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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
Select...
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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does S-217622 pose any health risks to those who use it?

"The safety of S-217622 has been rated a 3 due to multiple rounds of data that demonstrate its efficacy and back up prior clinical evidence."

Answered by AI

Are there any open enrollments for this experiment at the moment?

"Indeed, clinicaltrials.gov details that the trial is currently enrolling patients as of October 17th 2023. The study was initially posted on June 9th 2023 and seeks to find 2200 individuals across 73 different sites."

Answered by AI

How many locales are hosting this investigation?

"Participating sites in this trial include Preferred Research Partners - ClinEdge - PPDS located in Little Rock, Arkansas; Accel Research Site-Achieve - Birmingham - ERN - PPDS situated in Phoenix, Arizona; and Absolute Clinical Research LLC based in Escondido, California. There are an additional 73 locations that have been approved for enrollment."

Answered by AI

What is the current sample size of participants for this experiment?

"This trial requires 2200 patients, with appropriate qualifications, to contribute. Preferred Research Partners - ClinEdge - PPDS in Little Rock and Accel Research Site - Achieve - Birmingham - ERN-PPDS in Phoenix are two of the multiple sites offering participation."

Answered by AI

Who else is applying?

What site did they apply to?
Neighborhood Healthcare
Rancho Cucamonga Clinical Research
TrueBlue Clinical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

Just need to make some money.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection
2023. "Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05897541.
All > Covid 19
~733 spots leftby Sep 2024
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