa Clinica Ltds, Av Marechal Floriano Peixoto
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilien, 90410-000,
- Thainá Garbino dos Santos, Avenida Protásio Alves 211, Bloco C
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Porto Alegre, Rio Grande do Sul, Brasilien, 91350-180
- IPARGS, Rua Antonio Joaquim Mesquita
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São Paulo
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Baretos, São Paulo, Brasilien
- Fundação Pio XII - Hospital de Amor de, Barretos; Rua Antenor Duarte Villela
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Botucatu, São Paulo, Brasilien, 18618-686
- Unid Pesquisa Clínica Facultad Medicina, de Botucatu UNESP, Rua Prof. Dr. Armando,Alves s/n, Distrito de rubião Junior
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Bragança Paulista, São Paulo, Brasilien, 12916-350
- Hospital Universario Sao Francisco, na Providencia de Deus-Av. Sao Francisco de Assis
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Campinas, São Paulo, Brasilien, 13060-080
- Instituto de Pesquisa Clinica de Campinas IPECC Tua Oswaldo
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Jaú, São Paulo, Brasilien, 17201-210
- Cecip Jau
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Santo André, São Paulo, Brasilien, 09080-111
- Pesquisare Saúde
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São Bernardo do Campo, São Paulo, Brasilien, 09715-090
- CEMEC
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São Paulo, São Paulo, Brasilien, 01001-000
- Esperanca Clinica De Pesquisas
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Tatuí, São Paulo, Brasilien, 18273-170
- Instituto de Molestast Cardiovasculares
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Bogotá, Colombia, 110221
- Bluecare salud SAS
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Antioquia
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Medellín, Antioquia, Colombia, 050010
- Programa de estudios y control de, enfermedades tropicales PECET, Carrera 53 N°61-30 Torre 2, Lab. 632
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Atlántico
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Barranquilla, Atlántico, Colombia, 80020
- IPS CENTRO CIENTIFICO ASISTENCIAL S.A.S, Cra 45 #85-49
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Barranquilla, Atlántico, Colombia, 080020
- Centro de Investigación Medico, Asistencia - CIMEDICAL S.A.S, Cra 49C # 82-120
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Barranquilla, Atlántico, Colombia, 080020
- Corazon IPS S.A.S, Carrera 49 No 74 - 158
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Bogota D.C.
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Bogotá, Bogota D.C., Colombia, 110221
- Centro de investigación en Reumatología, y Especialidades Medicas S.A.S, CIREEM S.A.S.-Cra. 12#97-32
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Departamento de Córdoba
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Chuchurubi Monteria, Departamento de Córdoba, Colombia, 230002
- Fundación Centro Excelencia en Enferm., Crónicas No Transmisibles-FUNCENTRA, CRA 3 N°21 44 B,
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Magdalena Department
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Santa Marta, Magdalena Department, Colombia, 470003
- TyC Inversiones SAS Grupsalud 33-6 IPS, Avenida Libertador # 30-360, Barrio San Pedro Alejandrino
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Quindío Department
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Armenia, Quindío Department, Colombia, 630004
- Fundación Cardiomet Cequin,, Street 18 North # 14-25,
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Mandaluyong, Filippinerna, 1552
- Health Cube Medical Clinics, High Pointe Medical Hub, 241 Shaw Blvd
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Quezon City, Filippinerna, 1100
- Lung Center of the Philippines
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Batangas
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Lipa, Batangas, Filippinerna, 4217
- Mary Mediatrix Medical Cntr
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Manila
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Tondo, Manila, Filippinerna, 1221
- Mary Johnston Hospital, 1221 Juan Nolasco Street
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Molo
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Lloilo, Molo, Filippinerna, 5000
- Iloilo Doctors' Hospital, Room 706, New Condoclinics Bldg, West Ave
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Pampanga
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Mabalacat, Pampanga, Filippinerna, 2023
- The Medical City Clark, #100Eatwick, Gatewick, Global Gateway Logistics City, Industrial Estate 5, Clark Freeport Zone
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San Fernando
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La Union, San Fernando, Filippinerna, 2500
- Ilocos Training and Regional Medical Center
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Pampanga, San Fernando, Filippinerna, 2000
- Green City Medical Center
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Alabama
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Guntersville, Alabama, Förenta staterna, 35976
- Lakeview Clinical Research
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Arizona
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Tempe, Arizona, Förenta staterna, 85282
- Voyage Medical Services
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Tucson, Arizona, Förenta staterna, 85741
- Novak Clinical Research
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California
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Canoga Park, California, Förenta staterna, 91303
- Hope Clinical Research
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Culver City, California, Förenta staterna, 91606
- Carbon Health
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Garden Grove, California, Förenta staterna, 92866
- NICR
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Long Beach, California, Förenta staterna, 94110
- Ark Clinical Research (PARENT)
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San Diego, California, Förenta staterna, 92103
- UCSD Antiviral Research Center
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San Francisco, California, Förenta staterna, 94110
- University of California San Francisco (PARENT)
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Thousand Oaks, California, Förenta staterna, 91360
- Clinical Trials Management Services, 223 E. Thousand Oaks Blvd.
