En studie for å sammenligne S-217622 med placebo hos ikke-innlagte deltakere med covid-19 (SCORPIO-HR)
29. juli 2026 oppdatert av: Shionogi
En fase 3, multisenter, randomisert, dobbeltblind, 24-ukers studie av den kliniske og antivirale effekten av S-217622 sammenlignet med placebo hos ikke-innlagte deltakere med covid-19
Hovedmålet med denne studien er å evaluere effekten av S-217622 versus placebo blant deltakere som er i underpopulasjonen av deltakere som ikke var forventet å motta standard-of-care COVID-19 gruppe A-behandling (definert som monoklonalt antistoff [mAb) ] behandling eller poliklinisk intravenøs [IV] remdesivir).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
2093
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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, Brasil, 13034-685
- Hospital da Puc Campinas, Centro de Pesquisa Sao Lucas
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Rio de Janeiro, Brasil, 20241-180
- IBPClin, Rua da Gloria
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Rio de Janeiro, Brasil, 21040-360
- INI/Fiocruz
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Volta Redonda, Brasil, 27253-003
- Lóbus Cntr. de Pesquisa Cl.
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Estado de Bahia
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Salvador, Estado de Bahia, Brasil, 41650-010
- SENAI CIMATEC Clinical Trial Research Center
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Mato Grosso
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Cuiabá, Mato Grosso, Brasil, 78050-253
- AMB3 Servicos Medicos Ltda Rua Campinas
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasil, 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, Brasil, 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, Brasil, 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, Brasil, 90410-000,
- Thainá Garbino dos Santos, Avenida Protásio Alves 211, Bloco C
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Porto Alegre, Rio Grande do Sul, Brasil, 91350-180
- IPARGS, Rua Antonio Joaquim Mesquita
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São Paulo
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Baretos, São Paulo, Brasil
- Fundação Pio XII - Hospital de Amor de, Barretos; Rua Antenor Duarte Villela
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Botucatu, São Paulo, Brasil, 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, Brasil, 12916-350
- Hospital Universario Sao Francisco, na Providencia de Deus-Av. Sao Francisco de Assis
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Campinas, São Paulo, Brasil, 13060-080
- Instituto de Pesquisa Clinica de Campinas IPECC Tua Oswaldo
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Jaú, São Paulo, Brasil, 17201-210
- Cecip Jau
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Santo André, São Paulo, Brasil, 09080-111
- Pesquisare Saúde
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São Bernardo do Campo, São Paulo, Brasil, 09715-090
- CEMEC
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São Paulo, São Paulo, Brasil, 01001-000
- Esperanca Clinica De Pesquisas
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Tatuí, São Paulo, Brasil, 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, Filippinene, 1552
- Health Cube Medical Clinics, High Pointe Medical Hub, 241 Shaw Blvd
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Quezon City, Filippinene, 1100
- Lung Center of the Philippines
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Batangas
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Lipa, Batangas, Filippinene, 4217
- Mary Mediatrix Medical Cntr
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Manila
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Tondo, Manila, Filippinene, 1221
- Mary Johnston Hospital, 1221 Juan Nolasco Street
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Molo
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Lloilo, Molo, Filippinene, 5000
- Iloilo Doctors' Hospital, Room 706, New Condoclinics Bldg, West Ave
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Pampanga
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Mabalacat, Pampanga, Filippinene, 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, Filippinene, 2500
- Ilocos Training and Regional Medical Center
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Pampanga, San Fernando, Filippinene, 2000
- Green City Medical Center
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Alabama
-
Guntersville, Alabama, Forente stater, 35976
- Lakeview Clinical Research
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Arizona
-
Tempe, Arizona, Forente stater, 85282
- Voyage Medical Services
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Tucson, Arizona, Forente stater, 85741
- Novak Clinical Research
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California
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Canoga Park, California, Forente stater, 91303
- Hope Clinical Research
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Culver City, California, Forente stater, 91606
- Carbon Health
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Garden Grove, California, Forente stater, 92866
- NICR
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Long Beach, California, Forente stater, 94110
- Ark Clinical Research (PARENT)
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San Diego, California, Forente stater, 92103
- UCSD Antiviral Research Center
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San Francisco, California, Forente stater, 94110
- University of California San Francisco (PARENT)
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Thousand Oaks, California, Forente stater, 91360
- Clinical Trials Management Services, 223 E. Thousand Oaks Blvd.
