Kawasaki Disease During the COVID-19 Epidemic

NCT ID: NCT06309303

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2023-12-31

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.

Conditions

Kawasaki Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

KD with SARS-COV-2

Subjects with Kawasaki Disease and presence of concomitant SARS-COV-2 infection

Clinical evaluation

Intervention Type: OTHER

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

KD without SARS-COV-2

Subjects with Kawasaki Disease and absence of concomitant SARS-COV-2 infection

Clinical evaluation

Intervention Type: OTHER

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

Interventions

Clinical evaluation

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Burlo Garofolo

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Taddio, MD

Role: STUDY_DIRECTOR

IRCCS materno infantile Burlo Garofolo

Locations

Ospedale Pediatrico Meyer

Florence, , Italy

IRCCS Istituto Giannina Gaslini

Genova, , Italy

Ospedale Pediatrico Bambino Gesù

Roma, , Italy

IRCCS Burlo Garofolo

Trieste, , Italy

Countries

Italy

Other Identifiers

RC 12/20

Identifier Type: -

Identifier Source: org_study_id