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A Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of S-217622 in the prevention of symptomatic SARS-CoV-2 infection in household contacts of an individual with symptomatic COVID-19 (SCORPIO-PEP)

Phase 3 study of S-217622 in prevention of symptomatic SARS-CoV-2 infection (SCORPIO-PEP)

Gomez Juan Carlos

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

June. 07, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

-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

-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

Both

prevention of symptomatic SARS-CoV-2 infection

-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

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

+81-3-3764-0511

May. 24, 2023

No

Vietnam/South Africa/Argentina/United States of America