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

Primary Purpose

SARS-CoV-2 Infection

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
S-217622
Placebo
Sponsored by
Shionogi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SARS-CoV-2 Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 ≤120 hours (5 days) prior to randomization.
  • Participants are expected to begin study intervention ≤5 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 or 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 high risk are defined as having 1 or more factors that lead to a higher risk of progression to severe COVID-19:
  • 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
  • Cardiovascular disease (including congenital heart disease)
  • Chronic lung disease (for example, chronic obstructive pulmonary disease, moderate to severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension)
  • Chronic kidney disease, as long as the participant does not have known creatinine clearance (CrCl) <30 milliliters per minute (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 ˃120 hours (5 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 5 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. Use of Paxlovid at any time and the use of any oral, inhaled, or injectable medication intended to treat symptomatic SARS-CoV-2 infection before enrollment are excluded. After enrollment, 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.
  • 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 current 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 enrollment:
  • Strong cytochrome P453A (CYP 3A) inhibitor
  • Strong CYP3A inducer
  • Products containing St. John's Wort

Sites / Locations

  • Cullman Clinical TrialsRecruiting
  • Lakeview Clinical ResearchRecruiting
  • Clinical Research Inst. of Arizona LLCRecruiting
  • Voyage Medical ServicesRecruiting
  • Novak Clinical ResearchRecruiting
  • Hope Clinical ResearchRecruiting
  • Carbon HealthRecruiting
  • Ark Clinical Research (PARENT)Recruiting
  • UCSD Antiviral Research CenterRecruiting
  • University of California San Francisco (PARENT)Recruiting
  • Lundquist Institute for BMI, UCLA Medical CenterRecruiting
  • University of Colorado Anschutz Medical CampusRecruiting
  • Whitman-Walker HealthRecruiting
  • Medical Research Center of Miami
  • Miami Clinical ResearchRecruiting
  • Vista Health Research, LLC
  • Combined Research Orlando Phase I-IVRecruiting
  • Accel Research Sites Network, Ormond Clinical Research Unit, 77 West Granada BoulevardRecruiting
  • Invictus Clinical Research Group, LLCRecruiting
  • Santos Research Center, CORPRecruiting
  • Masters of Clinical ResearchRecruiting
  • Rush University Infectious DiseasesRecruiting
  • Tandem Clinical ResearchRecruiting
  • The Johns Hopkins HospitalRecruiting
  • Infusion Associates
  • Washington University, School of Medicine
  • AB Clinical TrialsRecruiting
  • SVG Clinical
  • Renal Medicine AssociatesRecruiting
  • Pime Global Research Inc
  • Columbia University Irving Medical Center Division of Infectious DiseasesRecruiting
  • NY Blood Center Project ACHIEVERecruiting
  • University of Rochester Medical CenterRecruiting
  • UNC Global Infectious Diseases
  • OnSite Clinical Solutions, LLCRecruiting
  • Burke Primary CareRecruiting
  • Carolina Research Center Inc.Recruiting
  • Progressive Medicine of the Triad, LLCRecruiting
  • WellNow Urgent Care
  • Ohio State University College of MedicineRecruiting
  • WellNow Urgent Care and Research
  • Infectious Disease Clinical Trials Unit-University of Pennsylvania Health SystemRecruiting
  • UPMC Eye Center - Eye and Ear InstituteRecruiting
  • The Miriam Hospital
  • Vanderbilt Health-One Hundred OaksRecruiting
  • Central Texas Medical ResearchRecruiting
  • Trinity Health and Wellness Center/AIDS Arms, Inc
  • Care United Research, 375 North FM 548, suite 100Recruiting
  • Valley Institute of ResearchRecruiting
  • Accurate Clinical Management, LLC
  • Sun Research Institute, LLCRecruiting
  • Progressive Clinical ResearchRecruiting
  • Clinical Research Partners LLCRecruiting
  • CINME Centro Investigaciones Metabolicas, Pres. Jose Evaristo Uriburu 754, Piso 3 dpto 12Recruiting
  • Sanatorio De La Trinidad, Mitre Bartolome MitreRecruiting
  • Hospital Italiano sede Central, Tte. Gral. Juan Domingo Perón 4190Recruiting
  • Centro Privado de Medicina Familiar, Mindout ResearchRecruiting
  • Centro De InvestigacionesRecruiting
  • DIM Clínica Privada, Belgrano 136 - 5to pisoRecruiting
  • Clínicas Zárate, F. Andrade 332Recruiting
  • Sanatorio Privado ,Duarte QuirosRecruiting
  • Instituto Médico de la, Fundación Estudios Clínicos, Italia 428, RosarioRecruiting
  • Clinica Mayo UMCBRecruiting
  • Sanatorio Allende, Av.Recruiting
  • AMB3 Servicos Medicos Ltda Rua CampinasRecruiting
  • Hosp Nossa Senhora das Gracas, Rue Alcides MunhozRecruiting
  • Instituto Atena de Psequisa Clinica Ltds, Av Marechal Floriano PeixotoRecruiting
  • Thainá Garbino dos Santos, Avenida Protásio Alves 211, Bloco CRecruiting
  • IPARGS, Rua Antonio Joaquim MesquitaRecruiting
  • Instituto de Pesquisa Clinica de Campinas IPECC Tua OswaldoRecruiting
  • Cecip JauRecruiting
  • Instituto de Molestast CardiovascularesRecruiting
  • Fundação Pio XII - Hospital de Amor de, Barretos; Rua Antenor Duarte VillelaRecruiting
  • Unid Pesquisa Clínica Facultad Medicina, de Botucatu UNESP, Rua Prof. Dr. Armando,Alves s/n, Distrito de rubião JuniorRecruiting
  • Hospital Universario Sao Francisco, na Providencia de Deus-Av. Sao Francisco de AssisRecruiting
  • Pesquisare SaudeRecruiting
  • Hospital da Puc Campinas, Centro de Pesquisa Sao LucasRecruiting
  • IBPClin, Rua da GloriaRecruiting
  • INI/FiocruzRecruiting
  • Programa de estudios y control de, enfermedades tropicales PECET, Carrera 53 N°61-30 Torre 2, Lab. 632Recruiting
  • Centro de Investigación Medico, Asistencia - CIMEDICAL S.A.S, Cra 49C # 82-120Recruiting
  • Corazon IPS S.A.S, Carrera 49 No 74 - 158Recruiting
  • IPS CENTRO CIENTIFICO ASISTENCIAL S.A.S, Cra 45 #85-49Recruiting
  • Centro de investigación en Reumatología, y Especialidades Medicas S.A.S, CIREEM S.A.S.-Cra. 12#97-32Recruiting
  • Fundación Cardiomet Cequin,, Street 18 North # 14-25,Recruiting
  • BlueCare Salud SASRecruiting
  • Navrongo Health Research CntrRecruiting
  • Kintampo Health Research CntrRecruiting
  • St. Theresa's HospitalRecruiting
  • DEC-Health Care HospitalRecruiting
  • Vijaya Super Speciality HospitalRecruiting
  • King George HospitalRecruiting
  • Indira Gandhi Inst of Medical SciencesRecruiting
  • Sir Ganga Ram HospitalRecruiting
  • Sangini Hospital 1st Flr & 7th flrRecruiting
  • Unity Hospital, Nr. D.R. WorldRecruiting
  • Aman Hospital and Research CenterRecruiting
  • Rhythm Heart Institute - A Unit Of SLPLRecruiting
  • ESIC Medical College & HospitalRecruiting
  • Sarvodaya Hospital and Research CentreRecruiting
  • BGS Global institute of Medical SciencesRecruiting
  • KLEs Dr. Prabhakar Kore Hospital & MRC BelagaviRecruiting
  • Sri Lakshmi Superspeciality HospitalRecruiting
  • Shettys HospitalRecruiting
  • Sri Venkateshwara Hospitals, SKY HEIGHTS,Site#1/2,Sarjapura-Attibele, Main rd,Indelebele VillageRecruiting
  • Yenepoya Med College Hosp, EMD Building, 5th fl., University Rd, DeralakatteRecruiting
  • BAJ RR Hosp and Res CntrRecruiting
  • Suyog Hospital, CR Dept, 2nd flr, B-wingRecruiting
  • Chopda Medicare & Research Centre Pvt. LtdRecruiting
  • Grant Medical FoundationRecruiting
  • J Govt Medical College & Sassoon, Gen Hospitals 1st Floor, ENT department, PGP Hall,Jai Prakash Narayan Road
  • Lifepoint Multispecialty Hosp.Recruiting
  • Aakash Healthcare Private LimitedRecruiting
  • Mavens'Hospital Ground Floor N 37, Opp Reliance Fresh, Vaishali Nagar
  • JNUIMSRCRecruiting
  • Tagore Hospital & Research InstituteRecruiting
  • Saveetha Medical College and hospitalRecruiting
  • Voluntary Health Services Infectious Diseases Medical CEN CART Clinical Research SiteRecruiting
  • Department of MedicineRecruiting
  • HB Specialty Hosp. & Res Inst.Recruiting
  • Calcutta School of Tropical MedicineRecruiting
  • Ruby General Hospital LimitedRecruiting
  • Kamezawa Clinic, Higashino-cho 10-12-2Recruiting
  • Kohokai Takagi HospitalRecruiting
  • Tsuchiura Beryl ClinicRecruiting
  • University of Tsukuba HospitalRecruiting
  • Tashiro Endocrinology ClinicRecruiting
  • Rinku General Medical CenterRecruiting
  • Kodaira HospitalRecruiting
  • Moi University Clin Res Centre, 2nd Fl, Chandaria Chronic, Disease and Cancer CentreRecruiting
  • CAIMED Investigación en Salud,, S.A. de C.V., Manzanillo #100. Piso 2. Roma SurRecruiting
  • Instituto Veracruzano, en Investigación Clínica S.C., Sabino s/n, Colonia Reserva Tarimoya llRecruiting
  • Oaxaca Site Management Organization S.C., Humboldt 302, Col. Centro.Recruiting
  • FAICIC S. DE R.L. DE C.V., Av. 16 de Septiembre 1165Recruiting
  • Indus Hospital and Health NetworkRecruiting
  • Rehman Medical Institute Clinical Trial UnitRecruiting
  • Central Park Teaching HospitalRecruiting
  • National Hospital & Medical CenterRecruiting
  • Akram Medical ComplexRecruiting
  • The Aga Khan UniversityRecruiting
  • Shifa International Hospital, 4 Pitras Bukhari Rd, H-8/4, H-8Recruiting
  • Dow Univ of Health Sciences Ojha CampusRecruiting
  • Sindh Infectious Disease Hospital and research CentreRecruiting
  • Maroof International HospitalRecruiting
  • Mary Mediatrix Medical CntrRecruiting
  • Pharmacy Office, LG/F, DLSMHSIRecruiting
  • Mary Johnston Hospital, 1221 Juan Nolasco StreetRecruiting
  • Ilocos Training and Regional Medical CenterRecruiting
  • Green City Medical CenterRecruiting
  • Healthlink Iloilo, Inc., No. 12, Mabini Str.Recruiting
  • Health Cube Medical Clinics, High Pointe Medical Hub, 241 Shaw BlvdRecruiting
  • Lung Center of the PhilippinesRecruiting
  • Ostrowieckie Centrum MedyczneRecruiting
  • Medicome sp. z o.o.Recruiting
  • Centrum Medyczne "Medyk"Recruiting
  • Clinmedica Research sp. z o.o.Recruiting
  • Centrum Badań KlinicznychRecruiting
  • Proyecto ACTU, Med. Sciences Campus-UPR
  • JOSHA ResearchRecruiting
  • Newton Clinical Research CentreRecruiting
  • Worthwhile Clinical TrialsRecruiting
  • (PHRU), New Nurses Home 9th floor ChrisRecruiting
  • CHRU, Themba Lethu ClinicRecruiting
  • Ubuntu Clinical ResearchRecruiting
  • Ubuntu Clinical ResearchRecruiting
  • T/A Midrand Medical Centre, Shop #1, Health EmporiumRecruiting
  • Global Clinical Trials
  • Right to Care Research Esizayo, Right Clinic EsizayoRecruiting
  • Limpopo Clin Res Inititative Tamboti Medical CentreRecruiting
  • The Arum Institute NPC Rustenburg CRSRecruiting
  • Task Eden Research CentreRecruiting
  • Be Part Research PTY (LTD)Recruiting
  • Roodepoort Medicross Clinical Research CentreRecruiting
  • Siriraj HospitalRecruiting
  • Thai Red Cross AIDS Research CentreRecruiting
  • Research Institute for Health SciencesRecruiting
  • Srinagarind HospitalRecruiting
  • Hacettepe Universitesi Tip Fakultesi, Hacettepe Universitesi Tip FakultesiRecruiting
  • Dicle University Medical Faculty, Infectious Diseases Hospital Floor:5, Clinical Research RoomRecruiting
  • Acibadem Atakent HospitalRecruiting
  • Karadeniz Teknik Üniversitesi Tıp Fakültesi, Klinik Arastirmalar Merkezi KatRecruiting
  • Infectious Diseases Institute (IDI), Mulago Hill RoadRecruiting
  • Joint Clinical Research CentreRecruiting
  • SICRA, Lira Regional Referral, Plot 21-41 Ngetta Road P.O. Box 330062Recruiting
  • IDRC Clinic, Tororo General Hospital, P.o.box 2, Station RdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

