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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
Must not have
Study Participants: Have an underlying disease requiring systemic corticosteroids, antipyretics/analgesics, or immunosuppressive agents
Study Participants: Known current renal impairment or severe liver dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal 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.
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).
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am on medication for an underlying condition that affects my immune system.
Select...
I have kidney problems or severe liver issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
39,285 Total Patients Enrolled
2 Trials studying COVID-19
11,902 Patients Enrolled for COVID-19
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