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Torrance, California, Förenta staterna, 90502
- Lundquist Institute for BMI, UCLA Medical Center
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- University of Colorado Anschutz Medical Campus
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District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20005
- Whitman-Walker Health
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Florida
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Gainesville, Florida, Förenta staterna, 32610
- University of Florida Clinical & Translational Science Institute
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Miami, Florida, Förenta staterna, 33155
- Miami Clinical Research
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Miami, Florida, Förenta staterna, 33176
- Vista Health Research, LLC
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Miami, Florida, Förenta staterna, 33134
- Universal Medical and Research Center
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Miami, Florida, Förenta staterna, 33144
- CCR Medical Center, Suite 201
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Miami Beach, Florida, Förenta staterna, 33140
- Quantum Clinical Trials, 333 Arthur Godfrey Road, Suite 202, suite 208
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Miami Lakes, Florida, Förenta staterna, 33016
- Quality Research of South Florida
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Ormond Beach, Florida, Förenta staterna, 32174
- Accel Research Sites Network, Ormond Clinical Research Unit, 77 West Granada Boulevard
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Pompano Beach, Florida, Förenta staterna, 33060
- Clinical Research Center of Florida, 550 SW 3rd St.,, Suite #305
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Pompano Beach, Florida, Förenta staterna, 33073
- Invictus Clinical Research Group, LLC
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Tampa, Florida, Förenta staterna, 33615
- Santos Research Center, CORP
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Georgia
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Augusta, Georgia, Förenta staterna, 30909
- Masters of Clinical Research
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Idaho
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Idaho Falls, Idaho, Förenta staterna, 83404
- Leavitt Clinical Research
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Illinois
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Berwyn, Illinois, Förenta staterna, 60402
- Research Network America
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Chicago, Illinois, Förenta staterna, 89109
- Rush University Infectious Diseases
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Louisiana
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Marrero, Louisiana, Förenta staterna, 70072
- Tandem Clinical Research
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Maryland
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Baltimore, Maryland, Förenta staterna, 21287
- The Johns Hopkins Hospital
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Michigan
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Grand Rapids, Michigan, Förenta staterna, 49525
- Infusion Associates
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Troy, Michigan, Förenta staterna, 48312
- Revival Research Institute LLC
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89119
- AB Clinical Trials
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Las Vegas, Nevada, Förenta staterna, 89113
- Las Vegas Medical Research
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87901
- Renal Medicine Associates
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New York
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New York, New York, Förenta staterna, 10032-3722
- Columbia University Irving Medical Center Division of Infectious Diseases
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New York, New York, Förenta staterna, 10065
- NY Blood Center Project ACHIEVE
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Rochester, New York, Förenta staterna, 14542
- University of Rochester Medical Center
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North Carolina
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Denver, North Carolina, Förenta staterna, 28037
- Lapis Clinical Research - North State
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Morgantown, North Carolina, Förenta staterna, 28655
- Burke Primary Care
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Winston-Salem, North Carolina, Förenta staterna, 27103
- Progressive Medicine of the Triad, LLC
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Ohio
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Columbus, Ohio, Förenta staterna, 43201
- Ohio State University College of Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Infectious Disease Clinical Trials Unit-University of Pennsylvania Health System
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- UPMC Eye Center - Eye and Ear Institute
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37204
- Vanderbilt Health-One Hundred Oaks
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Texas
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Austin, Texas, Förenta staterna, 78705
- Central Texas Medical Research
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Forney, Texas, Förenta staterna, 75126
- Care United Research, 375 North FM 548, suite 100
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Fort Worth, Texas, Förenta staterna, 76164
- Valley Institute of Research
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Houston, Texas, Förenta staterna, 77065
- Accurate Clinical Management, LLC
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Houston, Texas, Förenta staterna, 77008
- Trio Clinical Trials, LLC.
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San Antonio, Texas, Förenta staterna, 78215
- Sun Research Institute, LLC
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Utah
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Bountiful, Utah, Förenta staterna, 84010
- Progressive Clinical Research
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Virginia
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Richmond, Virginia, Förenta staterna, 23226
- Clinical Research Partners LLC
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Kintampo, Ghana, PO BOX 200
- Kintampo Health Research Cntr
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Kumasi, Ghana, AK-312-1059
- Kumasi Centre for Research, South End Asuogya Road, Kwame Nkrumah University
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Navrongo
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Upper East, Navrongo, Ghana, PO BOX 114
- Navrongo Health Research Cntr
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, Indien, 500018
- St. Theresa's Hospital
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Nellore, Andhra Pradesh, Indien, 524001
- Vijaya Super Speciality Hospital
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Nellore, Andhra Pradesh, Indien, 524001
- DEC-Health Care Hospital
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Visakhapatnam, Andhra Pradesh, Indien, 530002
- King George Hospital
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Gujarat
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Ahmedabad, Gujarat, Indien, 380015
- Sangini Hospital 1st Flr & 7th flr
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Vadodara, Gujarat, Indien, 390021
- Aman Hospital and Research Center
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Vadodara, Gujarat, Indien, 390022
- Rhythm Heart Institute - A Unit of SLPL
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Haryana
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Faridabad, Haryana, Indien, 121001
- ESIC Medical College & Hospital
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Faridabad, Haryana, Indien, 121006
- Sarvodaya Hospital and Research Centre
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Karnataka
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Bangalore, Karnataka, Indien, 560060
- BGS Global Institute of Medical Sciences
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Belagavi, Karnataka, Indien, 590010
- KLEs Dr. Prabhakar Kore Hospital & MRC Belagavi
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Bengaluru, Karnataka, Indien, 560068
- Shettys Hospital
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Bengaluru, Karnataka, Indien, 560036
- Sri Lakshmi Super Speciality Hospital
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Bengaluru, Karnataka, Indien, 562107
- Sri Venkateshwara Hospitals, SKY HEIGHTS, Site#1/2, Sarjapura-Attibele, Main rd, Indelebele Village
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Mangalore, Karnataka, Indien, 575018
- Yenepoya Med College Hosp, EMD Building, 5th fl., University Rd, Deralakatte
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Maharashtra
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Dombivali, Maharashtra, Indien, 421203
- BAJ RR Hosp and Res Cntr
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Nashik, Maharashtra, Indien, 422005
- Chopda Medicare & Research Centre Pvt. Ltd
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Pune, Maharashtra, Indien, 411057
- Lifepoint Multispecialty Hosp.
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, Indien, 110060
- Sir Ganga Ram Hospital
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New Delhi
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Dwārka, New Delhi, Indien, 110075
- Aakash Healthcare Private Limited
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Rajasthan
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Jaipur, Rajasthan, Indien, 302020
- JNUIMSRC
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Jaipur, Rajasthan, Indien, 302020
- Tagore Hospital & Research Institute
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Tamil Nadu
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Chennai, Tamil Nadu, Indien, 600113
- Voluntary Health Services Infectious Diseases Medical CEN CART Clinical Research Site
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Uttar Pradesh
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Kanpur, Uttar Pradesh, Indien, 208002
- Department of Medicine
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Uttarakhand
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Rudrapur, Uttarakhand, Indien, 263135
- HB Specialty Hosp. & Res Inst.
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West Bengal
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Kolkata, West Bengal, Indien, 700073
- Calcutta School of Tropical Medicine
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Fukuuoka-Ken
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Okawa-shi, Fukuuoka-Ken, Japan, 831-0016
- Kohokai Takagi Hospital
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Ibaraki
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Tsuchiura-shi, Ibaraki, Japan, 300-0062
- Tsuchiura Beryl Clinic
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Tsuchiura-shi, Ibaraki, Japan, 305-8576
- University of Tsukuba Hospital
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Tsukuba, Ibaraki, Japan, 305-8576
- Tashiro Endocrinology Clinic
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Saitama
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Toda-shi, Saitama, Japan, 335-0035
- KODAIRA Hospital
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Eldoret, Kenya, 30100
- Moi University Clin Res Centre, 2nd Fl, Chandaria Chronic, Disease and Cancer Centre
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Kisumu, Kenya, 40100
- KEMRI CGHR HIVR Site
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-
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Lilongwe, Malawi, 00000
- UNC Project, Private Bag A-104
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Mangochi, Malawi, 301400
- Mangochi PHNG Study Site, Kamuzu University of Health Sciences, Private Bag 360, Room 805
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Blantyre
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Chipatala Avenue, Blantyre, Malawi, 312200
- Johns Hopkins Research Project, Queen Elizabeth Central Hospital
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Aguascalientes, Mexiko, C.P 20230
- Hospital Cardiológica Aguascalientes, Ecuador 200 Fracc Las Américas
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Aguascalientes, Mexiko, C.P. 20116
- Centro de Inv. Médica Aguascalientes, (CIMA) Av. Independencia 2130, Int. A. Trojes de Alonso
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CP
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Veracruz, CP, Mexiko, 91851
- Instituto Veracruzano, en Investigación Clínica S.C., Sabino s/n, Colonia Reserva Tarimoya ll
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Cdmx, C.P
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Cuauhtémoc, Cdmx, C.P, Mexiko, 06760
- CAIMED Investigación en Salud, S.A. de C.V., Manzanillo #100. Piso 2. Roma Sur
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Morelos
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Cuernavaca, Morelos, Mexiko, C.P62210
- Avenida Universidad 1001, Edificio 19, planta baja, colonia Chamilpa
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Oaxaca
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Oaxaca City, Oaxaca, Mexiko, 68000
- Oaxaca Site Management Organization S.C., Humboldt 302, Col. Centro.
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Quintana Roo
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Cancún, Quintana Roo, Mexiko, C.P. 77500
- Centro Inv. y Avances Med Especializados, (CIAME) Av. Kabah, Lote 38, 39 y 41., Manzana 4, supermanzana 44. Col., Alborada, Benito Juárez
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Veracruz
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Ricardo Flores Magón, Veracruz, Mexiko, 91900
- FAICIC S. DE R.L. DE C.V., Av. 16 de Septiembre 1165
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Islamabad, Pakistan, 44000
- Shifa International Hospital, 4 Pitras Bukhari Rd, H-8/4, H-8
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Karachi, Pakistan, 75300
- Dow Univ of Health Sciences Ojha Campus
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Karachi, Pakistan, 75300
- Sindh Infectious Disease Hospital and research Centre
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Peshawar, Pakistan, 74800
- Maroof International Hospital
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Karachi
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Korangi, Karachi, Pakistan, 75190
- Indus Hospital and Health Network
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Peshawar
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Hayatabad, Peshawar, Pakistan, 25000
- Rehman Medical Institute Clinical Trial Unit
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Central Park Teaching Hospital
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Lahore, Punjab Province, Pakistan, 54000
- National Hospital & Medical Center
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Lahore, Punjab Province, Pakistan, 54660
- Akram Medical Complex
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Sindh
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Karachi, Sindh, Pakistan, 74800
- The Aga Khan University
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Lima, Peru, 7006
- Centro de Inv. Tecnológicas Biomédicas y Medioambientales
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Lima, Peru
- Asoc. Civil Impacta Salud y Educación - Sede San Miguel
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Lima Cercado, Peru, 15082
- Patricia Ortiz Bazan
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Lima region
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San Isidro, Lima region, Peru, 15036
- Centro de Investigacion
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Loreto
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Iquitos, Loreto, Peru, 16000
- Asoc. Civil Selva Amazonica
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-
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Ostrowiec Świętokrzyski, Polen, 27-400
- Ostrowieckie Centrum Medyczne
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Oświęcim, Polen, 32-600
- Medicome Sp. z o.o.
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Rzeszów, Polen, 35-326
- Centrum Medyczne "MEDYK"
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Skierniewice, Polen, 96-100
- Clinmedica Research Sp. Z O.O.
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Wroclaw, Polen, 51-162
- Centrum Badań Klinicznych
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-
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Roodepoort, Sydafrika, 1724
- Roodepoort Medicross Clinical Research Centre
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Free State
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Bloemfontein, Free State, Sydafrika, 9300
- Josha Research
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Gauteng
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Johanesburg, Gauteng, Sydafrika, 2001
- Newton Clinical Research Centre
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Johannesburg, Gauteng, Sydafrika, 1500
- Worthwhile Clinical Trials
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Johannesburg, Gauteng, Sydafrika, 1862
- (PHRU), New Nurses Home 9th floor Chris
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Johannesburg, Gauteng, Sydafrika, 2092
- CHRU, Themba Lethu Clinic
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Krugersdorp, Gauteng, Sydafrika, 1739
- Ubuntu Clinical Research
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Lenasia, Gauteng, Sydafrika, 1829
- Ubuntu Clinical Research
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Midrand, Gauteng, Sydafrika, 1685
- T/A Midrand Medical Centre, Shop #1, Health Emporium
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Pretoria, Gauteng, Sydafrika, 83
- Global Clinical Trials
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Randburg, Gauteng, Sydafrika, 2087
- Right to Care Research Esizayo, Right Clinic Esizayo
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Limpopo
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Thabazimbi, Limpopo, Sydafrika, 0380
- Limpopo Clin Res Initiative Tamboti Medical Centre
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North West
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Rustenburg, North West, Sydafrika, 0299
- The Arum Institute NPC Rustenburg CRS
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Western Cape
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George, Western Cape, Sydafrika, 6529
- Task Eden Research Centre
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Paarl, Western Cape, Sydafrika, 7626
- Be Part Research PTY (LTD)
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Bangkok
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Bangkok Noi, Bangkok, Thailand, 10700
- Siriraj Hospital
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Pathum Wan, Bangkok, Thailand, 10330
- Thai Red Cross AIDS Research Centre
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Changwat Khon Kaen
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Mueang Khon Kaen District, Changwat Khon Kaen, Thailand, 40002
- Srinagarind Hospital
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Chiang Mai
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Mueang Chiang Mai District, Chiang Mai, Thailand, 50200
- Research Institute for Health Sciences
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Kampala, Uganda
- Joint Clinical Research Centre
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Kampala, Uganda, 10005
- Joint Clinical Research Centre
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Kampala, Uganda
- Infectious Diseases Institute (IDI), Mulago Hill Road
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Lira, Uganda
- SICRA, Lira Regional Referral, Plot 21-41 Ngetta Road P.O. Box 330062
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Tororo, Uganda
- IDRC Clinic, Tororo General Hospital, P.O. Box 2, Station Rd
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Beskrivning
Inklusionskriterier:
- Dokumentation av laboratoriebekräftad aktiv SARS-CoV-2-infektion, fastställd av en nukleinsyra (till exempel omvänt transkriptas PCR) eller antigentest från något luftvägsprov (till exempel orofaryngeal, NP eller nasal pinne eller saliv) samlas in ≤120 timmar (5 dagar) före randomisering.
- Deltagarna förväntas påbörja studieintervention ≤5 dagar från självrapporterat datum för debut av något av de covid-19-relaterade symptomen från följande lista:
- Hosta
- Andnöd eller andningssvårigheter
- Känner mig febrig
- Frossa
- Trötthet
- Kroppsvärk eller muskelvärk eller värk
- Diarre
- Illamående
- Kräkningar
- Huvudvärk
- Öm hals
- Nästäppning eller nästäppa
- Nasala flytningar
- Förlust av smak eller lukt
- Ett eller flera av följande tecken/symtom uppträder inom 24 timmar före randomisering:
- Hosta
- Andnöd eller andningssvårigheter
- Känner mig febrig
- Frossa
- Trötthet
- Kroppsvärk eller muskelvärk eller värk
- Diarre
- Illamående
- Kräkningar
- Huvudvärk
- Öm hals
- Nästäppning eller nästäppa
- Nasala flytningar
- Deltagare med hög risk definieras som att de har en eller flera faktorer som leder till en högre risk för utveckling till allvarlig covid-19:
- Ålder ≥65 år
- Ålder ≥18 med 1 av följande:
- Fetma (body mass index [BMI] ≥30 kilogram per kvadratmeter [kg/m^2]). Obs: BMI avrundas till närmaste heltal, till exempel avrundas 29,5 kg/m^2 till 30 kg/m^2.
- Diabetes mellitus
- Hypertoni
- Kardiovaskulär sjukdom (inklusive medfödd hjärtsjukdom)
- Kronisk lungsjukdom (till exempel kronisk obstruktiv lungsjukdom, måttlig till svår astma, interstitiell lungsjukdom, cystisk fibros, pulmonell hypertoni)
- Kronisk njursjukdom, så länge som deltagaren inte har känt kreatininclearance (CrCl)
- Downs syndrom
- Sicklecellanemi
- En av följande immunkomprometterande tillstånd eller immunsuppressiva behandlingar:
- Får kemoterapi eller andra behandlingar för cancer
- Hematologisk malignitet (aktiv eller i remission)
- Historik om en hematopoetisk stamcell eller en solid organtransplantation
- Humant immunbristvirusinfektion: inte på antiretroviral terapi eller med kluster av differentiering 4+ cellantal
- Kombinerad primär immunbriststörning
- Att ta immunsuppressiva läkemedel (till exempel läkemedel för att undertrycka avstötning av transplanterade organ eller för att behandla reumatologiska och gastrointestinala tillstånd, såsom medel mot tumörnekrosfaktor, mykofenolat och rituximab).
Obs: Nuvarande användning av vissa kortikosteroider är uteslutande på grund av oro för möjlig läkemedelsinteraktion (DDI) med S-217622.
Exklusions kriterier:
- Historik av sjukhusvistelse för den aktuella SARS-CoV-2-infektionen (det vill säga tidigare sjukhusvistelse för en tidigare episod av SARS-CoV-2-infektion är tillåten)
- För den aktuella SARS-CoV-2-infektionen samlades alla positiva SARS-CoV-2-molekylära (nukleinsyra) eller antigentest från något luftvägsprov (till exempel orofaryngeal, NP eller nasal pinne eller saliv) ˃120 timmar ( 5 dagar) före randomisering. Deltagare med återinfektion, definierad som tidigare SARS-CoV-2-infektion som började >90 dagar före den nuvarande symtomdebuten med intervallupplösning av symtomen är berättigade så länge som den aktuella infektionen inte har varit närvarande i mer än 5 dagar före randomisering .
