A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19 (SCORPIO-HR)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: SARS-CoV-2 Infection
• Intervention / Treatment: Drug: S-217622; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 2093
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Shionogi Clinical Trials Administrator Clinical Support Help Line; Phone Number: 1-800-849-9707; Email: Shionogiclintrials-admin@shionogi.co.jp

Study Locations

• Argentina
  • Cordoba, Argentina, X5000JHQ
    • Sanatorio Allende, Av.
  • Santa Fe, Argentina, S2000PBJ
    • Mendoza 2612, Rosario
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1027AAP
      • CINME Centro Investigaciones Metabolicas, Pres. Jose Evaristo Uriburu 754, Piso 3 dpto 12
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1039AAO
      • Sanatorio De La Trinidad, Mitre Bartolome Mitre
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1199
      • Hospital Italiano sede Central, Tte. Gral. Juan Domingo Perón 4190
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1412
      • Centro Privado de Medicina Familiar, Mindout Research
    • Mar De Plata, Buenos Aires, Argentina, B7600FYK
      • Centro De Investigaciones
    • Ramos Mejía, Buenos Aires, Argentina, 1704
      • DIM Clínica Privada, Belgrano 136 - 5to piso
    • Ramos Mejía, Buenos Aires, Argentina, C1221ADC
      • Hospital General Agudos Dr. J.M., Grl Justo José de Urquiza 609 2do piso, Pabellón Clínica Médica, Enf. Emergentes
    • Zarate, Buenos Aires, Argentina, B2800DGH
      • Clínicas Zárate, F. Andrade 332
  • Cordoba
    • Quiros, Cordoba, Argentina, 1948
      • Sanatorio Privado ,Duarte Quiros
  • Sante Fe
    • Rosario, Sante Fe, Argentina, 2000
      • Instituto Médico de la, Fundación Estudios Clínicos, Italia 428, Rosario
  • Tucuman
    • San Miguel de Tucuman, Tucuman, Argentina, 4000
      • Clinica Mayo UMCB
• Brazil
  • Campinas, Brazil, 13034-685
    • Hospital da Puc Campinas, Centro de Pesquisa Sao Lucas
  • Rio de Janeiro, Brazil, 20241-180
    • IBPClin, Rua da Gloria
  • Rio de Janeiro, Brazil, 21040-360
    • INI/Fiocruz
  • Mato Grosso
    • Cuiabá, Mato Grosso, Brazil, 78050-253
      • AMB3 Servicos Medicos Ltda Rua Campinas
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-100
      • Faculdade de Medicina da univ., Federal, Av Alfredo Balena, 190, 1° andar - sala 161
  • Paraná
    • Curitiba, Paraná, Brazil, 80810-040
      • Hosp Nossa Senhora das Gracas, Rue Alcides Munhoz
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil, 59020-500
      • Instituto Atena de Psequisa Clinica Ltds, Av Marechal Floriano Peixoto
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-180
      • IPARGS, Rua Antonio Joaquim Mesquita
  • Rio Grande Do Sul,
    • Porto Alegre, Rio Grande Do Sul,, Brazil, 90410-000,
      • Thainá Garbino dos Santos, Avenida Protásio Alves 211, Bloco C
  • Sao Paolo
    • Campinas, Sao Paolo, Brazil, 13060-080
      • Instituto de Pesquisa Clinica de Campinas IPECC Tua Oswaldo
    • Jau, Sao Paolo, Brazil, 17201-210
      • Cecip Jau
    • Tatui, Sao Paolo, Brazil, 18273-170
      • Instituto de Molestast Cardiovasculares
  • Sao Paulo
    • Baretos, Sao Paulo, Brazil
      • Fundação Pio XII - Hospital de Amor de, Barretos; Rua Antenor Duarte Villela
    • Botucatu, Sao Paulo, Brazil, 18618-686
      • Unid Pesquisa Clínica Facultad Medicina, de Botucatu UNESP, Rua Prof. Dr. Armando,Alves s/n, Distrito de rubião Junior
    • Bragança Paulista, Sao Paulo, Brazil, 12916-350
      • Hospital Universario Sao Francisco, na Providencia de Deus-Av. Sao Francisco de Assis
    • Santo André, Sao Paulo, Brazil, 09080-111
      • Pesquisare Saude
• Colombia