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Torrance, California, Forente stater, 90502
- Lundquist Institute for BMI, UCLA Medical Center
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Colorado
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Aurora, Colorado, Forente stater, 80045
- University of Colorado Anschutz Medical Campus
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District of Columbia
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Washington D.C., District of Columbia, Forente stater, 20005
- Whitman-Walker Health
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Florida
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Gainesville, Florida, Forente stater, 32610
- University of Florida Clinical & Translational Science Institute
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Miami, Florida, Forente stater, 33155
- Miami Clinical Research
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Miami, Florida, Forente stater, 33176
- Vista Health Research, LLC
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Miami, Florida, Forente stater, 33134
- Universal Medical and Research Center
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Miami, Florida, Forente stater, 33144
- CCR Medical Center, Suite 201
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Miami Beach, Florida, Forente stater, 33140
- Quantum Clinical Trials, 333 Arthur Godfrey Road, Suite 202, suite 208
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Miami Lakes, Florida, Forente stater, 33016
- Quality Research of South Florida
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Ormond Beach, Florida, Forente stater, 32174
- Accel Research Sites Network, Ormond Clinical Research Unit, 77 West Granada Boulevard
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Pompano Beach, Florida, Forente stater, 33060
- Clinical Research Center of Florida, 550 SW 3rd St.,, Suite #305
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Pompano Beach, Florida, Forente stater, 33073
- Invictus Clinical Research Group, LLC
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Tampa, Florida, Forente stater, 33615
- Santos Research Center, CORP
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Georgia
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Augusta, Georgia, Forente stater, 30909
- Masters of Clinical Research
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Idaho
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Idaho Falls, Idaho, Forente stater, 83404
- Leavitt Clinical Research
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Illinois
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Berwyn, Illinois, Forente stater, 60402
- Research Network America
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Chicago, Illinois, Forente stater, 89109
- Rush University Infectious Diseases
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Louisiana
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Marrero, Louisiana, Forente stater, 70072
- Tandem Clinical Research
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Maryland
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Baltimore, Maryland, Forente stater, 21287
- The Johns Hopkins Hospital
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Michigan
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Grand Rapids, Michigan, Forente stater, 49525
- Infusion Associates
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Troy, Michigan, Forente stater, 48312
- Revival Research Institute LLC
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Nevada
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Las Vegas, Nevada, Forente stater, 89119
- AB Clinical Trials
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Las Vegas, Nevada, Forente stater, 89113
- Las Vegas Medical Research
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New Mexico
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Albuquerque, New Mexico, Forente stater, 87901
- Renal Medicine Associates
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New York
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New York, New York, Forente stater, 10032-3722
- Columbia University Irving Medical Center Division of Infectious Diseases
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New York, New York, Forente stater, 10065
- NY Blood Center Project ACHIEVE
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Rochester, New York, Forente stater, 14542
- University of Rochester Medical Center
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North Carolina
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Denver, North Carolina, Forente stater, 28037
- Lapis Clinical Research - North State
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Morgantown, North Carolina, Forente stater, 28655
- Burke Primary Care
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Winston-Salem, North Carolina, Forente stater, 27103
- Progressive Medicine of the Triad, LLC
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Ohio
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Columbus, Ohio, Forente stater, 43201
- Ohio State University College of Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Infectious Disease Clinical Trials Unit-University of Pennsylvania Health System
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Pittsburgh, Pennsylvania, Forente stater, 15213
- UPMC Eye Center - Eye and Ear Institute
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Tennessee
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Nashville, Tennessee, Forente stater, 37204
- Vanderbilt Health-One Hundred Oaks
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Texas
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Austin, Texas, Forente stater, 78705
- Central Texas Medical Research
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Forney, Texas, Forente stater, 75126
- Care United Research, 375 North FM 548, suite 100
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Fort Worth, Texas, Forente stater, 76164
- Valley Institute of Research
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Houston, Texas, Forente stater, 77065
- Accurate Clinical Management, LLC
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Houston, Texas, Forente stater, 77008
- Trio Clinical Trials, LLC.
