SARS-CoV-2 InfectionPhase 3SCORPIO-HRNCT05305547
A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19
A Phase 3 study testing S-217622 in people with SARS-CoV-2 Infection, run by Shionogi at 196 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- S-217622
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,093 participants
- Where
- 196 sitesin 17 countries
- Study dates
- 3 Aug 2022to 24 May 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 50Show fewer
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
196 sites in 17 countries.
196 sites in 17 countries
United States53 sites
Renal Medicine Associates
Albuquerque, New Mexico, 87901
Masters of Clinical Research
Augusta, Georgia, 30909
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Central Texas Medical Research
Austin, Texas, 78705
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Research Network America
Berwyn, Illinois, 60402
Progressive Clinical Research
Bountiful, Utah, 84010
Hope Clinical Research
Canoga Park, California, 91303
Rush University Infectious Diseases
Chicago, Illinois, 89109
Ohio State University College of Medicine
Columbus, Ohio, 43201
Carbon Health
Culver City, California, 91606
Lapis Clinical Research - North State
Denver, North Carolina, 28037
Care United Research, 375 North FM 548, suite 100
Forney, Texas, 75126
Valley Institute of Research
Fort Worth, Texas, 76164
University of Florida Clinical & Translational Science Institute
Gainesville, Florida, 32610
NICR
Garden Grove, California, 92866
Infusion Associates
Grand Rapids, Michigan, 49525
Lakeview Clinical Research
Guntersville, Alabama, 35976
Trio Clinical Trials, LLC.
Houston, Texas, 77008
Accurate Clinical Management, LLC
Houston, Texas, 77065
Leavitt Clinical Research
Idaho Falls, Idaho, 83404
Las Vegas Medical Research
Las Vegas, Nevada, 89113
AB Clinical Trials
Las Vegas, Nevada, 89119
Ark Clinical Research (PARENT)
Long Beach, California, 94110
Tandem Clinical Research
Marrero, Louisiana, 70072
Universal Medical and Research Center
Miami, Florida, 33134
CCR Medical Center, Suite 201
Miami, Florida, 33144
Miami Clinical Research
Miami, Florida, 33155
Vista Health Research, LLC
Miami, Florida, 33176
Quantum Clinical Trials, 333 Arthur Godfrey Road, Suite 202, suite 208
Miami Beach, Florida, 33140
Quality Research of South Florida
Miami Lakes, Florida, 33016
Burke Primary Care
Morgantown, North Carolina, 28655
Vanderbilt Health-One Hundred Oaks
Nashville, Tennessee, 37204
Columbia University Irving Medical Center Division of Infectious Diseases
New York, New York, 10032-3722
NY Blood Center Project ACHIEVE
New York, New York, 10065
Accel Research Sites Network, Ormond Clinical Research Unit, 77 West Granada Boulevard
Ormond Beach, Florida, 32174
Infectious Disease Clinical Trials Unit-University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
UPMC Eye Center - Eye and Ear Institute
Pittsburgh, Pennsylvania, 15213
Clinical Research Center of Florida, 550 SW 3rd St.,, Suite #305
Pompano Beach, Florida, 33060
Invictus Clinical Research Group, LLC
Pompano Beach, Florida, 33073
Clinical Research Partners LLC
Richmond, Virginia, 23226
University of Rochester Medical Center
Rochester, New York, 14542
Sun Research Institute, LLC
San Antonio, Texas, 78215
UCSD Antiviral Research Center
San Diego, California, 92103
University of California San Francisco (PARENT)
San Francisco, California, 94110
Santos Research Center, CORP
Tampa, Florida, 33615
Voyage Medical Services
Tempe, Arizona, 85282
Clinical Trials Management Services, 223 E. Thousand Oaks Blvd.
Thousand Oaks, California, 91360
Lundquist Institute for BMI, UCLA Medical Center
Torrance, California, 90502
Revival Research Institute LLC
Troy, Michigan, 48312
Novak Clinical Research
Tucson, Arizona, 85741
Whitman-Walker Health
Washington D.C., District of Columbia, 20005
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, 27103
India26 sites
Sangini Hospital 1st Flr & 7th flr
Ahmedabad, Gujarat, 380015
BGS Global institute of Medical Sciences
Bangalore, Karnataka, 560060
KLEs Dr. Prabhakar Kore Hospital & MRC Belagavi
Belagavi, Karnataka, 590010
Sri Lakshmi Super Speciality Hospital
Bengaluru, Karnataka, 560036
Shettys Hospital
Bengaluru, Karnataka, 560068
Sri Venkateshwara Hospitals, SKY HEIGHTS, Site#1/2, Sarjapura-Attibele, Main rd, Indelebele Village
Bengaluru, Karnataka, 562107
Voluntary Health Services Infectious Diseases Medical CEN CART Clinical Research Site
Chennai, Tamil Nadu, 600113
BAJ RR Hosp and Res Cntr
Dombivali, Maharashtra, 421203
Aakash Healthcare Private Limited
Dwārka, New Delhi, 110075
ESIC Medical College & Hospital
Faridabad, Haryana, 121001
Sarvodaya Hospital and Research Centre
Faridabad, Haryana, 121006
St. Theresa's Hospital
Hyderabad, Andhra Pradesh, 500018
JNUIMSRC
Jaipur, Rajasthan, 302020
Tagore Hospital & Research Institute
Jaipur, Rajasthan, 302020
Department of Medicine
Kanpur, Uttar Pradesh, 208002
Calcutta School of Tropical Medicine
Kolkata, West Bengal, 700073
Yenepoya Med College Hosp, EMD Building, 5th fl., University Rd, Deralakatte
Mangalore, Karnataka, 575018
Chopda Medicare & Research Centre Pvt. Ltd
Nashik, Maharashtra, 422005
DEC-Health Care Hospital
Nellore, Andhra Pradesh, 524001
Vijaya Super Speciality Hospital
Nellore, Andhra Pradesh, 524001
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
Lifepoint Multispecialty Hosp.
Pune, Maharashtra, 411057
HB Specialty Hosp. & Res Inst.
Rudrapur, Uttarakhand, 263135
Aman Hospital and Research Center
Vadodara, Gujarat, 390021
Rhythm Heart Institute - A Unit Of SLPL
Vadodara, Gujarat, 390022
King George Hospital
Visakhapatnam, Andhra Pradesh, 530002
Brazil20 sites
Fundação Pio XII - Hospital de Amor de, Barretos; Rua Antenor Duarte Villela
Baretos, São Paulo
Faculdade de Medicina da univ., Federal, Av Alfredo Balena, 190, 1° andar - sala 161
Belo Horizonte, Minas Gerais, 30130-100
Unid Pesquisa Clínica Facultad Medicina, de Botucatu UNESP, Rua Prof. Dr. Armando,Alves s/n, Distrito de rubião Junior
Botucatu, São Paulo, 18618-686
Hospital Universario Sao Francisco, na Providencia de Deus-Av. Sao Francisco de Assis
Bragança Paulista, São Paulo, 12916-350
Instituto de Pesquisa Clinica de Campinas IPECC Tua Oswaldo
Campinas, São Paulo, 13060-080
Hospital da Puc Campinas, Centro de Pesquisa Sao Lucas
Campinas, 13034-685
AMB3 Servicos Medicos Ltda Rua Campinas
Cuiabá, Mato Grosso, 78050-253
Hosp Nossa Senhora das Gracas, Rue Alcides Munhoz
Curitiba, Paraná, 80810-040
Cecip Jau
Jaú, São Paulo, 17201-210
Instituto Atena de Psequisa Clinica Ltds, Av Marechal Floriano Peixoto
Natal, Rio Grande do Norte, 59020-500
Thainá Garbino dos Santos, Avenida Protásio Alves 211, Bloco C
Porto Alegre, Rio Grande do Sul, 90410-000,
IPARGS, Rua Antonio Joaquim Mesquita
Porto Alegre, Rio Grande do Sul, 91350-180
IBPClin, Rua da Gloria
Rio de Janeiro, 20241-180
INI/Fiocruz
Rio de Janeiro, 21040-360
SENAI CIMATEC Clinical Trial Research Center
Salvador, Estado de Bahia, 41650-010
Pesquisare Saude
Santo André, São Paulo, 09080-111
CEMEC
São Bernardo do Campo, São Paulo, 09715-090
Esperanca Clinica De Pesquisas
São Paulo, São Paulo, 01001-000
Instituto de Molestast Cardiovasculares
Tatuí, São Paulo, 18273-170
Lóbus Cntr. de Pesquisa Cl.
Volta Redonda, 27253-003
Argentina15 sites
Clínica Olivos
Buenos Aires, 1602
CINME Centro Investigaciones Metabolicas, Pres. Jose Evaristo Uriburu 754, Piso 3 dpto 12
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1027AAP
Sanatorio De La Trinidad, Mitre Bartolome Mitre
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1039AAO
Hospital Italiano sede Central, Tte. Gral. Juan Domingo Perón 4190
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199
Centro Privado de Medicina Familiar, Mindout Research
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1412
Sanatorio Allende, Av.
Córdoba, X5000JHQ
Centro De Investigaciones
Mar del Plata, Buenos Aires, B7600FYK
Sanatorio Privado ,Duarte Quiros
Quiros, Córdoba Province, 1948
DIM Clínica Privada, Belgrano 136 - 5to piso
Ramos Mejía, Buenos Aires, 1704
Hospital General Agudos Dr. J.M., Grl Justo José de Urquiza 609 2do piso, Pabellón Clínica Médica, Enf. Emergentes
Ramos Mejía, Buenos Aires, C1221ADC
Instituto Médico de la, Fundación Estudios Clínicos, Italia 428, Rosario
Rosario, Sante Fe, 2000
CER San Juan,
San Juan, 5400
Clinica Mayo UMCB
San Miguel de Tucumán, Tucumán Province, 4000
Mendoza 2612, Rosario
Santa Fe, S2000PBJ
Clínicas Zárate, F. Andrade 332
Zárate, Buenos Aires, B2800DGH
South Africa15 sites
JOSHA Research
Bloemfontein, Free State, 9300
Task Eden Research Centre
George, Western Cape, 6529
Newton Clinical Research Centre
Johanesburg, Gauteng, 2001
Worthwhile Clinical Trials
Johannesburg, Gauteng, 1500
(PHRU), New Nurses Home 9th floor Chris
Johannesburg, Gauteng, 1862
CHRU, Themba Lethu Clinic
Johannesburg, Gauteng, 2092
Ubuntu Clinical Research
Krugersdorp, Gauteng, 1739
Ubuntu Clinical Research
Lenasia, Gauteng, 1829
T/A Midrand Medical Centre, Shop #1, Health Emporium
Midrand, Gauteng, 1685
Be Part Research PTY (LTD)
Paarl, Western Cape, 7626
Global Clinical Trials
Pretoria, Gauteng, 83
Right to Care Research Esizayo, Right Clinic Esizayo
Randburg, Gauteng, 2087
Roodepoort Medicross Clinical Research Centre
Roodepoort, 1724
The Arum Institute NPC Rustenburg CRS
Rustenburg, North West, 0299
Limpopo Clin Res Initiative Tamboti Medical Centre
Thabazimbi, Limpopo, 0380
Pakistan10 sites
Rehman Medical Institute Clinical Trial Unit
Hayatabad, Peshawar, 25000
Shifa International Hospital, 4 Pitras Bukhari Rd, H-8/4, H-8
Islamabad, 44000
The Aga Khan University
Karachi, Sindh, 74800
Dow Univ of Health Sciences Ojha Campus
Karachi, 75300
Sindh Infectious Disease Hospital and research Centre
Karachi, 75300
Indus Hospital and Health Network
Korangi, Karachi, 75190
Central Park Teaching Hospital
Lahore, Punjab Province, 54000
National Hospital & Medical Center
Lahore, Punjab Province, 54000
Akram Medical Complex
Lahore, Punjab Province, 54660
Maroof International Hospital
Peshawar, 74800
Colombia9 sites
Fundación Cardiomet Cequin,, Street 18 North # 14-25,
Armenia, Quindío Department, 630004
Centro de Investigación Medico, Asistencia - CIMEDICAL S.A.S, Cra 49C # 82-120
Barranquilla, Atlántico, 080020
Corazon IPS S.A.S, Carrera 49 No 74 - 158
Barranquilla, Atlántico, 080020
IPS CENTRO CIENTIFICO ASISTENCIAL S.A.S, Cra 45 #85-49
Barranquilla, Atlántico, 80020
Centro de investigación en Reumatología, y Especialidades Medicas S.A.S, CIREEM S.A.S.-Cra. 12#97-32
Bogotá, Bogota D.C., 110221
BlueCare Salud SAS
Bogotá, 110221
Fundación Centro Excelencia en Enferm., Crónicas No Transmisibles-FUNCENTRA, CRA 3 N°21 44 B,
Chuchurubi Monteria, Departamento de Córdoba, 230002
Programa de estudios y control de, enfermedades tropicales PECET, Carrera 53 N°61-30 Torre 2, Lab. 632
Medellín, Antioquia, 050010
TyC Inversiones SAS Grupsalud 33-6 IPS, Avenida Libertador # 30-360, Barrio San Pedro Alejandrino
Santa Marta, Magdalena Department, 470003
Mexico8 sites
Hospital Cardiológica Aguascalientes, Ecuador 200 Fracc Las Américas
Aguascalientes, C.P 20230
Centro de Inv. Médica Aguascalientes, (CIMA) Av. Independencia 2130, Int. A. Trojes de Alonso
Aguascalientes, C.P. 20116
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, C.P. 77500
CAIMED Investigación en Salud, S.A. de C.V., Manzanillo #100. Piso 2. Roma Sur
Cuauhtémoc, Cdmx, C.P, 06760
Avenida Universidad 1001, Edificio 19, planta baja, colonia Chamilpa
Cuernavaca, Morelos, C.P62210
Oaxaca Site Management Organization S.C., Humboldt 302, Col. Centro.
Oaxaca City, Oaxaca, 68000
FAICIC S. DE R.L. DE C.V., Av. 16 de Septiembre 1165
Ricardo Flores Magón, Veracruz, 91900
Instituto Veracruzano, en Investigación Clínica S.C., Sabino s/n, Colonia Reserva Tarimoya ll
Veracruz, CP, 91851
Philippines8 sites
Ilocos Training and Regional Medical Center
La Union, San Fernando, 2500
Mary Mediatrix Medical Cntr
Lipa, Batangas, 4217
Iloilo Doctors' Hospital, Room 706, New Condoclinics Bldg, West Ave
Lloilo, Molo, 5000
The Medical City Clark, #100Eatwick, Gatewick, Global Gateway Logistics City, Industrial Estate 5, Clark Freeport Zone
Mabalacat, Pampanga, 2023
Health Cube Medical Clinics, High Pointe Medical Hub, 241 Shaw Blvd
Mandaluyong, 1552
Green City Medical Center
Pampanga, San Fernando, 2000
Lung Center of the Philippines
Quezon City, 1100
Mary Johnston Hospital, 1221 Juan Nolasco Street
Tondo, Manila, 1221
Japan5 sites
Kohokai Takagi Hospital
Okawa-shi, Fukuuoka-Ken, 831-0016
Kodaira Hospital
Toda-shi, Saitama, 335-0035
Tsuchiura Beryl Clinic
Tsuchiura-shi, Ibaraki, 300-0062
University of Tsukuba Hospital
Tsuchiura-shi, Ibaraki, 305-8576
Tashiro Endocrinology Clinic
Tsukuba, Ibaraki, 305-8576
Peru5 sites
Asoc. Civil Selva Amazonica
Iquitos, Loreto, 16000
Centro de Inv. Tecnológicas Biomédicas y Medioambientales
Lima, 7006
Asoc. Civil Impacta Salud y Educación - Sede San Miguel
Lima
Patricia Ortiz Bazan
Lima Cercado, 15082
Centro de Investigación
San Isidro, Lima region, 15036
Poland5 sites
Ostrowieckie Centrum Medyczne
Ostrowiec Świętokrzyski, 27-400
Medicome sp. z o.o.
Oświęcim, 32-600
Centrum Medyczne "Medyk"
Rzeszów, 35-326
Clinmedica Research sp. z o.o.
Skierniewice, 96-100
Centrum Badań Klinicznych
Wroclaw, 51-162
Uganda5 sites
Joint Clinical Research Centre
Kampala, 10005
Infectious Diseases Institute (IDI), Mulago Hill Road
Kampala
Joint Clinical Research Centre
Kampala
SICRA, Lira Regional Referral, Plot 21-41 Ngetta Road P.O. Box 330062
Lira
IDRC Clinic, Tororo General Hospital, P.O. Box 2, Station Rd
Tororo
Thailand4 sites
Siriraj Hospital
Bangkok Noi, Bangkok, 10700
Research Institute for Health Sciences
Mueang Chiang Mai District, Chiang Mai, 50200
Srinagarind Hospital
Mueang Khon Kaen District, Changwat Khon Kaen, 40002
Thai Red Cross AIDS Research Centre
Pathum Wan, Bangkok, 10330
Ghana3 sites
Kintampo Health Research Cntr
Kintampo, PO BOX 200
Kumasi Centre for Research, South End Asuogya Road, Kwame Nkrumah University
Kumasi, AK-312-1059
Navrongo Health Research Cntr
Upper East, Navrongo, PO BOX 114
Malawi3 sites
Johns Hopkins Research Project, Queen Elizabeth Central Hospital
Chipatala Avenue, Blantyre, 312200
UNC Project, Private Bag A-104
Lilongwe, 00000
Mangochi PHNG Study Site, Kamuzu University of Health Sciences, Private Bag 360, Room 805
Mangochi, 301400
Kenya2 sites
Moi University Clin Res Centre, 2nd Fl, Chandaria Chronic, Disease and Cancer Centre
Eldoret, 30100
KEMRI CGHR HIVR Site
Kisumu, 40100
About this study
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
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.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- S-217622, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-217622Drug
Administered as a round tablet.
PlaceboDrug
Administered as a round tablet.
| Study group | Role | What they receive |
|---|---|---|
| S-217622 | Experimental | S-217622 will be administered orally for 5 days. Receives: Drug: S-217622 |
| Placebo | Placebo comparator | Placebo matching to S-217622 will be administered orally for 5 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Sustained Symptom Resolution
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.
Measured: Up to Day 29
Secondary outcomes (23)
Change From Baseline at Day 4 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Levels on Nasopharyngeal (NP) Swabs
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]).
Measured: Baseline, Day 4
Number of Participants Who Experienced Hospitalization (Adjudicated) or Death Due to Any Cause
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.
Measured: Up to Day 29
Time to Sustained Symptom Resolution in the mITT1 Set
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.
Measured: Up to Day 29
Median Change From Baseline at Day 8 in SARS-CoV-2 RNA Levels on NP Swabs
NP swabs were collected by staff during in-person visits for measurement of SARS-CoV-2 RNA levels by quantitative log10 PCR.
Measured: Baseline, Day 8
Number of Participants With Persistent and/or Late-Onset Symptoms of COVID-19 at 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.
Measured: Week 12
Time to Sustained Resolution of 6 Targeted Symptoms and Being Alive and Without Hospitalization for Any Reason by 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.
Measured: 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
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).
Measured: Day 1 through Day 29
Number of Participants With Undetectable SARS-CoV-2 on NP Swabs on 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.
Measured: Day 4 and Day 8
Number of Participants Experiencing Hospitalization (All Cause) or Death Due to Any Cause
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.
Measured: 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
NP swabs were collected by staff during in-person visits for measurement of SARS-CoV-2 RNA levels by log10 quantitative PCR.
Measured: 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
NP swabs were collected by staff during in-person visits per protocol for measurement of log10 SARS-CoV-2 RNA levels by quantitative PCR.
Measured: Baseline, Day 4, Day 8
Time to Self-Reported Return to Usual (Pre-COVID-19) Health
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.
Measured: 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
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.
Measured: Day 29
Change From Baseline at Day 29 in Resting Peripheral Oxygen Saturation
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.
Measured: Baseline, Day 29
Number of Participants With Resting Peripheral Oxygen Saturation <96% Versus ≥96%
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.
Measured: Up to Day 29
Severity of Persistent and/or Late-Onset Symptoms of COVID-19 at 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.
Measured: Week 24
Number of Participants With Symptomatic Viral Rebound Between Day 6 and 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.
Measured: Day 6 up to Day 29
Number of Participants With Viral Rebound Between Day 6 and 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.
Measured: 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
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.
Measured: Baseline, Week 24
Change From Baseline at Week 24 in EuroQol-5 Dimension 5 Level (EQ-5D-5L): Visual Analog Scale (VAS)
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.
Measured: Baseline, Week 24
Number of Participants With a Response as Measured by the Post-Acute COVID-19 Questionnaire
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.
Measured: Week 24
Number of Participants Who Experienced Death Due to Any Cause
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.
Measured: Baseline through Week 24
Plasma Concentration of Ensitrelvir at Day 4
Plasma samples were collected at specified timepoints to measure ensitrelvir levels. Results reported as micrograms/milliliter (ug/mL).
Measured: Day 4 (up to 90 minutes postdose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start3 Aug 2022
- Primary completion7 Jan 2024
- Study completion24 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by ShionogiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,093 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305547
- Sponsor's protocol ID
- ACTIV-2d/A5407
- Acronym
- SCORPIO-HR
- Status last verified
- Jul 2026
- First submitted
- 30 Mar 2022
- Last updated
- 20 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luetkemeyer AF, Chew KW, Lacey S, Hughes MD, Harrison LJ, Daar ES, Eron J, Fletcher CV, Greninger AL, Hessinger D, Li JZ, Mailhot D, Wohl D, Chayakulkeeree M, Mendoza JLA, Elistratova P, Makinde O, Morgan G, Portsmouth S, Uehara T, Smith D, Currier JS. Ensitrelvir for the Treatment of Nonhospitalized Adults with COVID-19: Results from the SCORPIO-HR, Phase 3, Randomized, Double-blind, Placebo-Controlled Trial. Clin Infect Dis. 2025 Jul 18;80(6):1235-1244. doi: 10.1093/cid/ciaf029.
PubMed 39960062