  • Bogota, Colombia, 110221
    • BlueCare Salud SAS
  • Antioquia
    • Medellín, Antioquia, Colombia, 050010
      • Programa de estudios y control de, enfermedades tropicales PECET, Carrera 53 N°61-30 Torre 2, Lab. 632
  • Atlantico
    • Barranquilla, Atlantico, Colombia, 080020
      • Centro de Investigación Medico, Asistencia - CIMEDICAL S.A.S, Cra 49C # 82-120
    • Barranquilla, Atlantico, Colombia, 080020
      • Corazon IPS S.A.S, Carrera 49 No 74 - 158
  • Atlántico
    • Barranquilla, Atlántico, Colombia, 80020
      • IPS CENTRO CIENTIFICO ASISTENCIAL S.A.S, Cra 45 #85-49
  • Bogotá
    • Bogota, Bogotá, Colombia, 110221
      • Centro de investigación en Reumatología, y Especialidades Medicas S.A.S, CIREEM S.A.S.-Cra. 12#97-32
  • Cordoba
    • Chuchurubi Monteria, Cordoba, Colombia, 230002
      • Fundación Centro Excelencia en Enferm., Crónicas No Transmisibles-FUNCENTRA, CRA 3 N°21 44 B,
  • Magdalena
    • Santa Marta, Magdalena, Colombia, 470003
      • TyC Inversiones SAS Grupsalud 33-6 IPS, Avenida Libertador # 30-360, Barrio San Pedro Alejandrino
  • Quindío
    • Armenia, Quindío, Colombia, 630004
      • Fundación Cardiomet Cequin,, Street 18 North # 14-25,
• Ghana
  • Kintampo, Ghana, PO BOX 200
    • Kintampo Health Research Cntr
  • Kumasi, Ghana, AK-312-1059
    • Kumasi Centre for Research, South End Asuogya Road, Kwame Nkrumah University
  • Navrongo
    • Upper East, Navrongo, Ghana, PO BOX 114
      • Navrongo Health Research Cntr
• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500018
      • St. Theresa's Hospital
    • Nellore, Andhra Pradesh, India, 524001
      • Vijaya Super Speciality Hospital
    • Nellore, Andhra Pradesh, India, 524001
      • DEC-Health Care Hospital
    • Visakhapatnam, Andhra Pradesh, India, 530002
      • King George Hospital
  • Bihar
    • Patna, Bihar, India, 800014
      • Indira Gandhi Inst of Medical Sciences
  • Delhi
    • New Delhi, Delhi, India, 110060
      • Sir Ganga Ram Hospital
  • Gujarat
    • Ahmedabad, Gujarat, India, 380015
      • Sangini Hospital 1st Flr & 7th flr
    • Surat, Gujarat, India, 395010
      • Unity Hospital, Nr. D.R. World
    • Vadodara, Gujarat, India, 390021
      • Aman Hospital and Research Center
    • Vadodara, Gujarat, India, 390022
      • Rhythm Heart Institute - A Unit Of SLPL
  • Haryana
    • Faridabad, Haryana, India, 121001
      • ESIC Medical College & Hospital
    • Faridabad, Haryana, India, 121006
      • Sarvodaya Hospital and Research Centre
  • Karnataka
    • Bangalore, Karnataka, India, 560060
      • BGS Global institute of Medical Sciences
    • Belgaum, Karnataka, India, 590010
      • KLEs Dr. Prabhakar Kore Hospital & MRC Belagavi
    • Bengaluru, Karnataka, India, 560036
      • Sri Lakshmi Superspeciality Hospital
    • Bengaluru, Karnataka, India, 560068
      • Shettys Hospital
    • Bengaluru, Karnataka, India, 562107
      • Sri Venkateshwara Hospitals, SKY HEIGHTS,Site#1/2,Sarjapura-Attibele, Main rd,Indelebele Village
    • Mangalore, Karnataka, India, 575018
      • Yenepoya Med College Hosp, EMD Building, 5th fl., University Rd, Deralakatte
  • Maharashtra
    • Dombivli, Maharashtra, India, 421203
      • BAJ RR Hosp and Res Cntr
    • Nashik, Maharashtra, India, 422005
      • Chopda Medicare & Research Centre pvt. Ltd
    • Nashik, Maharashtra, India, 422003
      • Suyog Hospital, CR Dept, 2nd flr, B-wing
    • Pune, Maharashtra, India, 411001
      • Grant Medical Foundation
    • Pune, Maharashtra, India, 411001
      • J Govt Medical College & Sassoon, Gen Hospitals 1st Floor, ENT department, PGP Hall,Jai Prakash Narayan Road
    • Pune, Maharashtra, India, 411057
      • Lifepoint Multispecialty Hosp.
