Kawasaki Disease During the COVID-19 Epidemic

Kawasaki Disease Clinical Trial

— KAWACOVID  

Official title:

Clinical Features and Manifestations of Kawasaki Disease During the SARS-COV-2 Epidemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06309303
• Other study ID #: RC 12/20
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2024
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 y/o) 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) and/or 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 1 Month to 18 Months

Eligibility

Inclusion Criteria:

• All children with clinical diagnosis of Kawasaki Disease

• age<18 years

• Absence of other underlying chronic diseases

Exclusion Criteria:

• Presence of underlying chronic diseases

• Not fulfilling clinical criteria for Kawasaki Disease diagnosis

Related Conditions & MeSH terms

• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome

Intervention

Other:
• Clinical evaluation
Evaluation of clinical manifestation, laboratory ad imaging testing results, disease course, treatment and outcome

Locations

Country	Name	City	State
Italy	Ospedale Pediatrico Meyer	Firenze
Italy	IRCCS Istituto Giannina Gaslini	Genova
Italy	Ospedale Pediatrico Bambino Gesù	Roma
Italy	IRCCS Burlo Garofolo	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with Kawasaki Disease and concomitant SARS-COV-2 infection	Subjects with KD-like multi-inflammatory syndrome diagnosis, named as KawaCOVID Group based on the presence of 1) persistent fever (> 48 h), lymphopenia and evidence of single or multi-organ dysfunction with other additional clinical, laboratory or imagining; 2) exclusion of any other microbial cause will be identified.	Through study completion, an average of 4 months
Secondary	Number of subjects with Kawasaki Disease without concomitant SARS-COV-2 infection		Through study completion, an average of 4 months