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

NCT05305547 | Completed Phase 3 FDA Drug

• 1 other identifier: ACTIV-2d/A5407
• Study Type: interventional
• Target: 2,093
• Locations: 17 countries
• Sites: 196

Brief 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.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (1)

• Median Time to Sustained Symptom Resolution

  Up to Day 29

Secondary Outcomes (19)

• 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 Detectable SARS-CoV-2 by Viral Culture on NP Swab at Day 4

  Day 4

• Percentage of Participants With Hospitalization (All Cause) or Death Due to Any Cause

  Up to Day 29

• Percentage of Participants With Detectable SARS-CoV-2 by Viral Culture on NP Swab at Day 8

  Day 8

Study Arms (2)

S-217622

EXPERIMENTAL

S-217622 will be administered orally for 5 days.

Drug: S-217622

Placebo

PLACEBO COMPARATOR

Placebo matching to S-217622 will be administered orally for 5 days.

Drug: Placebo

Interventions

S-217622 DRUG

Administered as a round tablet.

S-217622

Placebo DRUG

Administered as a round tablet.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Shionogi: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (196)

Lakeview Clinical Research

Guntersville, Alabama, 35976, United States

Location

Voyage Medical Services

Tempe, Arizona, 85282, United States

Location

Novak Clinical Research

Tucson, Arizona, 85741, United States

Location

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

Carbon Health

Culver City, California, 91606, United States

Location

NICR

Garden Grove, California, 92866, United States

Location

Ark Clinical Research (PARENT)

Long Beach, California, 94110, United States

Location

UCSD Antiviral Research Center

San Diego, California, 92103, United States

Location

University of California San Francisco (PARENT)

San Francisco, California, 94110, United States

Location

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

Thousand Oaks, California, 91360, United States

Location

Lundquist Institute for BMI, UCLA Medical Center

Torrance, California, 90502, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Whitman-Walker Health

Washington D.C., District of Columbia, 20005, United States

Location

University of Florida Clinical & Translational Science Institute

Gainesville, Florida, 32610, United States

Location

Universal Medical and Research Center

Miami, Florida, 33134, United States

Location

CCR Medical Center, Suite 201

Miami, Florida, 33144, United States

Location

Miami Clinical Research

Miami, Florida, 33155, United States

Location

Vista Health Research, LLC

Miami, Florida, 33176, United States

Location

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

Miami Beach, Florida, 33140, United States

Location

Quality Research of South Florida

Miami Lakes, Florida, 33016, United States

Location

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

Ormond Beach, Florida, 32174, United States

Location

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

Pompano Beach, Florida, 33060, United States

Location

Invictus Clinical Research Group, LLC

Pompano Beach, Florida, 33073, United States

Location

Santos Research Center, CORP

Tampa, Florida, 33615, United States

Location

Masters of Clinical Research

Augusta, Georgia, 30909, United States

Location

Leavitt Clinical Research

Idaho Falls, Idaho, 83404, United States

Location

Research Network America

Berwyn, Illinois, 60402, United States

Location

Rush University Infectious Diseases

Chicago, Illinois, 89109, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Infusion Associates

Grand Rapids, Michigan, 49525, United States

Location

Revival Research Institute LLC

Troy, Michigan, 48312, United States

Location

Las Vegas Medical Research

Las Vegas, Nevada, 89113, United States

Location

AB Clinical Trials

Las Vegas, Nevada, 89119, United States

Location

Renal Medicine Associates

Albuquerque, New Mexico, 87901, United States

Location

Columbia University Irving Medical Center Division of Infectious Diseases

New York, New York, 10032-3722, United States

Location

NY Blood Center Project ACHIEVE

New York, New York, 10065, United States

Location

University of Rochester Medical Center

Rochester, New York, 14542, United States

Location

Lapis Clinical Research - North State

Denver, North Carolina, 28037, United States

Location

Burke Primary Care

Morgantown, North Carolina, 28655, United States

Location

Progressive Medicine of the Triad, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Ohio State University College of Medicine

Columbus, Ohio, 43201, United States

Location

Infectious Disease Clinical Trials Unit-University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Eye Center - Eye and Ear Institute

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt Health-One Hundred Oaks

Nashville, Tennessee, 37204, United States

Location

Central Texas Medical Research

Austin, Texas, 78705, United States

Location

Care United Research, 375 North FM 548, suite 100

Forney, Texas, 75126, United States

Location

Valley Institute of Research

Fort Worth, Texas, 76164, United States

Location

Trio Clinical Trials, LLC.

