A Phase 3 study of S-217622 targeting non-hospitalized participants

JRCT ID: jRCT2031220353

Registered date:01/10/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 07/12/2022
• Target sample size: 2000
• Countries of recruitment: Argentina,Japan,Brazil,Japan,Colombia,Japan,Egypt,Japan,Ghana,Japan,India,Japan,Kenya,Japan,Malawi,Japan,Mexico,Japan,Pakistan,Japan,Philippines,Japan,Poland,Japan,Puerto Rico,Japan,South Africa,Japan,Tanzania,Japan,Thailand,Japan,Turkey,Japan,Uganda,Japan,US,Japan,Zimbabwe,Japan
• Study type: Interventional

Intervention(s)

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)

Outcome(s)

• Primary Outcome: - The time to sustained symptom resolution

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

- 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)

Related Information

• Primary Sponsor: Portsmouth Simon
• Source(s) of Monetary Support: National Institute of Allergy and Infectious Diseases (NIAID)