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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05605093




Registration number
NCT05605093
Ethics application status
Date submitted
28/10/2022
Date registered
4/11/2022
Date last updated
13/06/2024

Titles & IDs
Public title
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir)
Scientific title
Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor
Secondary ID [1] 0 0
S-217622
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Shionogi Protease Inhibitor (S-217622)
Treatment: Drugs - placebo

Experimental: S-217622 (ensitrelvir) plus standard of care (SOC) - Study investigational agent (ensitrelvir) 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.

Placebo comparator: placebo plus standard of care (SOC) - Study investigational placebo 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.


Treatment: Drugs: Shionogi Protease Inhibitor (S-217622)
S-217622 (ensitrelvir) 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).

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Days to Recovery Scale assessed over 60 days (DRS-60)
Timepoint [1] 0 0
60 days post-intervention
Secondary outcome [1] 0 0
mortality
Timepoint [1] 0 0
60 days post-treatment
Secondary outcome [2] 0 0
a 3-category ordinal outcome
Timepoint [2] 0 0
60 days post-treatment
Secondary outcome [3] 0 0
time to recovery
Timepoint [3] 0 0
60 days post-treatment
Secondary outcome [4] 0 0
proportion of participants who died or required new invasive mechanical ventilation
Timepoint [4] 0 0
60 days post-treatment

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
27/07/2025
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital (Site 612-002) - Sydney
Recruitment hospital [2] 0 0
Westmead Hospital (Site 612-058) - Westmead
Recruitment hospital [3] 0 0
Austin Health (612-020) - Heidelberg
Recruitment hospital [4] 0 0
The Alfred Hospital (Site 612-017) - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Colorado
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Connecticut
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District of Columbia
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Illinois
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Kentucky
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Massachusetts
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Michigan
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Minnesota
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Santa Fe
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SP
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N
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Aalborg
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Copenhagen
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Odense
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Roskilde
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Tbilisi
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Germany
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Attica
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Evros
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Aichi
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Tokyo
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Japan
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Osaka
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Korea, Republic of
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Gyeonggi
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Korea, Republic of
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Seoul
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Nigeria
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FCT
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Puerto Rico
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San Juan
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Singapore
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KwaZulu-Natal
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South Africa
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Western Cape
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Spain
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Barcelona
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Spain
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Madrid
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Thailand
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Bangkok
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Thailand
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Khon Kaen
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Uganda
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Entebbe
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Uganda
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Gulu
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Uganda
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Kampala
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Uganda
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Lira
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Uganda
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Masaka
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Ukraine
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Frankivs'k
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United Kingdom
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London
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United Kingdom
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Newcastle Upon Tyne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Minnesota
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Allergy and Infectious Diseases (NIAID)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 (ensitrelvir), 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 ensitrelvir 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.
Trial website
https://clinicaltrials.gov/study/NCT05605093
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jens Lundgren, PhD
Address 0 0
University of Copenhagen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cavan Reilly, PhD
Address 0 0
Country 0 0
Phone 0 0
612-624-9644
Fax 0 0
Email 0 0
cavanr@biostat.umn.edu
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05605093