Kawasaki Disease During the COVID-19 Epidemic
- Conditions
- Kawasaki Disease
- Interventions
- Other: Clinical evaluation
- Registration Number
- NCT06309303
- Lead Sponsor
- IRCCS Burlo Garofolo
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- All children with clinical diagnosis of Kawasaki Disease
- age<18 years
- Absence of other underlying chronic diseases
- Presence of underlying chronic diseases
- Not fulfilling clinical criteria for Kawasaki Disease diagnosis
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description KD with SARS-COV-2 Clinical evaluation Subjects with Kawasaki Disease and presence of concomitant SARS-COV-2 infection KD without SARS-COV-2 Clinical evaluation Subjects with Kawasaki Disease and absence of concomitant SARS-COV-2 infection
- Primary Outcome Measures
Name Time Method Number of subjects with Kawasaki Disease and concomitant SARS-COV-2 infection Through study completion, an average of 4 months 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.
- Secondary Outcome Measures
Name Time Method Number of subjects with Kawasaki Disease without concomitant SARS-COV-2 infection Through study completion, an average of 4 months
Trial Locations
- Locations (4)
Ospedale Pediatrico Bambino Gesù
🇮🇹Roma, Italy
Ospedale Pediatrico Meyer
🇮🇹Firenze, Italy
IRCCS Burlo Garofolo
🇮🇹Trieste, Italy
IRCCS Istituto Giannina Gaslini
🇮🇹Genova, Italy