一项将 S-217622 与安慰剂在未住院的 COVID-19 参与者中进行比较的研究 (SCORPIO-HR)
2026年7月29日 更新者：Shionogi
S-217622 与安慰剂相比对 COVID-19 非住院参与者的临床和抗病毒作用的 3 期、多中心、随机、双盲、24 周研究
本研究的主要目的是评估 S-217622 与安慰剂在参与者亚群中的疗效，这些参与者属于预计不会接受标准护理 COVID-19 A 组治疗（定义为单克隆抗体 [mAb ] 治疗或门诊静脉注射 [IV] 瑞德西韦）。
研究概览
研究类型
介入性
注册 (实际的)
2093
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Kampala、乌干达
- Joint Clinical Research Centre
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Kampala、乌干达、10005
- Joint Clinical Research Centre
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Kampala、乌干达
- Infectious Diseases Institute (IDI), Mulago Hill Road
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Lira、乌干达
- SICRA, Lira Regional Referral, Plot 21-41 Ngetta Road P.O. Box 330062
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Tororo、乌干达
- IDRC Clinic, Tororo General Hospital, P.O. Box 2, Station Rd
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Kintampo、加纳、PO BOX 200
- Kintampo Health Research Cntr
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Kumasi、加纳、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、加纳、PO BOX 114
- Navrongo Health Research Cntr
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Roodepoort、南非、1724
- Roodepoort Medicross Clinical Research Centre
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Free State
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Bloemfontein、Free State、南非、9300
- Josha Research
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Gauteng
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Johanesburg、Gauteng、南非、2001
- Newton Clinical Research Centre
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Johannesburg、Gauteng、南非、1500
- Worthwhile Clinical Trials
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Johannesburg、Gauteng、南非、1862
- (PHRU), New Nurses Home 9th floor Chris
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Johannesburg、Gauteng、南非、2092
- CHRU, Themba Lethu Clinic
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Krugersdorp、Gauteng、南非、1739
- Ubuntu Clinical Research
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Lenasia、Gauteng、南非、1829
- Ubuntu Clinical Research
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Midrand、Gauteng、南非、1685
- T/A Midrand Medical Centre, Shop #1, Health Emporium
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Pretoria、Gauteng、南非、83
- Global Clinical Trials
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Randburg、Gauteng、南非、2087
- Right to Care Research Esizayo, Right Clinic Esizayo
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Limpopo
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Thabazimbi、Limpopo、南非、0380
- Limpopo Clin Res Initiative Tamboti Medical Centre
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North West
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Rustenburg、North West、南非、0299
- The Arum Institute NPC Rustenburg CRS
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Western Cape
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George、Western Cape、南非、6529
- Task Eden Research Centre
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Paarl、Western Cape、南非、7626
- Be Part Research PTY (LTD)
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Andhra Pradesh
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Hyderabad、Andhra Pradesh、印度、500018
- St. Theresa's Hospital
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Nellore、Andhra Pradesh、印度、524001
- Vijaya Super Speciality Hospital
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Nellore、Andhra Pradesh、印度、524001
- DEC-Health Care Hospital
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Visakhapatnam、Andhra Pradesh、印度、530002
- King George Hospital
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Gujarat
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Ahmedabad、Gujarat、印度、380015
- Sangini Hospital 1st Flr & 7th flr
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Vadodara、Gujarat、印度、390021
- Aman Hospital and Research Center
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Vadodara、Gujarat、印度、390022
- Rhythm Heart Institute - A Unit of SLPL
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Haryana
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Faridabad、Haryana、印度、121001
- ESIC Medical College & Hospital
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Faridabad、Haryana、印度、121006
- Sarvodaya Hospital and Research Centre
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Karnataka
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Bangalore、Karnataka、印度、560060
- BGS Global Institute of Medical Sciences
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Belagavi、Karnataka、印度、590010
- KLEs Dr. Prabhakar Kore Hospital & MRC Belagavi
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Bengaluru、Karnataka、印度、560068
- Shettys Hospital
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Bengaluru、Karnataka、印度、560036
- Sri Lakshmi Super Speciality Hospital
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Bengaluru、Karnataka、印度、562107
- Sri Venkateshwara Hospitals, SKY HEIGHTS, Site#1/2, Sarjapura-Attibele, Main rd, Indelebele Village
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Mangalore、Karnataka、印度、575018
- Yenepoya Med College Hosp, EMD Building, 5th fl., University Rd, Deralakatte
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Maharashtra
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Dombivali、Maharashtra、印度、421203
- BAJ RR Hosp and Res Cntr
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Nashik、Maharashtra、印度、422005
- Chopda Medicare & Research Centre Pvt. Ltd
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Pune、Maharashtra、印度、411057
- Lifepoint Multispecialty Hosp.
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National Capital Territory of Delhi
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New Delhi、National Capital Territory of Delhi、印度、110060
- Sir Ganga Ram Hospital
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New Delhi
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Dwārka、New Delhi、印度、110075
- Aakash Healthcare Private Limited
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Rajasthan
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Jaipur、Rajasthan、印度、302020
- JNUIMSRC
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Jaipur、Rajasthan、印度、302020
- Tagore Hospital & Research Institute
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Tamil Nadu
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Chennai、Tamil Nadu、印度、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、印度、208002
- Department of Medicine
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Uttarakhand
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Rudrapur、Uttarakhand、印度、263135
- HB Specialty Hosp. & Res Inst.
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West Bengal
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Kolkata、West Bengal、印度、700073
- Calcutta School of Tropical Medicine
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Bogotá、哥伦比亚、110221
- Bluecare salud SAS
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Antioquia
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Medellín、Antioquia、哥伦比亚、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、哥伦比亚、80020
- IPS CENTRO CIENTIFICO ASISTENCIAL S.A.S, Cra 45 #85-49
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Barranquilla、Atlántico、哥伦比亚、080020
- Centro de Investigación Medico, Asistencia - CIMEDICAL S.A.S, Cra 49C # 82-120
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Barranquilla、Atlántico、哥伦比亚、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.、哥伦比亚、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、哥伦比亚、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、哥伦比亚、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、哥伦比亚、630004
- Fundación Cardiomet Cequin,, Street 18 North # 14-25,
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Aguascalientes、墨西哥、C.P 20230
- Hospital Cardiológica Aguascalientes, Ecuador 200 Fracc Las Américas
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Aguascalientes、墨西哥、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、墨西哥、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、墨西哥、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、墨西哥、C.P62210
- Avenida Universidad 1001, Edificio 19, planta baja, colonia Chamilpa
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Oaxaca
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Oaxaca City、Oaxaca、墨西哥、68000
- Oaxaca Site Management Organization S.C., Humboldt 302, Col. Centro.
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Quintana Roo
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Cancún、Quintana Roo、墨西哥、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、墨西哥、91900
- FAICIC S. DE R.L. DE C.V., Av. 16 de Septiembre 1165
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Islamabad、巴基斯坦、44000
- Shifa International Hospital, 4 Pitras Bukhari Rd, H-8/4, H-8
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Karachi、巴基斯坦、75300
- Dow Univ of Health Sciences Ojha Campus
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Karachi、巴基斯坦、75300
- Sindh Infectious Disease Hospital and research Centre
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Peshawar、巴基斯坦、74800
- Maroof International Hospital
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Karachi
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Korangi、Karachi、巴基斯坦、75190
- Indus Hospital and Health Network
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Peshawar
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Hayatabad、Peshawar、巴基斯坦、25000
- Rehman Medical Institute Clinical Trial Unit
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Punjab Province
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Lahore、Punjab Province、巴基斯坦、54000
- Central Park Teaching Hospital
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Lahore、Punjab Province、巴基斯坦、54000
- National Hospital & Medical Center
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Lahore、Punjab Province、巴基斯坦、54660
- Akram Medical Complex
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Sindh
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Karachi、Sindh、巴基斯坦、74800
- The Aga Khan University
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Campinas、巴西、13034-685
- Hospital da Puc Campinas, Centro de Pesquisa Sao Lucas
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Rio de Janeiro、巴西、20241-180
- IBPClin, Rua da Gloria
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Rio de Janeiro、巴西、21040-360
- INI/Fiocruz
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Volta Redonda、巴西、27253-003
- Lóbus Cntr. de Pesquisa Cl.
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Estado de Bahia
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Salvador、Estado de Bahia、巴西、41650-010
- SENAI CIMATEC Clinical Trial Research Center
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Mato Grosso
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Cuiabá、Mato Grosso、巴西、78050-253
- AMB3 Servicos Medicos Ltda Rua Campinas
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Minas Gerais
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Belo Horizonte、Minas Gerais、巴西、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、巴西、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、巴西、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、巴西、90410-000,
- Thainá Garbino dos Santos, Avenida Protásio Alves 211, Bloco C
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Porto Alegre、Rio Grande do Sul、巴西、91350-180
- IPARGS, Rua Antonio Joaquim Mesquita
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São Paulo
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Baretos、São Paulo、巴西
- Fundação Pio XII - Hospital de Amor de, Barretos; Rua Antenor Duarte Villela
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Botucatu、São Paulo、巴西、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、巴西、12916-350
- Hospital Universario Sao Francisco, na Providencia de Deus-Av. Sao Francisco de Assis
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Campinas、São Paulo、巴西、13060-080
- Instituto de Pesquisa Clinica de Campinas IPECC Tua Oswaldo
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Jaú、São Paulo、巴西、17201-210
- Cecip Jau
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Santo André、São Paulo、巴西、09080-111
- Pesquisare Saúde
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São Bernardo do Campo、São Paulo、巴西、09715-090
- CEMEC
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São Paulo、São Paulo、巴西、01001-000
- Esperanca Clinica De Pesquisas
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Tatuí、São Paulo、巴西、18273-170
- Instituto de Molestast Cardiovasculares
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Fukuuoka-Ken
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Okawa-shi、Fukuuoka-Ken、日本、831-0016
- Kohokai Takagi Hospital
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Ibaraki
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Tsuchiura-shi、Ibaraki、日本、300-0062
- Tsuchiura Beryl Clinic
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Tsuchiura-shi、Ibaraki、日本、305-8576
- University of Tsukuba Hospital
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Tsukuba、Ibaraki、日本、305-8576
- Tashiro Endocrinology Clinic
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Saitama
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Toda-shi、Saitama、日本、335-0035
- KODAIRA Hospital
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-
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Ostrowiec Świętokrzyski、波兰、27-400
- Ostrowieckie Centrum Medyczne
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Oświęcim、波兰、32-600
- Medicome Sp. z o.o.
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Rzeszów、波兰、35-326
- Centrum Medyczne "MEDYK"
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Skierniewice、波兰、96-100
- Clinmedica Research Sp. Z O.O.
-
Wroclaw、波兰、51-162
- Centrum Badań Klinicznych
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-
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Bangkok
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Bangkok Noi、Bangkok、泰国、10700
- Siriraj Hospital
-
Pathum Wan、Bangkok、泰国、10330
- Thai Red Cross AIDS Research Centre
-
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Changwat Khon Kaen
-
Mueang Khon Kaen District、Changwat Khon Kaen、泰国、40002
- Srinagarind Hospital
-
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Chiang Mai
-
Mueang Chiang Mai District、Chiang Mai、泰国、50200
- Research Institute for Health Sciences
-
-
-
-
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Lima、秘鲁、7006
- Centro de Inv. Tecnológicas Biomédicas y Medioambientales
-
Lima、秘鲁
- Asoc. Civil Impacta Salud y Educación - Sede San Miguel
-
Lima Cercado、秘鲁、15082
- Patricia Ortiz Bazan
-
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Lima region
-
San Isidro、Lima region、秘鲁、15036
- Centro de Investigacion
-
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Loreto
-
Iquitos、Loreto、秘鲁、16000
- Asoc. Civil Selva Amazonica
-
-
-
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Alabama
-
Guntersville、Alabama、美国、35976
- Lakeview Clinical Research
-
-
Arizona
-
Tempe、Arizona、美国、85282
- Voyage Medical Services
-
Tucson、Arizona、美国、85741
- Novak Clinical Research
-
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California
-
Canoga Park、California、美国、91303
- Hope Clinical Research
-
Culver City、California、美国、91606
- Carbon Health
-
Garden Grove、California、美国、92866
- NICR
-
Long Beach、California、美国、94110
- Ark Clinical Research (PARENT)
-
San Diego、California、美国、92103
- UCSD Antiviral Research Center
-
San Francisco、California、美国、94110
- University of California San Francisco (PARENT)
-
Thousand Oaks、California、美国、91360
- Clinical Trials Management Services, 223 E. Thousand Oaks Blvd.
-
Torrance、California、美国、90502
- Lundquist Institute for BMI, UCLA Medical Center
-
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Colorado
-
Aurora、Colorado、美国、80045
- University of Colorado Anschutz Medical Campus
-
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District of Columbia
-
Washington D.C.、District of Columbia、美国、20005
- Whitman-Walker Health
-
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Florida
-
Gainesville、Florida、美国、32610
- University of Florida Clinical & Translational Science Institute
-
Miami、Florida、美国、33155
- Miami Clinical Research
-
Miami、Florida、美国、33176
- Vista Health Research, LLC
-
Miami、Florida、美国、33134
- Universal Medical and Research Center
-
Miami、Florida、美国、33144
- CCR Medical Center, Suite 201
-
Miami Beach、Florida、美国、33140
- Quantum Clinical Trials, 333 Arthur Godfrey Road, Suite 202, suite 208
-
Miami Lakes、Florida、美国、33016
- Quality Research of South Florida
-
Ormond Beach、Florida、美国、32174
- Accel Research Sites Network, Ormond Clinical Research Unit, 77 West Granada Boulevard
-
Pompano Beach、Florida、美国、33060
- Clinical Research Center of Florida, 550 SW 3rd St.,, Suite #305
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Pompano Beach、Florida、美国、33073
- Invictus Clinical Research Group, LLC
-
Tampa、Florida、美国、33615
- Santos Research Center, CORP
-
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Georgia
-
Augusta、Georgia、美国、30909
- Masters of Clinical Research
-
-
Idaho
-
Idaho Falls、Idaho、美国、83404
- Leavitt Clinical Research
-
-
Illinois
-
Berwyn、Illinois、美国、60402
- Research Network America
-
Chicago、Illinois、美国、89109
- Rush University Infectious Diseases
-
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Louisiana
-
Marrero、Louisiana、美国、70072
- Tandem Clinical Research
-
-
Maryland
-
Baltimore、Maryland、美国、21287
- The Johns Hopkins Hospital
-
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Michigan
-
Grand Rapids、Michigan、美国、49525
- Infusion Associates
-
Troy、Michigan、美国、48312
- Revival Research Institute LLC
-
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Nevada
-
Las Vegas、Nevada、美国、89119
- AB Clinical Trials
-
Las Vegas、Nevada、美国、89113
- Las Vegas Medical Research
-
-
New Mexico
-
Albuquerque、New Mexico、美国、87901
- Renal Medicine Associates
-
-
New York
-
New York、New York、美国、10032-3722
- Columbia University Irving Medical Center Division of Infectious Diseases
-
New York、New York、美国、10065
- NY Blood Center Project ACHIEVE
-
Rochester、New York、美国、14542
- University of Rochester Medical Center
-
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North Carolina
-
Denver、North Carolina、美国、28037
- Lapis Clinical Research - North State
-
Morgantown、North Carolina、美国、28655
- Burke Primary Care
-
Winston-Salem、North Carolina、美国、27103
- Progressive Medicine of the Triad, LLC
-
-
Ohio
-
Columbus、Ohio、美国、43201
- Ohio State University College of Medicine
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104
- Infectious Disease Clinical Trials Unit-University of Pennsylvania Health System
-
Pittsburgh、Pennsylvania、美国、15213
- UPMC Eye Center - Eye and Ear Institute
-
-
Tennessee
-
Nashville、Tennessee、美国、37204
- Vanderbilt Health-One Hundred Oaks
-
-
Texas
-
Austin、Texas、美国、78705
- Central Texas Medical Research
-
Forney、Texas、美国、75126
- Care United Research, 375 North FM 548, suite 100
-
Fort Worth、Texas、美国、76164
- Valley Institute of Research
-
Houston、Texas、美国、77065
- Accurate Clinical Management, LLC
-
Houston、Texas、美国、77008
- Trio Clinical Trials, LLC.
-
San Antonio、Texas、美国、78215
- Sun Research Institute, LLC
-
-
Utah
-
Bountiful、Utah、美国、84010
- Progressive Clinical Research
-
-
Virginia
-
Richmond、Virginia、美国、23226
- Clinical Research Partners LLC
-
-
-
-
-
Eldoret、肯尼亚、30100
- Moi University Clin Res Centre, 2nd Fl, Chandaria Chronic, Disease and Cancer Centre
-
Kisumu、肯尼亚、40100
- KEMRI CGHR HIVR Site
-
-
-
-
-
Mandaluyong、菲律宾、1552
- Health Cube Medical Clinics, High Pointe Medical Hub, 241 Shaw Blvd
-
Quezon City、菲律宾、1100
- Lung Center of the Philippines
-
-
Batangas
-
Lipa、Batangas、菲律宾、4217
- Mary Mediatrix Medical Cntr
-
-
Manila
-
Tondo、Manila、菲律宾、1221
- Mary Johnston Hospital, 1221 Juan Nolasco Street
-
-
Molo
-
Lloilo、Molo、菲律宾、5000
- Iloilo Doctors' Hospital, Room 706, New Condoclinics Bldg, West Ave
-
-
Pampanga
-
Mabalacat、Pampanga、菲律宾、2023
- The Medical City Clark, #100Eatwick, Gatewick, Global Gateway Logistics City, Industrial Estate 5, Clark Freeport Zone
-
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San Fernando
-
La Union、San Fernando、菲律宾、2500
- Ilocos Training and Regional Medical Center
-
Pampanga、San Fernando、菲律宾、2000
- Green City Medical Center
-
-
-
-
-
Buenos Aires、阿根廷、1602
- Clínica Olivos
-
Córdoba、阿根廷、X5000JHQ
- Sanatorio Allende, Av.
-
San Juan、阿根廷、5400
- CER San Juan,
-
Santa Fe、阿根廷、S2000PBJ
- Mendoza 2612, Rosario
-
-
Buenos Aires
-
Ciudad Autonoma de Buenos Aires、Buenos Aires、阿根廷、C1027AAP
- CINME Centro Investigaciones Metabolicas, Pres. Jose Evaristo Uriburu 754, Piso 3 dpto 12
-
Ciudad Autonoma de Buenos Aires、Buenos Aires、阿根廷、C1039AAO
- Sanatorio De La Trinidad, Mitre Bartolome Mitre
-
Ciudad Autonoma de Buenos Aires、Buenos Aires、阿根廷、C1199
- Hospital Italiano sede Central, Tte. Gral. Juan Domingo Perón 4190
-
Ciudad Autonoma de Buenos Aires、Buenos Aires、阿根廷、C1412
- Centro Privado de Medicina Familiar, Mindout Research
-
Mar del Plata、Buenos Aires、阿根廷、B7600FYK
- Centro De Investigaciones
-
Ramos Mejía、Buenos Aires、阿根廷、1704
- DIM Clínica Privada, Belgrano 136 - 5to piso
-
Ramos Mejía、Buenos Aires、阿根廷、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、阿根廷、B2800DGH
- Clínicas Zárate, F. Andrade 332
-
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Córdoba Province
-
Quiros、Córdoba Province、阿根廷、1948
- Sanatorio Privado ,Duarte Quiros
-
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Sante Fe
-
Rosario、Sante Fe、阿根廷、2000
- Instituto Médico de la, Fundación Estudios Clínicos, Italia 428, Rosario
-
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Tucumán Province
-
San Miguel de Tucumán、Tucumán Province、阿根廷、4000
- Clinica Mayo UMCB
-
-
-
-
-
Lilongwe、马拉维、00000
- UNC Project, Private Bag A-104
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Mangochi、马拉维、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、马拉维、312200
- Johns Hopkins Research Project, Queen Elizabeth Central Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
描述
纳入标准：
- 实验室确认的活动性 SARS-CoV-2 感染的文件，通过核酸（例如，逆转录酶 PCR）或来自任何呼吸道标本（例如，口咽、NP 或鼻拭子，或唾液）的抗原测试确定在随机分组前 ≤ 120 小时（5 天）收集。
- 参与者应在自我报告的以下列表中任何 COVID-19 相关症状出现之日起 ≤5 天内开始研究干预：
- 咳嗽
- 呼吸急促或呼吸困难
- 感觉发烧
- 发冷
- 疲劳
- 身体疼痛或肌肉疼痛或酸痛
- 腹泻
- 恶心
- 呕吐
- 头痛
- 咽喉痛
- 鼻塞或充血
- 鼻涕
- 失去味觉或嗅觉
- 随机分组前 24 小时内出现以下一种或多种体征/症状：
- 咳嗽
- 呼吸急促或呼吸困难
- 感觉发烧
- 发冷
- 疲劳
- 身体疼痛或肌肉疼痛或酸痛
- 腹泻
- 恶心
- 呕吐
- 头痛
- 咽喉痛
- 鼻塞或充血
- 鼻涕
- 高风险参与者被定义为具有 1 个或多个导致进展为严重 COVID-19 的风险更高的因素：
- 年龄≥65岁
- 年龄 ≥18 岁且有以下 1 项：
- 肥胖（体重指数 [BMI] ≥30 千克每平方米 [kg/m^2]）。 注意：BMI 四舍五入到最接近的整数，例如 29.5 kg/m^2 四舍五入到 30 kg/m^2。
- 糖尿病
- 高血压
- 心血管疾病（包括先天性心脏病）
- 慢性肺病（例如，慢性阻塞性肺病、中度至重度哮喘、间质性肺病、囊性纤维化、肺动脉高压）
- 慢性肾病，只要参与者没有已知的肌酐清除率 (CrCl)
- 唐氏综合症
- 镰状细胞性贫血症
- 以下免疫妥协病症或免疫抑制治疗之一：
- 接受化学疗法或其他癌症疗法
- 血液系统恶性肿瘤（活动性或缓解期）
- 造血干细胞或实体器官移植史
- 人类免疫缺陷病毒感染：未接受抗逆转录病毒治疗或分化簇 4+ 细胞计数
- 联合原发性免疫缺陷病
- 服用免疫抑制药物（例如，抑制移植器官排斥或治疗风湿病和胃肠道疾病的药物，例如抗肿瘤坏死因子药物、霉酚酸酯和利妥昔单抗）。
注意：由于担心与 S-217622 可能发生药物相互作用 (DDI)，目前某些皮质类固醇的使用是排他性的。
排除标准：
- 当前 SARS-CoV-2 感染的住院史（即允许先前因 SARS-CoV-2 感染而住院）
- 对于当前的 SARS-CoV-2 感染，从任何呼吸道标本（例如口咽、NP 或鼻拭子或唾液）中收集的任何 SARS-CoV-2 分子（核酸）或抗原检测呈阳性 ˃120 小时（ 5 天）随机分组前。 再感染的参与者定义为在当前症状出现前 90 天以上开始感染 SARS-CoV-2，并且症状间歇性消退，只要当前感染在随机分组前 5 天以上未出现，则符合条件.
- 研究者认为当前需要住院治疗或立即就医
- 当前使用研究干预所禁止的任何药物。 任何时候使用 Paxlovid 以及在入组前使用任何口服、吸入或注射药物治疗有症状的 SARS-CoV-2 感染均被排除在外。 入组后，只要不担心 DDI，就允许使用当地可用的 SARS-CoV-2 治疗（包括但不限于 molnupiravir、单克隆抗体、门诊静脉注射瑞德西韦、恢复期血浆、吸入布地奈德、法匹拉韦和氟伏沙明）。
- 在随机化之前的任何时间接受过针对当前 SARS-CoV-2 发作的任何研究性治疗是排除性的。 注意：这不包括批准用于其他用途和用于这些适应症的药物或 COVID-19 疫苗。 注意：使用当地授权或批准的疗法来预防 COVID-19，例如仅用于预防 COVID-19 的单克隆抗体，并不是排他性的。
