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Strategies and Treatments for Respiratory Infections &; Viral Emergencies (STRIVE): Shionogi Protease Inhibitor

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Shionogi Protease Inhibitor (S-217622)
placebo
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

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

Inclusion Criteria: Age ≥18 years. Informed consent for trial participation. Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) with signs and/or symptoms of a respiratory infection. Confirmation of SARS-CoV2 infection by nucleic acid test (NAT) or equivalent non- NAT test [list of approved tests is in the PIM] collected within the prior 14 days. Onset of symptoms attributable to SARS-CoV2 infection occurred within 14 days before randomization. Hospitalized for the management of COVID-19, with signs and/or symptoms suggestive of lower respiratory tract infection. Exclusion Criteria: The patient is expected to be discharged from the hospital within the next 24 hours. Medical condition other than the acute respiratory infection (and its manifestations) that is likely to result in death within 7 days of randomization. Use of a strong CYP3A inducer within 14 days prior to enrollment Moribund condition, defined as prior cardiac arrest during this hospitalization and life expectancy less than 48 hours of randomization. Patient undergoing comfort care measures only such that treatment focuses on end-of- life symptom management over prolongation of life. Expected inability or unwillingness to participate in study procedures. In the opinion of the investigator, participation in a trial is not in the best interest of the patient. Allergy to investigational agent or vehicle Use of a concomitant medication that is contraindicated due to a drug-drug interaction with S-217622 Moderate to severe hepatic impairment (i.e., Child-Pugh class B or C) or acute liver failure. Known estimated glomerular filtration rate (eGRF) <30 mL/min/1.73m 2 Continuous renal replacement therapy or chronic dialysis Current pregnancy Current breastfeeding and unwillingness to defer breastfeeding for 30 days after the last dose of investigational agent. Women of child-bearing potential who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception through 30 days from the last dose of the investigational agent. Men who are unwilling to abstain from sexual intercourse with women of child- bearing potential or to use barrier contraception through 30 days from the last dose of the investigational agent. Inability to take investigational agent in tablet form by mouth.

Sites / Locations

  • University of Alabama Birmingham University Hospital (Site 213-002)Recruiting
  • Banner University Medical Center Tucson (Site 206-004)Recruiting
  • Southern Arizona VA Healthcare System (Site 074-009)Recruiting
  • UCSF Fresno (Site 203-005)Recruiting
  • VA Loma Linda Healthcare System (Site 074-017)Recruiting
  • MemorialCare Health System (Site 066-003Recruiting
  • VA Long Beach Healthcare System (Site 074-026)Recruiting
  • Ronald Reagan UCLA Medical Center (Site 203-002)Recruiting
  • VA Northern California Health Care System (Site 074-023)Recruiting
  • Veterans Affairs Palo Alto Health Care System (VAPAHCS) (Site 074-005)Recruiting
  • UC Davis Health (Site 203-004)Recruiting
  • VA San Diego Healthcare System (Site 074-016)Recruiting
  • Zuckerberg San Francisco General Hospital and Trauma Center (Site 213-007)Recruiting
  • San Francisco VAMC (Site 074-002)Recruiting
  • University of California San Francisco (Site 203-001)Recruiting
  • Stanford University Hospital & Clinics (Site 203-003)Recruiting
  • Lundquist Institute for Biomedical Innovation (Site 066-002)Recruiting
  • Rocky Mountain Regional VA Medical Center (Site 074-010)Recruiting
  • University of Colorado Hospital (Site 204-001)Recruiting
  • Public Health Institute at Denver Health (Site 017-004)Recruiting
  • MedStar Health Research Institute/MedStar Washington Hospital Center (Site 009-021)Recruiting
  • Washington DC VA Medical Center (Site 009-004)Recruiting
  • University of Florida - Gainesville (Site 201-004)Recruiting
  • Orlando VA Medical Center (Site 074-032)Recruiting
  • University of Illinois at Chicago (Site 00-012)Recruiting
  • Carle Foundation Hospital (Site 080-049)Recruiting
  • Lutheran Medical Group (Site 301-010)Recruiting
  • The University of Kansas Hospital (Site 080-044)Recruiting
  • University of Kentucky (Site 210-004)Recruiting
  • NIH Clinical Center (Site 080-043)Recruiting
  • Beth Israel Deaconess Medical Center (Site 202-001)Recruiting
  • Baystate Medical Center (Site 201-001)Recruiting
  • UMass Chan Medical School (Site 080-007)Recruiting
  • VA Ann Arbor Healthcare System (Site 074-028)Recruiting
  • Henry Ford Health System (Site 014-001)Recruiting
  • Hennepin Healthcare Research Institute (Site 027-001)Recruiting
  • M Health Fairview University of Minnesota Medical Center (Site 112-001)Recruiting
  • University of MinnesotaRecruiting
  • Mayo Clinic (Site 054-001)Recruiting
  • University of Mississippi Medical Center (Site 202-005)Recruiting
  • Washington University School of Medicine (Site 003-001)Recruiting
  • University of Nebraska Medical Center (Site 080-045)Recruiting
  • CHRISTUS - St. Vincent (Site 080-051)Recruiting
  • Lincoln Medical Center (Site 003-016)Recruiting
  • Montefiore Medical Center - Moses Hospital (Site 206-001)Recruiting
  • Montefiore Medical Center - Weiler campus (Site 206-003)Recruiting
  • James J. Peters VAMC (Site 023-003)Recruiting
  • Mount Sinai Queens (Site 081-105)Recruiting
  • New York University Tisch Hospital (Site 301-013)Recruiting
  • Mount Sinai Medical Center (Site 301-012)Recruiting
  • NYC Health + Hospital Harlem (Site 003-003)Recruiting
  • St. Lawrence Health System (Site 301-029)Recruiting
  • Duke University Hospital (Site 301-006)Recruiting
  • Wake Forest Baptist Health (Site 210-001)Recruiting
  • University of Cincinnati Medical Center (Site 207-003)Recruiting
  • Cleveland Clinic Foundation (Site 207-001)Recruiting
  • Penn State Health Milton S. Hershey Medical Center (Site 209-002)Recruiting
  • Rhode Island Hospital (Site 080-036)Recruiting
  • The Miriam Hospital (Site 080-039)Recruiting
  • Ralph H. Johnson VA Medical Center (Site 074-015)Recruiting
  • Medical University of South Carolina (Site 210-002)Recruiting
  • Monument Health Rapid City Hospital (Site 213-005)Recruiting
  • Vanderbilt University Medical Center (Site 212-001)Recruiting
  • Hendrick Medical Center (Site 080-014)Recruiting
  • CHRISTUS Spohn Shoreline Hospital (Site 080-001)Recruiting
  • Parkland Health and Hospital Systems (Site 084-002)Recruiting
  • UT Southwestern Medical Center (Site 084-001)Recruiting
  • Houston Methodist Hospital (Site 301-028)Recruiting
  • MEDVAMC (Site 074-006)Recruiting
  • University of Texas Health Science Center (Site 203-006)Recruiting
  • CHRISTUS Good Shepherd Medical Center (Site 080-031)Recruiting
  • UT Health San Antonio (Site 009-022)Recruiting
  • Intermountain Medical Center (Site 211-001)Recruiting
  • University of Utah Health (Site 211-002)Recruiting
  • University of Virginia Health System, University Hospital (Site 210-003)Recruiting
  • Salem VA Medical Center (Site 074-014)Recruiting
  • Providence (Sacred Heart) (Site 213-004)Recruiting
  • Westmead Hospital (Site 612-058)Recruiting
  • The Alfred Hospital (Site 612-017)Recruiting
  • Aalborg Hospital (Site 625-005)Recruiting
  • Rigshospitalet, CHIP (Site 625-006)Recruiting
  • Bispebjerg Hospital (Site 625-013)Recruiting
  • Herlev/Gentofte Hospital (Site 625-012)Recruiting
  • Nordsjaellands Hospital, Hillerod (Site 625-009)Recruiting
  • Hvidovre University Hospital, Department of Infections Diseases (Site 625-001)Recruiting
  • AIDS and Clinical Immunology Research Center (Site 627-201)Recruiting
  • Fujita Health University Hospital (Site 612-105)Recruiting
  • Center Hospital of the National Center for Global Health and Medicine (Site 612-101)Recruiting
  • Seoul National University Bundang Hospital (Site 612-904)Recruiting
  • Seoul St. Mary's Hospital (Site 612-903)Recruiting
  • Chung-Ang University Hospital (Site 612-902)Recruiting
  • Tan Tock Seng Hospital (Site 612-201)Recruiting
  • Chulalongkorn University and The HIV-NAT (Site 613-001)Recruiting
  • Central City Clinical Hospital of Ivano-Frankivsk City Council (Site 627-302)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

S-217622 plus standard of care (SOC)

placebo plus standard of care (SOC)

Arm Description

Study investigational agent (S-217622) will be administered as oral tablets with dosing of 375mg (3 tabs) once on Day 0 and 125mg (1 tab) once daily on Days 1-4. All participants will receive the full 5-day course, including those who are discharged from hospitalization prior to Day 4.

Study investigational placebo (S-217622) will be administered as oral tablets with dosing of 375mg (3 tabs) once on Day 0 and 125mg (1 tab) once daily on Days 1-4. All participants will receive the full 5-day course, including those who are discharged from hospitalization prior to Day 4.

Outcomes

Primary Outcome Measures

Days to Recovery Scale assessed over 60 days (DRS-60)
DRS-60 is a version of the STRIVE clinical recovery scale (CRS) which combines time to recovery with non-recovered clinical state and death to an ordinal outcome.0 indicates best results, 60 represents recovered on Day 60, with not recovered by Day 60 coded as 61 and death (worst outcome) as 62.

Secondary Outcome Measures

mortality
proportion of participants who died by Day 60
a 3-category ordinal outcome
the following categories: recovered (alive and at home at Day 60), alive and not recovered, and dead
time to recovery
proportion of participants who died or required new invasive mechanical ventilation

Full Information

First Posted
October 28, 2022
Last Updated
October 2, 2023
Sponsor
University of Minnesota
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT05605093
Brief Title
Strategies and Treatments for Respiratory Infections &; Viral Emergencies (STRIVE): Shionogi Protease Inhibitor
Official Title
Strategies and Treatments for Respiratory Infections &; Viral Emergencies (STRIVE): Shionogi Protease Inhibitor
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 23, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
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
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622, an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi &; Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of S-217622 when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
S-217622 plus standard of care (SOC)
Arm Type
Experimental
Arm Description
Study investigational agent (S-217622) will be administered as oral tablets with dosing of 375mg (3 tabs) once on Day 0 and 125mg (1 tab) once daily on Days 1-4. All participants will receive the full 5-day course, including those who are discharged from hospitalization prior to Day 4.
Arm Title
placebo plus standard of care (SOC)
Arm Type
Placebo Comparator
Arm Description
Study investigational placebo (S-217622) will be administered as oral tablets with dosing of 375mg (3 tabs) once on Day 0 and 125mg (1 tab) once daily on Days 1-4. All participants will receive the full 5-day course, including those who are discharged from hospitalization prior to Day 4.
Intervention Type
Drug
Intervention Name(s)
Shionogi Protease Inhibitor (S-217622)
Intervention Description
S-217622 is an oral anti-SARS-CoV2 PI that does not require ritonavir co-administration The dose is 375/125 (375 mg on Day 0, followed by 125 mg daily on Days 1-4).
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo is an oral tablet administered once (3 tabs) on Day 0 and once (1 tab) daily on days 1-4, 5-day course.
Primary Outcome Measure Information:
Title
Days to Recovery Scale assessed over 60 days (DRS-60)
Description
DRS-60 is a version of the STRIVE clinical recovery scale (CRS) which combines time to recovery with non-recovered clinical state and death to an ordinal outcome.0 indicates best results, 60 represents recovered on Day 60, with not recovered by Day 60 coded as 61 and death (worst outcome) as 62.
Time Frame
60 days post-intervention
Secondary Outcome Measure Information:
Title
mortality
Description
proportion of participants who died by Day 60
Time Frame
60 days post-treatment
Title
a 3-category ordinal outcome
Description
the following categories: recovered (alive and at home at Day 60), alive and not recovered, and dead
Time Frame
60 days post-treatment
Title
time to recovery
Time Frame
60 days post-treatment
Title
proportion of participants who died or required new invasive mechanical ventilation
Time Frame
60 days post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years. Informed consent for trial participation. Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) with signs and/or symptoms of a respiratory infection. Confirmation of SARS-CoV2 infection by nucleic acid test (NAT) or equivalent non- NAT test [list of approved tests is in the PIM] collected within the prior 14 days. Onset of symptoms attributable to SARS-CoV2 infection occurred within 14 days before randomization. Hospitalized for the management of COVID-19, with signs and/or symptoms suggestive of lower respiratory tract infection. Exclusion Criteria: The patient is expected to be discharged from the hospital within the next 24 hours. Medical condition other than the acute respiratory infection (and its manifestations) that is likely to result in death within 7 days of randomization. Use of a strong CYP3A inducer within 14 days prior to enrollment Moribund condition, defined as prior cardiac arrest during this hospitalization and life expectancy less than 48 hours of randomization. Patient undergoing comfort care measures only such that treatment focuses on end-of- life symptom management over prolongation of life. Expected inability or unwillingness to participate in study procedures. In the opinion of the investigator, participation in a trial is not in the best interest of the patient. Allergy to investigational agent or vehicle Use of a concomitant medication that is contraindicated due to a drug-drug interaction with S-217622 Moderate to severe hepatic impairment (i.e., Child-Pugh class B or C) or acute liver failure. Known estimated glomerular filtration rate (eGRF) <30 mL/min/1.73m 2 Continuous renal replacement therapy or chronic dialysis Current pregnancy Current breastfeeding and unwillingness to defer breastfeeding for 30 days after the last dose of investigational agent. Women of child-bearing potential who are unwilling to abstain from sexual intercourse with men or practice appropriate contraception through 30 days from the last dose of the investigational agent. Men who are unwilling to abstain from sexual intercourse with women of child- bearing potential or to use barrier contraception through 30 days from the last dose of the investigational agent. Inability to take investigational agent in tablet form by mouth.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cavan Reilly, PhD
Phone
612-624-9644
Email
cavanr@biostat.umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Lundgren, PhD
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cavan Reilly, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama Birmingham University Hospital (Site 213-002)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
Banner University Medical Center Tucson (Site 206-004)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
Southern Arizona VA Healthcare System (Site 074-009)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VA ICC
Email
striveva@insight-trials.org
Facility Name
UCSF Fresno (Site 203-005)
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
VA Loma Linda Healthcare System (Site 074-017)
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VA ICC
Email
striveva@insight-trials.org
Facility Name
MemorialCare Health System (Site 066-003
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Washington ICC
Email
strivewdc@insight-trials.org
Facility Name
VA Long Beach Healthcare System (Site 074-026)
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VA ICC
Email
striveva@insight-trials.org
Facility Name
Ronald Reagan UCLA Medical Center (Site 203-002)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
VA Northern California Health Care System (Site 074-023)
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VA ICC
Email
striveva@insight-trials.org
Facility Name
Veterans Affairs Palo Alto Health Care System (VAPAHCS) (Site 074-005)
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VA ICC
Email
striveva@insight-trials.org
Facility Name
UC Davis Health (Site 203-004)
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
VA San Diego Healthcare System (Site 074-016)
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VA ICC
Email
striveva@insight-trials.org
Facility Name
Zuckerberg San Francisco General Hospital and Trauma Center (Site 213-007)
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
San Francisco VAMC (Site 074-002)
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VA ICC
Email
striveva@insight-trials.org
Facility Name
University of California San Francisco (Site 203-001)
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
Stanford University Hospital & Clinics (Site 203-003)
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
Lundquist Institute for Biomedical Innovation (Site 066-002)
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Washington ICC
Email
strivewdc@insight-trials.org
Facility Name
Rocky Mountain Regional VA Medical Center (Site 074-010)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VA ICC
Email
striveva@insight-trials.org
Facility Name
University of Colorado Hospital (Site 204-001)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
Public Health Institute at Denver Health (Site 017-004)
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Washington ICC
Email
strivewdc@insight-trials.org
Facility Name
MedStar Health Research Institute/MedStar Washington Hospital Center (Site 009-021)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Washington ICC
Email
strivewdc@insight-trials.org
Facility Name
Washington DC VA Medical Center (Site 009-004)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Washington ICC
Email
strivewdc@insight-trials.org
Facility Name
University of Florida - Gainesville (Site 201-004)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Washington ICC
Email
strivewdc@insight-trials.org
Facility Name
Orlando VA Medical Center (Site 074-032)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VA ICC
Email
striveva@insight-trials.org
Facility Name
University of Illinois at Chicago (Site 00-012)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hennepin ICC
Email
strivehenn@insight-trials.org
Facility Name
Carle Foundation Hospital (Site 080-049)
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hennepin ICC
Email
strivehenn@insight-trials.org
Facility Name
Lutheran Medical Group (Site 301-010)
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
New York ICC
Email
striveny@insight-trials.org
Facility Name
The University of Kansas Hospital (Site 080-044)
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hennepin ICC
Email
strivehenn@insight-trials.org
Facility Name
University of Kentucky (Site 210-004)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
NIH Clinical Center (Site 080-043)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hennepin ICC
Email
strivehenn@insight-trials.org
Facility Name
Beth Israel Deaconess Medical Center (Site 202-001)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
Baystate Medical Center (Site 201-001)
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
UMass Chan Medical School (Site 080-007)
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Washington ICC
Email
strivewdc@insight-trials.org
Facility Name
VA Ann Arbor Healthcare System (Site 074-028)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VA ICC
Email
striveva@insight-trials.org
Facility Name
Henry Ford Health System (Site 014-001)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Washington ICC
Email
strivewdc@insight-trials.org
Facility Name
Hennepin Healthcare Research Institute (Site 027-001)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hennepin ICC
Facility Name
M Health Fairview University of Minnesota Medical Center (Site 112-001)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hennepin ICC
Email
strivehenn@insight-trials.org
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Schoenecker
Email
sitereg@insight-trials.org
Facility Name
Mayo Clinic (Site 054-001)
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hennepin ICC
Email
strivehenn@insight-trials.org
Facility Name
University of Mississippi Medical Center (Site 202-005)
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
Washington University School of Medicine (Site 003-001)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Washington ICC
Email
strivewdc@insight-trials.org
Facility Name
University of Nebraska Medical Center (Site 080-045)
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hennepin ICC
Email
strivehenn@insight-trials.org
Facility Name
CHRISTUS - St. Vincent (Site 080-051)
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hennepin ICC
Email
strivehenn@insight-trials.org
Facility Name
Lincoln Medical Center (Site 003-016)
City
Bronx
State/Province
New York
ZIP/Postal Code
10451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Washington ICC
Email
strivewdc@insight-trials.org
Facility Name
Montefiore Medical Center - Moses Hospital (Site 206-001)
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
Montefiore Medical Center - Weiler campus (Site 206-003)
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
James J. Peters VAMC (Site 023-003)
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VA ICC
Email
striveva@insight-trials.org
Facility Name
Mount Sinai Queens (Site 081-105)
City
Long Island City
State/Province
New York
ZIP/Postal Code
11102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
New York ICC
Email
striveny@insight-trials.org
Facility Name
New York University Tisch Hospital (Site 301-013)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
New York ICC
Email
striveny@insight-trials.org
Facility Name
Mount Sinai Medical Center (Site 301-012)
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
New York ICC
Email
striveny@insight-trials.org
Facility Name
NYC Health + Hospital Harlem (Site 003-003)
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Washington ICC
Email
strivewdc@insight-trials.org
Facility Name
St. Lawrence Health System (Site 301-029)
City
Potsdam
State/Province
New York
ZIP/Postal Code
13676
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
New York ICC
Email
striveny@insight-trials.org
Facility Name
Duke University Hospital (Site 301-006)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
New York ICC
Email
striveny@insight-trials.org
Facility Name
Wake Forest Baptist Health (Site 210-001)
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
University of Cincinnati Medical Center (Site 207-003)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
Cleveland Clinic Foundation (Site 207-001)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
Penn State Health Milton S. Hershey Medical Center (Site 209-002)
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hennepin ICC
Email
strivehenn@insight-trials.org
Facility Name
Rhode Island Hospital (Site 080-036)
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hennepin ICC
Email
strivehenn@insight-trials.org
Facility Name
The Miriam Hospital (Site 080-039)
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hennepin ICC
Email
strivehenn@insight-trials.org
Facility Name
Ralph H. Johnson VA Medical Center (Site 074-015)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VA ICC
Email
striveva@insight-trials.org
Facility Name
Medical University of South Carolina (Site 210-002)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
Monument Health Rapid City Hospital (Site 213-005)
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
Vanderbilt University Medical Center (Site 212-001)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
Hendrick Medical Center (Site 080-014)
City
Abilene
State/Province
Texas
ZIP/Postal Code
79601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hennepin ICC
Email
strivehenn@insight-trials.org
Facility Name
CHRISTUS Spohn Shoreline Hospital (Site 080-001)
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hennepin ICC
Email
strivehenn@insight-trials.org
Facility Name
Parkland Health and Hospital Systems (Site 084-002)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Washington ICC
Email
strivewdc@insight-trials.org
Facility Name
UT Southwestern Medical Center (Site 084-001)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Washington ICC
Email
strivewdc@insight-trials.org
Facility Name
Houston Methodist Hospital (Site 301-028)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hennepin ICC
Email
strivehenn@insight-trials.org
Facility Name
MEDVAMC (Site 074-006)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VA ICC
Email
striveva@insight-trials.org
Facility Name
University of Texas Health Science Center (Site 203-006)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
CHRISTUS Good Shepherd Medical Center (Site 080-031)
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hennepin ICC
Email
strivehenn@insight-trials.org
Facility Name
UT Health San Antonio (Site 009-022)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Washington ICC
Email
strivewdc@insight-trials.org
Facility Name
Intermountain Medical Center (Site 211-001)
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
University of Utah Health (Site 211-002)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
University of Virginia Health System, University Hospital (Site 210-003)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
Salem VA Medical Center (Site 074-014)
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VA ICC
Email
striveva@insight-trials.org
Facility Name
Providence (Sacred Heart) (Site 213-004)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nashville ICC
Email
strivenash@insight-trials.org
Facility Name
Westmead Hospital (Site 612-058)
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sydney ICC
Email
strivesyd@insight-trials.org
Facility Name
The Alfred Hospital (Site 612-017)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sydney ICC
Email
strivesyd@insight-trials.org
Facility Name
Aalborg Hospital (Site 625-005)
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Copenhagen ICC
Email
strivecph@insight-trials.org
Facility Name
Rigshospitalet, CHIP (Site 625-006)
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Copenhagen ICC
Email
strivecph@insight-trials.org
Facility Name
Bispebjerg Hospital (Site 625-013)
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Copenhagen ICC
Email
strivecph@insight-trials.org
Facility Name
Herlev/Gentofte Hospital (Site 625-012)
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Copenhagen ICC
Email
strivecph@insight-trials.org
Facility Name
Nordsjaellands Hospital, Hillerod (Site 625-009)
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Copenhagen ICC
Email
strivecph@insight-trials.org
Facility Name
Hvidovre University Hospital, Department of Infections Diseases (Site 625-001)
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Copenhagen ICC
Email
strivecph@insight-trials.org
Facility Name
AIDS and Clinical Immunology Research Center (Site 627-201)
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Copenhagen ICC
Email
strivecph@insight-trials.org
Facility Name
Fujita Health University Hospital (Site 612-105)
City
Toyoake
State/Province
Aichi
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sydney ICC
Email
strivesyd@insight-trials.org
Facility Name
Center Hospital of the National Center for Global Health and Medicine (Site 612-101)
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sydney ICC
Email
strivesyd@insight-trials.org
Facility Name
Seoul National University Bundang Hospital (Site 612-904)
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sydney ICC
Email
strivesyd@insight-trials.org
Facility Name
Seoul St. Mary's Hospital (Site 612-903)
City
Seocho
State/Province
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sydney ICC
Email
strivesyd@insight-trials.org
Facility Name
Chung-Ang University Hospital (Site 612-902)
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sydney ICC
Email
strivesyd@insight-trials.org
Facility Name
Tan Tock Seng Hospital (Site 612-201)
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sydney ICC
Email
strivesyd@insight-trials.org
Facility Name
Chulalongkorn University and The HIV-NAT (Site 613-001)
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sydney ICC
Email
strivesyd@insight-trials.org
Facility Name
Central City Clinical Hospital of Ivano-Frankivsk City Council (Site 627-302)
City
Ivano-Frankivs'k
State/Province
Frankivs'k
ZIP/Postal Code
76018
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Copenhagen ICC
Email
strivecph@insight-trials.org

12. IPD Sharing Statement

Learn more about this trial

Strategies and Treatments for Respiratory Infections &; Viral Emergencies (STRIVE): Shionogi Protease Inhibitor

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