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COMPLETED
NCT05305547
PHASE3

A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19

Sponsor: Shionogi

View on ClinicalTrials.gov

Summary

The main aim of this study is to evaluate the efficacy of S-217622 versus placebo among outpatient adults with mild and moderate COVID-19 starting intervention within 3 days of symptom onset.

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, 24-Week Study of the Clinical and Antiviral Effect of S-217622 Compared With Placebo in Non-Hospitalized Participants With COVID-19

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2093

Start Date

2022-08-03

Completion Date

2024-05-24

Last Updated

2026-08-20

Healthy Volunteers

No

Interventions

DRUG

S-217622

Administered as a round tablet.

DRUG

Placebo

Administered as a round tablet.

Locations (196)

Lakeview Clinical Research

Guntersville, Alabama, United States

Voyage Medical Services

Tempe, Arizona, United States

Novak Clinical Research

Tucson, Arizona, United States

Hope Clinical Research

Canoga Park, California, United States

Carbon Health

Culver City, California, United States

NICR

Garden Grove, California, United States

Ark Clinical Research (PARENT)

Long Beach, California, United States

UCSD Antiviral Research Center

San Diego, California, United States

University of California San Francisco (PARENT)

San Francisco, California, United States

Clinical Trials Management Services, 223 E. Thousand Oaks Blvd.

Thousand Oaks, California, United States

Lundquist Institute for BMI, UCLA Medical Center

Torrance, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Whitman-Walker Health

Washington D.C., District of Columbia, United States

University of Florida Clinical & Translational Science Institute

Gainesville, Florida, United States

Universal Medical and Research Center

Miami, Florida, United States

CCR Medical Center, Suite 201

Miami, Florida, United States

Miami Clinical Research

Miami, Florida, United States

Vista Health Research, LLC

Miami, Florida, United States

Quantum Clinical Trials, 333 Arthur Godfrey Road, Suite 202, suite 208

Miami Beach, Florida, United States

Quality Research of South Florida

Miami Lakes, Florida, United States

Accel Research Sites Network, Ormond Clinical Research Unit, 77 West Granada Boulevard

Ormond Beach, Florida, United States

Clinical Research Center of Florida, 550 SW 3rd St.,, Suite #305

Pompano Beach, Florida, United States

Invictus Clinical Research Group, LLC

Pompano Beach, Florida, United States

Santos Research Center, CORP

Tampa, Florida, United States

Masters of Clinical Research

Augusta, Georgia, United States

Leavitt Clinical Research

Idaho Falls, Idaho, United States

Research Network America

Berwyn, Illinois, United States

Rush University Infectious Diseases

Chicago, Illinois, United States

Tandem Clinical Research

Marrero, Louisiana, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Infusion Associates

Grand Rapids, Michigan, United States

Revival Research Institute LLC

Troy, Michigan, United States

Las Vegas Medical Research

Las Vegas, Nevada, United States

AB Clinical Trials

Las Vegas, Nevada, United States

Renal Medicine Associates

Albuquerque, New Mexico, United States

Columbia University Irving Medical Center Division of Infectious Diseases

New York, New York, United States

NY Blood Center Project ACHIEVE

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Lapis Clinical Research - North State

Denver, North Carolina, United States

Burke Primary Care

Morgantown, North Carolina, United States

Progressive Medicine of the Triad, LLC

Winston-Salem, North Carolina, United States

Ohio State University College of Medicine

Columbus, Ohio, United States

Infectious Disease Clinical Trials Unit-University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

UPMC Eye Center - Eye and Ear Institute

Pittsburgh, Pennsylvania, United States

Vanderbilt Health-One Hundred Oaks

Nashville, Tennessee, United States

Central Texas Medical Research

Austin, Texas, United States

Care United Research, 375 North FM 548, suite 100

Forney, Texas, United States

Valley Institute of Research

Fort Worth, Texas, United States

Trio Clinical Trials, LLC.

Houston, Texas, United States

Accurate Clinical Management, LLC

Houston, Texas, United States

Sun Research Institute, LLC

San Antonio, Texas, United States

Progressive Clinical Research

Bountiful, Utah, United States

Clinical Research Partners LLC

Richmond, Virginia, United States

CINME Centro Investigaciones Metabolicas, Pres. Jose Evaristo Uriburu 754, Piso 3 dpto 12

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Sanatorio De La Trinidad, Mitre Bartolome Mitre

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Italiano sede Central, Tte. Gral. Juan Domingo Perón 4190

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Centro Privado de Medicina Familiar, Mindout Research

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Centro De Investigaciones

Mar del Plata, Buenos Aires, Argentina

DIM Clínica Privada, Belgrano 136 - 5to piso

Ramos Mejía, Buenos Aires, Argentina

Hospital General Agudos Dr. J.M., Grl Justo José de Urquiza 609 2do piso, Pabellón Clínica Médica, Enf. Emergentes

Ramos Mejía, Buenos Aires, Argentina

Clínicas Zárate, F. Andrade 332

Zárate, Buenos Aires, Argentina

Sanatorio Privado ,Duarte Quiros

Quiros, Córdoba Province, Argentina

Instituto Médico de la, Fundación Estudios Clínicos, Italia 428, Rosario

Rosario, Sante Fe, Argentina

Clinica Mayo UMCB

San Miguel de Tucumán, Tucumán Province, Argentina

Clínica Olivos

Buenos Aires, Argentina

Sanatorio Allende, Av.

Córdoba, Argentina

CER San Juan,

San Juan, Argentina

Mendoza 2612, Rosario

Santa Fe, Argentina

SENAI CIMATEC Clinical Trial Research Center

Salvador, Estado de Bahia, Brazil

AMB3 Servicos Medicos Ltda Rua Campinas

Cuiabá, Mato Grosso, Brazil

Faculdade de Medicina da univ., Federal, Av Alfredo Balena, 190, 1° andar - sala 161

Belo Horizonte, Minas Gerais, Brazil

Hosp Nossa Senhora das Gracas, Rue Alcides Munhoz

Curitiba, Paraná, Brazil

Instituto Atena de Psequisa Clinica Ltds, Av Marechal Floriano Peixoto

Natal, Rio Grande do Norte, Brazil

Thainá Garbino dos Santos, Avenida Protásio Alves 211, Bloco C

Porto Alegre, Rio Grande do Sul, Brazil

IPARGS, Rua Antonio Joaquim Mesquita

Porto Alegre, Rio Grande do Sul, Brazil

Fundação Pio XII - Hospital de Amor de, Barretos; Rua Antenor Duarte Villela

Baretos, São Paulo, Brazil

Unid Pesquisa Clínica Facultad Medicina, de Botucatu UNESP, Rua Prof. Dr. Armando,Alves s/n, Distrito de rubião Junior

Botucatu, São Paulo, Brazil

Hospital Universario Sao Francisco, na Providencia de Deus-Av. Sao Francisco de Assis

Bragança Paulista, São Paulo, Brazil

Instituto de Pesquisa Clinica de Campinas IPECC Tua Oswaldo

Campinas, São Paulo, Brazil

Cecip Jau

Jaú, São Paulo, Brazil

Pesquisare Saude

Santo André, São Paulo, Brazil

CEMEC

São Bernardo do Campo, São Paulo, Brazil

Esperanca Clinica De Pesquisas

São Paulo, São Paulo, Brazil

Instituto de Molestast Cardiovasculares

Tatuí, São Paulo, Brazil

Hospital da Puc Campinas, Centro de Pesquisa Sao Lucas

Campinas, Brazil

IBPClin, Rua da Gloria

Rio de Janeiro, Brazil

INI/Fiocruz

Rio de Janeiro, Brazil

Lóbus Cntr. de Pesquisa Cl.

Volta Redonda, Brazil

Programa de estudios y control de, enfermedades tropicales PECET, Carrera 53 N°61-30 Torre 2, Lab. 632

Medellín, Antioquia, Colombia

Centro de Investigación Medico, Asistencia - CIMEDICAL S.A.S, Cra 49C # 82-120

Barranquilla, Atlántico, Colombia

Corazon IPS S.A.S, Carrera 49 No 74 - 158

Barranquilla, Atlántico, Colombia

IPS CENTRO CIENTIFICO ASISTENCIAL S.A.S, Cra 45 #85-49

Barranquilla, Atlántico, Colombia

Centro de investigación en Reumatología, y Especialidades Medicas S.A.S, CIREEM S.A.S.-Cra. 12#97-32

Bogotá, Bogota D.C., Colombia

Fundación Centro Excelencia en Enferm., Crónicas No Transmisibles-FUNCENTRA, CRA 3 N°21 44 B,

Chuchurubi Monteria, Departamento de Córdoba, Colombia

TyC Inversiones SAS Grupsalud 33-6 IPS, Avenida Libertador # 30-360, Barrio San Pedro Alejandrino

Santa Marta, Magdalena Department, Colombia

Fundación Cardiomet Cequin,, Street 18 North # 14-25,

Armenia, Quindío Department, Colombia

BlueCare Salud SAS

Bogotá, Colombia

Navrongo Health Research Cntr

Upper East, Navrongo, Ghana

Kintampo Health Research Cntr

Kintampo, Ghana

Kumasi Centre for Research, South End Asuogya Road, Kwame Nkrumah University

Kumasi, Ghana

St. Theresa's Hospital

Hyderabad, Andhra Pradesh, India

DEC-Health Care Hospital

Nellore, Andhra Pradesh, India

Vijaya Super Speciality Hospital

Nellore, Andhra Pradesh, India

King George Hospital

Visakhapatnam, Andhra Pradesh, India

Sangini Hospital 1st Flr & 7th flr

Ahmedabad, Gujarat, India

Aman Hospital and Research Center

Vadodara, Gujarat, India

Rhythm Heart Institute - A Unit Of SLPL

Vadodara, Gujarat, India

ESIC Medical College & Hospital

Faridabad, Haryana, India

Sarvodaya Hospital and Research Centre

Faridabad, Haryana, India

BGS Global institute of Medical Sciences

Bangalore, Karnataka, India

KLEs Dr. Prabhakar Kore Hospital & MRC Belagavi

Belagavi, Karnataka, India

Sri Lakshmi Super Speciality Hospital

Bengaluru, Karnataka, India

Shettys Hospital

Bengaluru, Karnataka, India

Sri Venkateshwara Hospitals, SKY HEIGHTS, Site#1/2, Sarjapura-Attibele, Main rd, Indelebele Village

Bengaluru, Karnataka, India

Yenepoya Med College Hosp, EMD Building, 5th fl., University Rd, Deralakatte

Mangalore, Karnataka, India

BAJ RR Hosp and Res Cntr

Dombivali, Maharashtra, India

Chopda Medicare & Research Centre Pvt. Ltd

Nashik, Maharashtra, India

Lifepoint Multispecialty Hosp.

Pune, Maharashtra, India

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, India

Aakash Healthcare Private Limited

Dwārka, New Delhi, India

JNUIMSRC

Jaipur, Rajasthan, India

Tagore Hospital & Research Institute

Jaipur, Rajasthan, India

Voluntary Health Services Infectious Diseases Medical CEN CART Clinical Research Site

Chennai, Tamil Nadu, India

Department of Medicine

Kanpur, Uttar Pradesh, India

HB Specialty Hosp. & Res Inst.

Rudrapur, Uttarakhand, India

Calcutta School of Tropical Medicine

Kolkata, West Bengal, India

Kohokai Takagi Hospital

Okawa-shi, Fukuuoka-Ken, Japan

Tsuchiura Beryl Clinic

Tsuchiura-shi, Ibaraki, Japan

University of Tsukuba Hospital

Tsuchiura-shi, Ibaraki, Japan

Tashiro Endocrinology Clinic

Tsukuba, Ibaraki, Japan

Kodaira Hospital

Toda-shi, Saitama, Japan

Moi University Clin Res Centre, 2nd Fl, Chandaria Chronic, Disease and Cancer Centre

Eldoret, Kenya

KEMRI CGHR HIVR Site

Kisumu, Kenya

Johns Hopkins Research Project, Queen Elizabeth Central Hospital

Chipatala Avenue, Blantyre, Malawi

UNC Project, Private Bag A-104

Lilongwe, Malawi

Mangochi PHNG Study Site, Kamuzu University of Health Sciences, Private Bag 360, Room 805

Mangochi, Malawi

CAIMED Investigación en Salud, S.A. de C.V., Manzanillo #100. Piso 2. Roma Sur

Cuauhtémoc, Cdmx, C.P, Mexico

Instituto Veracruzano, en Investigación Clínica S.C., Sabino s/n, Colonia Reserva Tarimoya ll

Veracruz, CP, Mexico

Avenida Universidad 1001, Edificio 19, planta baja, colonia Chamilpa

Cuernavaca, Morelos, Mexico

Oaxaca Site Management Organization S.C., Humboldt 302, Col. Centro.

Oaxaca City, Oaxaca, Mexico

Centro Inv. y Avances Med Especializados, (CIAME) Av. Kabah, Lote 38, 39 y 41., Manzana 4, supermanzana 44. Col., Alborada, Benito Juárez

Cancún, Quintana Roo, Mexico

FAICIC S. DE R.L. DE C.V., Av. 16 de Septiembre 1165

Ricardo Flores Magón, Veracruz, Mexico

Hospital Cardiológica Aguascalientes, Ecuador 200 Fracc Las Américas

Aguascalientes, Mexico

Centro de Inv. Médica Aguascalientes, (CIMA) Av. Independencia 2130, Int. A. Trojes de Alonso

Aguascalientes, Mexico

Indus Hospital and Health Network

Korangi, Karachi, Pakistan

Rehman Medical Institute Clinical Trial Unit

Hayatabad, Peshawar, Pakistan

Central Park Teaching Hospital

Lahore, Punjab Province, Pakistan

National Hospital & Medical Center

Lahore, Punjab Province, Pakistan

Akram Medical Complex

Lahore, Punjab Province, Pakistan

The Aga Khan University

Karachi, Sindh, Pakistan

Shifa International Hospital, 4 Pitras Bukhari Rd, H-8/4, H-8

Islamabad, Pakistan

Dow Univ of Health Sciences Ojha Campus

Karachi, Pakistan

Sindh Infectious Disease Hospital and research Centre

Karachi, Pakistan

Maroof International Hospital

Peshawar, Pakistan

Centro de Investigación

San Isidro, Lima region, Peru

Asoc. Civil Selva Amazonica

Iquitos, Loreto, Peru

Centro de Inv. Tecnológicas Biomédicas y Medioambientales

Lima, Peru

Asoc. Civil Impacta Salud y Educación - Sede San Miguel

Lima, Peru

Patricia Ortiz Bazan

Lima Cercado, Peru

Mary Mediatrix Medical Cntr

Lipa, Batangas, Philippines

Mary Johnston Hospital, 1221 Juan Nolasco Street

Tondo, Manila, Philippines

Iloilo Doctors' Hospital, Room 706, New Condoclinics Bldg, West Ave

Lloilo, Molo, Philippines

The Medical City Clark, #100Eatwick, Gatewick, Global Gateway Logistics City, Industrial Estate 5, Clark Freeport Zone

Mabalacat, Pampanga, Philippines

Ilocos Training and Regional Medical Center

La Union, San Fernando, Philippines

Green City Medical Center

Pampanga, San Fernando, Philippines

Health Cube Medical Clinics, High Pointe Medical Hub, 241 Shaw Blvd

Mandaluyong, Philippines

Lung Center of the Philippines

Quezon City, Philippines

Ostrowieckie Centrum Medyczne

Ostrowiec Świętokrzyski, Poland

Medicome sp. z o.o.

Oświęcim, Poland

Centrum Medyczne "Medyk"

Rzeszów, Poland

Clinmedica Research sp. z o.o.

Skierniewice, Poland

Centrum Badań Klinicznych

Wroclaw, Poland

JOSHA Research

Bloemfontein, Free State, South Africa

Newton Clinical Research Centre

Johanesburg, Gauteng, South Africa

Worthwhile Clinical Trials

Johannesburg, Gauteng, South Africa

(PHRU), New Nurses Home 9th floor Chris

Johannesburg, Gauteng, South Africa

CHRU, Themba Lethu Clinic

Johannesburg, Gauteng, South Africa

Ubuntu Clinical Research

Krugersdorp, Gauteng, South Africa

Ubuntu Clinical Research

Lenasia, Gauteng, South Africa

T/A Midrand Medical Centre, Shop #1, Health Emporium

Midrand, Gauteng, South Africa

Global Clinical Trials

Pretoria, Gauteng, South Africa

Right to Care Research Esizayo, Right Clinic Esizayo

Randburg, Gauteng, South Africa

Limpopo Clin Res Initiative Tamboti Medical Centre

Thabazimbi, Limpopo, South Africa

The Arum Institute NPC Rustenburg CRS

Rustenburg, North West, South Africa

Task Eden Research Centre

George, Western Cape, South Africa

Be Part Research PTY (LTD)

Paarl, Western Cape, South Africa

Roodepoort Medicross Clinical Research Centre

Roodepoort, South Africa

Siriraj Hospital

Bangkok Noi, Bangkok, Thailand

Thai Red Cross AIDS Research Centre

Pathum Wan, Bangkok, Thailand

Srinagarind Hospital

Mueang Khon Kaen District, Changwat Khon Kaen, Thailand

Research Institute for Health Sciences

Mueang Chiang Mai District, Chiang Mai, Thailand

Joint Clinical Research Centre

Kampala, Uganda

Infectious Diseases Institute (IDI), Mulago Hill Road

Kampala, Uganda

Joint Clinical Research Centre

Kampala, Uganda

SICRA, Lira Regional Referral, Plot 21-41 Ngetta Road P.O. Box 330062

Lira, Uganda

IDRC Clinic, Tororo General Hospital, P.O. Box 2, Station Rd

Tororo, Uganda