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San Antonio, Texas, Forente stater, 78215
- Sun Research Institute, LLC
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Utah
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Bountiful, Utah, Forente stater, 84010
- Progressive Clinical Research
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Virginia
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Richmond, Virginia, Forente stater, 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, India, 500018
- St. Theresa's Hospital
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Nellore, Andhra Pradesh, India, 524001
- Vijaya Super Speciality Hospital
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Nellore, Andhra Pradesh, India, 524001
- DEC-Health Care Hospital
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Visakhapatnam, Andhra Pradesh, India, 530002
- King George Hospital
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Gujarat
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Ahmedabad, Gujarat, India, 380015
- Sangini Hospital 1st Flr & 7th flr
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Vadodara, Gujarat, India, 390021
- Aman Hospital and Research Center
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Vadodara, Gujarat, India, 390022
- Rhythm Heart Institute - A Unit of SLPL
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Haryana
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Faridabad, Haryana, India, 121001
- ESIC Medical College & Hospital
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Faridabad, Haryana, India, 121006
- Sarvodaya Hospital and Research Centre
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Karnataka
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Bangalore, Karnataka, India, 560060
- BGS Global Institute of Medical Sciences
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Belagavi, Karnataka, India, 590010
- KLEs Dr. Prabhakar Kore Hospital & MRC Belagavi
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Bengaluru, Karnataka, India, 560068
- Shettys Hospital
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Bengaluru, Karnataka, India, 560036
- Sri Lakshmi Super Speciality Hospital
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Bengaluru, Karnataka, India, 562107
- Sri Venkateshwara Hospitals, SKY HEIGHTS, Site#1/2, Sarjapura-Attibele, Main rd, Indelebele Village
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Mangalore, Karnataka, India, 575018
- Yenepoya Med College Hosp, EMD Building, 5th fl., University Rd, Deralakatte
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Maharashtra
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Dombivali, Maharashtra, India, 421203
- BAJ RR Hosp and Res Cntr
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Nashik, Maharashtra, India, 422005
- Chopda Medicare & Research Centre Pvt. Ltd
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Pune, Maharashtra, India, 411057
- Lifepoint Multispecialty Hosp.
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National Capital Territory of Delhi
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New Delhi, National Capital Territory of Delhi, India, 110060
- Sir Ganga Ram Hospital
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New Delhi
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Dwārka, New Delhi, India, 110075
- Aakash Healthcare Private Limited
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Rajasthan
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Jaipur, Rajasthan, India, 302020
- JNUIMSRC
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Jaipur, Rajasthan, India, 302020
- Tagore Hospital & Research Institute
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Tamil Nadu
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Chennai, Tamil Nadu, India, 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, India, 208002
- Department of Medicine
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Uttarakhand
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Rudrapur, Uttarakhand, India, 263135
- HB Specialty Hosp. & Res Inst.
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West Bengal
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Kolkata, West Bengal, India, 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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-
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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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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, Mexico, C.P 20230
- Hospital Cardiológica Aguascalientes, Ecuador 200 Fracc Las Américas
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Aguascalientes, Mexico, 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, Mexico, 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, Mexico, 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, Mexico, C.P62210
- Avenida Universidad 1001, Edificio 19, planta baja, colonia Chamilpa
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Oaxaca
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Oaxaca City, Oaxaca, Mexico, 68000
- Oaxaca Site Management Organization S.C., Humboldt 302, Col. Centro.
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Quintana Roo
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Cancún, Quintana Roo, Mexico, 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, Mexico, 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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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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Roodepoort, Sør-Afrika, 1724
- Roodepoort Medicross Clinical Research Centre
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Free State
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Bloemfontein, Free State, Sør-Afrika, 9300
- Josha Research
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Gauteng
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Johanesburg, Gauteng, Sør-Afrika, 2001
- Newton Clinical Research Centre
-
Johannesburg, Gauteng, Sør-Afrika, 1500
- Worthwhile Clinical Trials
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Johannesburg, Gauteng, Sør-Afrika, 1862
- (PHRU), New Nurses Home 9th floor Chris
-
Johannesburg, Gauteng, Sør-Afrika, 2092
- CHRU, Themba Lethu Clinic
-
Krugersdorp, Gauteng, Sør-Afrika, 1739
- Ubuntu Clinical Research
-
Lenasia, Gauteng, Sør-Afrika, 1829
- Ubuntu Clinical Research
-
Midrand, Gauteng, Sør-Afrika, 1685
- T/A Midrand Medical Centre, Shop #1, Health Emporium
-
Pretoria, Gauteng, Sør-Afrika, 83
- Global Clinical Trials
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Randburg, Gauteng, Sør-Afrika, 2087
- Right to Care Research Esizayo, Right Clinic Esizayo
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Limpopo
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Thabazimbi, Limpopo, Sør-Afrika, 0380
- Limpopo Clin Res Initiative Tamboti Medical Centre
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North West
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Rustenburg, North West, Sør-Afrika, 0299
- The Arum Institute NPC Rustenburg CRS
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Western Cape
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George, Western Cape, Sør-Afrika, 6529
- Task Eden Research Centre
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Paarl, Western Cape, Sør-Afrika, 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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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Dokumentasjon av laboratoriebekreftet aktiv SARS-CoV-2-infeksjon, bestemt av en nukleinsyre (for eksempel revers-transkriptase PCR) eller antigentest fra en hvilken som helst luftveisprøve (for eksempel orofaryngeal, NP eller nasal vattpinne eller spytt) samlet ≤120 timer (5 dager) før randomisering.
- Deltakerne forventes å begynne studieintervensjon ≤5 dager fra selvrapportert dato for debut av noen av de covid-19-relaterte symptomene fra følgende liste:
- Hoste
- Kortpustethet eller pustevansker
- Føler feber
- Frysninger
- Utmattelse
- Kroppssmerter eller muskelsmerter eller smerter
- Diaré
- Kvalme
- Oppkast
- Hodepine
- Sår hals
- Nasal obstruksjon eller tetthet
- Neseutslipp
- Tap av smak eller lukt
- Ett eller flere av følgende tegn/symptomer forekommer innen 24 timer før randomisering:
- Hoste
- Kortpustethet eller pustevansker
- Føler feber
- Frysninger
- Utmattelse
- Kroppssmerter eller muskelsmerter eller smerter
- Diaré
- Kvalme
- Oppkast
- Hodepine
- Sår hals
- Nasal obstruksjon eller tetthet
- Neseutslipp
- Deltakere med høy risiko er definert som å ha 1 eller flere faktorer som fører til høyere risiko for progresjon til alvorlig COVID-19:
- Alder ≥65 år
- Alder ≥18 med 1 av følgende:
- Overvekt (kroppsmasseindeks [BMI] ≥30 kilo per kvadratmeter [kg/m^2]). Merk: BMI er avrundet til nærmeste hele tall, for eksempel er 29,5 kg/m^2 avrundet til 30 kg/m^2.
- Sukkersyke
- Hypertensjon
- Hjerte- og karsykdommer (inkludert medfødt hjertesykdom)
- Kronisk lungesykdom (for eksempel kronisk obstruktiv lungesykdom, moderat til alvorlig astma, interstitiell lungesykdom, cystisk fibrose, pulmonal hypertensjon)
- Kronisk nyresykdom, så lenge deltakeren ikke har kjent kreatininclearance (CrCl)
- Downs syndrom
- Sigdcellesykdom
- En av følgende immunkompromitterende tilstander eller immunsuppressive behandlinger:
- Får kjemoterapi eller andre terapier for kreft
- Hematologisk malignitet (aktiv eller i remisjon)
- Historie om en hematopoetisk stamcelle eller en solid organtransplantasjon
- Humant immunsviktvirusinfeksjon: ikke på antiretroviral terapi eller med cluster of differentiation 4+ celletall
- Kombinert primær immunsviktlidelse
- Tar immundempende medisiner (for eksempel medisiner for å undertrykke avstøtning av transplanterte organer eller for å behandle revmatologiske og gastrointestinale tilstander, som antitumornekrosefaktormidler, mykofenolat og rituximab).
Merk: Nåværende bruk av enkelte kortikosteroider er utelukkende på grunn av bekymring for mulig legemiddelinteraksjon (DDI) med S-217622.
