ACTIV-2d/A5407 - A Phase 3, multicenter, randomized, double-blind, 24-week study of the clinical and antiviral effect of S-217622 compared with placebo in non-hospitalized participants with COVID-19 (SCORPIO-HR)

COVID-19 is a disease caused by infection with a coronavirus called SARS-CoV-2. COVID-19 affects people in different ways. Infected people have had a wide range of symptoms reported – from no symptoms or mild symptoms to severe illness needing hospitalization and sometimes death. Severe illness is due to inflammation in the lungs (pneumonia) and damage to organs due to inflammation and blood clots.

Fever or chills, cough, shortness of breath or difficulty breathing, runny or stuffy nose, sore throat, muscle pain, diarrhea, nausea, headache, muscle or body aches, and new loss of taste or smell are typical symptoms for this condition. These symptoms usually occur a few days after infection with SARS-CoV-2 and the virus can easily be spread to others before symptoms are noticed.

This study is being performed to evaluate the safety, efficacy, and pharmacokinetics (PK) (the way that the body handles the study drug) of a new experimental drug called study drug ; we will refer to the PK part of the study as the PK “sub-study”. This study drug, a 3CL protease inhibitor, has been shown in animals to slow the growth of the virus and prevent the infection from becoming severe. It is designed as an antiviral specific to SARS-CoV-2. Proteases are enzymes that breakdown proteins. Some viruses rely on proteases to make copies of themselves. Study drug blocks a protease called 3CL protease that the SARS-CoV-2 virus (the virus that causes COVID-19) uses to make copies of itself. We want to learn if giving Study drug by mouth within 5 days of diagnosis can shorten the time you have COVID-19 symptoms,  reduce the amount of virus in the body, and prevent hospitalization or death.

This study will include approximately 1 out of 2 people at higher risk and 1 out of 2 people at lower risk of severe COVID-19 infection. People are at higher risk of developing severe illness if they are 65 years of age or older, have pre-existing conditions such a high blood pressure, heart disease, being overweight, diabetes, kidney problems, lung diseases such as asthma and chronic obstructive pulmonary disease (COPD), cancer, are immunocompromised (when the immune system’s defenses are low, affecting one’s ability to fight off infections and diseases), or take steroids regularly. People are considered at lower risk of severe disease if they do not have any of these risk factors.