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Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection (SCORPIO-PEP)

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

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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: Pediatric participants or adult participants (of any age) The index participant must: 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. 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 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: ≥ 12 years of age at the time of signing the informed consent 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). 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 Must not be considered by the investigator or subinvestigator to have SARS-CoV-2 infection and: 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) No COVID-19 symptoms at Screening (if a participant has COVID-19-like symptoms caused by comorbidities, only 1 symptom will be allowed) Capable and willing to complete a participant diary 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. 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: Tested positive for SARS-CoV-2 in the past 6 months. Have an underlying disease requiring systemic corticosteroids (excluding topical), antipyretics/analgesics, or immunosuppressive agents. Known current renal impairment defined as creatinine clearance < 30 milliliters/minute by Cockcroft Gault or requiring dialysis. Participants with severe liver dysfunction, such as known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy). Received approved, authorized, or investigational convalescent plasma, or other anti- SARS-CoV-2 biologic products within 3 months of the Screening Visit Received approved, authorized, or investigational anti-SARS-CoV-2 monoclonal antibodies (mAbs) in the last 6 months. 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. Participants who have used any of the following drugs within 14 days prior to enrollment: Strong cytochrome P450 (CYP) 3A inducer Products containing St. John's wort Exposed to an investigational drug within 30 days or 5 half-lives of the drug prior to the Screening Visit. Positive urine pregnancy test at Screening Visit or are lactating. Known allergy/sensitivity or any hypersensitivity to components of S-217622 or placebo for S-217622. 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.

Sites / Locations

  • Central Alabama ResearchRecruiting
  • Accel Research Site - Achieve - Birmingham - ERN - PPDSRecruiting
  • Absolute Clinical Research, LLCRecruiting
  • Preferred Research Partners - ClinEdge - PPDSRecruiting
  • Neighborhood HealthcareRecruiting
  • Apex Research GroupRecruiting
  • Ascada Research LLCRecruiting
  • Rancho Cucamonga Clinical ResearchRecruiting
  • Smart Cures Clinical ResearchRecruiting
  • Clinical Trials Management Services, LLCRecruiting
  • TrueBlue Clinical ResearchRecruiting
  • Invictus Clinical Research Group, LLCRecruiting
  • I.V.A.M. Clinical & Investigational CenterRecruiting
  • Quality Research of South FloridaRecruiting
  • Universal Medical and Research Center, LLCRecruiting
  • Suncoast Research Group LLC - Flourish - PPDSRecruiting
  • Oceane7 Medical & Research Center, Inc.Recruiting
  • Continental Clinical Research, LLCRecruiting
  • BioClinical Research AllianceRecruiting
  • Ivetmar Medical Group, LLCRecruiting
  • Global Health Clinical TrialsRecruiting
  • Valencia Medical and Research CenterRecruiting
  • GCP Global Clinical Professionals, LLCRecruiting
  • Entrust Clinical ResearchRecruiting
  • Kendall South Medical CenterRecruiting
  • Combined Research Orlando Phase I-IV LLVRecruiting
  • Accel Research Sites - Nona Pediatric Center - ERN - PPDSRecruiting
  • CTMD Research, Inc. Palm Springs - Hunt - PPDSRecruiting
  • American Research Centers of FloridaRecruiting
  • Progressive Medical Research - ClinEdge - PPDSRecruiting
  • Bayside Clinical Research-West TampaRecruiting
  • Tampa Bay Health CareRecruiting
  • Balanced Life Health Care Solutions - SKYCRNG - PPDSRecruiting
  • Velocity Clinical Research - Covington - PPDSRecruiting
  • Cyn3rgy Research - ClinEdge - PPDSRecruiting
  • Frontier Clinical Rsearch - ScottdaleRecruiting
  • Coastal Pediatric AssociatesRecruiting
  • Clinical Trials of South Carolina - ClinEdge - PPDSRecruiting
  • Alina Clinical Trials, LLCRecruiting
  • Southwest Family Medicine AssociatesRecruiting
  • DCT-McAllen Primary Care Research, LLC dba DiscoveRecruiting
  • Advances In Health IncRecruiting
  • Epic Medical Research LLC - Red OakRecruiting
  • Kamezawa ClinicRecruiting
  • Tomita Internal medicine clinicRecruiting
  • Irie Naika Syounika IinRecruiting
  • Tashiro Endocrinolgy ClinicRecruiting
  • Megumi ClinicRecruiting
  • Suto HospitalRecruiting
  • Shoda HospitalRecruiting
  • Uno Internal Medicine Respiratory ClinicRecruiting
  • Nishioka HospitalRecruiting
  • Morizono medical clinicRecruiting
  • Nishiyamato Keiwa HospitalRecruiting
  • Tsuchiura Beryl ClinicRecruiting
  • Kanagawa Himawari ClinicRecruiting
  • Kaiseikai Kita Shin Yokohama Internal Medicine Clinic
  • Yokohama Municipal Citizens HospitalRecruiting
  • Nagaoka Chuo General HospitalRecruiting
  • Rinku General Medical CenterRecruiting
  • Lee's ClinicRecruiting
  • Fujimino Emergency HospitalRecruiting
  • Fukuda Medical ClinicRecruiting
  • KODAIRA HospitalRecruiting
  • Hamamatsu Medical CenterRecruiting
  • Denenchofu Family ClinicRecruiting
  • Tokyo Center ClinicRecruiting
  • Nozaki ClinicalRecruiting
  • Shimamura Memorial HospitalRecruiting
  • MIH Clinic YoyogiRecruiting
  • Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kaiRecruiting
  • Yotsuya NaikaRecruiting
  • Okayama University HospitalRecruiting

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

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

Secondary Outcome Measures

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
Number of Participants Infected with SARS-CoV-2 Regardless of Occurrence of COVID-19 Symptoms
Time to the First Positive RT-PCR Result
Number of Participants with a Positive RT-PCR Result
Number of Participants Infected with SARS-CoV-2 with no COVID-19 Symptoms
Number of Participants with Sustained Resolution of all COVID-19 Symptoms
Number of Participants with Sustained Resolution of Each COVID-19 Symptom
Change in Total Score of COVID-19 Symptoms
Time From First Confirmed SARS-CoV-2 Until at Least 1 COVID-19 Symptom
Time From First Confirmed SARS-CoV-2 Until COVID-19 Symptoms Onset
Number of Participants Experiencing Hospitalization or Death from Any Cause
Plasma Concentration of S-217622
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Full Information

First Posted
June 6, 2023
Last Updated
October 17, 2023
Sponsor
Shionogi
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1. Study Identification

Unique Protocol Identification Number
NCT05897541
Brief Title
Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection
Acronym
SCORPIO-PEP
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 9, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shionogi

4. Oversight

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

5. Study Description

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.

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
2200 (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 tablet.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as a tablet.
Primary Outcome Measure Information:
Title
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
Time Frame
Day 1 through Day 10
Secondary Outcome Measure Information:
Title
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
Time Frame
Day 1 through Day 10
Title
Number of Participants Infected with SARS-CoV-2 Regardless of Occurrence of COVID-19 Symptoms
Time Frame
Day 1 through Days 10, 15, or 28
Title
Time to the First Positive RT-PCR Result
Time Frame
Day 1 through Day 10
Title
Number of Participants with a Positive RT-PCR Result
Time Frame
Day 1 through Day 10
Title
Number of Participants Infected with SARS-CoV-2 with no COVID-19 Symptoms
Time Frame
Day 1 through Day 10
Title
Number of Participants with Sustained Resolution of all COVID-19 Symptoms
Time Frame
Day 1 through Day 28
Title
Number of Participants with Sustained Resolution of Each COVID-19 Symptom
Time Frame
Day 1 through Day 28
Title
Change in Total Score of COVID-19 Symptoms
Time Frame
Day 1 through Day 10
Title
Time From First Confirmed SARS-CoV-2 Until at Least 1 COVID-19 Symptom
Time Frame
Day 1 through Day 28
Title
Time From First Confirmed SARS-CoV-2 Until COVID-19 Symptoms Onset
Time Frame
Day 1 through Day 28
Title
Number of Participants Experiencing Hospitalization or Death from Any Cause
Time Frame
Day 1 through Day 28
Title
Plasma Concentration of S-217622
Time Frame
Day 3, Day 6, and Event Driven
Title
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame
Day 1 through Day 28

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: Pediatric participants or adult participants (of any age) The index participant must: 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. 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 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: ≥ 12 years of age at the time of signing the informed consent 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). 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 Must not be considered by the investigator or subinvestigator to have SARS-CoV-2 infection and: 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) No COVID-19 symptoms at Screening (if a participant has COVID-19-like symptoms caused by comorbidities, only 1 symptom will be allowed) Capable and willing to complete a participant diary 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. 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: Tested positive for SARS-CoV-2 in the past 6 months. Have an underlying disease requiring systemic corticosteroids (excluding topical), antipyretics/analgesics, or immunosuppressive agents. Known current renal impairment defined as creatinine clearance < 30 milliliters/minute by Cockcroft Gault or requiring dialysis. Participants with severe liver dysfunction, such as known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy). Received approved, authorized, or investigational convalescent plasma, or other anti- SARS-CoV-2 biologic products within 3 months of the Screening Visit Received approved, authorized, or investigational anti-SARS-CoV-2 monoclonal antibodies (mAbs) in the last 6 months. 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. Participants who have used any of the following drugs within 14 days prior to enrollment: Strong cytochrome P450 (CYP) 3A inducer Products containing St. John's wort Exposed to an investigational drug within 30 days or 5 half-lives of the drug prior to the Screening Visit. Positive urine pregnancy test at Screening Visit or are lactating. Known allergy/sensitivity or any hypersensitivity to components of S-217622 or placebo for S-217622. 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.
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
Central Alabama Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209-8401
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Research Site - Achieve - Birmingham - ERN - PPDS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Individual Site Status
Recruiting
Facility Name
Absolute Clinical Research, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85051-5775
Country
United States
Individual Site Status
Recruiting
Facility Name
Preferred Research Partners - ClinEdge - PPDS
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211-3868
Country
United States
Individual Site Status
Recruiting
Facility Name
Neighborhood Healthcare
City
Escondido
State/Province
California
ZIP/Postal Code
92025-4604
Country
United States
Individual Site Status
Recruiting
Facility Name
Apex Research Group
City
Fair Oaks
State/Province
California
ZIP/Postal Code
95628-2501
Country
United States
Individual Site Status
Recruiting
Facility Name
Ascada Research LLC
City
Fullerton
State/Province
California
ZIP/Postal Code
92835-4127
Country
United States
Individual Site Status
Recruiting
Facility Name
Rancho Cucamonga Clinical Research
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730-3062
Country
United States
Individual Site Status
Recruiting
Facility Name
Smart Cures Clinical Research
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274-7604
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials Management Services, LLC
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Individual Site Status
Recruiting
Facility Name
TrueBlue Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511-4850
Country
United States
Individual Site Status
Recruiting
Facility Name
Invictus Clinical Research Group, LLC
City
Coconut Creek
State/Province
Florida
ZIP/Postal Code
33073-3458
Country
United States
Individual Site Status
Recruiting
Facility Name
I.V.A.M. Clinical & Investigational Center
City
Doral
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Name
Quality Research of South Florida
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016-1811
Country
United States
Individual Site Status
Recruiting
Facility Name
Universal Medical and Research Center, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021-6467
Country
United States
Individual Site Status
Recruiting
Facility Name
Suncoast Research Group LLC - Flourish - PPDS
City
Miami
State/Province
Florida
ZIP/Postal Code
33135-1687
Country
United States
Individual Site Status
Recruiting
Facility Name
Oceane7 Medical & Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144-2155
Country
United States
Individual Site Status
Recruiting
Facility Name
Continental Clinical Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33144-4273
Country
United States
Individual Site Status
Recruiting
Facility Name
BioClinical Research Alliance
City
Miami
State/Province
Florida
ZIP/Postal Code
33155-6542
Country
United States
Individual Site Status
Recruiting
Facility Name
Ivetmar Medical Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33155-6542
Country
United States
Individual Site Status
Recruiting
Facility Name
Global Health Clinical Trials
City
Miami
State/Province
Florida
ZIP/Postal Code
33165-2968
Country
United States
Individual Site Status
Recruiting
Facility Name
Valencia Medical and Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33165-3912
Country
United States
Individual Site Status
Recruiting
Facility Name
GCP Global Clinical Professionals, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33169-5732
Country
United States
Individual Site Status
Recruiting
Facility Name
Entrust Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176-1530
Country
United States
Individual Site Status
Recruiting
Facility Name
Kendall South Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33185-4082
Country
United States
Individual Site Status
Recruiting
Facility Name
Combined Research Orlando Phase I-IV LLV
City
Orlando
State/Province
Florida
ZIP/Postal Code
32807-3555
Country
United States
Individual Site Status
Recruiting
Facility Name
Accel Research Sites - Nona Pediatric Center - ERN - PPDS
City
Orlando
State/Province
Florida
ZIP/Postal Code
32829-8070
Country
United States
Individual Site Status
Recruiting
Facility Name
CTMD Research, Inc. Palm Springs - Hunt - PPDS
City
Palm Springs
State/Province
Florida
ZIP/Postal Code
33406-7671
Country
United States
Individual Site Status
Recruiting
Facility Name
American Research Centers of Florida
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33027-1717
Country
United States
Individual Site Status
Recruiting
Facility Name
Progressive Medical Research - ClinEdge - PPDS
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Individual Site Status
Recruiting
Facility Name
Bayside Clinical Research-West Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Name
Tampa Bay Health Care
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Recruiting
Facility Name
Balanced Life Health Care Solutions - SKYCRNG - PPDS
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046-8703
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research - Covington - PPDS
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503-2637
Country
United States
Individual Site Status
Recruiting
Facility Name
Cyn3rgy Research - ClinEdge - PPDS
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030-8319
Country
United States
Individual Site Status
Recruiting
Facility Name
Frontier Clinical Rsearch - Scottdale
City
Scottdale
State/Province
Pennsylvania
ZIP/Postal Code
15683-2460
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Pediatric Associates
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414-5834
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials of South Carolina - ClinEdge - PPDS
City
Moncks Corner
State/Province
South Carolina
ZIP/Postal Code
29461-5017
Country
United States
Individual Site Status
Recruiting
Facility Name
Alina Clinical Trials, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75225-6301
Country
United States
Individual Site Status
Recruiting
Facility Name
Southwest Family Medicine Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-1715
Country
United States
Individual Site Status
Recruiting
Facility Name
DCT-McAllen Primary Care Research, LLC dba Discove
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503-1397
Country
United States
Individual Site Status
Recruiting
Facility Name
Advances In Health Inc
City
Pearland
State/Province
Texas
ZIP/Postal Code
77584-8075
Country
United States
Individual Site Status
Recruiting
Facility Name
Epic Medical Research LLC - Red Oak
City
Red Oak
State/Province
Texas
ZIP/Postal Code
75154
Country
United States
Individual Site Status
Recruiting
Facility Name
Kamezawa Clinic
City
Kasugai-Shi
State/Province
Aiti
ZIP/Postal Code
486-0817
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tomita Internal medicine clinic
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
810-0033
Country
Japan
Individual Site Status
Recruiting
Facility Name
Irie Naika Syounika Iin
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-0053
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tashiro Endocrinolgy Clinic
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0153
Country
Japan
Individual Site Status
Recruiting
Facility Name
Megumi Clinic
City
Shimemachi
State/Province
Fukuoka
ZIP/Postal Code
811-2201
Country
Japan
Individual Site Status
Recruiting
Facility Name
Suto Hospital
City
Annaka-shi
State/Province
Gunma
ZIP/Postal Code
379-0016
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shoda Hospital
City
Annaka-Shi
State/Province
Gunma
ZIP/Postal Code
379-0116
Country
Japan
Individual Site Status
Recruiting
Facility Name
Uno Internal Medicine Respiratory Clinic
City
Isesaki-Shi
State/Province
G
ZIP/Postal Code
372-0831
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nishioka Hospital
City
Toyohira-Ku Sapporo-Shi
State/Province
Hokkaido
ZIP/Postal Code
062-0034
Country
Japan
Individual Site Status
Recruiting
Facility Name
Morizono medical clinic
City
Kitakyushu-shi
State/Province
Hukuoka
ZIP/Postal Code
807-0072
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nishiyamato Keiwa Hospital
City
Naka
State/Province
Ibaraki
ZIP/Postal Code
311-0133
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tsuchiura Beryl Clinic
City
Tsuchiura-Shi
State/Province
Ibaraki
ZIP/Postal Code
300-0062
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanagawa Himawari Clinic
City
Kawasaki-Shi
State/Province
Kanagawa
ZIP/Postal Code
216-0006
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kaiseikai Kita Shin Yokohama Internal Medicine Clinic
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
223-0059
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Yokohama Municipal Citizens Hospital
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
240-0062
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nagaoka Chuo General Hospital
City
Nagaoka-Shi
State/Province
Niigata
ZIP/Postal Code
940-8653
Country
Japan
Individual Site Status
Recruiting
Facility Name
Rinku General Medical Center
City
Izumisano-Shi
State/Province
Osaka
ZIP/Postal Code
598-0048
Country
Japan
Individual Site Status
Recruiting
Facility Name
Lee's Clinic
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
531-0073
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fujimino Emergency Hospital
City
Miyoshi-machi, Iruma-gun
State/Province
Saitama
ZIP/Postal Code
354-0044
Country
Japan
Individual Site Status
Recruiting
Facility Name
Fukuda Medical Clinic
City
Toda-shi
State/Province
Saitama
ZIP/Postal Code
335-0015
Country
Japan
Individual Site Status
Recruiting
Facility Name
KODAIRA Hospital
City
Toda-Shi
State/Province
Saitama
ZIP/Postal Code
335-0035
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hamamatsu Medical Center
City
Hamamatsu-city
State/Province
Sizuoka
ZIP/Postal Code
432-8580
Country
Japan
Individual Site Status
Recruiting
Facility Name
Denenchofu Family Clinic
City
Ota-ku
State/Province
Tokyo Province
ZIP/Postal Code
145-0071
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Center Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0028
Country
Japan
Individual Site Status
Recruiting
Facility Name
Nozaki Clinical
City
Musashino-Shi
State/Province
Tokyo
ZIP/Postal Code
180-0022
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shimamura Memorial Hospital
City
Nerima-Ku
State/Province
Tokyo
ZIP/Postal Code
177-0051
Country
Japan
Individual Site Status
Recruiting
Facility Name
MIH Clinic Yoyogi
City
Shibuya-Ku
State/Province
Tokyo
ZIP/Postal Code
151-0051
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Shinagawa Hospital Social Medical Corporation Association Tokyokyojuno-kai
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
140-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yotsuya Naika
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
160-0017
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection

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