Skip to content

Kawasaki Disease During the COVID-19 Epidemic

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06309303
Acronym
KAWACOVID
Enrollment
25
Registered
2024-03-13
Start date
2020-07-01
Completion date
2023-12-31
Last updated
2024-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kawasaki Disease

Keywords

Kawasaki Disease, SARS-COV-2, Children

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 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.

Interventions

OTHERClinical evaluation

Evaluation of clinical manifestation, laboratory ad imaging testing results, disease course, treatment and outcome

Sponsors

IRCCS Burlo Garofolo
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Months

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

Design outcomes

Primary

MeasureTime frameDescription
Number of subjects with Kawasaki Disease and concomitant SARS-COV-2 infectionThrough study completion, an average of 4 monthsSubjects 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.

Secondary

MeasureTime frame
Number of subjects with Kawasaki Disease without concomitant SARS-COV-2 infectionThrough study completion, an average of 4 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026