Houston, Texas, 77008, United States

Location

Accurate Clinical Management, LLC

Houston, Texas, 77065, United States

Location

Sun Research Institute, LLC

San Antonio, Texas, 78215, United States

Location

Progressive Clinical Research

Bountiful, Utah, 84010, United States

Location

Clinical Research Partners LLC

Richmond, Virginia, 23226, United States

Location

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

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1027AAP, Argentina

Location

Sanatorio De La Trinidad, Mitre Bartolome Mitre

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1039AAO, Argentina

Location

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

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199, Argentina

Location

Centro Privado de Medicina Familiar, Mindout Research

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1412, Argentina

Location

Centro De Investigaciones

Mar del Plata, Buenos Aires, B7600FYK, Argentina

Location

DIM Clínica Privada, Belgrano 136 - 5to piso

Ramos Mejía, Buenos Aires, 1704, Argentina

Location

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

Ramos Mejía, Buenos Aires, C1221ADC, Argentina

Location

Clínicas Zárate, F. Andrade 332

Zárate, Buenos Aires, B2800DGH, Argentina

Location

Sanatorio Privado ,Duarte Quiros

Quiros, Córdoba Province, 1948, Argentina

Location

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

Rosario, Sante Fe, 2000, Argentina

Location

Clinica Mayo UMCB

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Clínica Olivos

Buenos Aires, 1602, Argentina

Location

Sanatorio Allende, Av.

Córdoba, X5000JHQ, Argentina

Location

CER San Juan,

San Juan, 5400, Argentina

Location

Mendoza 2612, Rosario

Santa Fe, S2000PBJ, Argentina

Location

SENAI CIMATEC Clinical Trial Research Center

Salvador, Estado de Bahia, 41650-010, Brazil

Location

AMB3 Servicos Medicos Ltda Rua Campinas

Cuiabá, Mato Grosso, 78050-253, Brazil

Location

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

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Hosp Nossa Senhora das Gracas, Rue Alcides Munhoz

Curitiba, Paraná, 80810-040, Brazil

Location

Instituto Atena de Psequisa Clinica Ltds, Av Marechal Floriano Peixoto

Natal, Rio Grande do Norte, 59020-500, Brazil

Location

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

Porto Alegre, Rio Grande do Sul, 90410-000,, Brazil

Location

IPARGS, Rua Antonio Joaquim Mesquita

Porto Alegre, Rio Grande do Sul, 91350-180, Brazil

Location

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

Baretos, São Paulo, Brazil

Location

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

Botucatu, São Paulo, 18618-686, Brazil

Location

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

Bragança Paulista, São Paulo, 12916-350, Brazil

Location

Instituto de Pesquisa Clinica de Campinas IPECC Tua Oswaldo

Campinas, São Paulo, 13060-080, Brazil

Location

Cecip Jau

Jaú, São Paulo, 17201-210, Brazil

Location

Pesquisare Saude

Santo André, São Paulo, 09080-111, Brazil

Location

CEMEC

São Bernardo do Campo, São Paulo, 09715-090, Brazil

Location

Esperanca Clinica De Pesquisas

São Paulo, São Paulo, 01001-000, Brazil

Location

Instituto de Molestast Cardiovasculares

Tatuí, São Paulo, 18273-170, Brazil

Location

Hospital da Puc Campinas, Centro de Pesquisa Sao Lucas

Campinas, 13034-685, Brazil

Location

IBPClin, Rua da Gloria

Rio de Janeiro, 20241-180, Brazil

Location

INI/Fiocruz

Rio de Janeiro, 21040-360, Brazil

Location

Lóbus Cntr. de Pesquisa Cl.

