What is the SCORPIO-PEP study?
Despite global COVID-19 vaccination efforts, different variants of SARS-CoV-2 have appeared. These new forms of the virus may spread more easily and reduce vaccine protection. There is risk of severe disease, hospitalization, and death in vaccinated people with underlying medical conditions. New treatments are needed to prevent the spread of COVID-19.
The SCORPIO-PEP study is being done to learn whether an investigational medicine, S-217622, can prevent COVID-19 in those exposed to it.
Understanding the SCORPIO-PEP study
Watch this video to learn more about the SCORPIO-PEP study.
Understanding Clinical Trials
Clinical studies are types of research studies done to learn more about how the body responds to a certain intervention and whether that intervention works for a specific disease or medical condition. Watch this video to learn more about clinical trials and how they work.
Who can participate?
There are two types of individuals who can join this study.
Participants
are those who:
Are 12 years of age or older
Have a negative COVID-19 test
Agree to join the study within 72 hours after the beginning of COVID-19 symptoms in the index patient
Are willing to complete a patient diary
Index patients
are those who:
Are children or adults of any age
Was the first person within the household to test positive with COVID-19
Have a positive COVID-19 test within 72 hours or less of randomization of the participant
Have at least 1 COVID-19 symptom within 24 hours of providing consent/assent
What is the preventative study treatment?
The preventative treatment being studied is S-217622. S-217622 is an oral therapy taken by mouth for 5 days straight.
No preventative study treatment will be administered for index patients.
There will be two study treatment groups for participants in the SCORPIO-PEP study.
Group 1: S-217622
Group 2: Placebo
(no active ingredient)
What happens during the study?
For index patients, the study duration is a minimum of 1 day and a maximum of 3 days.
For participants, the study consists of 3 parts: screening, study treatment, and follow-up.
The study duration is 28 days with 7 or 8 study visits.
Screening Period
Day 1
1 visit
You will be given a form that contains all the information about the study. Please ask the study doctor or study staff about anything you don’t understand or would like explained further. If you/your child agree to join, you will be asked to sign and date an Informed Consent Form before any tests or procedures are done. Adolescents will sign and date an Informed Assent Form. Health checks and tests will be done to see if the study is right for you/your child.
Study Treatment Period
Days 1 to 5
1 visit
If the study is right for you/your child, preventative study treatment will start. The first dose of preventative study treatment will be taken at the study site on Day 1. All other doses will be taken at home.
Participants will be asked to record their COVID-19 symptoms in a diary twice daily through Day 28. The diary should be completed at approximately the same times every day.
Follow-up Period
Days 6 to 28
5 visits
During follow-up there will be additional health checks and tests to monitor your safety.
What kinds of tests and health checks can I expect?
Not every test will be done at every visit.
Medical history
Pregnancy test
Physical exam
Vital signs
Nasopharyngeal swab
Blood tests
Questionnaires
Body temperature
Ready to get started?
See if you may be a good fit for the SCORPIO-PEP study or find a study site near you.