Ekskluderingskriterier:
- Sykehusinnleggelseshistorie for den aktuelle SARS-CoV-2-infeksjonen (det vil si at tidligere sykehusinnleggelse for en tidligere episode med SARS-CoV-2-infeksjon er tillatt)
- For den nåværende SARS-CoV-2-infeksjonen ble enhver positiv SARS-CoV-2-molekylær (nukleinsyre)- eller antigentest fra alle luftveisprøver (for eksempel orofaryngeal, NP eller nesepinne eller spytt) samlet ˃120 timer ( 5 dager) før randomisering. Deltakere med reinfeksjon, definert som tidligere SARS-CoV-2-infeksjon som begynte >90 dager før nåværende symptomdebut med intervalloppløsning av symptomene er kvalifisert så lenge den nåværende infeksjonen ikke har vært tilstede i mer enn 5 dager før randomisering .
- Nåværende behov for sykehusinnleggelse eller øyeblikkelig legehjelp etter utrederens oppfatning
- Nåværende bruk av medisiner som er forbudt med studieintervensjonen. Bruk av Paxlovid når som helst og bruk av orale, inhalerte eller injiserbare medisiner beregnet på å behandle symptomatisk SARS-CoV-2-infeksjon før påmelding er utelukket. Etter påmelding vil lokalt tilgjengelig SARS-CoV-2-behandling (inkludert men ikke begrenset til molnupiravir, mAbs, poliklinisk IV remdesivir, rekonvalesent plasma, inhalert budesonid, favipiravir og fluvoksamin) være tillatt, så lenge det ikke er bekymring for DDI.
- Mottak av eventuelle undersøkelsesbehandlinger for den aktuelle episoden av SARS-CoV-2 når som helst før randomisering er ekskluderende. Merk: Dette inkluderer ikke legemidler som er godkjent for annen bruk og tatt for disse indikasjonene eller covid-19-vaksiner. Merk: Bruk av lokalt godkjente eller godkjente terapier for å forhindre COVID-19, slik som mAbs gitt utelukkende for å forhindre COVID-19, er ikke ekskluderende.
- Enhver komorbiditet som krever kirurgi innen 7 dager før randomisering eller som anses som livstruende etter etterforskerens mening innen 28 dager før randomisering
- Kjent allergi/sensitivitet eller overfølsomhet overfor komponenter av S-217622 eller placebo for S-217622
- Kjent nåværende nedsatt nyrefunksjon definert som CrCl
- Kjent historie med skrumplever eller leverdekompensasjon (inkludert ascites, variceal blødning eller hepatisk encefalopati)
- Deltakere som har brukt noen av følgende legemidler innen 14 dager før påmelding:
- Sterk cytokrom P453A (CYP 3A) hemmer
- Sterk CYP3A-induktor
- Produkter som inneholder johannesurt
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: S-217622
S-217622 vil bli administrert oralt i 5 dager.
|
Administreres som en rund tablett.
|
|
Placebo komparator: Placebo
Placebo-matching til S-217622 vil bli administrert oralt i 5 dager.
|
Administreres som en rund tablett.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to Sustained Symptom Resolution
Tidsramme: 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.
|
Up to Day 29
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change From Baseline at Day 4 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Levels on Nasopharyngeal (NP) Swabs
Tidsramme: 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]).
|
Baseline, Day 4
|
|
Number of Participants Who Experienced Hospitalization (Adjudicated) or Death Due to Any Cause
Tidsramme: Up to 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.
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
|
|
Time to Sustained Symptom Resolution in the mITT1 Set
Tidsramme: 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.
|
Up to Day 29
|
|
Median Change From Baseline at Day 8 in SARS-CoV-2 RNA Levels on NP Swabs
Tidsramme: Baseline, Day 8
|
NP swabs were collected by staff during in-person visits for measurement of SARS-CoV-2 RNA levels by quantitative log10 PCR.
|
Baseline, Day 8
|
|
Number of Participants With Persistent and/or Late-Onset Symptoms of COVID-19 at Week 12
Tidsramme: Week 12
|
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.
|
Week 12
|
|
Time to Sustained Resolution of 6 Targeted Symptoms and Being Alive and Without Hospitalization for Any Reason by Day 29
Tidsramme: Day 1 through Day 29
|
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.
|
Day 1 through Day 29
|
|
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
Tidsramme: Day 1 through Day 29
|
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).
|
Day 1 through Day 29
|
|
Number of Participants With Undetectable SARS-CoV-2 on NP Swabs on Day 4 and Day 8
Tidsramme: Day 4 and Day 8
|
NP swabs were collected by staff during in-person visits for measurement of SARS-CoV-2 RNA levels by viral titer by culture.
|
Day 4 and Day 8
|
|
Number of Participants Experiencing Hospitalization (All Cause) or Death Due to Any Cause
Tidsramme: Up to 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.
