Phase 3 study of S-217622 in prevention of symptomatic SARS-CoV-2 infection

JRCT ID: jRCT2031230124

Registered date:08/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: prevention of symptomatic SARS-CoV-2 infection
• Date of first enrollment: 09/06/2023
• Target sample size: 2200
• Countries of recruitment: Vietnam,Japan,South Africa,Japan,Argentina,Japan,United States of America,Japan
• Study type: Interventional

Intervention(s)

-S-217622 (ensitrelvir fumaric acid) at a dose of 375 mg for Day 1 and 125 mg for Days 2 to 5 once daily
-Placebo orally once daily for 5 days

Outcome(s)

• Primary Outcome: Proportion of participants in the mITT population with a negative screening SARS-CoV-2 infection (central laboratory-confirmed negative RT-PCR test) who are infected with SARS-CoV-2 (central laboratory-confirmed positive RT-PCR test) and have COVID-19 symptoms onset through Day 10

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Participant who has a negative screening SARS-CoV-2 infection, as determined by SARS-CoV-2 test from any respiratory tract specimen at the local laboratory
-Participant who has lived in household with SARS-CoV-2-infected patient and will continue to live in same household and share common areas such as dining rooms and bathrooms until the end of the study
-Participant who is not considered by the investigator or subinvestigator to have SARS-CoV-2 infection, have no measured fever, and have no COVID-19 symptoms at Screening
-Participant who can be randomized less than 72 hours from onset of COVID-19 symptoms in SARS-CoV-2-infected patient

Exclude criteria

-Participant in whom respiratory infection (eg, flu virus infection) other than COVID-19 was documented within 14 days prior to the Screening Visit
-Participant who tested positive for SARS-CoV-2 in the past 6 months
-Participant who received approved, authorized, or investigational anti-SARS-CoV-2 mAbs in the last 3 months
-Participant who received any SARS-CoV-2 vaccine within 6 months prior to the Screening Visit or is expected to receive a SARS-CoV-2 vaccine or other approved, authorized, or investigational postexposure prophylaxis treatments until the end of the study
-Participant who has a positive urine pregnancy test at Screening Visit or are lactating

Related Information

• Primary Sponsor: Gomez Juan Carlos
• Secondary ID(s): NCT05897541