38
Participants
Start Date
April 1, 2025
Primary Completion Date
April 1, 2026
Study Completion Date
April 1, 2027
Anakinra
"Patients who fulfill the eligibility criteria a will be randomized 1:1 to receive either~1. IVIG 2g/kg administered in 10-12 hours as per local standard of care (standard treatment) OR~2. Anakinra 2mg/kg intravenously, max 100 mg/dose 4 times/day (investigational treatment)~Patients showing fever, between 36 hours and 72 hours from the end of first line treatment will be considered failures. Failures from the investigational treatment arm will receive a dose of IVIG and they will drop from the study.~Children who remained afebrile between the 36th and 72nd hour will be considered as responders, and they will proceed into the study.~Patients in the standard treatment arm will continue ancillary treatment and follow-up .~Patients in the investigational treatment arm will enter the tapering phase."
Intravenous Immunoglobulins, Human
see previous section
Asst Degli Spedali Civili Di Brescia
OTHER
IRCCS Burlo Garofolo
OTHER
Meyer Children's Hospital IRCCS
OTHER