All deaths regardless of occurrence outside of hospital or during hospitalization (not adjudicated) are reported.
|
Up to Day 29
|
|
Number of Participants With NP SARS-CoV-2 RNA Levels Below the Lower Limit of Quantification on Day 4 and Day 8
Tidsramme: Day 4 and Day 8
|
NP swabs were collected by staff during in-person visits for measurement of SARS-CoV-2 RNA levels by log10 quantitative PCR.
|
Day 4 and Day 8
|
|
Median Change From Baseline at Day 4 and Day 8 in SARS-CoV-2 RNA by Quantitative PCR in NP Swabs
Tidsramme: Baseline, Day 4, Day 8
|
NP swabs were collected by staff during in-person visits per protocol for measurement of log10 SARS-CoV-2 RNA levels by quantitative PCR.
|
Baseline, Day 4, Day 8
|
|
Time to Self-Reported Return to Usual (Pre-COVID-19) Health
Tidsramme: Day 1 up to Day 29
|
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.
|
Day 1 up to Day 29
|
|
Number of Participants Reaching a Score ≥2, ≥3, ≥4, ≥5, ≥6, ≥7, or ≥8 on the WHO Ordinal Scale
Tidsramme: Day 29
|
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.
|
Day 29
|
|
Change From Baseline at Day 29 in Resting Peripheral Oxygen Saturation
Tidsramme: Baseline, Day 29
|
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.
|
Baseline, Day 29
|
|
Number of Participants With Resting Peripheral Oxygen Saturation <96% Versus ≥96%
Tidsramme: Up to Day 29
|
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.
|
Up to Day 29
|
|
Severity of Persistent and/or Late-Onset Symptoms of COVID-19 at Week 24
Tidsramme: Week 24
|
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.
|
Week 24
|
|
Number of Participants With Symptomatic Viral Rebound Between Day 6 and Day 29
Tidsramme: Day 6 up to Day 29
|
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.
|
Day 6 up to Day 29
|
|
Number of Participants With Viral Rebound Between Day 6 and Day 29
Tidsramme: Day 6 up to Day 29
|
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.
|
Day 6 up to Day 29
|
|
Change From Baseline at Week 24 in Short Form 36 Version 2.0 (SF-36 V2) Quality of Life Score
Tidsramme: Baseline, Week 24
|
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.
|
Baseline, Week 24
|
|
Change From Baseline at Week 24 in EuroQol-5 Dimension 5 Level (EQ-5D-5L): Visual Analog Scale (VAS)
Tidsramme: Baseline, Week 24
|
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.
|
Baseline, Week 24
|
|
Number of Participants With a Response as Measured by the Post-Acute COVID-19 Questionnaire
Tidsramme: Week 24
|
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.
|
Week 24
|
|
Number of Participants Who Experienced Death Due to Any Cause
Tidsramme: Baseline through Week 24
|
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.
|
Baseline through Week 24
|
|
Plasma Concentration of Ensitrelvir at Day 4
Tidsramme: Day 4 (up to 90 minutes postdose)
|
Plasma samples were collected at specified timepoints to measure ensitrelvir levels.
Results reported as micrograms/milliliter (ug/mL).
|
Day 4 (up to 90 minutes postdose)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
3. august 2022
Primær fullføring (Faktiske)
7. januar 2024
Studiet fullført (Faktiske)
24. mai 2024
Datoer for studieregistrering
Først innsendt
30. mars 2022
Først innsendt som oppfylte QC-kriteriene
30. mars 2022
Først lagt ut (Faktiske)
31. mars 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ACTIV-2d/A5407
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .