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

Phase 3

Recruiting

Conditions: prevention of symptomatic SARS-CoV-2 infection

Registration Number: JPRN-jRCT2031230124

Lead Sponsor: Gomez Juan Carlos

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 2200

Inclusion 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

Exclusion 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures