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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)

A Phase 3 study of S-217622 targeting non-hospitalized participants (SCORPIO-HR)

Portsmouth Simon

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

shionogiclintrials-admin@shionogi.co.jp

Corporate Communications Department

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

Not Recruiting

Sept. 30, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

For all participants:
- Participants who are >= 18 years at the time of signing the informed consent.
- Participants who were diagnosed as SARS-CoV-2 positive within 72 hours before randomization.
- Participants with time from COVID-19 onset to randomization of =< 72 hours.
(COVID-19 symptoms: Cough, Shortness of breath or difficulty breathing, Feeling feverish, Chills, Fatigue, Body pain or muscle pain or aches, Diarrhea, Nausea, Vomiting, Headache, Sore throat, Nasal obstruction or congestion, Nasal discharge, Loss of taste or smell)
- Participants who have one or more of the above signs/symptoms(except loss of taste or smell) present within 24h prior to randomization.
- Participants with oxygenation saturation of >= 92% on room air adjusted for altitude and obtained at rest by study staff within 24h prior to randomization.

For high-risk participants:
- Participants who are >= 65 years at the time of signing the informed consent.
- Participants who are >= 18 years at the time of signing the informed consent with 1 of the following: Obesity (BMI>=30), Diabetes mellitus, Hypertension, Cardiovascular disease, Chronic lung disease (e.g., COPD, modrate to severe asthma, interstitial lung disease, cystic fibrosis, pulmonary hypertension), Chronic kideney disease (except for CrCl<30mL/min), Down syndrome, Sickle cell disease, Immunocompromising conditions or immunosuppressive treatments.

For Standard-risk participants:
- Participants at low risk for progression to severe COVID-19 are defined as <65 years of age and with none of the risk factors

- Participants who have history of hospitalization for the current SARS-CoV-2 infection.
- Participants with current need for hospitalization or immediate medical attention in the opinion of the
investigator.
- Participants with current use of any medications prohibited with the study intervention, or use of any medication intended to treat symptomatic SARS-CoV-2 infection before randomization.
- Participants with any comorbidity requiring surgery within 7 days prior to randomization or that is
considered life threatening in the opinion of the investigator within 28 days prior to randomization.
- Known current renal impairment defined as CrCl <30 mL/min by Cockcroft-Gault or requiring dialysis.
- Known history of cirrhosis or liver decompensation (including ascites, variceal bleeding, or hepatic encephalopathy).
- Participants who have used any of the following drugs within 14 days prior to randomization (strong CYP 3A inducer, products containing St. John's wort)

Both

COVID-19

S-217622
Oral administration of S-217622 tablet once daily for 5 days (5 times in total)
Placebo
Oral administration of placebo tablet once daily for 5 days (5 times in total)

- The time to sustained symptom resolution

+81-42-648-5551

Sept. 22, 2022

No

Argentina/Brazil/Colombia/Egypt/Ghana/India/Kenya/Malawi/Mexico/Pakistan/Philippines/Poland/Puerto Rico/South Africa/Tanzania/Thailand/Turkey/Uganda/US/Zimbabwe