How long is the study?

For index patients, the study will be a minimum of 1 day and a maximum of 3 days. Day 3 is an optional visit for nasal swab collection and symptom recording. The study treatment duration will be up to 5 days, then follow-up from Days 6 to 28 for participants.

What does the SCORPIO‑PEP study hope to learn?

The SCORPIO-PEP study is being done to learn whether an investigational medicine, S-217622, can prevent COVID-19 in those exposed to it. The study will compare the number of participants who become infected with SARS-CoV-2 (the virus that causes COVID-19) with symptoms while taking S‑217622 tablets compared with those taking placebo tablets.

What is the preventative treatment?

The preventative treatment being studied is S-217622. S-217622 is an oral therapy taken by mouth for 5 consecutive days.

How is the preventative treatment thought to work?

S-217622 is a SARS-CoV-2 protease inhibitor. Protease inhibitors are medications that act by interfering with enzymes that separate proteins essential to the life cycle of the virus. Protease inhibitors are widely used to treat other viruses such as HIV/AIDS and hepatitis C.

Who can join the study?

There are two types of individuals who can join this study. People aged 12 years and older who live in the same household as someone with COVID-19 (but still have a negative COVID-19 test) and paediatric or adult people of any age who have symptomatic COVID-19 and who have tested positive.

What if I decide to join the study but then change my mind?

Participation in the study is completely voluntary and you can leave the study at any time.

Why do we need new treatments to prevent COVID-19 if we already have vaccines?

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, hospitalisation, and death in vaccinated people with underlying medical conditions. New treatments are needed to prevent the spread of COVID-19.

How is my personal data protected?

Everyone in the trial will be assigned a unique identifier number by the sponsor, Shionogi. Any records or datasets will contain only the number and not a participant’s name or other identifiable information.

Where will I be able to find the results of this study?

Results of this study will be made public on the US National Institutes of Health’s website www.ClinicalTrials.gov. The results of this study may be published or presented at scientific meetings.