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Shionogi Protease Inhibitor for COVID-19

Phase 3

Recruiting

Led By Jens Lundgren, PhD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Hospitalized for the management of COVID-19, with signs and/or symptoms suggestive of lower respiratory tract infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 days post-treatment

Awards & highlights

Study Summary

This trial will evaluate a drug, S-217622, to treat COVID-19 inpatients to improve outcomes when given in addition to existing treatments.

Who is the study for?

Adults hospitalized for COVID-19 with symptoms of a lower respiratory tract infection can join this trial. They must have tested positive for SARS-CoV2 within the last 14 days and shown symptoms in the past two weeks. Excluded are those with severe health conditions, certain drug interactions, or women who could get pregnant but won't use contraception.Check my eligibility

What is being tested?

The STRIVE trial is testing Shionogi's Protease Inhibitor (S-217622) against a placebo to see if it helps hospitalized COVID-19 patients when added to standard treatments like remdesivir. It's randomized and controlled, meaning some people will get the real drug and others a dummy pill without knowing which one they're taking.See study design

What are the potential side effects?

Potential side effects aren't specified here, but protease inhibitors may commonly cause gastrointestinal issues like diarrhea, nausea; liver problems; rash; or metabolic changes such as increased blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am hospitalized for COVID-19 with symptoms affecting my lungs.

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I was admitted to the hospital with signs of a respiratory infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 days post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 days post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Days to Recovery Scale assessed over 60 days (DRS-60)

Secondary outcome measures

a 3-category ordinal outcome

mortality

proportion of participants who died or required new invasive mechanical ventilation

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: S-217622 (ensitrelvir) plus standard of care (SOC)Experimental Treatment1 Intervention

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.

Group II: placebo plus standard of care (SOC)Placebo Group1 Intervention

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.

0 / 3Eligibility criteria met