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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

Conditions

SARS-CoV-2 Infection

Interventions

DRUG

S-217622

Administered as a round tablet.

DRUG

Placebo

Administered as a round tablet.

Inclusion Criteria: * Documentation of laboratory-confirmed active SARS-CoV-2 infection, as determined by a nucleic acid (for example, reverse-transcriptase PCR) or antigen test from any respiratory tract specimen (for example, oropharyngeal, NP or nasal swab, or saliva) collected ≤72 hours (3 days) prior to randomization. * Participants are expected to begin study intervention ≤3 days from self-reported date of onset of any of the COVID-19-related symptoms from the following list: * 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 * Nasal discharge * Loss of taste * Loss of smell * One or more of the following signs/symptoms present within 24 hours prior to randomization: * 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 * Nasal discharge * Participants at higher risk of progression to severe COVID-19 are defined as follows: * Age ≥65 years * Age ≥18 with 1 of the following: * Obesity (body mass index \[BMI\] ≥30 kilograms per square meter \[kg/m\^2\]). Note: BMI is rounded to the nearest whole number, for example 29.5 kg/m\^2 is rounded to 30 kg/m\^2. * Diabetes mellitus * Hypertension requiring daily prescribed therapy * Cardiovascular disease (requiring daily prescribed therapy or congenital heart disease) * Chronic lung disease (for example, chronic obstructive pulmonary disease, moderate to severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension) requiring daily prescribed therapy * Chronic kidney disease, defined as known current kidney impairment with a creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) \<60 milliliters (mL)/minute (min)/1.73 square meter (m\^2) within the past 12 months prior to randomization, as long as the participant does not have known CrCl \<30 mL/min by Cockcroft-Gault or require dialysis * Down syndrome * Sickle cell disease * One of the following immunocompromising conditions or immunosuppressive treatments: * Receiving chemotherapy or other therapies for cancer * Hematologic malignancy (active or in remission) * History of a hematopoietic stem cell or a solid organ transplant * Human immunodeficiency virus infection: not on antiretroviral therapy or with cluster of differentiation 4+ cell count \<200 cells per cubic millimeter * Combined primary immunodeficiency disorder * Taking immunosuppressive medications (for example, drugs to suppress rejection of transplanted organs or to treat rheumatologic and gastrointestinal conditions, such as anti-tumor necrosis factor agents, mycophenolate, and rituximab). Note: Current use of some corticosteroids is exclusionary, due to concern for possible drug-drug interaction (DDI) with S-217622. Exclusion Criteria: * History of hospitalization for the current SARS-CoV-2 infection (that is, prior hospitalization for a prior episode of SARS-CoV-2 infection is allowable) * For the current SARS-CoV-2 infection, any positive SARS-CoV-2 molecular (nucleic acid) or antigen test from any respiratory tract specimen (for example, oropharyngeal, NP, or nasal swab, or saliva) collected ˃72 hours (3 days) prior to randomization. Participants with reinfection, defined as prior SARS-CoV-2 infection that began \>90 days prior to the current onset of symptoms with interval resolution of symptoms are eligible as long as the current infection has not been present for more than 3 days prior to randomization. * Current need for hospitalization or immediate medical attention in the opinion of the investigator * Current use of any medications prohibited with the study intervention. Individuals who have used Paxlovid or any other oral, inhaled, or injectable medication intended to treat the current SARS-CoV-2 infection before randomization are excluded. After randomization, locally available SARS-CoV-2 treatment (including but not limited to molnupiravir, mAbs, outpatient IV remdesivir, convalescent plasma, inhaled budesonide, favipiravir, and fluvoxamine) will be permitted, as long as there are no concerns for DDIs. Note: Paxlovid use for a prior episode of COVID-19 is permitted. * Receipt of any investigational treatments for the current episode of SARS-CoV-2 at any time prior to randomization is exclusionary. Note: This does not include drugs approved for other uses and taken for those indications or COVID-19 vaccines. Note: Use of locally authorized or approved therapies to prevent COVID-19, such as mAbs given solely to prevent COVID-19, are not exclusionary. * Any co-morbidity requiring surgery within 7 days prior to randomization or that is considered life threatening in the opinion of the investigator within 28 days prior to randomization * Known allergy/sensitivity or any hypersensitivity to components of S-217622 or placebo for S-217622 * Known (within 12 months prior to randomization) renal impairment defined as CrCl \<30 mL/min by Cockcroft-Gault or requiring dialysis * Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy) * Participants who have used any of the following drugs within 14 days prior to randomization: * Strong cytochrome P453A inducer * Products containing St. John's Wort

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

And 96 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (196)