S-217622

Placebo

Arm Description

S-217622 will be administered orally for 5 days.

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

Outcomes

Primary Outcome Measures

Median Time to Sustained Symptom Resolution

Secondary Outcome Measures

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

Full Information

First Posted
March 30, 2022
Last Updated
October 9, 2023
Sponsor
Shionogi
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT05305547
Brief Title
A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19
Acronym
SCORPIO-HR
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shionogi
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
S-217622
Arm Type
Experimental
Arm Description
S-217622 will be administered orally for 5 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matching to S-217622 will be administered orally for 5 days.
Intervention Type
Drug
Intervention Name(s)
S-217622
Intervention Description
Administered as a round tablet.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as a round tablet.
Primary Outcome Measure Information:
Title
Median Time to Sustained Symptom Resolution
Time Frame
Up to Day 29
Secondary Outcome Measure Information:
Title
Change From Baseline in Quantitative log10 SARS-CoV-2 RNA Levels by Polymerase Chain Reaction (PCR) on Nasopharyngeal (NP) Swab at Day 4
Time Frame
Baseline, Day 4
Title
Percentage of Participants With Adjudicated Hospitalization Due to COVID-19 or Death Due to Any Cause
Time Frame
Up to Day 29
Title
Percentage of Participants With Detectable SARS-CoV-2 by Viral Culture on NP Swab at Day 4
Time Frame
Day 4
Title
Percentage of Participants With Hospitalization (All Cause) or Death Due to Any Cause
Time Frame
Up to Day 29
Title
Percentage of Participants With Detectable SARS-CoV-2 by Viral Culture on NP Swab at Day 8
Time Frame
Day 8
Title
Percentage of Participants With NP SARS-CoV-2 RNA Levels by Quantitative PCR Below the Lower Limit of Quantification on Days 4 and 8
Time Frame
Days 4 and 8
Title
Median Change From Baseline of SARS-CoV-2 RNA by Quantitative PCR in NP Swabs on Day 8
Time Frame
Baseline, Day 8
Title
Median Time to Self-Reported Return to Usual (Pre-COVID-19) Health
Time Frame
Up to Day 29
Title
Percentage of Participants Reaching a Score ≥2, ≥3, ≥4, ≥5, ≥6, ≥7, or ≥8 on the Ordinal Scale
Time Frame
Up to Day 29
Title
Change From Baseline in Resting Peripheral Oxygen Saturation at Day 29
Time Frame
Baseline, Day 29
Title
Percentage of Participants With Resting Peripheral Oxygen Saturation ≥96%
Time Frame
Up to Day 29
Title
Percentage of Participants Exhibiting Persistent Symptoms and Clinical Sequelae
Time Frame
Up to Week 24
Title
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
Time Frame
Day 4 up to Day 29
Title
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
Time Frame
Day 4 up to Day 29
Title
Number of Participants With Adverse Events
Time Frame
Up to Week 24
Title
Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Quality of Life Score
Time Frame
Baseline, Week 24
Title
Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
Time Frame
Baseline, Week 24
Title
Change From Baseline in Post-Acute COVID-19 Questionnaire
Time Frame
Baseline, Week 24
Title
Percentage of Participants Who Experienced Death Due to Any Cause
Time Frame
Up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shionogi Clinical Trials Administrator Clinical Support Help Line
Phone
1-800-849-9707
Email
Shionogiclintrials-admin@shionogi.co.jp
Facility Information:
Facility Name
Cullman Clinical Trials
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35055
Country
United States
Individual Site Status
Recruiting
Facility Name
Lakeview Clinical Research
City
Guntersville
State/Province
Alabama
ZIP/Postal Code
35976
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Inst. of Arizona LLC
City
Sun City West
State/Province
Arizona
ZIP/Postal Code
85375
Country
United States
Individual Site Status
Recruiting
Facility Name
Voyage Medical Services
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Individual Site Status
Recruiting
Facility Name
Novak Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Individual Site Status
Recruiting
Facility Name
Hope Clinical Research
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Individual Site Status
Recruiting
Facility Name
Carbon Health
City
Culver City
State/Province
California
ZIP/Postal Code
91606
Country
United States
Individual Site Status
Recruiting
Facility Name
Ark Clinical Research (PARENT)
City
Long Beach
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Name
UCSD Antiviral Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Francisco (PARENT)
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Name
Lundquist Institute for BMI, UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Whitman-Walker Health
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20005
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Research Center of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Withdrawn
Facility Name
Miami Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Vista Health Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Terminated
Facility Name
Combined Research Orlando Phase I-IV
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Research Sites Network, Ormond Clinical Research Unit, 77 West Granada Boulevard
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Recruiting
Facility Name
Invictus Clinical Research Group, LLC
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33073
Country
United States
Individual Site Status
Recruiting
Facility Name
Santos Research Center, CORP
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Recruiting
Facility Name
Masters of Clinical Research
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Individual Site Status
Recruiting
Facility Name
Rush University Infectious Diseases
City
Chicago
State/Province
Illinois
ZIP/Postal Code
89109
Country
United States
Individual Site Status
Recruiting
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Name
Infusion Associates
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Washington University, School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Withdrawn
Facility Name
AB Clinical Trials
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Individual Site Status
Recruiting
Facility Name
SVG Clinical
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Individual Site Status
Withdrawn
Facility Name
Renal Medicine Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87901
Country
United States
Individual Site Status
Recruiting
Facility Name
Pime Global Research Inc
City
Bronx
State/Province
New York
ZIP/Postal Code
10456
Country
United States
Individual Site Status
Withdrawn
Facility Name
Columbia University Irving Medical Center Division of Infectious Diseases
City
New York
State/Province
New York
ZIP/Postal Code
10032-3722
Country
United States
Individual Site Status
Recruiting
Facility Name
NY Blood Center Project ACHIEVE
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14542
Country
United States
Individual Site Status
Recruiting
Facility Name
UNC Global Infectious Diseases
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
OnSite Clinical Solutions, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28226
Country
United States
Individual Site Status
Recruiting
Facility Name
Burke Primary Care
City
Morgantown
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina Research Center Inc.
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Individual Site Status
Recruiting
Facility Name
Progressive Medicine of the Triad, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
WellNow Urgent Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Individual Site Status
Withdrawn
Facility Name
Ohio State University College of Medicine
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43201
Country
United States
Individual Site Status
Recruiting
Facility Name
WellNow Urgent Care and Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Individual Site Status
Withdrawn
Facility Name
Infectious Disease Clinical Trials Unit-University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
UPMC Eye Center - Eye and Ear Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Withdrawn
Facility Name
Vanderbilt Health-One Hundred Oaks
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37204
Country
United States
Individual Site Status
Recruiting
Facility Name
Central Texas Medical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
Trinity Health and Wellness Center/AIDS Arms, Inc
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Withdrawn
Facility Name
Care United Research, 375 North FM 548, suite 100
City
Forney
State/Province
Texas
ZIP/Postal Code
75126
Country
United States
Individual Site Status
Recruiting
Facility Name
Valley Institute of Research
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76164
Country
United States
Individual Site Status
Recruiting
Facility Name
Accurate Clinical Management, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Individual Site Status
Suspended
Facility Name
Sun Research Institute, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Name
Progressive Clinical Research
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Partners LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Individual Site Status
Recruiting
Facility Name
CINME Centro Investigaciones Metabolicas, Pres. Jose Evaristo Uriburu 754, Piso 3 dpto 12
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1027AAP
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sanatorio De La Trinidad, Mitre Bartolome Mitre
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1039AAO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Italiano sede Central, Tte. Gral. Juan Domingo Perón 4190
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1199
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Privado de Medicina Familiar, Mindout Research
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1412
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro De Investigaciones
City
Mar De Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FYK
Country
Argentina
Individual Site Status
Recruiting
Facility Name
DIM Clínica Privada, Belgrano 136 - 5to piso
City
Ramos Mejía
State/Province
Buenos Aires
ZIP/Postal Code
1704
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Clínicas Zárate, F. Andrade 332
City
Zarate
State/Province
Buenos Aires
ZIP/Postal Code
B2800DGH
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sanatorio Privado ,Duarte Quiros
City
Quiros
State/Province
Cordoba
ZIP/Postal Code
1948
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto Médico de la, Fundación Estudios Clínicos, Italia 428, Rosario
City
Rosario
State/Province
Sante Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Clinica Mayo UMCB
City
San Miguel de Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Sanatorio Allende, Av.
City
Cordoba
ZIP/Postal Code
X5000JHQ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
AMB3 Servicos Medicos Ltda Rua Campinas
City
Cuiabá
State/Province
Mato Grosso
ZIP/Postal Code
78050-253
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hosp Nossa Senhora das Gracas, Rue Alcides Munhoz
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80810-040
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto Atena de Psequisa Clinica Ltds, Av Marechal Floriano Peixoto
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59020-500
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Thainá Garbino dos Santos, Avenida Protásio Alves 211, Bloco C
City
Porto Alegre
State/Province
Rio Grande Do Sul,
ZIP/Postal Code
90410-000,
Country
Brazil
Individual Site Status
Recruiting
Facility Name
IPARGS, Rua Antonio Joaquim Mesquita
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-180
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto de Pesquisa Clinica de Campinas IPECC Tua Oswaldo
City
Campinas
State/Province
Sao Paolo
ZIP/Postal Code
13060-080
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Cecip Jau
City
Jau
State/Province
Sao Paolo
ZIP/Postal Code
17201-210
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto de Molestast Cardiovasculares
City
Tatui
State/Province
Sao Paolo
ZIP/Postal Code
18273-170
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Fundação Pio XII - Hospital de Amor de, Barretos; Rua Antenor Duarte Villela
City
Baretos
State/Province
Sao Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Unid Pesquisa Clínica Facultad Medicina, de Botucatu UNESP, Rua Prof. Dr. Armando,Alves s/n, Distrito de rubião Junior
City
Botucatu
State/Province
Sao Paulo
ZIP/Postal Code
18618-686
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Universario Sao Francisco, na Providencia de Deus-Av. Sao Francisco de Assis
City
Bragança Paulista
State/Province
Sao Paulo
ZIP/Postal Code
12916-350
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Pesquisare Saude
City
Santo André
State/Province
Sao Paulo
ZIP/Postal Code
09080-111
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital da Puc Campinas, Centro de Pesquisa Sao Lucas
City
Campinas
ZIP/Postal Code
13034-685
Country
Brazil
Individual Site Status
Recruiting
Facility Name
IBPClin, Rua da Gloria
City
Rio de Janeiro
ZIP/Postal Code
20241-180
Country
Brazil
Individual Site Status
Recruiting
Facility Name
INI/Fiocruz
City
Rio de Janeiro
ZIP/Postal Code
21040-360
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Programa de estudios y control de, enfermedades tropicales PECET, Carrera 53 N°61-30 Torre 2, Lab. 632
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
050010
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Centro de Investigación Medico, Asistencia - CIMEDICAL S.A.S, Cra 49C # 82-120
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Corazon IPS S.A.S, Carrera 49 No 74 - 158
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Recruiting
Facility Name
IPS CENTRO CIENTIFICO ASISTENCIAL S.A.S, Cra 45 #85-49
City
Barranquilla
State/Province
Atlántico
ZIP/Postal Code
80020
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Centro de investigación en Reumatología, y Especialidades Medicas S.A.S, CIREEM S.A.S.-Cra. 12#97-32
City
Bogota
State/Province
Bogotá
ZIP/Postal Code
110221
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Fundación Cardiomet Cequin,, Street 18 North # 14-25,
City
Armenia
State/Province
Quindío
ZIP/Postal Code
630004
Country
Colombia
Individual Site Status
Recruiting
Facility Name
BlueCare Salud SAS
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Navrongo Health Research Cntr
City
Upper East
State/Province
Navrongo
ZIP/Postal Code
PO BOX 114
Country
Ghana
Individual Site Status
Recruiting
Facility Name
Kintampo Health Research Cntr
City
Kintampo
ZIP/Postal Code
PO BOX 200
Country
Ghana
Individual Site Status
Recruiting
Facility Name
St. Theresa's Hospital
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500018
Country
India
Individual Site Status
Recruiting
Facility Name
DEC-Health Care Hospital
City
Nellore
State/Province
Andhra Pradesh
ZIP/Postal Code
524001
Country
India
Individual Site Status
Recruiting
Facility Name
Vijaya Super Speciality Hospital
City
Nellore
State/Province
Andhra Pradesh
ZIP/Postal Code
524001
Country
India
Individual Site Status
Recruiting
Facility Name
King George Hospital
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530002
Country
India
Individual Site Status
Recruiting
Facility Name
Indira Gandhi Inst of Medical Sciences
City
Patna
State/Province
Bihar
ZIP/Postal Code
800014
Country
India
Individual Site Status
Recruiting
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110060
Country
India
Individual Site Status
Recruiting
Facility Name
Sangini Hospital 1st Flr & 7th flr
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Individual Site Status
Recruiting
Facility Name
Unity Hospital, Nr. D.R. World
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395010
Country
India
Individual Site Status
Recruiting
Facility Name
Aman Hospital and Research Center
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390021
Country
India
Individual Site Status
Recruiting
Facility Name
Rhythm Heart Institute - A Unit Of SLPL
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390022
Country
India
Individual Site Status
Recruiting
Facility Name
ESIC Medical College & Hospital
City
Faridabad
State/Province
Haryana
ZIP/Postal Code
121001
Country
India
Individual Site Status
Recruiting
Facility Name
Sarvodaya Hospital and Research Centre
City
Faridabad
State/Province
Haryana
ZIP/Postal Code
121006
Country
India
Individual Site Status
Recruiting
Facility Name
BGS Global institute of Medical Sciences
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560060
Country
India
Individual Site Status
Recruiting
Facility Name
KLEs Dr. Prabhakar Kore Hospital & MRC Belagavi
City
Belgaum
State/Province
Karnataka
ZIP/Postal Code
590010
Country
India
Individual Site Status
Recruiting
Facility Name
Sri Lakshmi Superspeciality Hospital
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560036
Country
India
Individual Site Status
Recruiting
Facility Name
Shettys Hospital
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560068
Country
India
Individual Site Status
Recruiting
Facility Name
Sri Venkateshwara Hospitals, SKY HEIGHTS,Site#1/2,Sarjapura-Attibele, Main rd,Indelebele Village
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
562107
Country
India
Individual Site Status
Recruiting
Facility Name
Yenepoya Med College Hosp, EMD Building, 5th fl., University Rd, Deralakatte
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575018
Country
India
Individual Site Status
Recruiting
Facility Name
BAJ RR Hosp and Res Cntr
City
Dombivli
State/Province
Maharashtra
ZIP/Postal Code
421203
Country
India
Individual Site Status
Recruiting
Facility Name
Suyog Hospital, CR Dept, 2nd flr, B-wing
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422003
Country
India
Individual Site Status
Recruiting
Facility Name
Chopda Medicare & Research Centre Pvt. Ltd
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422005
Country
India
Individual Site Status
Recruiting
Facility Name
Grant Medical Foundation
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Individual Site Status
Recruiting
Facility Name
J Govt Medical College & Sassoon, Gen Hospitals 1st Floor, ENT department, PGP Hall,Jai Prakash Narayan Road
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Individual Site Status
Not yet recruiting
Facility Name
Lifepoint Multispecialty Hosp.
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411057
Country
India
Individual Site Status
Recruiting
Facility Name
Aakash Healthcare Private Limited
City
Dwarka
State/Province
New Delhi
ZIP/Postal Code
110075
Country
India
Individual Site Status
Recruiting
Facility Name
Mavens'Hospital Ground Floor N 37, Opp Reliance Fresh, Vaishali Nagar
City
Ajmer
State/Province
Rajasthan
ZIP/Postal Code
305001
Country
India
Individual Site Status
Not yet recruiting
Facility Name
JNUIMSRC
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302020
Country
India
Individual Site Status
Recruiting
Facility Name
Tagore Hospital & Research Institute
City
Jaipur
State/Province
Rajasthan
ZIP/Postal Code
302020
Country
India
Individual Site Status
Recruiting
Facility Name
Saveetha Medical College and hospital
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
602 015
Country
India
Individual Site Status
Recruiting
Facility Name
Voluntary Health Services Infectious Diseases Medical CEN CART Clinical Research Site
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600113
Country
India
Individual Site Status
Recruiting
Facility Name
Department of Medicine
City
Kanpur
State/Province
Uttar Pradesh
ZIP/Postal Code
208002
Country
India
Individual Site Status
Recruiting
Facility Name
HB Specialty Hosp. & Res Inst.
City
Rudrapur
State/Province
Uttarakhand
ZIP/Postal Code
263135
Country
India
Individual Site Status
Recruiting
Facility Name
Calcutta School of Tropical Medicine
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700073
Country
India
Individual Site Status
Recruiting
Facility Name
Ruby General Hospital Limited
City
Kolkata
State/Province
West Bengal
ZIP/Postal Code
700107
Country
India
Individual Site Status
Recruiting
Facility Name
Kamezawa Clinic, Higashino-cho 10-12-2
City
Kasugai-shi
State/Province
Aichi-Ken
ZIP/Postal Code
486-0817
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kohokai Takagi Hospital
City
Okawa-shi
State/Province
Fukuuoka-Ken
ZIP/Postal Code
831-0016
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tsuchiura Beryl Clinic
City
Tsuchiura-shi
State/Province
Ibaraki-Ken
ZIP/Postal Code
300-0062
Country
Japan
Individual Site Status
Recruiting
Facility Name
University of Tsukuba Hospital
City
Tsuchiura-shi
State/Province
Ibaraki-Ken
ZIP/Postal Code
305-8576
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tashiro Endocrinology Clinic
City
Tsukuba-shi
State/Province
Ibaraki-Ken
ZIP/Postal Code
305-8576
Country
Japan
Individual Site Status
Recruiting
Facility Name
Rinku General Medical Center
City
Izumisano-shi
State/Province
Osaka-Fu
ZIP/Postal Code
5988577
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kodaira Hospital
City
Toda-shi
State/Province
Saitama-Ken
ZIP/Postal Code
335-0035
Country
Japan
Individual Site Status
Recruiting
Facility Name
Moi University Clin Res Centre, 2nd Fl, Chandaria Chronic, Disease and Cancer Centre
City
Eldoret
ZIP/Postal Code
30100
Country
Kenya
Individual Site Status
Recruiting
Facility Name
CAIMED Investigación en Salud,, S.A. de C.V., Manzanillo #100. Piso 2. Roma Sur
City
Cuauhtémoc
State/Province
Cdmx,c.p
ZIP/Postal Code
06760
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Instituto Veracruzano, en Investigación Clínica S.C., Sabino s/n, Colonia Reserva Tarimoya ll
City
Veracruz
State/Province
CP
ZIP/Postal Code
91851
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Oaxaca Site Management Organization S.C., Humboldt 302, Col. Centro.
City
Oaxaca de Juárez
State/Province
Oaxaca
ZIP/Postal Code
68000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
FAICIC S. DE R.L. DE C.V., Av. 16 de Septiembre 1165
City
Ricardo Flores Magón
State/Province
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Indus Hospital and Health Network
City
Korangi
State/Province
Karachi
ZIP/Postal Code
75190
Country
Pakistan
Individual Site Status
Recruiting
Facility Name
Rehman Medical Institute Clinical Trial Unit
City
Hayatabad
State/Province
Peshawar
ZIP/Postal Code
25000
Country
Pakistan
Individual Site Status
Recruiting
Facility Name
Central Park Teaching Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Name
National Hospital & Medical Center
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Name
Akram Medical Complex
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54660
Country
Pakistan
Individual Site Status
Recruiting
Facility Name
The Aga Khan University
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Recruiting
Facility Name
Shifa International Hospital, 4 Pitras Bukhari Rd, H-8/4, H-8
City
Islamabad
ZIP/Postal Code
44000
Country
Pakistan
Individual Site Status
Recruiting
Facility Name
Dow Univ of Health Sciences Ojha Campus
City
Karachi
ZIP/Postal Code
75300
Country
Pakistan
Individual Site Status
Recruiting
Facility Name
Sindh Infectious Disease Hospital and research Centre
City
Karachi
ZIP/Postal Code
75300
Country
Pakistan
Individual Site Status
Recruiting
Facility Name
Maroof International Hospital
City
Peshawar
ZIP/Postal Code
74800
Country
Pakistan
Individual Site Status
Recruiting
Facility Name
Mary Mediatrix Medical Cntr
City
Lipa
State/Province
Batangas
ZIP/Postal Code
4217
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Pharmacy Office, LG/F, DLSMHSI
City
Dasmariñas
State/Province
Cavite
ZIP/Postal Code
4114
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Mary Johnston Hospital, 1221 Juan Nolasco Street
City
Tondo
State/Province
Manila
ZIP/Postal Code
1221
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Ilocos Training and Regional Medical Center
City
La Union
State/Province
San Fernando
ZIP/Postal Code
2500
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Green City Medical Center
City
Pampanga
State/Province
San Fernando
ZIP/Postal Code
2000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Healthlink Iloilo, Inc., No. 12, Mabini Str.
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Health Cube Medical Clinics, High Pointe Medical Hub, 241 Shaw Blvd
City
Mandaluyong
ZIP/Postal Code
1552
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Lung Center of the Philippines
City
Quezon City
ZIP/Postal Code
1100
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Ostrowieckie Centrum Medyczne
City
Ostrowiec Świętokrzyski
ZIP/Postal Code
27-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Medicome sp. z o.o.
City
Oświęcim
ZIP/Postal Code
32-600
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne "Medyk"
City
Rzeszów
ZIP/Postal Code
35-326
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinmedica Research sp. z o.o.
City
Skierniewice
ZIP/Postal Code
96-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Badań Klinicznych
City
Wrocław
ZIP/Postal Code
51-162
Country
Poland
Individual Site Status
Recruiting
Facility Name
Proyecto ACTU, Med. Sciences Campus-UPR
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Individual Site Status
Withdrawn
Facility Name
JOSHA Research
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9300
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Newton Clinical Research Centre
City
Johanesburg
State/Province
Gauteng
ZIP/Postal Code
2001
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Worthwhile Clinical Trials
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1500
Country
South Africa
Individual Site Status
Recruiting
Facility Name
(PHRU), New Nurses Home 9th floor Chris
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
1862
Country
South Africa
Individual Site Status
Recruiting
Facility Name
CHRU, Themba Lethu Clinic
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2092
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Ubuntu Clinical Research
City
Krugersdorp
State/Province
Gauteng
ZIP/Postal Code
1739
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Ubuntu Clinical Research
City
Lenasia
State/Province
Gauteng
ZIP/Postal Code
1829
Country
South Africa
Individual Site Status
Recruiting
Facility Name
T/A Midrand Medical Centre, Shop #1, Health Emporium
City
Midrand
State/Province
Gauteng
ZIP/Postal Code
1685
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Global Clinical Trials
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
83
Country
South Africa
Individual Site Status
Active, not recruiting
Facility Name
Right to Care Research Esizayo, Right Clinic Esizayo
City
Randburg
State/Province
Gauteng
ZIP/Postal Code
2087
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Limpopo Clin Res Inititative Tamboti Medical Centre
City
Thabazimbi
State/Province
Limpopo
ZIP/Postal Code
0380
Country
South Africa
Individual Site Status
Recruiting
Facility Name
The Arum Institute NPC Rustenburg CRS
City
Rustenburg
State/Province
North West
ZIP/Postal Code
0299
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Task Eden Research Centre
City
George
State/Province
Western Cape
ZIP/Postal Code
6529
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Be Part Research PTY (LTD)
City
Paarl
State/Province
Western Cape
ZIP/Postal Code
7626
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Roodepoort Medicross Clinical Research Centre
City
Roodepoort
ZIP/Postal Code
1724
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Siriraj Hospital
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Thai Red Cross AIDS Research Centre
City
Pathum Wan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Institute for Health Sciences
City
Mueang Chiang Mai District
State/Province
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Srinagarind Hospital
City
Mueang Khon Kaen District
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Hacettepe Universitesi Tip Fakultesi, Hacettepe Universitesi Tip Fakultesi
City
Altındag
State/Province
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Dicle University Medical Faculty, Infectious Diseases Hospital Floor:5, Clinical Research Room
City
Sur
State/Province
Diyarbakir
ZIP/Postal Code
21200
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Acibadem Atakent Hospital
City
Kucukcekmece
State/Province
Instanbul
ZIP/Postal Code
34303
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Karadeniz Teknik Üniversitesi Tıp Fakültesi, Klinik Arastirmalar Merkezi Kat
City
Ortahisar
State/Province
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Infectious Diseases Institute (IDI), Mulago Hill Road
City
Kampala
Country
Uganda
Individual Site Status
Recruiting
Facility Name
Joint Clinical Research Centre
City
Kampala
Country
Uganda
Individual Site Status
Recruiting
Facility Name
SICRA, Lira Regional Referral, Plot 21-41 Ngetta Road P.O. Box 330062
City
Lira
Country
Uganda
Individual Site Status
Recruiting
Facility Name
IDRC Clinic, Tororo General Hospital, P.o.box 2, Station Rd
City
Tororo
Country
Uganda
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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