- 在随机分组前 7 天内需要手术的任何合并症，或在随机分组前 28 天内研究者认为被认为危及生命的合并症
- 已知对 S-217622 的成分或 S-217622 的安慰剂过敏/敏感或任何超敏反应
- 已知的当前肾损伤定义为 CrCl
- 已知的肝硬化或肝功能失代偿病史（包括腹水、静脉曲张破裂出血或肝性脑病）
- 在入组前 14 天内使用过以下任何药物的参与者：
- 强细胞色素 P453A (CYP 3A) 抑制剂
- 强 CYP3A 诱导剂
- 含有圣约翰草的产品
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：S-217622
S-217622 将口服给药 5 天。
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作为圆形片剂给药。
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安慰剂比较：安慰剂
与 S-217622 匹配的安慰剂将口服给药 5 天。
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作为圆形片剂给药。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to Sustained Symptom Resolution
大体时间：Up to Day 29
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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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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
大体时间：Baseline, Day 4
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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 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
大体时间：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.
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Up to Day 29
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Time to Sustained Symptom Resolution in the mITT1 Set
大体时间：Up to Day 29
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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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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.
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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
大体时间：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
大体时间：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
大体时间：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.
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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
大体时间：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
大体时间：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%
大体时间：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
大体时间：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
大体时间：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.
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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
大体时间：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.
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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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
|
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Plasma Concentration of Ensitrelvir at Day 4
大体时间：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).
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Day 4 (up to 90 minutes postdose)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2022年8月3日
初级完成 (实际的)
2024年1月7日
研究完成 (实际的)
2024年5月24日
研究注册日期
首次提交
2022年3月30日
首先提交符合 QC 标准的
2022年3月30日
首次发布 (实际的)
2022年3月31日
研究记录更新
最后更新发布 (实际的)
2026年8月20日
上次提交的符合 QC 标准的更新
2026年7月29日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.