Clinical trial NCT05305547: A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: SARS-CoV-2 Infection
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2022-03-31
Enrollment: 2093
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 inducer
* Products containing St. John's Wort

Primary outcomes:
measure: Median Time to Sustained Symptom Resolution
timeFrame: Up to Day 29
Secondary outcomes:
measure: Change From Baseline in Quantitative log10 SARS-CoV-2 RNA Levels by Polymerase Chain Reaction (PCR) on Nasopharyngeal (NP) Swab at Day 4
timeFrame: Baseline, Day 4
measure: Percentage of Participants With Adjudicated Hospitalization Due to COVID-19 or Death Due to Any Cause
timeFrame: Up to Day 29
measure: Percentage of Participants With Detectable SARS-CoV-2 by Viral Culture on NP Swab at Day 4
timeFrame: Day 4
measure: Percentage of Participants With Hospitalization (All Cause) or Death Due to Any Cause
timeFrame: Up to Day 29
measure: Percentage of Participants With Detectable SARS-CoV-2 by Viral Culture on NP Swab at Day 8
timeFrame: Day 8
measure: Percentage of Participants With NP SARS-CoV-2 RNA Levels by Quantitative PCR Below the Lower Limit of Quantification on Days 4 and 8
timeFrame: Days 4 and 8
measure: Median Change From Baseline of SARS-CoV-2 RNA by Quantitative PCR in NP Swabs on Day 8
timeFrame: Baseline, Day 8
measure: Median Time to Self-Reported Return to Usual (Pre-COVID-19) Health
timeFrame: Up to Day 29
measure: Percentage of Participants Reaching a Score ≥2, ≥3, ≥4, ≥5, ≥6, ≥7, or ≥8 on the Ordinal Scale
timeFrame: Up to Day 29
measure: Change From Baseline in Resting Peripheral Oxygen Saturation at Day 29
timeFrame: Baseline, Day 29
measure: Percentage of Participants With Resting Peripheral Oxygen Saturation ≥96%
timeFrame: Up to Day 29
measure: Percentage of Participants Exhibiting Persistent Symptoms and Clinical Sequelae
timeFrame: Up to Week 24
measure: 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
timeFrame: Day 4 up to Day 29
measure: 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
timeFrame: Day 4 up to Day 29
measure: Number of Participants With Adverse Events
timeFrame: Up to Week 24
measure: Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Quality of Life Score
timeFrame: Baseline, Week 24
measure: Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score
timeFrame: Baseline, Week 24
measure: Change From Baseline in Post-Acute COVID-19 Questionnaire
timeFrame: Baseline, Week 24
measure: Percentage of Participants Who Experienced Death Due to Any Cause
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Guntersville
country: United States
facility: Lakeview Clinical Research
state: Alabama
city: Tempe
country: United States
facility: Voyage Medical Services
state: Arizona
city: Tucson
country: United States
facility: Novak Clinical Research
state: Arizona
city: Canoga Park
country: United States
facility: Hope Clinical Research
state: California
city: Culver City
country: United States
facility: Carbon Health
state: California
city: Garden Grove
country: United States
facility: NICR
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research (PARENT)
state: California
city: San Diego
country: United States
facility: UCSD Antiviral Research Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco (PARENT)
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Management Services, 223 E. Thousand Oaks Blvd.
state: California
city: Torrance
country: United States
facility: Lundquist Institute for BMI, UCLA Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: Washington
country: United States
facility: Whitman-Walker Health
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida Clinical & Translational Science Institute
state: Florida
city: Miami Beach
country: United States
facility: Quantum Clinical Trials, 333 Arthur Godfrey Road, Suite 202, suite 208
state: Florida
city: Miami Lakes
country: United States
facility: Quality Research of South Florida
state: Florida
city: Miami
country: United States
facility: Universal Medical and Research Center
state: Florida
city: Miami
country: United States
facility: CCR Medical Center, Suite 201
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research
state: Florida
city: Miami
country: United States
facility: Vista Health Research, LLC
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando Phase I-IV
state: Florida
city: Ormond Beach
country: United States
facility: Accel Research Sites Network, Ormond Clinical Research Unit, 77 West Granada Boulevard
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida, 550 SW 3rd St.,, Suite #305
state: Florida
city: Pompano Beach
country: United States
facility: Invictus Clinical Research Group, LLC
state: Florida
city: Tampa
country: United States
facility: Santos Research Center, CORP
state: Florida
city: Augusta
country: United States
facility: Masters of Clinical Research
state: Georgia
city: Idaho Falls
country: United States
facility: Leavitt Clinical Research
state: Idaho
city: Berwyn
country: United States
facility: Research Network America
state: Illinois
city: Chicago
country: United States
facility: Rush University Infectious Diseases
state: Illinois
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Grand Rapids
country: United States
facility: Infusion Associates
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute LLC
state: Michigan
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Las Vegas
country: United States
facility: AB Clinical Trials
state: Nevada
city: Albuquerque
country: United States
facility: Renal Medicine Associates
state: New Mexico
city: New York
country: United States
facility: Columbia University Irving Medical Center Division of Infectious Diseases
state: New York
city: New York
country: United States
facility: NY Blood Center Project ACHIEVE
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Global Infectious Diseases
state: North Carolina
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC
state: North Carolina
city: Denver
country: United States
facility: Lapis Clinical Research - North State
state: North Carolina
city: Morgantown
country: United States
facility: Burke Primary Care
state: North Carolina
city: Winston-Salem
country: United States
facility: Progressive Medicine of the Triad, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: WellNow Urgent Care and Research
state: Ohio
city: Columbus
country: United States
facility: Ohio State University College of Medicine
state: Ohio
city: Philadelphia
country: United States
facility: Infectious Disease Clinical Trials Unit-University of Pennsylvania Health System
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Eye Center - Eye and Ear Institute
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Health-One Hundred Oaks
state: Tennessee
city: Austin
country: United States
facility: Central Texas Medical Research
state: Texas
city: Forney
country: United States
facility: Care United Research, 375 North FM 548, suite 100
state: Texas
city: Fort Worth
country: United States
facility: Valley Institute of Research
state: Texas
city: Houston
country: United States
facility: Trio Clinical Trials, LLC.
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Management, LLC
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute, LLC
state: Texas
city: Bountiful
country: United States
facility: Progressive Clinical Research
state: Utah
city: Richmond
country: United States
facility: Clinical Research Partners LLC
state: Virginia
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: CINME Centro Investigaciones Metabolicas, Pres. Jose Evaristo Uriburu 754, Piso 3 dpto 12
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Sanatorio De La Trinidad, Mitre Bartolome Mitre
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Italiano sede Central, Tte. Gral. Juan Domingo Perón 4190
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Privado de Medicina Familiar, Mindout Research
state: Buenos Aires
city: Mar De Plata
country: Argentina
facility: Centro De Investigaciones
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Instituto de Investigaciones Clinicas Quilmes SRL
state: Buenos Aires
city: Ramos Mejía
country: Argentina
facility: DIM Clínica Privada, Belgrano 136 - 5to piso
state: Buenos Aires
city: Ramos Mejía
country: Argentina
facility: Hospital General Agudos Dr. J.M., Grl Justo José de Urquiza 609 2do piso, Pabellón Clínica Médica, Enf. Emergentes
state: Buenos Aires
city: Zarate
country: Argentina
facility: Clínicas Zárate, F. Andrade 332
state: Buenos Aires
city: Quiros
country: Argentina
facility: Sanatorio Privado ,Duarte Quiros
state: Cordoba
city: Rosario
country: Argentina
facility: Instituto Médico de la, Fundación Estudios Clínicos, Italia 428, Rosario
state: Sante Fe
city: San Miguel de Tucuman
country: Argentina
facility: Clinica Mayo UMCB
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Clínica Olivos
city: Cordoba
country: Argentina
facility: Sanatorio Allende, Av.