Volta Redonda, 27253-003, Brazil

Location

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

Medellín, Antioquia, 050010, Colombia

Location

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

Barranquilla, Atlántico, 080020, Colombia

Location

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

Barranquilla, Atlántico, 080020, Colombia

Location

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

Barranquilla, Atlántico, 80020, Colombia

Location

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

Bogotá, Bogota D.C., 110221, Colombia

Location

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

Chuchurubi Monteria, Departamento de Córdoba, 230002, Colombia

Location

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

Santa Marta, Magdalena Department, 470003, Colombia

Location

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

Armenia, Quindío Department, 630004, Colombia

Location

BlueCare Salud SAS

Bogotá, 110221, Colombia

Location

Navrongo Health Research Cntr

Upper East, Navrongo, PO BOX 114, Ghana

Location

Kintampo Health Research Cntr

Kintampo, PO BOX 200, Ghana

Location

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

Kumasi, AK-312-1059, Ghana

Location

St. Theresa's Hospital

Hyderabad, Andhra Pradesh, 500018, India

Location

DEC-Health Care Hospital

Nellore, Andhra Pradesh, 524001, India

Location

Vijaya Super Speciality Hospital

Nellore, Andhra Pradesh, 524001, India

Location

King George Hospital

Visakhapatnam, Andhra Pradesh, 530002, India

Location

Sangini Hospital 1st Flr & 7th flr

Ahmedabad, Gujarat, 380015, India

Location

Aman Hospital and Research Center

Vadodara, Gujarat, 390021, India

Location

Rhythm Heart Institute - A Unit Of SLPL

Vadodara, Gujarat, 390022, India

Location

ESIC Medical College & Hospital

Faridabad, Haryana, 121001, India

Location

Sarvodaya Hospital and Research Centre

Faridabad, Haryana, 121006, India

Location

BGS Global institute of Medical Sciences

Bangalore, Karnataka, 560060, India

Location

KLEs Dr. Prabhakar Kore Hospital & MRC Belagavi

Belagavi, Karnataka, 590010, India

Location

Sri Lakshmi Super Speciality Hospital

Bengaluru, Karnataka, 560036, India

Location

Shettys Hospital

Bengaluru, Karnataka, 560068, India

Location

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

Bengaluru, Karnataka, 562107, India

Location

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

Mangalore, Karnataka, 575018, India

Location

BAJ RR Hosp and Res Cntr

Dombivali, Maharashtra, 421203, India

Location

Chopda Medicare & Research Centre Pvt. Ltd

Nashik, Maharashtra, 422005, India

Location

Lifepoint Multispecialty Hosp.

Pune, Maharashtra, 411057, India

Location

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

Location

Aakash Healthcare Private Limited

Dwārka, New Delhi, 110075, India

Location

JNUIMSRC

Jaipur, Rajasthan, 302020, India

Location

Tagore Hospital & Research Institute

Jaipur, Rajasthan, 302020, India

Location

Voluntary Health Services Infectious Diseases Medical CEN CART Clinical Research Site

Chennai, Tamil Nadu, 600113, India

Location

Department of Medicine

Kanpur, Uttar Pradesh, 208002, India

Location

HB Specialty Hosp. & Res Inst.

