Clinical trial NCT05897541: Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of S-217622 in the Prevention of Symptomatic SARS-CoV-2 Infection in Household Contacts of an Individual With Symptomatic COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: SARS-CoV-2 Infection
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-09
Enrollment: 2387
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to measure the proportion of participants who are infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (positive reverse transcription polymerase chain reaction \[RT-PCR\] test) and have coronavirus disease 2019 (COVID-19) symptom(s) with S-217622 tablets compared with placebo tablets in participants who are household contacts of an individual with symptomatic COVID-19.

Detailed description: This study will enroll 2 types of participants: 1. those with a negative screening SARS-CoV-2 infection (referred to as "study participants"); 2. those with a positive screening SARS-CoV-2-infection (referred to as "index participants"). Study participants will receive study intervention (S-217622 or placebo), index participants will receive no study intervention.

Eligibility criteria: Inclusion Criteria:

Index Participants

Only 1 index participant from each household will be enrolled in the study. Participants are eligible to be included as an index participant if all of the following criteria apply:

1. Pediatric participants or adult participants (of any age)
2. The index participant must:

   1. Have at least 1 COVID-19 symptom within 24 hours before the index participant providing informed consent. COVID-19 symptom(s) must be deemed by the investigator as related to the current SARS-CoV-2 infection (not related to preexisting comorbidities) or deemed as preexisting and worsened due to SARS-CoV-2 infection.
   2. Must have positive SARS-CoV-2 test (a nucleic acid amplification test or antigen test) from any respiratory tract specimen from a sample collected prior to randomization of the participant
3. Must have a potential study participant who can participate in the study after onset of COVID-19 symptoms in an index participant

Study Participants

Multiple study participants from the same household are allowed to be enrolled in the study. The study intervention randomization will be performed based at the study participant's level. Participants will be eligible to be included in the study only if all of the following criteria apply:

1. ≥ 12 years of age at the time of signing the informed consent
2. Has a negative screening for SARS-CoV-2 infection, as determined by SARS-CoV-2 test (a nucleic acid amplification test or antigen test) from any respiratory tract specimen (for example, oropharyngeal, nasopharyngeal or nasal swab, or saliva).
3. Has lived in household with index participant and will continue to live in same household and share common areas such as dining rooms and bathrooms until the end of the study
4. Must not be considered by the investigator or subinvestigator to have SARS-CoV-2 infection and:

   1. No measured fever at Screening (defined as body temperature ≥ 38.0°Celsius \[C\] per tympanic or rectal thermometer or ≥ 37.5°C per axillary, oral, or forehead/temporal thermometer)
   2. No COVID-19 symptoms at Screening (if a participant has COVID-19-like symptoms caused by comorbidities, only 1 symptom will be allowed)
5. Capable and willing to complete a participant diary
6. a. Male participants: Participants with partners that are woman of childbearing potential (WOCBP) must agree to use effective contraception. Participants with pregnant partners must agree to use effective contraception.

   b. Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and the following conditions applies:
   * Is not a WOCBP or
   * All of the following apply:

     * Is a WOCBP and using a contraceptive method that is effective as described in the protocol.
     * A WOCBP must have a negative urine pregnancy test within 24 hours before the first dose of study intervention period.
     * If a urine pregnancy test cannot be confirmed as negative (for example, an ambiguous result), a serum pregnancy test must be negative.
   * Additional requirements for pregnancy testing during and after study intervention as described in the protocol.
   * The investigator/subinvestigator will review medical history, menstrual history, and recent sexual activity to decrease the risk of inclusion of a woman with an early undetected pregnancy.
7. Participant must be randomized ≤ 72 hours from onset of COVID-19 symptoms in the index participant.

Exclusion Criteria:

Study Participants: Participants will be excluded from the study if any of the following criteria apply:

1. Tested positive for SARS-CoV-2 in the past 6 months.
2. Have an underlying disease requiring systemic corticosteroids (excluding topical), antipyretics/analgesics, or immunosuppressive agents.
3. Known current renal impairment defined as creatinine clearance \< 30 milliliters/minute by Cockcroft Gault or requiring dialysis.
4. Participants with severe liver dysfunction, such as known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).
5. Received approved, authorized, or investigational convalescent plasma, or other anti- SARS-CoV-2 biologic products within 3 months of the Screening Visit
6. Received approved, authorized, or investigational anti-SARS-CoV-2 monoclonal antibodies (mAbs) in the last 6 months.
7. Received any SARS-CoV-2 vaccine within 6 months prior to the Screening Visit or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments until the end of the study.
8. Participants who have used any of the following drugs within 14 days prior to enrollment:

   1. Strong cytochrome P450 (CYP) 3A inducer
   2. Products containing St. John's wort
9. Exposed to an investigational drug within 30 days or 5 half-lives of the drug prior to the Screening Visit.
10. Positive urine pregnancy test at Screening Visit or are lactating.
11. Known allergy/sensitivity or any hypersensitivity to components of S-217622 or placebo for S-217622.
12. Any condition or circumstance that, in the opinion of the investigator or subinvestigator, would compromise the safety of the participant or the quality of the study data.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants in the Modified Intention-to-treat (mITT) Population with a Negative Screening SARS-CoV-2 Infection who are Infected with SARS-CoV-2 and Have COVID-19 Symptoms Onset
timeFrame: Day 1 through Day 10
Secondary outcomes:
measure: Number of Participants in the Intention-to-treat (ITT) Population with a Negative Screening SARS-CoV-2 Infection who are Infected with SARS-CoV-2 and Have COVID-19 Symptoms Onset
timeFrame: Day 1 through Day 10
measure: Number of Participants Infected with SARS-CoV-2 Regardless of Occurrence of COVID-19 Symptoms
timeFrame: Day 1 through Days 10, 15, or 28
measure: Time to the First Positive RT-PCR Result
timeFrame: Day 1 through Day 10
measure: Number of Participants with a Positive RT-PCR Result
timeFrame: Day 1 through Day 10
measure: Number of Participants Infected with SARS-CoV-2 with no COVID-19 Symptoms
timeFrame: Day 1 through Day 10
measure: Number of Participants with Sustained Resolution of all COVID-19 Symptoms
timeFrame: Day 1 through Day 28
measure: Number of Participants with Sustained Resolution of Each COVID-19 Symptom
timeFrame: Day 1 through Day 28
measure: Change in Total Score of COVID-19 Symptoms
timeFrame: Day 1 through Day 10
measure: Time From First Confirmed SARS-CoV-2 Until at Least 1 COVID-19 Symptom
timeFrame: Day 1 through Day 28
measure: Time From First Confirmed SARS-CoV-2 Until COVID-19 Symptoms Onset
timeFrame: Day 1 through Day 28
measure: Number of Participants Experiencing Hospitalization or Death from Any Cause
timeFrame: Day 1 through Day 28
measure: Plasma Concentration of S-217622
timeFrame: Day 3, Day 6, and Event Driven
measure: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: Day 1 through Day 28
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Alabama Research
state: Alabama
city: Birmingham
country: United States
facility: Accel Research Site - Achieve - Birmingham - ERN - PPDS
state: Alabama
city: Cullman
country: United States
facility: Cullman Clinical Trials
state: Alabama
city: Phoenix
country: United States
facility: Absolute Clinical Research, LLC
state: Arizona
city: Scottsdale
country: United States
facility: One of a Kind Clinical Research Center LLC
state: Arizona
city: Hot Springs
country: United States
facility: Healthstar Research
state: Arkansas
city: Little Rock
country: United States
facility: Preferred Research Partners - ClinEdge - PPDS
state: Arkansas
city: Escondido
country: United States
facility: Neighborhood Healthcare
state: California
city: Fair Oaks
country: United States
facility: Apex Research Group
state: California
city: Fullerton
country: United States
facility: Ascada Research LLC
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research - Long Beach - ClinEdge - PPDS
state: California
city: Rancho Cucamonga
country: United States
facility: Rancho Cucamonga Clinical Research
state: California
city: Rolling Hills Estates
country: United States
facility: Smart Cures Clinical Research
state: California
city: Thousand Oaks
country: United States
facility: Clinical Trials Management Services, LLC
state: California
city: Colorado Springs
country: United States
facility: Lynn Institute of The Rockies - ERN - PPDS
state: Colorado
city: Brandon
country: United States
facility: TrueBlue Clinical Research
state: Florida
city: Coconut Creek
country: United States
facility: Invictus Clinical Research Group, LLC
state: Florida
city: Coral Gables
country: United States
facility: Universal Medical and Research Center, LLC
state: Florida
city: Coral Gables
country: United States
facility: Hope Clinical Trials
state: Florida
city: Doral
country: United States
facility: I.V.A.M. Clinical & Investigational Center
state: Florida
city: Hialeah
country: United States
facility: Quality Research of South Florida
state: Florida
city: Homestead
country: United States
facility: Universal Medical and Research Center, LLC Homestead
state: Florida
city: Leesburg
country: United States
facility: Flourish Research - Leesburg - PPDS
state: Florida
city: Miami Lakes
country: United States
facility: Meridian International Research
state: Florida
city: Miami Lakes
country: United States
facility: MedQuest Translational Sciences
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute - Miami - ClinEdge - PPDS
state: Florida
city: Miami
country: United States
facility: LCC Medical Research - Miami - ClinEdge - PPDS
state: Florida
city: Miami
country: United States
facility: CCM Clinical Research Group
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group LLC - Flourish - PPDS
state: Florida
city: Miami
country: United States
facility: University of Miami - 1150 NW 14th St
state: Florida
city: Miami
country: United States
facility: Florida Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Oceane7 Medical & Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Continental Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: BioClinical Research Alliance
state: Florida
city: Miami
country: United States
facility: Ivetmar Medical Group, LLC
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research - ClinEdge - PPDS
state: Florida
city: Miami
country: United States
facility: Global Health Clinical Trials
state: Florida
city: Miami
country: United States
facility: Valencia Medical and Research Center
state: Florida
city: Miami
country: United States
facility: Alma Research
state: Florida
city: Miami
country: United States
facility: GCP Global Clinical Professionals, LLC
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida Inc
state: Florida
city: Miami
country: United States
facility: Entrust Clinical Research
state: Florida
city: Miami
country: United States
facility: Kendall South Medical Center
state: Florida
city: Miami
country: United States
facility: Flourish Research - Miami - PPDS
state: Florida
city: Orlando
country: United States
facility: Combined Research Orlando Phase I-IV LLC
state: Florida
city: Orlando
country: United States
facility: Central Florida Internists - Conway
state: Florida
city: Orlando
country: United States
facility: Accel Research Sites - Nona Pediatric Center - ERN - PPDS
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Beach Clinical Research
state: Florida
city: Palm Springs
country: United States
facility: CTMD Research, Inc. Palm Springs - Hunt - PPDS
state: Florida
city: Pembroke Pines
country: United States
facility: American Research Centers of Florida
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research - ClinEdge - PPDS
state: Florida
city: Tampa
country: United States
facility: Renew Health Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Bayside Clinical Research-West Tampa
state: Florida
city: Tampa
country: United States
facility: Tampa Bay Health Care
state: Florida
city: Lawrenceville
country: United States
facility: Balanced Life Health Care Solutions - SKYCRNG - PPDS
state: Georgia
city: Chicago
country: United States
facility: Olivo Medical and Wellness Center
state: Illinois
city: Chicago
country: United States
facility: Eagle Clinical Research
state: Illinois
city: Wichita
country: United States
facility: KU Wichita Center for Clinical Research
state: Kansas
city: Canton
country: United States
facility: Voyage Medical - Michigan
state: Michigan
city: Dearborn Heights
country: United States
facility: Vida Clinical Sites
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Gulfport
country: United States
facility: Velocity Clinical Research - Covington - PPDS
state: Mississippi
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: East Syracuse
country: United States
facility: Child Healthcare Associates - East Syracuse
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research - ATLAS - Rochester - PPDS
state: New York
city: Denver
country: United States
facility: Lapis Clinical Research-Denver
state: North Carolina
city: Winston-Salem
country: United States
facility: Progressive Medicine of the Triad, LLC
state: North Carolina
city: Dayton
country: United States
facility: WellNow Urgent Care & Research - Huber Heights
state: Ohio
city: Dayton
country: United States
facility: PriMed Clinical Research - ClinEdge - PPDS
state: Ohio
city: Gresham
country: United States
facility: Cyn3rgy Research - ClinEdge - PPDS
state: Oregon
city: Philadelphia
country: United States
facility: Tristar Clinical Investigations, P.C.
state: Pennsylvania
city: Scottdale
country: United States
facility: Frontier Clinical Research - Scottdale
state: Pennsylvania
city: Charleston
country: United States
facility: Coastal Pediatric Associates
state: South Carolina
city: Columbia
country: United States
facility: SPICA Clinical Research
state: South Carolina
city: Little River
country: United States
facility: Main Street Physicians Care - Waterway
state: South Carolina
city: Moncks Corner
country: United States
facility: Clinical Trials of South Carolina - ClinEdge - PPDS
state: South Carolina
city: Bellaire
country: United States
facility: Saint Hope Foundation Inc
state: Texas
city: Carrollton
country: United States
facility: ACRC Trials - Carrollton - Hunt - PPDS
state: Texas
city: Dallas
country: United States
facility: Global Medical Research - M3 WR
state: Texas
city: Dallas
country: United States
facility: Alina Clinical Trials, LLC
state: Texas
city: Dallas
country: United States
facility: Southwest Family Medicine Associates
state: Texas
city: DeSoto
country: United States
facility: Epic Medical Research LLC - DeSoto
state: Texas
city: Forney
country: United States
facility: Care United Research, LLC - Elligo - PPDS
state: Texas
city: Fort Worth
country: United States
facility: Valley Institute of Research
state: Texas
city: Houston
country: United States
facility: C & R Research Services USA
state: Texas
city: Houston
country: United States
facility: New Horizon Medical Group, LLC
state: Texas
city: Houston
country: United States
facility: Care and Cure Clinic
state: Texas
city: McAllen
country: United States
facility: DCT-McAllen Primary Care Research, LLC dba Discove
state: Texas
city: Pearland
country: United States
facility: Advances In Health Inc
state: Texas
city: San Antonio
country: United States
facility: Clinical Associates in Research Therapeutics of America
state: Texas
city: San Antonio
country: United States
facility: VIP Trials
state: Texas
city: Webster
country: United States
facility: Tranquil Clinical Research
state: Texas
city: Kaysville
country: United States
facility: Alliance for Multispecialty Research, LLC - Kaysville - PPDS
state: Utah
city: Roy
country: United States
facility: Alliance for Multispecialty Research LLC - Roy
state: Utah
city: General Rodríguez
country: Argentina
facility: Hospital Interzonal General de Agudos Vicente Lopez Y Planes
state: Buenos Aires
city: Munro
country: Argentina
facility: Clínica Privada Independencia
state: Buenos Aires
city: San Nicolás de los Arroyos
country: Argentina
facility: Centro Médico San Nicolás Grupo Oroño
state: Buenos Aires
city: Zárate
country: Argentina
facility: Instituto de Investigaciones Clínicas Zárate
state: Buenos Aires
city: Río Cuarto
country: Argentina
facility: Instituto Médico Río Cuarto
state: Córdoba
city: Rosario
country: Argentina
facility: INECO Neurociencias Oroño
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto Médico de la Fundación Estudios Clínicos
state: Santa Fe
city: San Miguel de Tucumán
country: Argentina
facility: Clínica Mayo de U.M.C.B. S.R.L
state: Tucumán
city: Córdoba
country: Argentina
facility: Hospital Rawson
city: Córdoba
country: Argentina
facility: Sanatorio Allende S.A
city: Santa Fe
country: Argentina
facility: Sanatorio Medico de Diagnostico Y Tratamiento
city: Kasugai-Shi
country: Japan
facility: Kamezawa Clinic
state: Aiti
city: Nagoya-Shi Nakamura-Ku
country: Japan
facility: Hosokawa Surgical Clinic
state: Aiti
city: Fukuoka-shi
country: Japan
facility: Tomita Internal medicine clinic
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Irie Naika Syounika Iin
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Tashiro Endocrinolgy Clinic
state: Fukuoka
city: Kasuyagun Shimemachi
country: Japan
facility: Megumi Clinic
state: Fukuoka
city: Annaka-shi
country: Japan
facility: Suto Hospital
state: Gunma
city: Annaka-Shi
country: Japan
facility: Shoda Hospital
state: Gunma
city: Isesaki-Shi
country: Japan
facility: Uno Internal Medicine Respiratory Clinic
state: Gunma
city: Maebashi-Shi
country: Japan
facility: Kikuchi Internal clinic
state: Gunma
city: Sapporo City
country: Japan
facility: Teine Otolaryngology Clinic
state: Hokkaidô
city: Sapporo City
country: Japan
facility: Maruyama Tame Pediatrics
state: Hokkaidô
city: Sapporo-Shi Toyohira-Ku
country: Japan
facility: Nishioka Hospital
state: Hokkaidô
city: Fukuoka-shi
country: Japan
facility: Japanese Red Cross Fukuoka Hospital
state: Hukuoka Province
city: Iizuka-Shi
country: Japan
facility: Iizuka Hospital
state: Hukuoka
city: Kitakyushu-shi
country: Japan
facility: Morizono medical clinic
state: Hukuoka
city: Yanagawa-Shi
country: Japan
facility: Nagata Hospital
state: Hukuoka
city: Akashi-Shi
country: Japan
facility: Toda Internal Medicine ＆ Neurology
state: Hyôgo
city: Himeji-shi
country: Japan
facility: Terada Clinic Respiratory Medicine and General Practice
state: Hyôgo
city: Kobe-Shi Nada-Ku
country: Japan
facility: Takahashi Pediatric Clinic
state: Hyôgo
city: Naka
country: Japan
facility: Nishiyamato Keiwa Hospital
state: Ibaraki
city: Tsuchiura-city
country: Japan
facility: Hitachi,Ltd.,Tsuchiura Medical & Health Care Center
state: Ibaraki
city: Tsuchiura-Shi
country: Japan
facility: Tsuchiura Beryl Clinic
state: Ibaraki
city: Tsukuba-Shi
country: Japan
facility: University of Tsukuba Hospital
state: Ibaraki
city: Kagoshima-Shi
country: Japan
facility: Moriyama Otolaryngology
state: Kagosima
city: Kagoshima-Shi
country: Japan
facility: Kamoike Otolaryngology Clinic
state: Kagosima
city: Kagoshima-Shi
country: Japan
facility: Murasakibaru Tahara Hospital
state: Kagosima
city: Kawasaki-Shi
country: Japan
facility: Motosumiyoshi-ekimae Cocoromi Clinic
state: Kanagawa
city: Kawasaki-Shi
country: Japan
facility: Kanagawa Himawari Clinic
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Medical Corporation Nakano Children's Clinic
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Kaiseikai Kita Shin Yokohama Internal Medicine Clinic
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama Municipal Citizens Hospital
state: Kanagawa
city: Nagaoka-Shi
country: Japan
facility: Nagaoka Chuo General Hospital
state: Niigata
city: Ginowan-Shi
country: Japan
facility: NHO Okinawa Hospital
state: Okinawa
city: Okinawa-Shi
country: Japan
facility: University of the Ryukyus Hospital - 207 Uehara
state: Okinawa
city: Izumisano-Shi
country: Japan
facility: Rinku General Medical Center
state: Osaka
city: Osaka-shi
country: Japan
facility: Lee's Clinic
state: Osaka
city: Kasukabe City
country: Japan
facility: Kasukabe Medical Center
state: Saitama
city: Miyoshi-machi, Iruma-gun
country: Japan
facility: Fujimino Emergency Hospital
state: Saitama
city: Toda-shi
country: Japan
facility: Fukuda Medical Clinic
state: Saitama
city: Toda-Shi
country: Japan
facility: KODAIRA Hospital
state: Saitama
city: Tokorozawa-Shi
country: Japan
facility: Medical Corporation Kojyokai Hirose Clinic
state: Saitama
city: Hamamatsu-city
country: Japan
facility: Hamamatsu Medical Center
state: Sizuoka
city: Ichikawa-Shi
country: Japan
facility: Fujimaki Ear, Nose and Throat Clinic (Ent Clinic)
state: Tiba
city: Ota-ku
country: Japan
facility: Denenchofu Family Clinic
state: Tokyo Province
city: Chiyoda-Ku
country: Japan
facility: Global Healthcare Clinic
state: Tokyo
city: Chuo-ku
country: Japan
facility: Tokyo Center Clinic
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Nishikasai ekimae Family Clinic
state: Tokyo
city: Kita-Ku
country: Japan
facility: Takinogawa Hospital
state: Tokyo
city: Kodaira-Shi
country: Japan
facility: Musashino Hospital
state: Tokyo
city: Kokubunji-Shi
country: Japan
facility: Takahashi Medical Clinic
state: Tokyo
city: Musashino-Shi
country: Japan
facility: Nozaki Clinical
state: Tokyo
city: Nerima-Ku
country: Japan
facility: Shimamura Memorial Hospital
state: Tokyo
city: Shibuya-Ku
country: Japan
facility: MIH Clinic Yoyogi
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Yotsuya Naika
state: Tokyo
city: Suginami-ku
country: Japan
facility: Yoshida Clinic
state: Tokyo
city: Uozu-Shi
country: Japan
facility: Toyama Rosai Hospital
state: Toyama
city: Higashiokitama-gun
country: Japan
facility: Kijima Kids Clinic
state: Yamagata
city: Nagasaki
country: Japan
facility: Nakayama Pediatric Clinic
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Osaka City Juso Hospital
city: Ota-ku
country: Japan
facility: Soyukai Medical Corporation Yamaguchi clinic
city: Shiwa-gun
country: Japan
facility: Shiwa Chuo Syounika
city: Takasaki-shi
country: Japan
facility: Shizuka Medical Clinic
city: Toshima-ku
country: Japan
facility: Ikebukuro Higashiguchi Mame Clinic
city: Suita
country: Japan
facility: Suita Municipal Hospital
state: Ôsaka
city: City Of Johannesburg
country: South Africa
facility: Newtown Clinical Research Centre
state: Gauteng
city: Lombardy East, Johannesburg
country: South Africa
facility: NMMM PHARMEDICA Health Research Institute
state: Gauteng
city: Sol Plaatjie
country: South Africa
facility: Trident Clinical
state: Northern Cape
city: Quận Đống Đa
country: Vietnam
facility: Hanoi University of Medicine - Clinical Trial Unit
state: Ha Noi, Thu Do
city: Ho Chi Minh City
country: Vietnam
facility: University of Medicine Center, Ho Chi Minh City
Study officials:
References: