A Phase 3 study of S-217622 in pediatric participants

Phase 3

Recruiting

• Conditions: SARS-CoV-2 infection

• Registration Number: JPRN-jRCT2031230140
• Lead Sponsor: Gomez Juan Carlos

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified