Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-29 @ 3:02 AM
Study NCT ID:
NCT06309303
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2023-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kawasaki Disease During the COVID-19 Epidemic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009080', 'term': 'Mucocutaneous Lymph Node Syndrome'}], 'ancestors': [{'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2023-03-29', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with Kawasaki Disease and concomitant SARS-COV-2 infection', 'timeFrame': 'Through study completion, an average of 4 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with Kawasaki Disease without concomitant SARS-COV-2 infection', 'timeFrame': 'Through study completion, an average of 4 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kawasaki Disease', 'SARS-COV-2', 'Children'], 'conditions': ['Kawasaki Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '1 Month', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children (age 0-17 years) affected by Kawasaki Disease', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children with clinical diagnosis of Kawasaki Disease\n* age\\<18 years\n* Absence of other underlying chronic diseases\n\nExclusion Criteria:\n\n* Presence of underlying chronic diseases\n* Not fulfilling clinical criteria for Kawasaki Disease diagnosis'}, 'identificationModule': {'nctId': 'NCT06309303', 'acronym': 'KAWACOVID', 'briefTitle': 'Kawasaki Disease During the COVID-19 Epidemic', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Burlo Garofolo'}, 'officialTitle': 'Clinical Features and Manifestations of Kawasaki Disease During the SARS-COV-2 Epidemic', 'orgStudyIdInfo': {'id': 'RC 12/20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'KD with SARS-COV-2', 'description': 'Subjects with Kawasaki Disease and presence of concomitant SARS-COV-2 infection', 'interventionNames': ['Other: Clinical evaluation']}, {'label': 'KD without SARS-COV-2', 'description': 'Subjects with Kawasaki Disease and absence of concomitant SARS-COV-2 infection', 'interventionNames': ['Other: Clinical evaluation']}], 'interventions': [{'name': 'Clinical evaluation', 'type': 'OTHER', 'description': 'Evaluation of clinical manifestation, laboratory ad imaging testing results, disease course, treatment and outcome', 'armGroupLabels': ['KD with SARS-COV-2', 'KD without SARS-COV-2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Florence', 'country': 'Italy', 'facility': 'Ospedale Pediatrico Meyer', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'IRCCS Istituto Giannina Gaslini', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Ospedale Pediatrico Bambino Gesù', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '34137', 'city': 'Trieste', 'country': 'Italy', 'facility': 'IRCCS Burlo Garofolo', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}], 'overallOfficials': [{'name': 'Andrea Taddio, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRCCS materno infantile Burlo Garofolo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Burlo Garofolo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}