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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05605093
Recruitment Status : Recruiting
First Posted : November 4, 2022
Last Update Posted : May 26, 2023
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Shionogi Protease Inhibitor (S-217622) Drug: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Strategies and Treatments for Respiratory Infections &Amp; Viral Emergencies (STRIVE): Shionogi Protease Inhibitor
Actual Study Start Date : December 23, 2022
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: S-217622 plus standard of care (SOC)
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.
 Drug: Shionogi Protease Inhibitor (S-217622)
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).
Placebo Comparator: placebo plus standard of care (SOC)
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.
 Drug: placebo
Placebo is an oral tablet administered once (3 tabs) on Day 0 and once (1 tab) daily on days 1-4, 5-day course.


Outcome Measures
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Primary Outcome Measures :
  1. Days to Recovery Scale assessed over 60 days (DRS-60) [ Time Frame: 60 days post-intervention ]
    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 :
  1. mortality [ Time Frame: 60 days post-treatment ]
    proportion of participants who died by Day 60

  2. a 3-category ordinal outcome [ Time Frame: 60 days post-treatment ]
    the following categories: recovered (alive and at home at Day 60), alive and not recovered, and dead

  3. time to recovery [ Time Frame: 60 days post-treatment ]
  4. proportion of participants who died or required new invasive mechanical ventilation [ Time Frame: 60 days post-treatment ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05605093


Contacts
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Contact: James Neaton, PhD 612-626-9040 neato001@umn.edu

Locations
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Sponsors and Collaborators
University of Minnesota
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Jens Lundgren, PhD University of Copenhagen
Study Chair: James Neaton, PhD University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT05605093    
Other Study ID Numbers: S-217622
First Posted: November 4, 2022    Key Record Dates
Last Update Posted: May 26, 2023
Last Verified: May 2023

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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
Additional relevant MeSH terms:
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Respiratory Tract Infections
Emergencies
Infections
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
HIV Protease Inhibitors
Protease Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Viral Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents