Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309303
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2023-03-29
Brief Title:
Kawasaki Disease During the COVID-19 Epidemic
Sponsor:
IRCCS Burlo Garofolo
Organization:
IRCCS Burlo Garofolo
Study Overview
Official Title:
Clinical Features and Manifestations of Kawasaki Disease During the SARS-COV-2 Epidemic
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KAWACOVID
Brief Summary:
Northern Italy is the second region hit by the SARS-COV2 infection worldwide Data on COVID-19 clinical presentation in children is still scarce but fewer rate of infection and milder disease seem typical of this age group In the last three weeks it has been reported an abnormal number of critically ill patients with clinical characteristics consistent with Kawasaki Shock Syndrome KSS The common manifestations are middle aged children 6-9 yo with a history of persistent high spiking fever in the last days abdominal pain diarrhea skin rash and rapidly deteriorating clinical condition with the onset of shock without clear signs of dehydration Other less common features are arthralgia cough meningism conjunctivitis and reddened cracked lips Labworks usually show high inflammatory markers low lymphocyte counts low sodium and high troponin levels Echocardiography have been consistent with myocarditis in the majority of patient instead of classical coronary artery abnormalities Patients have been diagnosed as Kawasaki disease typical or incomplete and treated accordingly with IntraVenous ImmunoGlobulin IVIG andor steroids One patient refractory to such treatments responded successfully to intravenous Anakinra All the patients reported a family history consistent with COVID-19 serology and naso-pharyngeal swabs were inconsistently positive To date we are aware of at least 10 such cases KSS is a rare and dreadful complication with an estimated prevalence of 5 of patients with Kawasaki Disease KD Given the extreme rarity of this condition the occurrence of so many cases in the last weeks points to a possible causative agent As our hospitals are in high endemic area SARS-COV2 seems the most obvious although testing for such infection in patients returned conflicting results It is not clear at this moment if this clinical entity is a proper KD triggered by SARS-COV2 or a systemic vasculitis with similar features of KD secondary to SARS-COV2 infection The aim of this nationwide study is to better define this clinical entity
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None