Kawasaki Disease During the COVID-19 Epidemic (KAWACOVID)

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

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.

Study Overview

• Status: Completed
• Conditions: Kawasaki Disease
• Intervention / Treatment: Other: Clinical evaluation

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Italy
  • Firenze, Italy
    • Ospedale Pediatrico Meyer
  • Genova, Italy
    • IRCCS Istituto Giannina Gaslini
  • Roma, Italy
    • Ospedale Pediatrico Bambino Gesu
  • Trieste, Italy, 34137
    • IRCCS Burlo Garofolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Children (age 0-17 years) affected by Kawasaki Disease

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
KD with SARS-COV-2; Subjects with Kawasaki Disease and presence of concomitant SARS-COV-2 infection	Other: Clinical evaluation; 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	Other: Clinical evaluation; Evaluation of clinical manifestation, laboratory ad imaging testing results, disease course, treatment and outcome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of subjects with Kawasaki Disease without concomitant SARS-COV-2 infection	Through study completion, an average of 4 months

Collaborators and Investigators

• Sponsor: IRCCS Burlo Garofolo
• Investigators: Study Director: Andrea Taddio, MD, IRCCS Materno Infantile Burlo Garofolo

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Children; SARS-COV-2; Kawasaki Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Lymphatic Diseases; Vasculitis; Skin Diseases, Vascular; Mucocutaneous Lymph Node Syndrome
• Other Study ID Numbers: RC 12/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No