Clinical Trials Logo
  1. Home
  2. Kawasaki Disease
  3. NCT06309303

Kawasaki Disease During the COVID-19 Epidemic — KAWACOVID  

Kawasaki Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06309303
Study type Observational
Source IRCCS Burlo Garofolo
Contact
Status Completed
Phase
Start date July 1, 2020
Completion date December 31, 2023
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05911386 - Multiparametric Echocardiography and Cardiac Biomarkers in Pediatric Inflammatory Heart Diseases
Recruiting NCT02951234 - A Multi-center, Randomized to Compare the Efficacy of IVIG Alone and IVIG Plus High-dose Aspirin in Kawasaki Disease N/A
Active, not recruiting NCT02853266 - Measurement of Antibodies in Adults With a History of Kawasaki Disease N/A
Active, not recruiting NCT04747847 - Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease Early Phase 1
Withdrawn NCT04535518 - Efficacy of Immunoglobulin Plus Infliximab for the Early Regression of Coronary Artery Lesion in Kawasaki Disease Phase 3
Recruiting NCT01917721 - Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease Phase 2
Recruiting NCT04656184 - A Trial Comparing the Efficacy and Safety of Anakinra Versus Intravenous Immunoglobulin (IVIG) Retreatment, in Patients With Kawasaki Disease Who Failed to Respond to Initial Standard IVIG Treatment Phase 3
Recruiting NCT03200561 - A Trial to Evaluate the Efficacy of Immunoglobulin Plus Steroid for Prevention of Coronary Artery Abnormalities in Taiwanese Refractory Kawasaki Disease (RAST Study) Phase 3
Completed NCT01440075 - Prevalence and Early Markers of Atherosclerosis in Adults With a History of Kawasaki Disease N/A
Completed NCT02179853 - Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease Phase 1/Phase 2
Withdrawn NCT02980263 - Study of Efficacy and Safety of Canakinumab in Pediatric Patients With Kawasaki Disease Phase 2
Enrolling by invitation NCT02359643 - Multi-center Prospective Randomized Control Trail of High Dose Aspirin in Acute Stage of Kawasaki Disease N/A
Recruiting NCT04278404 - Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Completed NCT00841789 - A Randomized, Double Blind, Placebo Controlled Study of Etanercept in Children With Kawasaki Disease Phase 2
Completed NCT00760435 - Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease Phase 3
Not yet recruiting NCT05643651 - Rivaroxaban for Children With Giant Coronary Artery Aneurysms After Kawasaki Disease Phase 4
Recruiting NCT02114099 - Trial of Atorvastatin on the Persistent Coronary Aneurysm in Children With Kawasaki Disease Phase 2
Not yet recruiting NCT05091229 - A Blood Test to Diagnose Kawasaki Disease
Completed NCT01431105 - Pharmacokinetics (PK)/Safety Study of Atorvastatin in Children With Kawasaki Disease and Coronary Artery Abnormalities Phase 1/Phase 2
Recruiting NCT01793168 - Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford