COVID-19로 입원하지 않은 참가자의 S-217622와 위약을 비교하는 연구 (SCORPIO-HR)
2026년 7월 29일 업데이트: Shionogi
COVID-19로 입원하지 않은 참가자에서 위약과 비교한 S-217622의 임상 및 항바이러스 효과에 대한 3상, 다기관, 무작위, 이중맹검, 24주 연구
이 연구의 주요 목표는 표준 치료 COVID-19 그룹 A 요법(단클론 항체[단클론항체[mAb] ] 치료 또는 외래 정맥주사[IV] 렘데시비르).
연구 개요
연구 유형
중재적
등록 (실제)
2093
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Kintampo, 가나, PO BOX 200
- Kintampo Health Research Cntr
-
Kumasi, 가나, AK-312-1059
- Kumasi Centre for Research, South End Asuogya Road, Kwame Nkrumah University
-
-
Navrongo
-
Upper East, Navrongo, 가나, PO BOX 114
- Navrongo Health Research Cntr
-
-
-
-
-
Roodepoort, 남아프리카, 1724
- Roodepoort Medicross Clinical Research Centre
-
-
Free State
-
Bloemfontein, Free State, 남아프리카, 9300
- Josha Research
-
-
Gauteng
-
Johanesburg, Gauteng, 남아프리카, 2001
- Newton Clinical Research Centre
-
Johannesburg, Gauteng, 남아프리카, 1500
- Worthwhile Clinical Trials
-
Johannesburg, Gauteng, 남아프리카, 1862
- (PHRU), New Nurses Home 9th floor Chris
-
Johannesburg, Gauteng, 남아프리카, 2092
- CHRU, Themba Lethu Clinic
-
Krugersdorp, Gauteng, 남아프리카, 1739
- Ubuntu Clinical Research
-
Lenasia, Gauteng, 남아프리카, 1829
- Ubuntu Clinical Research
-
Midrand, Gauteng, 남아프리카, 1685
- T/A Midrand Medical Centre, Shop #1, Health Emporium
-
Pretoria, Gauteng, 남아프리카, 83
- Global Clinical Trials
-
Randburg, Gauteng, 남아프리카, 2087
- Right to Care Research Esizayo, Right Clinic Esizayo
-
-
Limpopo
-
Thabazimbi, Limpopo, 남아프리카, 0380
- Limpopo Clin Res Initiative Tamboti Medical Centre
-
-
North West
-
Rustenburg, North West, 남아프리카, 0299
- The Arum Institute NPC Rustenburg CRS
-
-
Western Cape
-
George, Western Cape, 남아프리카, 6529
- Task Eden Research Centre
-
Paarl, Western Cape, 남아프리카, 7626
- Be Part Research PTY (LTD)
-
-
-
-
-
Lilongwe, 말라위, 00000
- UNC Project, Private Bag A-104
-
Mangochi, 말라위, 301400
- Mangochi PHNG Study Site, Kamuzu University of Health Sciences, Private Bag 360, Room 805
-
-
Blantyre
-
Chipatala Avenue, Blantyre, 말라위, 312200
- Johns Hopkins Research Project, Queen Elizabeth Central Hospital
-
-
-
-
-
Aguascalientes, 멕시코, C.P 20230
- Hospital Cardiológica Aguascalientes, Ecuador 200 Fracc Las Américas
-
Aguascalientes, 멕시코, C.P. 20116
- Centro de Inv. Médica Aguascalientes, (CIMA) Av. Independencia 2130, Int. A. Trojes de Alonso
-
-
CP
-
Veracruz, CP, 멕시코, 91851
- Instituto Veracruzano, en Investigación Clínica S.C., Sabino s/n, Colonia Reserva Tarimoya ll
-
-
Cdmx, C.P
-
Cuauhtémoc, Cdmx, C.P, 멕시코, 06760
- CAIMED Investigación en Salud, S.A. de C.V., Manzanillo #100. Piso 2. Roma Sur
-
-
Morelos
-
Cuernavaca, Morelos, 멕시코, C.P62210
- Avenida Universidad 1001, Edificio 19, planta baja, colonia Chamilpa
-
-
Oaxaca
-
Oaxaca City, Oaxaca, 멕시코, 68000
- Oaxaca Site Management Organization S.C., Humboldt 302, Col. Centro.
-
-
Quintana Roo
-
Cancún, Quintana Roo, 멕시코, 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
-
-
Veracruz
-
Ricardo Flores Magón, Veracruz, 멕시코, 91900
- FAICIC S. DE R.L. DE C.V., Av. 16 de Septiembre 1165
-
-
-
-
Alabama
-
Guntersville, Alabama, 미국, 35976
- Lakeview Clinical Research
-
-
Arizona
-
Tempe, Arizona, 미국, 85282
- Voyage Medical Services
-
Tucson, Arizona, 미국, 85741
- Novak Clinical Research
-
-
California
-
Canoga Park, California, 미국, 91303
- Hope Clinical Research
-
Culver City, California, 미국, 91606
- Carbon Health
-
Garden Grove, California, 미국, 92866
- NICR
-
Long Beach, California, 미국, 94110
- Ark Clinical Research (PARENT)
-
San Diego, California, 미국, 92103
- UCSD Antiviral Research Center
-
San Francisco, California, 미국, 94110
- University of California San Francisco (PARENT)
-
Thousand Oaks, California, 미국, 91360
- Clinical Trials Management Services, 223 E. Thousand Oaks Blvd.
-
Torrance, California, 미국, 90502
- Lundquist Institute for BMI, UCLA Medical Center
-
-
Colorado
-
Aurora, Colorado, 미국, 80045
- University of Colorado Anschutz Medical Campus
-
-
District of Columbia
-
Washington D.C., District of Columbia, 미국, 20005
- Whitman-Walker Health
-
-
Florida
-
Gainesville, Florida, 미국, 32610
- University of Florida Clinical & Translational Science Institute
-
Miami, Florida, 미국, 33155
- Miami Clinical Research
-
Miami, Florida, 미국, 33176
- Vista Health Research, LLC
-
Miami, Florida, 미국, 33134
- Universal Medical and Research Center
-
Miami, Florida, 미국, 33144
- CCR Medical Center, Suite 201
-
Miami Beach, Florida, 미국, 33140
- Quantum Clinical Trials, 333 Arthur Godfrey Road, Suite 202, suite 208
-
Miami Lakes, Florida, 미국, 33016
- Quality Research of South Florida
-
Ormond Beach, Florida, 미국, 32174
- Accel Research Sites Network, Ormond Clinical Research Unit, 77 West Granada Boulevard
-
Pompano Beach, Florida, 미국, 33060
- Clinical Research Center of Florida, 550 SW 3rd St.,, Suite #305
-
Pompano Beach, Florida, 미국, 33073
- Invictus Clinical Research Group, LLC
-
Tampa, Florida, 미국, 33615
- Santos Research Center, CORP
-
-
Georgia
-
Augusta, Georgia, 미국, 30909
- Masters of Clinical Research
-
-
Idaho
-
Idaho Falls, Idaho, 미국, 83404
- Leavitt Clinical Research
-
-
Illinois
-
Berwyn, Illinois, 미국, 60402
- Research Network America
-
Chicago, Illinois, 미국, 89109
- Rush University Infectious Diseases
-
-
Louisiana
-
Marrero, Louisiana, 미국, 70072
- Tandem Clinical Research
-
-
Maryland
-
Baltimore, Maryland, 미국, 21287
- The Johns Hopkins Hospital
-
-
Michigan
-
Grand Rapids, Michigan, 미국, 49525
- Infusion Associates
-
Troy, Michigan, 미국, 48312
- Revival Research Institute LLC
-
-
Nevada
-
Las Vegas, Nevada, 미국, 89119
- AB Clinical Trials
-
Las Vegas, Nevada, 미국, 89113
- Las Vegas Medical Research
-
-
New Mexico
-
Albuquerque, New Mexico, 미국, 87901
- Renal Medicine Associates
-
-
New York
-
New York, New York, 미국, 10032-3722
- Columbia University Irving Medical Center Division of Infectious Diseases
-
New York, New York, 미국, 10065
- NY Blood Center Project ACHIEVE
-
Rochester, New York, 미국, 14542
- University of Rochester Medical Center
-
-
North Carolina
-
Denver, North Carolina, 미국, 28037
- Lapis Clinical Research - North State
-
Morgantown, North Carolina, 미국, 28655
- Burke Primary Care
-
Winston-Salem, North Carolina, 미국, 27103
- Progressive Medicine of the Triad, LLC
-
-
Ohio
-
Columbus, Ohio, 미국, 43201
- Ohio State University College of Medicine
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19104
- Infectious Disease Clinical Trials Unit-University of Pennsylvania Health System
-
Pittsburgh, Pennsylvania, 미국, 15213
- UPMC Eye Center - Eye and Ear Institute
-
-
Tennessee
-
Nashville, Tennessee, 미국, 37204
- Vanderbilt Health-One Hundred Oaks
-
-
Texas
-
Austin, Texas, 미국, 78705
- Central Texas Medical Research
-
Forney, Texas, 미국, 75126
- Care United Research, 375 North FM 548, suite 100
-
Fort Worth, Texas, 미국, 76164
- Valley Institute of Research
-
Houston, Texas, 미국, 77065
- Accurate Clinical Management, LLC
-
Houston, Texas, 미국, 77008
- Trio Clinical Trials, LLC.
-
San Antonio, Texas, 미국, 78215
- Sun Research Institute, LLC
-
-
Utah
-
Bountiful, Utah, 미국, 84010
- Progressive Clinical Research
-
-
Virginia
-
Richmond, Virginia, 미국, 23226
- Clinical Research Partners LLC
-
-
-
-
-
Campinas, 브라질, 13034-685
- Hospital da Puc Campinas, Centro de Pesquisa Sao Lucas
-
Rio de Janeiro, 브라질, 20241-180
- IBPClin, Rua da Gloria
-
Rio de Janeiro, 브라질, 21040-360
- INI/Fiocruz
-
Volta Redonda, 브라질, 27253-003
- Lóbus Cntr. de Pesquisa Cl.
-
-
Estado de Bahia
-
Salvador, Estado de Bahia, 브라질, 41650-010
- SENAI CIMATEC Clinical Trial Research Center
-
-
Mato Grosso
-
Cuiabá, Mato Grosso, 브라질, 78050-253
- AMB3 Servicos Medicos Ltda Rua Campinas
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, 브라질, 30130-100
- Faculdade de Medicina da univ., Federal, Av Alfredo Balena, 190, 1° andar - sala 161
-
-
Paraná
-
Curitiba, Paraná, 브라질, 80810-040
- Hosp Nossa Senhora das Gracas, Rue Alcides Munhoz
-
-
Rio Grande do Norte
-
Natal, Rio Grande do Norte, 브라질, 59020-500
- Instituto Atena de Psequisa Clinica Ltds, Av Marechal Floriano Peixoto
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, 브라질, 90410-000,
- Thainá Garbino dos Santos, Avenida Protásio Alves 211, Bloco C
-
Porto Alegre, Rio Grande do Sul, 브라질, 91350-180
- IPARGS, Rua Antonio Joaquim Mesquita
-
-
São Paulo
-
Baretos, São Paulo, 브라질
- Fundação Pio XII - Hospital de Amor de, Barretos; Rua Antenor Duarte Villela
-
Botucatu, São Paulo, 브라질, 18618-686
- Unid Pesquisa Clínica Facultad Medicina, de Botucatu UNESP, Rua Prof. Dr. Armando,Alves s/n, Distrito de rubião Junior
-
Bragança Paulista, São Paulo, 브라질, 12916-350
- Hospital Universario Sao Francisco, na Providencia de Deus-Av. Sao Francisco de Assis
-
Campinas, São Paulo, 브라질, 13060-080
- Instituto de Pesquisa Clinica de Campinas IPECC Tua Oswaldo
-
Jaú, São Paulo, 브라질, 17201-210
- Cecip Jau
-
Santo André, São Paulo, 브라질, 09080-111
- Pesquisare Saúde
-
São Bernardo do Campo, São Paulo, 브라질, 09715-090
- CEMEC
-
São Paulo, São Paulo, 브라질, 01001-000
- Esperanca Clinica De Pesquisas
-
Tatuí, São Paulo, 브라질, 18273-170
- Instituto de Molestast Cardiovasculares
-
-
-
-
-
Buenos Aires, 아르헨티나, 1602
- Clínica Olivos
-
Córdoba, 아르헨티나, X5000JHQ
- Sanatorio Allende, Av.
-
San Juan, 아르헨티나, 5400
- CER San Juan,
-
Santa Fe, 아르헨티나, S2000PBJ
- Mendoza 2612, Rosario
-
-
Buenos Aires
-
Ciudad Autonoma de Buenos Aires, Buenos Aires, 아르헨티나, C1027AAP
- CINME Centro Investigaciones Metabolicas, Pres. Jose Evaristo Uriburu 754, Piso 3 dpto 12
-
Ciudad Autonoma de Buenos Aires, Buenos Aires, 아르헨티나, C1039AAO
- Sanatorio De La Trinidad, Mitre Bartolome Mitre
-
Ciudad Autonoma de Buenos Aires, Buenos Aires, 아르헨티나, C1199
- Hospital Italiano sede Central, Tte. Gral. Juan Domingo Perón 4190
-
Ciudad Autonoma de Buenos Aires, Buenos Aires, 아르헨티나, C1412
- Centro Privado de Medicina Familiar, Mindout Research
-
Mar del Plata, Buenos Aires, 아르헨티나, B7600FYK
- Centro De Investigaciones
-
Ramos Mejía, Buenos Aires, 아르헨티나, 1704
- DIM Clínica Privada, Belgrano 136 - 5to piso
-
Ramos Mejía, Buenos Aires, 아르헨티나, C1221ADC
- Hospital General Agudos Dr. J.M., Grl Justo José de Urquiza 609 2do piso, Pabellón Clínica Médica, Enf. Emergentes
-
Zárate, Buenos Aires, 아르헨티나, B2800DGH
- Clínicas Zárate, F. Andrade 332
-
-
Córdoba Province
-
Quiros, Córdoba Province, 아르헨티나, 1948
- Sanatorio Privado ,Duarte Quiros
-
-
Sante Fe
-
Rosario, Sante Fe, 아르헨티나, 2000
- Instituto Médico de la, Fundación Estudios Clínicos, Italia 428, Rosario
-
-
Tucumán Province
-
San Miguel de Tucumán, Tucumán Province, 아르헨티나, 4000
- Clinica Mayo UMCB
-
-
-
-
-
Kampala, 우간다
- Joint Clinical Research Centre
-
Kampala, 우간다, 10005
- Joint Clinical Research Centre
-
Kampala, 우간다
- Infectious Diseases Institute (IDI), Mulago Hill Road
-
Lira, 우간다
- SICRA, Lira Regional Referral, Plot 21-41 Ngetta Road P.O. Box 330062
-
Tororo, 우간다
- IDRC Clinic, Tororo General Hospital, P.O. Box 2, Station Rd
-
-
-
-
Andhra Pradesh
-
Hyderabad, Andhra Pradesh, 인도, 500018
- St. Theresa's Hospital
-
Nellore, Andhra Pradesh, 인도, 524001
- Vijaya Super Speciality Hospital
-
Nellore, Andhra Pradesh, 인도, 524001
- DEC-Health Care Hospital
-
Visakhapatnam, Andhra Pradesh, 인도, 530002
- King George Hospital
-
-
Gujarat
-
Ahmedabad, Gujarat, 인도, 380015
- Sangini Hospital 1st Flr & 7th flr
-
Vadodara, Gujarat, 인도, 390021
- Aman Hospital and Research Center
-
Vadodara, Gujarat, 인도, 390022
- Rhythm Heart Institute - A Unit of SLPL
-
-
Haryana
-
Faridabad, Haryana, 인도, 121001
- ESIC Medical College & Hospital
-
Faridabad, Haryana, 인도, 121006
- Sarvodaya Hospital and Research Centre
-
-
Karnataka
-
Bangalore, Karnataka, 인도, 560060
- BGS Global Institute of Medical Sciences
-
Belagavi, Karnataka, 인도, 590010
- KLEs Dr. Prabhakar Kore Hospital & MRC Belagavi
-
Bengaluru, Karnataka, 인도, 560068
- Shettys Hospital
-
Bengaluru, Karnataka, 인도, 560036
- Sri Lakshmi Super Speciality Hospital
-
Bengaluru, Karnataka, 인도, 562107
- Sri Venkateshwara Hospitals, SKY HEIGHTS, Site#1/2, Sarjapura-Attibele, Main rd, Indelebele Village
-
Mangalore, Karnataka, 인도, 575018
- Yenepoya Med College Hosp, EMD Building, 5th fl., University Rd, Deralakatte
-
-
Maharashtra
-
Dombivali, Maharashtra, 인도, 421203
- BAJ RR Hosp and Res Cntr
-
Nashik, Maharashtra, 인도, 422005
- Chopda Medicare & Research Centre Pvt. Ltd
-
Pune, Maharashtra, 인도, 411057
- Lifepoint Multispecialty Hosp.
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, 인도, 110060
- Sir Ganga Ram Hospital
-
-
New Delhi
-
Dwārka, New Delhi, 인도, 110075
- Aakash Healthcare Private Limited
-
-
Rajasthan
-
Jaipur, Rajasthan, 인도, 302020
- JNUIMSRC
-
Jaipur, Rajasthan, 인도, 302020
- Tagore Hospital & Research Institute
-
-
Tamil Nadu
-
Chennai, Tamil Nadu, 인도, 600113
- Voluntary Health Services Infectious Diseases Medical CEN CART Clinical Research Site
-
-
Uttar Pradesh
-
Kanpur, Uttar Pradesh, 인도, 208002
- Department of Medicine
-
-
Uttarakhand
-
Rudrapur, Uttarakhand, 인도, 263135
- HB Specialty Hosp. & Res Inst.
-
-
West Bengal
-
Kolkata, West Bengal, 인도, 700073
- Calcutta School of Tropical Medicine
-
-
-
-
Fukuuoka-Ken
-
Okawa-shi, Fukuuoka-Ken, 일본, 831-0016
- Kohokai Takagi Hospital
-
-
Ibaraki
-
Tsuchiura-shi, Ibaraki, 일본, 300-0062
- Tsuchiura Beryl Clinic
-
Tsuchiura-shi, Ibaraki, 일본, 305-8576
- University of Tsukuba Hospital
-
Tsukuba, Ibaraki, 일본, 305-8576
- Tashiro Endocrinology Clinic
-
-
Saitama
-
Toda-shi, Saitama, 일본, 335-0035
- KODAIRA Hospital
-
-
-
-
-
Eldoret, 케냐, 30100
- Moi University Clin Res Centre, 2nd Fl, Chandaria Chronic, Disease and Cancer Centre
-
Kisumu, 케냐, 40100
- KEMRI CGHR HIVR Site
-
-
-
-
-
Bogotá, 콜롬비아, 110221
- Bluecare salud SAS
-
-
Antioquia
-
Medellín, Antioquia, 콜롬비아, 050010
- Programa de estudios y control de, enfermedades tropicales PECET, Carrera 53 N°61-30 Torre 2, Lab. 632
-
-
Atlántico
-
Barranquilla, Atlántico, 콜롬비아, 80020
- IPS CENTRO CIENTIFICO ASISTENCIAL S.A.S, Cra 45 #85-49
-
Barranquilla, Atlántico, 콜롬비아, 080020
- Centro de Investigación Medico, Asistencia - CIMEDICAL S.A.S, Cra 49C # 82-120
-
Barranquilla, Atlántico, 콜롬비아, 080020
- Corazon IPS S.A.S, Carrera 49 No 74 - 158
-
-
Bogota D.C.
-
Bogotá, Bogota D.C., 콜롬비아, 110221
- Centro de investigación en Reumatología, y Especialidades Medicas S.A.S, CIREEM S.A.S.-Cra. 12#97-32
-
-
Departamento de Córdoba
-
Chuchurubi Monteria, Departamento de Córdoba, 콜롬비아, 230002
- Fundación Centro Excelencia en Enferm., Crónicas No Transmisibles-FUNCENTRA, CRA 3 N°21 44 B,
-
-
Magdalena Department
-
Santa Marta, Magdalena Department, 콜롬비아, 470003
- TyC Inversiones SAS Grupsalud 33-6 IPS, Avenida Libertador # 30-360, Barrio San Pedro Alejandrino
-
-
Quindío Department
-
Armenia, Quindío Department, 콜롬비아, 630004
- Fundación Cardiomet Cequin,, Street 18 North # 14-25,
-
-
-
-
Bangkok
-
Bangkok Noi, Bangkok, 태국, 10700
- Siriraj Hospital
-
Pathum Wan, Bangkok, 태국, 10330
- Thai Red Cross AIDS Research Centre
-
-
Changwat Khon Kaen
-
Mueang Khon Kaen District, Changwat Khon Kaen, 태국, 40002
- Srinagarind Hospital
-
-
Chiang Mai
-
Mueang Chiang Mai District, Chiang Mai, 태국, 50200
- Research Institute for Health Sciences
-
-
-
-
-
Islamabad, 파키스탄, 44000
- Shifa International Hospital, 4 Pitras Bukhari Rd, H-8/4, H-8
-
Karachi, 파키스탄, 75300
- Dow Univ of Health Sciences Ojha Campus
-
Karachi, 파키스탄, 75300
- Sindh Infectious Disease Hospital and research Centre
-
Peshawar, 파키스탄, 74800
- Maroof International Hospital
-
-
Karachi
-
Korangi, Karachi, 파키스탄, 75190
- Indus Hospital and Health Network
-
-
Peshawar
-
Hayatabad, Peshawar, 파키스탄, 25000
- Rehman Medical Institute Clinical Trial Unit
-
-
Punjab Province
-
Lahore, Punjab Province, 파키스탄, 54000
- Central Park Teaching Hospital
-
Lahore, Punjab Province, 파키스탄, 54000
- National Hospital & Medical Center
-
Lahore, Punjab Province, 파키스탄, 54660
- Akram Medical Complex
-
-
Sindh
-
Karachi, Sindh, 파키스탄, 74800
- The Aga Khan University
-
-
-
-
-
Lima, 페루, 7006
- Centro de Inv. Tecnológicas Biomédicas y Medioambientales
-
Lima, 페루
- Asoc. Civil Impacta Salud y Educación - Sede San Miguel
-
Lima Cercado, 페루, 15082
- Patricia Ortiz Bazan
-
-
Lima region
-
San Isidro, Lima region, 페루, 15036
- Centro de Investigacion
-
-
Loreto
-
Iquitos, Loreto, 페루, 16000
- Asoc. Civil Selva Amazonica
-
-
-
-
-
Ostrowiec Świętokrzyski, 폴란드, 27-400
- Ostrowieckie Centrum Medyczne
-
Oświęcim, 폴란드, 32-600
- Medicome Sp. z o.o.
-
Rzeszów, 폴란드, 35-326
- Centrum Medyczne "MEDYK"
-
Skierniewice, 폴란드, 96-100
- Clinmedica Research Sp. Z O.O.
-
Wroclaw, 폴란드, 51-162
- Centrum Badań Klinicznych
-
-
-
-
-
Mandaluyong, 필리핀 제도, 1552
- Health Cube Medical Clinics, High Pointe Medical Hub, 241 Shaw Blvd
-
Quezon City, 필리핀 제도, 1100
- Lung Center of the Philippines
-
-
Batangas
-
Lipa, Batangas, 필리핀 제도, 4217
- Mary Mediatrix Medical Cntr
-
-
Manila
-
Tondo, Manila, 필리핀 제도, 1221
- Mary Johnston Hospital, 1221 Juan Nolasco Street
-
-
Molo
-
Lloilo, Molo, 필리핀 제도, 5000
- Iloilo Doctors' Hospital, Room 706, New Condoclinics Bldg, West Ave
-
-
Pampanga
-
Mabalacat, Pampanga, 필리핀 제도, 2023
- The Medical City Clark, #100Eatwick, Gatewick, Global Gateway Logistics City, Industrial Estate 5, Clark Freeport Zone
-
-
San Fernando
-
La Union, San Fernando, 필리핀 제도, 2500
- Ilocos Training and Regional Medical Center
-
Pampanga, San Fernando, 필리핀 제도, 2000
- Green City Medical Center
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 핵산(예: 역전사효소 PCR) 또는 호흡기 표본의 항원 검사(예: 구인두, NP 또는 비강 면봉 또는 타액)에 의해 결정된 실험실에서 확인된 활동성 SARS-CoV-2 감염 문서 무작위화 전 ≤120시간(5일) 수집됨.
- 참가자는 다음 목록에 있는 COVID-19 관련 증상이 발생한 자가 보고한 날짜로부터 ≤5일 이내에 연구 개입을 시작할 것으로 예상됩니다.
- 기침
- 숨가쁨 또는 호흡 곤란
- 열이 나는 느낌
- 오한
- 피로
- 신체 통증 또는 근육통 또는 통증
- 설사
- 메스꺼움
- 구토
- 두통
- 목 쓰림
- 비강 폐쇄 또는 혼잡
- 콧물
- 미각 또는 후각 상실
- 무작위 배정 전 24시간 이내에 다음 징후/증상 중 하나 이상이 나타납니다.
- 기침
- 숨가쁨 또는 호흡 곤란
- 열이 나는 느낌
- 오한
- 피로
- 신체 통증 또는 근육통 또는 통증
- 설사
- 메스꺼움
- 구토
- 두통
- 목 쓰림
- 비강 폐쇄 또는 혼잡
- 콧물
- 고위험 참가자는 중증 COVID-19로 진행될 위험이 더 높은 요인이 1개 이상 있는 것으로 정의됩니다.
- 연령 ≥65세
- 다음 중 하나에 해당하는 18세 이상:
- 비만(체질량 지수[BMI] ≥30kg/제곱미터[kg/m^2]). 참고: BMI는 가장 가까운 정수로 반올림됩니다. 예를 들어 29.5kg/m^2는 30kg/m^2로 반올림됩니다.
- 진성 당뇨병
- 고혈압
- 심혈관 질환(선천성 심장병 포함)
- 만성 폐질환(예: 만성 폐쇄성 폐질환, 중등도에서 중증 천식, 간질성 폐질환, 낭포성 섬유증, 폐고혈압)
- 참가자가 Cockcroft-Gault에 의해 분당 30밀리리터(mL/분) 미만의 크레아티닌 청소율(CrCl)을 알지 못하거나 투석이 필요한 만성 신장 질환
- 다운 증후군
- 겸상 적혈구 질환
- 다음 면역 저하 상태 또는 면역 억제 치료 중 하나:
- 화학 요법 또는 암에 대한 기타 요법을 받는 경우
- 혈액 악성 종양(활동성 또는 관해 상태)
- 조혈 줄기 세포 또는 고형 장기 이식의 병력
- 인간 면역결핍 바이러스 감염: 항레트로바이러스 요법을 받고 있지 않거나 분화 군집이 있는 경우 4+ 세포 수 < 200 세포/세제곱 밀리미터
- 복합 원발성 면역결핍 질환
- 면역억제제 복용(예: 항종양 괴사 인자제, 마이코페놀레이트 및 리툭시맙과 같이 이식된 장기 거부를 억제하거나 류마티스 및 위장 상태를 치료하는 약물).
참고: 현재 일부 코르티코스테로이드 사용은 S-217622와의 약물 간 상호 작용(DDI) 가능성에 대한 우려로 인해 배타적입니다.
제외 기준:
- 현재 SARS-CoV-2 감염으로 입원한 이력(즉, 이전 SARS-CoV-2 감염 에피소드로 인한 이전 입원은 허용됨)
- 현재 SARS-CoV-2 감염의 경우, 모든 호흡기 표본(예: 구인두, NP, 비강 면봉 또는 타액)의 양성 SARS-CoV-2 분자(핵산) 또는 항원 검사가 ˃120시간 동안 수집되었습니다( 5일) 무작위 배정 전. 현재 증상이 시작되기 >90일 이전에 시작된 이전 SARS-CoV-2 감염으로 정의되는 재감염이 있는 참가자는 현재 감염이 무작위 배정 전 5일 이상 존재하지 않는 한 자격이 있습니다. .
- 조사관의 의견에 따라 현재 입원 또는 즉각적인 치료가 필요한 경우
- 연구 개입으로 금지된 약물의 현재 사용. 등록 전 SARS-CoV-2 감염 증상을 치료하기 위해 Paxlovid를 언제든지 사용하고 경구, 흡입 또는 주사 가능한 약물을 사용하는 것은 제외됩니다. 등록 후 DDI에 대한 우려가 없는 한 현지에서 사용 가능한 SARS-CoV-2 치료(몰누피라비르, mAb, 외래 환자 IV 렘데시비르, 회복기 혈장, 흡입 부데소니드, 파비피라비르 및 플루복사민을 포함하되 이에 국한되지 않음)가 허용됩니다.
- 무작위화 이전 어느 시점에서든 SARS-CoV-2의 현재 에피소드에 대한 조사 치료를 받는 것은 제외됩니다. 참고: 여기에는 다른 용도로 승인되고 해당 적응증에 사용되는 약물 또는 COVID-19 백신은 포함되지 않습니다. 참고: COVID-19 예방 목적으로만 제공되는 mAbs와 같이 COVID-19 예방을 위해 현지에서 승인되거나 승인된 요법의 사용은 배타적이지 않습니다.
- 무작위화 전 7일 이내에 수술을 필요로 하거나 무작위화 전 28일 이내에 조사자의 의견으로 생명을 위협하는 것으로 간주되는 모든 동반이환
- S-217622의 구성 요소 또는 S-217622에 대한 위약에 대한 알려진 알레르기/과민성 또는 과민성
- Cockcroft-Gault에 의해 CrCl <30 mL/min으로 정의되거나 투석이 필요한 알려진 현재 신장 손상
- 간경화 또는 간 대상부전(복수, 정맥류 출혈 또는 간성 뇌병증 포함)의 알려진 병력
- 등록 전 14일 이내에 다음 약물 중 하나를 사용한 참가자:
- 강력한 시토크롬 P453A(CYP 3A) 억제제
- 강력한 CYP3A 유도제
- 세인트 존스 워트 함유 제품
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: S-217622
S-217622는 5일 동안 구두로 투여됩니다.
|
원형 정제로 투여한다.
|
|
위약 비교기: 위약
S-217622에 일치하는 위약을 5일 동안 구두로 투여합니다.
|
원형 정제로 투여한다.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to Sustained Symptom Resolution
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change From Baseline at Day 4 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Levels on Nasopharyngeal (NP) Swabs
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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%
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 8월 3일
기본 완료 (실제)
2024년 1월 7일
연구 완료 (실제)
2024년 5월 24일
연구 등록 날짜
최초 제출
2022년 3월 30일
QC 기준을 충족하는 최초 제출
2022년 3월 30일
처음 게시됨 (실제)
2022년 3월 31일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 29일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ACTIV-2d/A5407
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .