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S-217622 for COVID-19 Prevention (SCORPIO-PEP Trial)

Phase 3
Recruiting
Research Sponsored by Shionogi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Index Participants: Must have at least 1 COVID-19 symptom within 24 hours before providing informed consent, deemed related to the current SARS-CoV-2 infection
Study Participants: ≥ 12 years of age at the time of signing the informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through days 10, 15, or 28
Awards & highlights

SCORPIO-PEP Trial Summary

This trial looks at how a drug affects household contacts of people with COVID-19 symptoms to see if it helps protect them from SARS-CoV-2 infection.

Who is the study for?
This trial is for people who live with someone showing COVID-19 symptoms and have tested positive. Participants must be over 12, not show fever or COVID-19 symptoms themselves, agree to use contraception if necessary, and test negative for SARS-CoV-2. They can't join if they've used certain drugs recently, have kidney/liver issues, are pregnant/breastfeeding, had a vaccine or biologic product within specific timeframes, or have allergies to the study medication.Check my eligibility
What is being tested?
The trial tests whether S-217622 tablets prevent symptomatic COVID-19 in household contacts of infected individuals compared to placebo tablets. It measures how many participants develop symptoms after taking either the actual drug or a dummy pill (placebo).See study design
What are the potential side effects?
While specific side effects of S-217622 aren't listed here, common ones may include allergic reactions to components of the drug or placebo. The exclusion criteria suggest avoiding participation if you're sensitive to these substances.

SCORPIO-PEP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had at least one COVID-19 symptom in the last 24 hours.
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I am 12 years old or older.
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I do not have a fever or symptoms of COVID-19.
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I started having COVID-19 symptoms less than 72 hours ago.

SCORPIO-PEP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through days 10, 15, or 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through days 10, 15, or 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
Change in Total Score of COVID-19 Symptoms
Number of Participants Experiencing Hospitalization or Death from Any Cause
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
+10 more

SCORPIO-PEP Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: S-217622Experimental Treatment1 Intervention
S-217622 will be administered orally for 5 days.
Group II: PlaceboPlacebo Group1 Intervention
Placebo matching to S-217622 will be administered orally for 5 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
S-217622
2022
Completed Phase 1
~60

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Who is running the clinical trial?

ShionogiLead Sponsor
116 Previous Clinical Trials
39,286 Total Patients Enrolled
2 Trials studying COVID-19
11,902 Patients Enrolled for COVID-19
~440 spots leftby Sep 2024
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