Rudrapur, Uttarakhand, 263135, India

Location

Calcutta School of Tropical Medicine

Kolkata, West Bengal, 700073, India

Location

Kohokai Takagi Hospital

Okawa-shi, Fukuuoka-Ken, 831-0016, Japan

Location

Tsuchiura Beryl Clinic

Tsuchiura-shi, Ibaraki, 300-0062, Japan

Location

University of Tsukuba Hospital

Tsuchiura-shi, Ibaraki, 305-8576, Japan

Location

Tashiro Endocrinology Clinic

Tsukuba, Ibaraki, 305-8576, Japan

Location

Kodaira Hospital

Toda-shi, Saitama, 335-0035, Japan

Location

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

Eldoret, 30100, Kenya

Location

KEMRI CGHR HIVR Site

Kisumu, 40100, Kenya

Location

Johns Hopkins Research Project, Queen Elizabeth Central Hospital

Chipatala Avenue, Blantyre, 312200, Malawi

Location

UNC Project, Private Bag A-104

Lilongwe, 00000, Malawi

Location

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

Mangochi, 301400, Malawi

Location

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

Cuauhtémoc, Cdmx, C.P, 06760, Mexico

Location

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

Veracruz, CP, 91851, Mexico

Location

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

Cuernavaca, Morelos, C.P62210, Mexico

Location

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

Oaxaca City, Oaxaca, 68000, Mexico

Location

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, Mexico

Location

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

Ricardo Flores Magón, Veracruz, 91900, Mexico

Location

Hospital Cardiológica Aguascalientes, Ecuador 200 Fracc Las Américas

Aguascalientes, C.P 20230, Mexico

Location

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

Aguascalientes, C.P. 20116, Mexico

Location

Indus Hospital and Health Network

Korangi, Karachi, 75190, Pakistan

Location

Rehman Medical Institute Clinical Trial Unit

Hayatabad, Peshawar, 25000, Pakistan

Location

Central Park Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

National Hospital & Medical Center

Lahore, Punjab Province, 54000, Pakistan

Location

Akram Medical Complex

Lahore, Punjab Province, 54660, Pakistan

Location

The Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

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

Islamabad, 44000, Pakistan

Location

Dow Univ of Health Sciences Ojha Campus

Karachi, 75300, Pakistan

Location

Sindh Infectious Disease Hospital and research Centre

Karachi, 75300, Pakistan

Location

Maroof International Hospital

Peshawar, 74800, Pakistan

Location

Centro de Investigación

San Isidro, Lima region, 15036, Peru

Location

Asoc. Civil Selva Amazonica

Iquitos, Loreto, 16000, Peru

Location

Centro de Inv. Tecnológicas Biomédicas y Medioambientales

Lima, 7006, Peru

Location

Asoc. Civil Impacta Salud y Educación - Sede San Miguel

Lima, Peru

Location

Patricia Ortiz Bazan

Lima Cercado, 15082, Peru

Location

Mary Mediatrix Medical Cntr

Lipa, Batangas, 4217, Philippines

Location

Mary Johnston Hospital, 1221 Juan Nolasco Street

Tondo, Manila, 1221, Philippines

Location

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

Lloilo, Molo, 5000, Philippines

Location

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

Mabalacat, Pampanga, 2023, Philippines

Location

Ilocos Training and Regional Medical Center

La Union, San Fernando, 2500, Philippines

Location

Green City Medical Center

Pampanga, San Fernando, 2000, Philippines

Location

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

Mandaluyong, 1552, Philippines

Location

Lung Center of the Philippines

Quezon City, 1100, Philippines

Location

Ostrowieckie Centrum Medyczne

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Medicome sp. z o.o.

Oświęcim, 32-600, Poland

Location

Centrum Medyczne "Medyk"

Rzeszów, 35-326, Poland

Location

Clinmedica Research sp. z o.o.

Skierniewice, 96-100, Poland

Location

Centrum Badań Klinicznych

Wroclaw, 51-162, Poland

Location

JOSHA Research

Bloemfontein, Free State, 9300, South Africa

Location

Newton Clinical Research Centre

Johanesburg, Gauteng, 2001, South Africa

Location

Worthwhile Clinical Trials

Johannesburg, Gauteng, 1500, South Africa

Location

(PHRU), New Nurses Home 9th floor Chris

Johannesburg, Gauteng, 1862, South Africa

Location

CHRU, Themba Lethu Clinic

Johannesburg, Gauteng, 2092, South Africa

Location

Ubuntu Clinical Research

Krugersdorp, Gauteng, 1739, South Africa

Location

Ubuntu Clinical Research

Lenasia, Gauteng, 1829, South Africa

Location

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

Midrand, Gauteng, 1685, South Africa

Location

Global Clinical Trials

Pretoria, Gauteng, 83, South Africa

Location

Right to Care Research Esizayo, Right Clinic Esizayo

Randburg, Gauteng, 2087, South Africa

Location

Limpopo Clin Res Initiative Tamboti Medical Centre

Thabazimbi, Limpopo, 0380, South Africa

Location

The Arum Institute NPC Rustenburg CRS

Rustenburg, North West, 0299, South Africa

Location

Task Eden Research Centre

George, Western Cape, 6529, South Africa

Location

Be Part Research PTY (LTD)

Paarl, Western Cape, 7626, South Africa

Location

Roodepoort Medicross Clinical Research Centre

Roodepoort, 1724, South Africa

Location

Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Thai Red Cross AIDS Research Centre

Pathum Wan, Bangkok, 10330, Thailand

Location

Srinagarind Hospital

Mueang Khon Kaen District, Changwat Khon Kaen, 40002, Thailand

Location

Research Institute for Health Sciences

Mueang Chiang Mai District, Chiang Mai, 50200, Thailand

Location

Joint Clinical Research Centre

Kampala, 10005, Uganda

Location

Infectious Diseases Institute (IDI), Mulago Hill Road

Kampala, Uganda

Location

Joint Clinical Research Centre

Kampala, Uganda

Location

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

Lira, Uganda

Location

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

Tororo, Uganda

Location

Related Publications (1)

• 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.

  PMID: 39960062 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

ensitrelvir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: March 31, 2022
• Study Start: August 3, 2022
• Primary Completion: January 7, 2024
• Study Completion: May 24, 2024
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5); MA (3); CO (9); UG (5); KE (2); ZA (15); AR (15); US (53); IN (26); BR (20); PA (10); PE (5); TH (4); PL (5); GH (3); ME (8); PH (8)