- Aktuellt behov av sjukhusvistelse eller omedelbar läkarvård enligt utredarens uppfattning
- Aktuell användning av mediciner som är förbjudna med studieinterventionen. Användning av Paxlovid när som helst och användning av orala, inhalerade eller injicerbara läkemedel avsedda att behandla symtomatisk SARS-CoV-2-infektion före inskrivning är uteslutna. Efter inskrivningen kommer lokalt tillgänglig SARS-CoV-2-behandling (inklusive men inte begränsat till molnupiravir, mAbs, poliklinisk IV remdesivir, konvalescent plasma, inhalerad budesonid, favipiravir och fluvoxamin) tillåtas, så länge det inte finns några farhågor för DDI.
- Mottagande av eventuella undersökningsbehandlingar för den aktuella episoden av SARS-CoV-2 när som helst före randomisering är uteslutande. Obs: Detta inkluderar inte läkemedel som är godkända för annan användning och som tas för dessa indikationer eller covid-19-vacciner. Obs: Användning av lokalt auktoriserade eller godkända terapier för att förhindra COVID-19, såsom mAbs som endast ges för att förhindra COVID-19, är inte uteslutande.
- Alla samsjukligheter som kräver operation inom 7 dagar före randomisering eller som enligt utredaren anses vara livshotande inom 28 dagar före randomisering
- Känd allergi/känslighet eller någon överkänslighet mot komponenter i S-217622 eller placebo för S-217622
- Känd nuvarande njurfunktionsnedsättning definierad som CrCl
- Känd historia av cirros eller leverdekompensation (inklusive ascites, variceal blödning eller leverencefalopati)
- Deltagare som har använt något av följande läkemedel inom 14 dagar före registreringen:
- Stark cytokrom P453A (CYP 3A) hämmare
- Stark CYP3A-inducerare
- Produkter som innehåller johannesört
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: S-217622
S-217622 kommer att administreras oralt i 5 dagar.
|
Administreras som en rund tablett.
|
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Placebo-jämförare: Placebo
Placebo som matchar S-217622 kommer att administreras oralt i 5 dagar.
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Administreras som en rund tablett.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to Sustained Symptom Resolution
Tidsram: Up to Day 29
|
Time to sustained symptom resolution was defined as the time from start of study intervention to the first day of 2 consecutive days with complete resolution of COVID-19 symptoms on participant self-assessment and alive and without hospitalization for any reason by Day 29.
Hospitalization was defined as ≥24 hours of acute care in a hospital or similar acute care facility, including emergency rooms, urgent care clinics, or facilities instituted to address medical needs of those with COVID-19.
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Up to Day 29
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change From Baseline at Day 4 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Levels on Nasopharyngeal (NP) Swabs
Tidsram: Baseline, Day 4
|
NP swabs were collected by staff during in-person visits for measurement of SARS-CoV-2 RNA levels by quantitative log10 polymerase chain reaction (PCR).
Results reported as log10 (RNA copies/milliliter [mL]).
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Baseline, Day 4
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Number of Participants Who Experienced Hospitalization (Adjudicated) or Death Due to Any Cause
Tidsram: Up to Day 29
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Hospitalization was defined as ≥24 hours of acute care in a hospital or similar acute care facility, including emergency rooms, urgent care clinics, or facilities instituted to address medical needs of those with COVID-19.
Hospitalization was adjudicated to be COVID-19-related.
All deaths regardless of occurrence outside of hospital or during hospitalization (not adjudicated) are reported.
|
Up to Day 29
|
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Time to Sustained Symptom Resolution in the mITT1 Set
Tidsram: Up to Day 29
|
Time to sustained symptom resolution was defined as the time from start of study intervention to the first day of 2 consecutive days with complete resolution of COVID-19 symptoms on participant self-assessment and alive and without hospitalization for any reason by Day 29.
Hospitalization was defined as ≥24 hours of acute care in a hospital or similar acute care facility, including emergency rooms, urgent care clinics, or facilities instituted to address medical needs of those with COVID-19.
Wald confidence interval reported.
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Up to Day 29
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Median Change From Baseline at Day 8 in SARS-CoV-2 RNA Levels on NP Swabs
Tidsram: Baseline, Day 8
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NP swabs were collected by staff during in-person visits for measurement of SARS-CoV-2 RNA levels by quantitative log10 PCR.
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Baseline, Day 8
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Number of Participants With Persistent and/or Late-Onset Symptoms of COVID-19 at Week 12
Tidsram: Week 12
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The number of participants with persistent and/or late-onset symptoms of COVID-19 at Week 12 based on participant assessment of the 5 symptoms specified by the World Health Organization (WHO) (fatigue, shortness of breath/difficulty breathing, difficulty with concentration/ thinking, difficulty reasoning/solving problems, and memory loss) plus taste disturbance and smell disturbance.
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Week 12
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Time to Sustained Resolution of 6 Targeted Symptoms and Being Alive and Without Hospitalization for Any Reason by Day 29
Tidsram: Day 1 through Day 29
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The time to sustained symptom resolution was defined as the first day of 2 consecutive days with complete resolution of COVID-19 symptoms on participant self-assessment and being alive and without hospitalization for any reason by Day 29.
Data are reported for time (days) from start of ensitrelvir or placebo (Day 1) until sustained resolution based on assessments for 2 consecutive days of 6 targeted symptoms (nasal obstruction or congestion, nasal discharge, sore throat, cough, feeling feverish, and fatigue) and being alive and not hospitalized for any reason.
Hospitalization was defined as ≥24 hours of acute care in a hospital or similar acute care facility, including emergency rooms, urgent care clinics, or facilities instituted to address medical needs of those with COVID-19.
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Day 1 through Day 29
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Time to Sustained Resolution of Targeted Symptoms (Excluding Loss of Taste and Loss of Smell) and Being Alive and Without Hospitalization for Any Reason by Day 29
Tidsram: Day 1 through Day 29
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The time to sustained symptom resolution was defined as the first day of 2 consecutive days with complete resolution of COVID-19 symptoms on participant self-assessment and being alive and without hospitalization for any reason by Day 29.
Time (days) from start of ensitrelvir or placebo (Day 1) until sustained resolution (where cough and fatigue were considered resolved if they remain mild) based on assessments for 2 consecutive days of all targeted symptoms excluding loss of taste and loss of smell (cough, shortness of breath or difficulty breathing, feeling feverish, chills, fatigue, body pain or muscle pain or aches, diarrhea, nausea, vomiting, headache, sore throat, nasal obstruction or congestion, and nasal discharge) and being alive and not hospitalized for any reason by Day 29.
Hospitalization was ≥24 hours of acute care, in a hospital or similar acute care facility (emergency rooms, urgent care clinics, or facilities instituted to address medical needs of those with COVID-19).
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Day 1 through Day 29
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Number of Participants With Undetectable SARS-CoV-2 on NP Swabs on Day 4 and Day 8
Tidsram: Day 4 and Day 8
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NP swabs were collected by staff during in-person visits for measurement of SARS-CoV-2 RNA levels by viral titer by culture.
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Day 4 and Day 8
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Number of Participants Experiencing Hospitalization (All Cause) or Death Due to Any Cause
Tidsram: Up to Day 29
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Hospitalization was defined as ≥24 hours of acute care in a hospital or similar acute care facility, including emergency rooms, urgent care clinics, or facilities instituted to address medical needs.
All deaths regardless of occurrence outside of hospital or during hospitalization (not adjudicated) are reported.
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Up to Day 29
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Number of Participants With NP SARS-CoV-2 RNA Levels Below the Lower Limit of Quantification on Day 4 and Day 8
Tidsram: Day 4 and Day 8
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NP swabs were collected by staff during in-person visits for measurement of SARS-CoV-2 RNA levels by log10 quantitative PCR.
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Day 4 and Day 8
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Median Change From Baseline at Day 4 and Day 8 in SARS-CoV-2 RNA by Quantitative PCR in NP Swabs
Tidsram: Baseline, Day 4, Day 8
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NP swabs were collected by staff during in-person visits per protocol for measurement of log10 SARS-CoV-2 RNA levels by quantitative PCR.
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Baseline, Day 4, Day 8
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Time to Self-Reported Return to Usual (Pre-COVID-19) Health
Tidsram: Day 1 up to Day 29
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Participants kept a log of symptoms and major events in their study diary.
The time to self-reported return to health (in days) was derived as: (the date of self-reported return to usual [pre-COVID-19 health] - (the date of first dose of study intervention) + 1.
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Day 1 up to Day 29
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Number of Participants Reaching a Score ≥2, ≥3, ≥4, ≥5, ≥6, ≥7, or ≥8 on the WHO Ordinal Scale
Tidsram: Day 29
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The severity of COVID-19 disease was assessed using the WHO ordinal scale.
The scale ranged from 1 to 8 and focuses primarily on the participant's oxygen need when they first came to the hospital.
Scores include: 1 = no limitation of activities; 2 = limitation of activities; 3 = hospitalized no oxygen therapy; 4 = oxygen by mask or nasal prongs; 5 = non-invasive ventilation or high flow oxygen; 6 = intubation and mechanical ventilation; 7 = ventilation and additional organ support, pressors, renal replacement therapy, extra corporeal membrane oxygenation; 8 = death.
Higher scores indicated greater severity of illness and a need for more intensive medical support.
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Day 29
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Change From Baseline at Day 29 in Resting Peripheral Oxygen Saturation
Tidsram: Baseline, Day 29
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Resting peripheral oxygen saturation was measured as the percentage of oxygen transported throughout the participant's body.
An increase in percentage indicated an increased oxygen supply throughout the body.
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Baseline, Day 29
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Number of Participants With Resting Peripheral Oxygen Saturation <96% Versus ≥96%
Tidsram: Up to Day 29
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Resting peripheral oxygen saturation was measured as the percentage of oxygen transported throughout the participant's body.
Saturation levels at ≥96% indicated effective oxygen transportation throughout the body.
A decrease in percentage indicated decreased oxygen supply throughout the body.
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Up to Day 29
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Severity of Persistent and/or Late-Onset Symptoms of COVID-19 at Week 24
Tidsram: Week 24
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A participant was considered to have persistent and/or late-onset symptoms if either 1 of the following criteria was met: occurrence of at least 1 of the following symptoms at Week 24: difficulty with concentration/thinking, difficulty reasoning/solving problems, or memory loss; or occurrence of at least 1 of the following symptoms at Week 24: fatigue, shortness of breath/difficulty breathing, taste disturbance, or smell disturbance.
Symptom severity assessed as: None; Mild; Moderate; Severe; At least Mild.
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Week 24
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Number of Participants With Symptomatic Viral Rebound Between Day 6 and Day 29
Tidsram: Day 6 up to Day 29
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NP swabs were collected by staff during in-person visits for measurement of SARS-CoV-2 RNA levels by log10 quantitative PCR.
Symptomatic viral rebound was defined as an increase in NP SARS-CoV-2 RNA levels by quantitative PCR or an increase in NP SARS-CoV-2 viral culture.
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Day 6 up to Day 29
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Number of Participants With Viral Rebound Between Day 6 and Day 29
Tidsram: Day 6 up to Day 29
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NP swabs were collected by staff during in-person visits for measurement of SARS-CoV-2 RNA levels by quantitative PCR.
Viral rebound was defined as an increase in quantitative NP SARS-CoV-2 viral culture or NP SARS CoV-2 RNA levels by quantitative PCR.
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Day 6 up to Day 29
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Change From Baseline at Week 24 in Short Form 36 Version 2.0 (SF-36 V2) Quality of Life Score
Tidsram: Baseline, Week 24
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The SF-36v2 is a 36-item, participant-reported survey of participant health that measures 8 scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.
Each component was directly transformed into a 0 to 100 scale on the assumption that each question carried equal weight.
A score of 0 was equal to maximum disability, and a score of 100 indicated no disability.
Mean change could range from -100 to 100.
A positive mean change indicated an improved outcome.
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Baseline, Week 24
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Change From Baseline at Week 24 in EuroQol-5 Dimension 5 Level (EQ-5D-5L): Visual Analog Scale (VAS)
Tidsram: Baseline, Week 24
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The EQ-5D-5L VAS is an instrument for self-reported assessment that ranks participant health status.
Participants self-rate their health status using a scale of best health imaginable (100) to worst health imaginable (0).
An increase in score indicates an improved health status.
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Baseline, Week 24
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Number of Participants With a Response as Measured by the Post-Acute COVID-19 Questionnaire
Tidsram: Week 24
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Participants completed a post-acute COVID-19 questionnaire at each scheduled visit.
The questionnaire is a survey instrument used to help measure functional health and health-related quality of life post-acute COVID-19.
One of the items the questionnaire captures was whether the participant sought urgent medical care at an emergency room or clinic for specified symptoms (answered 'Yes' or 'No').
Symptoms ranged from cough and shortness of breath or difficult breathing to difficulty reasoning and solving problems and memory loss (short or long term).
The number of participants answering 'Yes' to this question is reported.
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Week 24
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Number of Participants Who Experienced Death Due to Any Cause
Tidsram: Baseline through Week 24
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All participants in the mITT set who experienced death due to any cause are reported.
All deaths regardless of occurrence outside of hospital or during hospitalization (not adjudicated) are reported.
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Baseline through Week 24
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Plasma Concentration of Ensitrelvir at Day 4
Tidsram: Day 4 (up to 90 minutes postdose)
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Plasma samples were collected at specified timepoints to measure ensitrelvir levels.
Results reported as micrograms/milliliter (ug/mL).
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Day 4 (up to 90 minutes postdose)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
3 augusti 2022
Primärt slutförande (Faktisk)
7 januari 2024
Avslutad studie (Faktisk)
24 maj 2024
Studieregistreringsdatum
Först inskickad
30 mars 2022
Först inskickad som uppfyllde QC-kriterierna
30 mars 2022
Första postat (Faktisk)
31 mars 2022
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ACTIV-2d/A5407
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .