A Phase 3 study of S-217622 in pediatric participants

JRCT ID: jRCT2031230140

Registered date:16/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: SARS-CoV-2 infection
• Date of first enrollment: 29/06/2023
• Target sample size: 120
• Study type: Interventional

Intervention(s)

S-217622
Oral administration of S-217622 tablet once daily for 5 days
Placebo
Oral administration of placebo tablet once daily for 5 days

Outcome(s)

Primary Outcome

-Adverse events, laboratory tests, vital signs
-Plasma concentration of S-217622

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: < 12age old
• Gender: Both

Include criteria

-Participant who was diagnosed as SARS-CoV-2 positive within 72 hours before randomization
-Participant who may be randomized within 72 hours after COVID-19 onset
-Participant who has at least one moderate or severe COVID-19 symptom at screening
-Participant with body weight of >= 20 kg at screening

Exclude criteria

-Participant with SpO2 of <= 93% (room air)
-Participant requiring oxygen treatment
-Participant requiring mechanical ventilation
-Participant who is strongly suspected to have worsening of SARS-CoV-2 infection symptoms within 48 hours after randomization
-Participant who is suspected to have active systemic infection requiring treatment
-Participant who has or suspected to have MIS-C/PIMS
-Participant who is known to have renal impairment with CrCl of < 30 mL/min by the Schwartz formula or requiring dialysis
-Participant who has severe hepatic impairment
-Participant who has history of febrile seizure or epilepsy

Related Information

• Primary Sponsor: Gomez Juan Carlos