city: San Juan
country: Argentina
facility: CER San Juan,
city: Santa Fe
country: Argentina
facility: Mendoza 2612, Rosario
city: Gozée
country: Belgium
facility: De Meulemeester, Marc
city: Wetteren
country: Belgium
facility: BVBA Dr. Luc Capiau, Massemsesteenweg 247
city: Salvador
country: Brazil
facility: SENAI CIMATEC Clinical Trial Research Center
state: Bahia
city: Cuiabá
country: Brazil
facility: AMB3 Servicos Medicos Ltda Rua Campinas
state: Mato Grosso
city: Belo Horizonte
country: Brazil
facility: Faculdade de Medicina da univ., Federal, Av Alfredo Balena, 190, 1° andar - sala 161
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Hosp Nossa Senhora das Gracas, Rue Alcides Munhoz
state: Paraná
city: Natal
country: Brazil
facility: Instituto Atena de Psequisa Clinica Ltds, Av Marechal Floriano Peixoto
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Thainá Garbino dos Santos, Avenida Protásio Alves 211, Bloco C
state: Rio Grande Do Sul,
city: Porto Alegre
country: Brazil
facility: IPARGS, Rua Antonio Joaquim Mesquita
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Instituto de Pesquisa Clinica de Campinas IPECC Tua Oswaldo
state: Sao Paolo
city: Jau
country: Brazil
facility: Cecip Jau
state: Sao Paolo
city: Tatui
country: Brazil
facility: Instituto de Molestast Cardiovasculares
state: Sao Paolo
city: Baretos
country: Brazil
facility: Fundação Pio XII - Hospital de Amor de, Barretos; Rua Antenor Duarte Villela
state: Sao Paulo
city: Botucatu
country: Brazil
facility: Unid Pesquisa Clínica Facultad Medicina, de Botucatu UNESP, Rua Prof. Dr. Armando,Alves s/n, Distrito de rubião Junior
state: Sao Paulo
city: Bragança Paulista
country: Brazil
facility: Hospital Universario Sao Francisco, na Providencia de Deus-Av. Sao Francisco de Assis
state: Sao Paulo
city: Santo André
country: Brazil
facility: Pesquisare Saude
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Esperanca Clinica De Pesquisas
state: Sao Paulo
city: São Bernardo Do Campo
country: Brazil
facility: CEMEC
state: São Paulo
city: Campinas
country: Brazil
facility: Hospital da Puc Campinas, Centro de Pesquisa Sao Lucas
city: Rio de Janeiro
country: Brazil
facility: IBPClin, Rua da Gloria
city: Rio de Janeiro
country: Brazil
facility: INI/Fiocruz
city: Volta Redonda
country: Brazil
facility: Lóbus Cntr. de Pesquisa Cl.
city: Medellín
country: Colombia
facility: Programa de estudios y control de, enfermedades tropicales PECET, Carrera 53 N°61-30 Torre 2, Lab. 632
state: Antioquia
city: Barranquilla
country: Colombia
facility: Centro de Investigación Medico, Asistencia - CIMEDICAL S.A.S, Cra 49C # 82-120
state: Atlantico
city: Barranquilla
country: Colombia
facility: Corazon IPS S.A.S, Carrera 49 No 74 - 158
state: Atlantico
city: Barranquilla
country: Colombia
facility: IPS CENTRO CIENTIFICO ASISTENCIAL S.A.S, Cra 45 #85-49
state: Atlántico
city: Bogota
country: Colombia
facility: Centro de investigación en Reumatología, y Especialidades Medicas S.A.S, CIREEM S.A.S.-Cra. 12#97-32
state: Bogotá
city: Chuchurubi Monteria
country: Colombia
facility: Fundación Centro Excelencia en Enferm., Crónicas No Transmisibles-FUNCENTRA, CRA 3 N°21 44 B,
state: Cordoba
city: Santa Marta
country: Colombia
facility: TyC Inversiones SAS Grupsalud 33-6 IPS, Avenida Libertador # 30-360, Barrio San Pedro Alejandrino
state: Magdalena
city: Armenia
country: Colombia
facility: Fundación Cardiomet Cequin,, Street 18 North # 14-25,
state: Quindío
city: Bogota
country: Colombia
facility: BlueCare Salud SAS
city: New Cairo
country: Egypt
facility: Air Force Specialized Hospital
state: Cairo
city: Imbaba
country: Egypt
facility: Imbaba Fever Hospital
state: Giza
city: Alexandria
country: Egypt
facility: Alexandria Clinical Research Center
city: Cairo
country: Egypt
facility: Ain Shams University Hospital, Clinical Research Center (MASRI-CRC)
city: Cairo
country: Egypt
facility: National Hepatolgy&Trpcl Mdcn Rsrch Inst
city: Cairo
country: Egypt
facility: National Inst for Chest Allergy&Diseases
city: Upper East
country: Ghana
facility: Navrongo Health Research Cntr
state: Navrongo
city: Kintampo
country: Ghana
facility: Kintampo Health Research Cntr
city: Kumasi
country: Ghana
facility: Kumasi Centre for Research, South End Asuogya Road, Kwame Nkrumah University
city: Hyderabad
country: India
facility: St. Theresa's Hospital
state: Andhra Pradesh
city: Nellore
country: India
facility: DEC-Health Care Hospital
state: Andhra Pradesh
city: Nellore
country: India
facility: Vijaya Super Speciality Hospital
state: Andhra Pradesh
city: Srikakulam
country: India
facility: Great Eastern Medical School & Hospital
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: King George Hospital
state: Andhra Pradesh
city: Patna
country: India
facility: Indira Gandhi Inst of Medical Sciences
state: Bihar
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Ahmedabad
country: India
facility: Sangini Hospital 1st Flr & 7th flr
state: Gujarat
city: Surat
country: India
facility: Unity Hospital, Nr. D.R. World
state: Gujarat
city: Vadodara
country: India
facility: Sir Sayajirao General Hospital, Medical College-Baroda
state: Gujarat
city: Vadodara
country: India
facility: Aman Hospital and Research Center
state: Gujarat
city: Vadodara
country: India
facility: Rhythm Heart Institute - A Unit Of SLPL
state: Gujarat
city: Faridabad
country: India
facility: ESIC Medical College & Hospital
state: Haryana
city: Faridabad
country: India
facility: Sarvodaya Hospital and Research Centre
state: Haryana
city: Bangalore
country: India
facility: BGS Global institute of Medical Sciences
state: Karnataka
city: Belgaum
country: India
facility: KLEs Dr. Prabhakar Kore Hospital & MRC Belagavi
state: Karnataka
city: Bengaluru
country: India
facility: Sri Lakshmi Super Speciality Hospital
state: Karnataka
city: Bengaluru
country: India
facility: Shettys Hospital
state: Karnataka
city: Bengaluru
country: India
facility: Sri Venkateshwara Hospitals, SKY HEIGHTS, Site#1/2, Sarjapura-Attibele, Main rd, Indelebele Village
state: Karnataka
city: Mangalore
country: India
facility: Yenepoya Med College Hosp, EMD Building, 5th fl., University Rd, Deralakatte
state: Karnataka
city: Dombivli
country: India
facility: BAJ RR Hosp and Res Cntr
state: Maharashtra
city: Nagpur
country: India
facility: Government Med. College and Hospital
state: Maharashtra
city: Nagpur
country: India
facility: NKP Salve Instit. of Med Sc. & Res Cntr Lata Mangeshkar Hosp
state: Maharashtra
city: Nashik
country: India
facility: Suyog Hospital, CR Dept, 2nd flr, B-wing
state: Maharashtra
city: Nashik
country: India
facility: Chopda Medicare & Research Centre Pvt. Ltd
state: Maharashtra
city: Nashik
country: India
facility: Siddhi Hospital C/o Dr Mutha Hospital
state: Maharashtra
city: Pune
country: India
facility: Grant Medical Foundation
state: Maharashtra
city: Pune
country: India
facility: J Govt Medical College & Sassoon, Gen Hospitals 1st Floor, ENT department, PGP Hall, Jai Prakash Narayan Road
state: Maharashtra
city: Pune
country: India
facility: Lifepoint Multispecialty Hosp.
state: Maharashtra
city: Dwarka
country: India
facility: Aakash Healthcare Private Limited
state: New Delhi
city: Ajmer
country: India
facility: Mavens' Hospital Ground Floor N 37, Opp Reliance Fresh, Vaishali Nagar
state: Rajasthan
city: Jaipur
country: India
facility: JNUIMSRC
state: Rajasthan
city: Jaipur
country: India
facility: Tagore Hospital & Research Institute
state: Rajasthan
city: Chennai
country: India
facility: Saveetha Medical College and hospital
state: Tamil Nadu
city: Chennai
country: India
facility: Voluntary Health Services Infectious Diseases Medical CEN CART Clinical Research Site
state: Tamilnadu
city: Kanpur
country: India
facility: Department of Medicine
state: Uttar Pradesh
city: Rudrapur
country: India
facility: HB Specialty Hosp. & Res Inst.
state: Uttarakhand
city: Kolkata
country: India
facility: Calcutta School of Tropical Medicine
state: West Bengal
city: Kolkata
country: India
facility: Ruby General Hospital Limited
state: West Bengal
city: Delhi
country: India
facility: Batra Hospital & Medical Research Centre
city: Okawa-shi
country: Japan
facility: Kohokai Takagi Hospital
state: Fukuuoka-Ken
city: Tsuchiura-shi
country: Japan
facility: Tsuchiura Beryl Clinic
state: Ibaraki-Ken
city: Tsuchiura-shi
country: Japan
facility: University of Tsukuba Hospital
state: Ibaraki-Ken
city: Tsukuba-shi
country: Japan
facility: Tashiro Endocrinology Clinic
state: Ibaraki-Ken
city: Izumisano-shi
country: Japan
facility: Rinku General Medical Center
state: Osaka-Fu
city: Toda-shi
country: Japan
facility: Kodaira Hospital
state: Saitama-Ken
city: Butere
country: Kenya
facility: KEMRI-CCR Butere County Hospital
city: Eldoret
country: Kenya
facility: Moi University Clin Res Centre, 2nd Fl, Chandaria Chronic, Disease and Cancer Centre
city: Kericho
country: Kenya
facility: Kenya Med Res Inst
city: Kisumu
country: Kenya
facility: KEMRI CGHR HIVR Site
city: Kisumu
country: Kenya
facility: VIBRI - Kisumu County Referral Hospital
city: Nairobi
country: Kenya
facility: Ahero Clinical Trials Unit
city: Nairobi
country: Kenya
facility: Kenyatta National Hospital
city: Chipatala Avenue
country: Malawi
facility: Johns Hopkins Research Project, Queen Elizabeth Central Hospital
state: Blantyre
city: Mangochi
country: Malawi
facility: Mangochi PHNG Study Site, Kamuzu University of Health Sciences, Private Bag 360, Room 805
city: Cuauhtémoc
country: Mexico
facility: CAIMED Investigación en Salud, S.A. de C.V., Manzanillo #100. Piso 2. Roma Sur
state: Cdmx, C.P
city: Veracruz
country: Mexico
facility: Instituto Veracruzano, en Investigación Clínica S.C., Sabino s/n, Colonia Reserva Tarimoya ll
state: CP
city: Cuernavaca
country: Mexico
facility: Avenida Universidad 1001, Edificio 19, planta baja, colonia Chamilpa
state: Morelos
city: Oaxaca de Juárez
country: Mexico
facility: Oaxaca Site Management Organization S.C., Humboldt 302, Col. Centro.
