Kawasaki Disease During the COVID-19 Epidemic

NCT06309303 | Completed

• 1 other identifier: RC 12/20
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 4

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

Keywords

Kawasaki Disease; SARS-COV-2; Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of subjects with Kawasaki Disease without concomitant SARS-COV-2 infection

  Through study completion, an average of 4 months

Study Arms (2)

KD with SARS-COV-2

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

Other: Clinical evaluation

KD without SARS-COV-2

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

Other: Clinical evaluation

Interventions

Clinical evaluation OTHER

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

KD with SARS-COV-2; KD without SARS-COV-2

Eligibility Criteria

• Age: 1 Month - 18 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All children with clinical diagnosis of Kawasaki Disease
• age\<18 years
• Absence of other underlying chronic diseases

You may not qualify if:

• Presence of underlying chronic diseases
• Not fulfilling clinical criteria for Kawasaki Disease diagnosis

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (4)

Ospedale Pediatrico Meyer

Florence, Italy

Location

IRCCS Istituto Giannina Gaslini

Genova, Italy

Location

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Location

IRCCS Burlo Garofolo

Trieste, 34137, Italy

Location

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Andrea Taddio, MD

  IRCCS materno infantile Burlo Garofolo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: March 13, 2024
• Study Start: July 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

IT (4)