臨床研究等提出・公開システム

A Phase 2/3 study of S-217622 in participants with SARS-CoV-2 infection

A Phase 2/3 study of S-217622

Gomez JuanCarlos

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. 27, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

For mild/moderate SARS-CoV-2-infected participants:
- Participants who were diagnosed as SARS-CoV-2 positive within 120 hours before randomization.
- Participants with time from COVID-19 onset to randomization of =< 120 hours.
- Participants who have at least one moderate or severe symptom among the following 12 symptoms of COVID-19 at the time of randomization.
(low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, stuffy or runny nose, sore throat, cough, shortness of breath, nausea, vomiting, diarrhea)
For asymptomatic SARS-CoV-2-infected participants (Phase 2a Part):
- Participants who were diagnosed as SARS-CoV-2 positive within 120 hours before randomizationt.
- Participants who have none of the following 14 symptoms of COVID-19 within 2 weeks before randomization.
(low energy or tiredness, muscle or body aches, headache, chills or shivering, feeling hot or feverish, taste disorder, smell disorder, stuffy or runny nose, sore throat, cough, shortness of breath, nausea, vomiting, diarrhea)
For asymptomatic/only mild symptoms SARS-CoV-2-infected participants (Phase 2b/3 Part):
- Participants who were diagnosed as SARS-CoV-2 positive within 120 hours before randomizationt.
- Participants who do not have any symtoms of moderate or severe symptom among the 12 symptoms of COVID-19 at the time of randomization.

Common for Phase 2a Part and Phase 2b/3 Part
And commmon for mild/moderate and asumptomatic SARS-CoV-2-infected participants
- Participants with a percutaneous oxygen saturation (SpO2) during wakefulness of =< 93% (room air)
- Participants strongly suspected to have pneumonia
- Participants who need oxygen administration
- Participants who need a mechanical ventilation
- Participants who are strongly suspected to have worsening of symptoms of SARS-CoV-2 infection within 48 hours after randomization, in the opinion of the investigator/subinvestigator
- Participants with suspected active and systemic infections requiring treatment at the time of randomization (excluding SARS-CoV-2)
- Current or chronic history of moderate or severe liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- Current or chronic history of moderate or severe kidney disease
- Participants who have used any of the following drugs within 7 days prior to randomization
(approved/unapproved drugs for the treatment of SARS-CoV-2 infection, antiviral, antibacterial, or antifungal drugs [excluding topical use])
- Participants who have used any of the following drugs within 14 days prior to randomization
(strong CYP 3A inhibitor, 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)

Phase 2a Part
Change from baseline in SARS-CoV-2 viral titer at each time point
Phase 2b Part
Time-weighted average change in total score of 12 COVID-19 symptoms from Day 1 up to Day 6
Change from baseline on Day 4 in SARS-CoV-2 viral titer
Phase 3 Part
Time to resolution of 5 COVID-19 symptoms
Change from baseline on Day 4 in the amount of SARS-CoV-2 viral RNA
Time to the first negative SARS CoV-2 viral titer
Phase 2b/3 Part
Primary endpoint and key secondary endpoint are not set.

+81-3-5491-4478

Sept. 10, 2021

No

Republic of Korea/Republic of Singapore/Socialist Republic of Vietnam