  • New Delhi
    • Dwarka, New Delhi, India, 110075
      • Aakash Healthcare Private Limited
  • Rajasthan
    • Ajmer, Rajasthan, India, 305001
      • Mavens'Hospital Ground Floor N 37, Opp Reliance Fresh, Vaishali Nagar
    • Jaipur, Rajasthan, India, 302020
      • JNUIMSRC
    • Jaipur, Rajasthan, India, 302020
      • Tagore Hospital & Research Institute
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 602 015
      • Saveetha Medical College and hospital
  • Tamilnadu
    • Chennai, Tamilnadu, India, 600113
      • Voluntary Health Services Infectious Diseases Medical CEN CART Clinical Research Site
  • Uttar Pradesh
    • Kanpur, Uttar Pradesh, India, 208002
      • Department of Medicine
  • Uttarakhand
    • Rudrapur, Uttarakhand, India, 263135
      • HB Specialty Hosp. & Res Inst.
  • West Bengal
    • Kolkata, West Bengal, India, 700073
      • Calcutta School of Tropical Medicine
    • Kolkata, West Bengal, India, 700107
      • Ruby General Hospital Limited
• Japan
  • Fukuuoka-Ken
    • Okawa-shi, Fukuuoka-Ken, Japan, 831-0016
      • Kohokai Takagi Hospital
  • Ibaraki-Ken
    • Tsuchiura-shi, Ibaraki-Ken, Japan, 300-0062
      • Tsuchiura Beryl Clinic
    • Tsuchiura-shi, Ibaraki-Ken, Japan, 305-8576
      • University of Tsukuba Hospital
    • Tsukuba-shi, Ibaraki-Ken, Japan, 305-8576
      • Tashiro Endocrinology Clinic
  • Osaka-Fu
    • Izumisano-shi, Osaka-Fu, Japan, 5988577
      • Rinku General Medical Center
  • Saitama-Ken
    • Toda-shi, Saitama-Ken, Japan, 335-0035
      • KODAIRA Hospital
• Kenya
  • Eldoret, Kenya, 30100
    • Moi University Clin Res Centre, 2nd Fl, Chandaria Chronic, Disease and Cancer Centre
• Malawi
  • Mangochi, Malawi, 301400
    • Mangochi PHNG Study Site, Kamuzu University of Health Sciences, Private Bag 360, Room 805
  • Blantyre
    • Chipatala Avenue, Blantyre, Malawi, 312200
      • Johns Hopkins Research Project, Queen Elizabeth Central Hospital
• Mexico
  • Aguascalientes, Mexico, C.P 20230
    • Hospital Cardiológica Aguascalientes, Ecuador 200 Fracc Las Américas
  • Aguascalientes, Mexico, C.P. 20116
    • Centro de Inv. Médica Aguascalientes, (CIMA) Av. Independencia 2130, Int. A. Trojes de Alonso
  • CP
    • Veracruz, CP, Mexico, 91851
      • Instituto Veracruzano, en Investigación Clínica S.C., Sabino s/n, Colonia Reserva Tarimoya ll
  • Cdmx,c.p
    • Cuauhtémoc, Cdmx,c.p, Mexico, 06760
      • CAIMED Investigación en Salud,, S.A. de C.V., Manzanillo #100. Piso 2. Roma Sur
  • Morelos
    • Cuernavaca, Morelos, Mexico, C.P62210
      • Avenida Universidad 1001, Edificio 19, planta baja, colonia Chamilpa
  • Oaxaca
    • Oaxaca de Juárez, Oaxaca, Mexico, 68000
      • Oaxaca Site Management Organization S.C., Humboldt 302, Col. Centro.
  • Q. Roo
    • Cancún, Q. Roo, Mexico, C.P. 77500
      • Centro Inv. y Avances Med Especializados, (CIAME) Av. Kabah, Lote 38, 39 y 41., Manzana 4, supermanzana 44. Col., Alborada, Benito Juárez
  • Veracruz
    • Ricardo Flores Magón, Veracruz, Mexico, 91900
      • FAICIC S. DE R.L. DE C.V., Av. 16 de Septiembre 1165
• Pakistan
  • Islamabad, Pakistan, 44000
    • Shifa International Hospital, 4 Pitras Bukhari Rd, H-8/4, H-8
  • Karachi, Pakistan, 75300
    • Dow Univ of Health Sciences Ojha Campus
  • Karachi, Pakistan, 75300
    • Sindh Infectious Disease Hospital and research Centre
  • Peshawar, Pakistan, 74800
    • Maroof International Hospital
  • Karachi
    • Korangi, Karachi, Pakistan, 75190
      • Indus Hospital and Health Network
  • Peshawar
    • Hayatabad, Peshawar, Pakistan, 25000
      • Rehman Medical Institute Clinical Trial Unit
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Central Park Teaching Hospital
    • Lahore, Punjab, Pakistan, 54000
      • National Hospital & Medical Center
    • Lahore, Punjab, Pakistan, 54660
      • Akram Medical Complex
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • The Aga Khan University
• Philippines
  • Iloilo City, Philippines, 5000
    • Healthlink Iloilo, Inc., No. 12, Mabini Str.
  • Mandaluyong, Philippines, 1552
    • Health Cube Medical Clinics, High Pointe Medical Hub, 241 Shaw Blvd
  • Quezon City, Philippines, 1100
    • Lung Center of the Philippines
  • Batangas
    • Lipa, Batangas, Philippines, 4217
      • Mary Mediatrix Medical Cntr
  • Manila
    • Tondo, Manila, Philippines, 1221
      • Mary Johnston Hospital, 1221 Juan Nolasco Street
  • Molo
    • Lloilo, Molo, Philippines, 5000
      • Iloilo Doctors' Hospital, Room 706, New Condoclinics Bldg, West Ave
  • Pampanga
    • Mabalacat, Pampanga, Philippines, 2023
      • The Medical City Clark, #100Eatwick, Gatewick,Global Gateway Logistics City, Industrial Estate 5,Clark Freeport Zone
  • San Fernando
    • La Union, San Fernando, Philippines, 2500
      • Ilocos Training and Regional Medical Center
    • Pampanga, San Fernando, Philippines, 2000
      • Green City Medical Center
• Poland
  • Ostrowiec Świętokrzyski, Poland, 27-400
    • Ostrowieckie Centrum Medyczne
  • Oświęcim, Poland, 32-600
    • Medicome Sp. z o.o.
  • Rzeszów, Poland, 35-326
    • Centrum Medyczne "Medyk"
  • Skierniewice, Poland, 96-100
    • Clinmedica Research sp. z o.o.
  • Wrocław, Poland, 51-162
    • Centrum Badan Klinicznych
• South Africa
  • Roodepoort, South Africa, 1724
    • Roodepoort Medicross Clinical Research Centre
  • Free State
    • Bloemfontein, Free State, South Africa, 9300
      • Josha Research
  • Gauteng
    • Johanesburg, Gauteng, South Africa, 2001
      • Newton Clinical Research Centre
    • Johannesburg, Gauteng, South Africa, 1500
      • Worthwhile Clinical Trials
    • Johannesburg, Gauteng, South Africa, 1862
      • (PHRU), New Nurses Home 9th floor Chris
    • Johannesburg, Gauteng, South Africa, 2092
      • CHRU, Themba Lethu Clinic
    • Krugersdorp, Gauteng, South Africa, 1739
      • Ubuntu Clinical Research
    • Lenasia, Gauteng, South Africa, 1829
      • Ubuntu Clinical Research
    • Midrand, Gauteng, South Africa, 1685
      • T/A Midrand Medical Centre, Shop #1, Health Emporium
    • Pretoria, Gauteng, South Africa, 83
      • Global Clinical Trials
    • Randburg, Gauteng, South Africa, 2087
      • Right to Care Research Esizayo, Right Clinic Esizayo
  • Limpopo
    • Thabazimbi, Limpopo, South Africa, 0380
      • Limpopo Clin Res Inititative Tamboti Medical Centre
  • North West
    • Rustenburg, North West, South Africa, 0299
      • The Arum Institute NPC Rustenburg CRS
  • Western Cape
    • George, Western Cape, South Africa, 6529
      • Task Eden Research Centre
    • Paarl, Western Cape, South Africa, 7626
      • Be Part Research PTY (LTD)
• Thailand
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Siriraj Hospital
    • Pathum Wan, Bangkok, Thailand, 10330
      • Thai Red Cross AIDS Research Centre
  • Chiang Mai
    • Mueang Chiang Mai District, Chiang Mai, Thailand, 50200
      • Research Institute for Health Sciences
  • Khon Kaen
    • Mueang Khon Kaen District, Khon Kaen, Thailand, 40002
      • Srinagarind Hospital
• Turkey
  • Ankara
    • Altındag, Ankara, Turkey, 06230
      • Hacettepe Universitesi Tip Fakultesi, Hacettepe Universitesi Tip Fakultesi
  • Diyarbakir
    • Sur, Diyarbakir, Turkey, 21200
      • Dicle University Medical Faculty, Infectious Diseases Hospital Floor:5, Clinical Research Room
  • Instanbul
    • Kucukcekmece, Instanbul, Turkey, 34303
      • Acibadem Atakent Hospital
• Uganda
  • Kampala, Uganda
    • Joint Clinical Research Centre
  • Kampala, Uganda
    • Infectious Diseases Institute (IDI), Mulago Hill Road
  • Lira, Uganda
    • SICRA, Lira Regional Referral, Plot 21-41 Ngetta Road P.O. Box 330062
  • Tororo, Uganda
    • IDRC Clinic, Tororo General Hospital, P.o.box 2, Station Rd
• United States
  • Alabama
    • Guntersville, Alabama, United States, 35976
      • Lakeview Clinical Research
  • Arizona
    • Tempe, Arizona, United States, 85282
      • Voyage Medical Services
    • Tucson, Arizona, United States, 85741
      • Novak Clinical Research
  • California
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research
    • Culver City, California, United States, 91606
      • Carbon Health
    • Long Beach, California, United States, 94110
      • Ark Clinical Research (PARENT)
    • San Diego, California, United States, 92103
      • UCSD Antiviral Research Center
    • San Francisco, California, United States, 94110
      • University of California San Francisco (PARENT)
    • Thousand Oaks, California, United States, 91360
      • Clinical Trials Management Services, 223 E. Thousand Oaks Blvd.
    • Torrance, California, United States, 90502
      • Lundquist Institute for BMI, UCLA Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
  • District of Columbia
    • Washington, District of Columbia, United States, 20005
      • Whitman-Walker Health
  • Florida
    • Miami, Florida, United States, 33155
      • Miami Clinical Research
    • Miami, Florida, United States, 33176
      • Vista Health Research, LLC
    • Miami Beach, Florida, United States, 33140
      • Quantum Clinical Trials, 333 Arthur Godfrey Road, Suite 202, suite 208
    • Orlando, Florida, United States, 32807
      • Combined Research Orlando Phase I-IV
    • Ormond Beach, Florida, United States, 32174
      • Accel Research Sites Network, Ormond Clinical Research Unit, 77 West Granada Boulevard
    • Pompano Beach, Florida, United States, 33060
      • Clinical Research Center of Florida, 550 SW 3rd St.,, Suite #305
    • Pompano Beach, Florida, United States, 33073
      • Invictus Clinical Research Group, LLC
    • Tampa, Florida, United States, 33615
      • Santos Research Center, CORP
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Masters of Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 89109
      • Rush University Infectious Diseases
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Tandem Clinical Research
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins Hospital
  • Michigan
    • Grand Rapids, Michigan, United States, 49525
      • Infusion Associates
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • AB Clinical Trials
  • New Mexico
    • Albuquerque, New Mexico, United States, 87901
      • Renal Medicine Associates
  • New York
    • New York, New York, United States, 10032-3722
      • Columbia University Irving Medical Center Division of Infectious Diseases
    • New York, New York, United States, 10065
      • NY Blood Center Project ACHIEVE
    • Rochester, New York, United States, 14542
      • University of Rochester Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Global Infectious Diseases
    • Charlotte, North Carolina, United States, 28226
      • OnSite Clinical Solutions, LLC
    • Morgantown, North Carolina, United States, 28655
      • Burke Primary Care
    • Winston-Salem, North Carolina, United States, 27103
      • Progressive Medicine of the Triad, LLC
  • Ohio
    • Cincinnati, Ohio, United States, 45215
      • Wellnow Urgent Care and Research
    • Columbus, Ohio, United States, 43201
      • Ohio State University College of Medicine
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Infectious Disease Clinical Trials Unit-University of Pennsylvania Health System
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Eye Center - Eye and Ear Institute
  • Tennessee
    • Nashville, Tennessee, United States, 37204
      • Vanderbilt Health-One Hundred Oaks
  • Texas
    • Austin, Texas, United States, 78705
      • Central Texas Medical Research
    • Forney, Texas, United States, 75126
      • Care United Research, 375 North FM 548, suite 100
    • Fort Worth, Texas, United States, 76164
      • Valley Institute of Research
    • Houston, Texas, United States, 77065
      • Accurate Clinical Management, LLC
    • San Antonio, Texas, United States, 78215
      • Sun Research Institute, LLC
  • Utah
    • Bountiful, Utah, United States, 84010
      • Progressive Clinical Research
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Clinical Research Partners Llc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 (CYP 3A) inhibitor
• Strong CYP3A inducer
• Products containing St. John's Wort

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: S-217622; S-217622 will be administered orally for 5 days.	Drug: S-217622; Administered as a round tablet.
Placebo Comparator: Placebo; Placebo matching to S-217622 will be administered orally for 5 days.	Drug: Placebo; Administered as a round tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Median Time to Sustained Symptom Resolution	Up to Day 29

Secondary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Quantitative log10 SARS-CoV-2 RNA Levels by Polymerase Chain Reaction (PCR) on Nasopharyngeal (NP) Swab at Day 4	Baseline, Day 4
Percentage of Participants With Adjudicated Hospitalization Due to COVID-19 or Death Due to Any Cause	Up to Day 29
Percentage of Participants With Hospitalization (All Cause) or Death Due to Any Cause	Up to Day 29
Percentage of Participants With NP SARS-CoV-2 RNA Levels by Quantitative PCR Below the Lower Limit of Quantification on Days 4 and 8	Days 4 and 8
Median Time to Self-Reported Return to Usual (Pre-COVID-19) Health	Up to Day 29
Percentage of Participants With Resting Peripheral Oxygen Saturation ≥96%	Up to Day 29
Number of Participants With Adverse Events	Up to Week 24
Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Quality of Life Score	Baseline, Week 24
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score	Baseline, Week 24
Change From Baseline in Post-Acute COVID-19 Questionnaire	Baseline, Week 24
Percentage of Participants Who Experienced Death Due to Any Cause	Up to Week 24
Percentage of Participants With Detectable SARS-CoV-2 by Viral Culture on NP Swab at Day 4	Day 4
Percentage of Participants With Detectable SARS-CoV-2 by Viral Culture on NP Swab at Day 8	Day 8
Median Change From Baseline of SARS-CoV-2 RNA by Quantitative PCR in NP Swabs on Day 8	Baseline, Day 8
Percentage of Participants Reaching a Score ≥2, ≥3, ≥4, ≥5, ≥6, ≥7, or ≥8 on the Ordinal Scale	Up to Day 29
Change From Baseline in Resting Peripheral Oxygen Saturation at Day 29	Baseline, Day 29
Percentage of Participants Exhibiting Persistent Symptoms and Clinical Sequelae	Up to Week 24
Percentage of Participants With Symptomatic Viral Rebound as an Increase in Quantitative NP SARS-CoV-2 Viral Culture or NP SARS-CoV-2 RNA Levels by Quantitative PCR After Day 4 up to Day 29	Day 4 up to Day 29
Percentage of Participants With Viral Rebound as an Increase in Quantitative NP SARS-CoV-2 Viral Culture or NP SARS-CoV-2 RNA Levels by Quantitative PCR After Day 4 up to Day 29	Day 4 up to Day 29

Collaborators and Investigators

• Sponsor: Shionogi
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2022
• Primary Completion (Actual): January 7, 2024
• Study Completion (Estimated): May 24, 2024

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ACTIV-2d/A5407

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No