JRCT ID: jRCT2031230140
Registered date:16/06/2023
A Phase 3 study of S-217622 in pediatric participants
Basic Information
Recruitment status | Recruiting |
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Health condition(s) or Problem(s) studied | SARS-CoV-2 infection |
Date of first enrollment | 29/06/2023 |
Target sample size | 120 |
Countries of recruitment | |
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 |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 6age old |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Corporate Communications Department |
Address | 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka Osaka Japan 541-0045 |
Telephone | +81-6-6209-7885 |
shionogiclintrials-admin@shionogi.co.jp | |
Affiliation | Shionogi & Co., Ltd. |
Scientific contact | |
Name | Juan Carlos Gomez |
Address | 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka Osaka Japan 541-0045 |
Telephone | +81-6-6209-7885 |
shionogiclintrials-admin@shionogi.co.jp | |
Affiliation | Shionogi & Co., Ltd. |