state: Oaxaca
city: Cancún
country: Mexico
facility: Centro Inv. y Avances Med Especializados, (CIAME) Av. Kabah, Lote 38, 39 y 41., Manzana 4, supermanzana 44. Col., Alborada, Benito Juárez
state: Q. Roo
city: Ricardo Flores Magón
country: Mexico
facility: FAICIC S. DE R.L. DE C.V., Av. 16 de Septiembre 1165
state: Veracruz
city: Aguascalientes
country: Mexico
facility: Hospital Cardiológica Aguascalientes, Ecuador 200 Fracc Las Américas
city: Aguascalientes
country: Mexico
facility: Centro de Inv. Médica Aguascalientes, (CIMA) Av. Independencia 2130, Int. A. Trojes de Alonso
city: Korangi
country: Pakistan
facility: Indus Hospital and Health Network
state: Karachi
city: Hayatabad
country: Pakistan
facility: Rehman Medical Institute Clinical Trial Unit
state: Peshawar
city: Lahore
country: Pakistan
facility: Central Park Teaching Hospital
state: Punjab
city: Lahore
country: Pakistan
facility: National Hospital & Medical Center
state: Punjab
city: Lahore
country: Pakistan
facility: Akram Medical Complex
state: Punjab
city: Karachi
country: Pakistan
facility: The Aga Khan University
state: Sindh
city: Islamabad
country: Pakistan
facility: Shifa International Hospital, 4 Pitras Bukhari Rd, H-8/4, H-8
city: Karachi
country: Pakistan
facility: Dow Univ of Health Sciences Ojha Campus
city: Karachi
country: Pakistan
facility: Sindh Infectious Disease Hospital and research Centre
city: Peshawar
country: Pakistan
facility: Maroof International Hospital
city: San Isidro
country: Peru
facility: Centro de Investigación
state: Lima
city: Iquitos
country: Peru
facility: Asoc. Civil Selva Amazonica
state: Loreto
city: Lima Cercado
country: Peru
facility: Patricia Ortiz Bazan
city: Lima
country: Peru
facility: Centro de Inv. Tecnológicas Biomédicas y Medioambientales
city: Lima
country: Peru
facility: Asoc. Civil Impacta Salud y Educación - Sede San Miguel
city: Lipa
country: Philippines
facility: Mary Mediatrix Medical Cntr
state: Batangas
city: Tondo
country: Philippines
facility: Mary Johnston Hospital, 1221 Juan Nolasco Street
state: Manila
city: Lloilo
country: Philippines
facility: Iloilo Doctors' Hospital, Room 706, New Condoclinics Bldg, West Ave
state: Molo
city: Mabalacat
country: Philippines
facility: The Medical City Clark, #100Eatwick, Gatewick, Global Gateway Logistics City, Industrial Estate 5, Clark Freeport Zone
state: Pampanga
city: La Union
country: Philippines
facility: Ilocos Training and Regional Medical Center
state: San Fernando
city: Pampanga
country: Philippines
facility: Green City Medical Center
state: San Fernando
city: Iloilo City
country: Philippines
facility: Healthlink Iloilo, Inc., No. 12, Mabini Str.
city: Mandaluyong
country: Philippines
facility: Health Cube Medical Clinics, High Pointe Medical Hub, 241 Shaw Blvd
city: Quezon City
country: Philippines
facility: Lung Center of the Philippines
city: Ostrowiec Świętokrzyski
country: Poland
facility: Ostrowieckie Centrum Medyczne
city: Oświęcim
country: Poland
facility: Medicome sp. z o.o.
city: Rzeszów
country: Poland
facility: Centrum Medyczne "Medyk"
city: Skierniewice
country: Poland
facility: Clinmedica Research sp. z o.o.
city: Wrocław
country: Poland
facility: Centrum Badań Klinicznych
city: Bloemfontein
country: South Africa
facility: JOSHA Research
state: Free State
city: Johanesburg
country: South Africa
facility: Newton Clinical Research Centre
state: Gauteng
city: Johannesburg
country: South Africa
facility: Worthwhile Clinical Trials
state: Gauteng
city: Johannesburg
country: South Africa
facility: (PHRU), New Nurses Home 9th floor Chris
state: Gauteng
city: Johannesburg
country: South Africa
facility: CHRU, Themba Lethu Clinic
state: Gauteng
city: Krugersdorp
country: South Africa
facility: Ubuntu Clinical Research
state: Gauteng
city: Lenasia
country: South Africa
facility: Ubuntu Clinical Research
state: Gauteng
city: Midrand
country: South Africa
facility: T/A Midrand Medical Centre, Shop #1, Health Emporium
state: Gauteng
city: Pretoria
country: South Africa
facility: Global Clinical Trials
state: Gauteng
city: Randburg
country: South Africa
facility: Right to Care Research Esizayo, Right Clinic Esizayo
state: Gauteng
city: Thabazimbi
country: South Africa
facility: Limpopo Clin Res Initiative Tamboti Medical Centre
state: Limpopo
city: Rustenburg
country: South Africa
facility: The Arum Institute NPC Rustenburg CRS
state: North West
city: George
country: South Africa
facility: Task Eden Research Centre
state: Western Cape
city: Paarl
country: South Africa
facility: Be Part Research PTY (LTD)
state: Western Cape
city: Roodepoort
country: South Africa
facility: Roodepoort Medicross Clinical Research Centre
city: Dar Es Salaam
country: Tanzania
facility: Ifakara Health Institute
city: Mbeya
country: Tanzania
facility: NIMR-Mbeya Medical Research Center
city: Moshi
country: Tanzania
facility: Kilimanjaro Christian Medical Centre
city: Mwanza
country: Tanzania
facility: National institute for medical research
city: Bangkok Noi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
city: Pathum Wan
country: Thailand
facility: Thai Red Cross AIDS Research Centre
state: Bangkok
city: Mueang Chiang Mai District
country: Thailand
facility: Research Institute for Health Sciences
state: Chiang Mai
city: Mueang Khon Kaen District
country: Thailand
facility: Srinagarind Hospital
state: Khon Kaen
city: Altındag
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi, Hacettepe Universitesi Tip Fakultesi
state: Ankara
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University Medical Faculty
state: Atakum
city: Sur
country: Turkey
facility: Dicle University Medical Faculty, Infectious Diseases Hospital Floor:5, Clinical Research Room
state: Diyarbakir
city: Kucukcekmece
country: Turkey
facility: Acibadem Atakent Hospital
state: Instanbul
city: İzmit
country: Turkey
facility: Kocaeli Uni Medical Faculty Hospital
state: Kocaeli
city: Gaziantep
country: Turkey
facility: Gaziantep Uni Tip Fakultesi Hastanesi
state: Sehitkami
city: Istanbul
country: Turkey
facility: Medipol Universitesi Tip Fakultesi
city: İzmir
country: Turkey
facility: Dr. Suat Seren Chest Diseases Hospital
city: Kampala
country: Uganda
facility: Joint Clinical Research Centre
city: Kampala
country: Uganda
facility: Infectious Diseases Institute (IDI), Mulago Hill Road
city: Kampala
country: Uganda
facility: Joint Clinical Research Centre
city: Lira
country: Uganda
facility: SICRA, Lira Regional Referral, Plot 21-41 Ngetta Road P.O. Box 330062
city: Tororo
country: Uganda
facility: IDRC Clinic, Tororo General Hospital, P.O. Box 2, Station Rd
city: Chitungwiza
country: Zimbabwe
facility: St Mary's CRS, Chitungwiza Primary Care Clinic
city: Chitungwiza
country: Zimbabwe
facility: Seke South Clinical Research Site
city: Harare
country: Zimbabwe
facility: Harare Family Care CRS
city: Harare
country: Zimbabwe
facility: Milton Park CRS
city: Harare
country: Zimbabwe
facility: Spilhaus Clinical Research Site, UZ Obstetrics & Gynecology Clinic
city: Harare
country: Zimbabwe
facility: University of Zimbabwe CTRC
Study officials:
References: