Kawasaki DiseaseKAWACOVIDNCT06309303
Kawasaki Disease During the COVID-19 Epidemic
An observational study of Kawasaki Disease, run by IRCCS Burlo Garofolo at 4 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 months
- Conditions the study is for
- Kawasaki Disease
- What is being tested?
- Clinical evaluation
- How many people
- 25 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Jul 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 months
- All sexes
- Child
Study population: Children (age 0-17 years) affected by Kawasaki Disease
Who may be able to join
- All children with clinical diagnosis of Kawasaki Disease
- age<18 years
- Absence of other underlying chronic diseases
Who cannot join
- Presence of underlying chronic diseases
- Not fulfilling clinical criteria for Kawasaki Disease diagnosis
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Ospedale Pediatrico Meyer
Florence
IRCCS Istituto Giannina Gaslini
Genova
Ospedale Pediatrico Bambino Gesù
Roma
IRCCS Burlo Garofolo
Trieste, 34137
About this study
Official title: 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.
- Conditions
- Kawasaki Disease
- Being tested
- Clinical evaluation
- Keywords
- Kawasaki Disease, SARS-COV-2, Children
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical evaluationOther
Evaluation of clinical manifestation, laboratory ad imaging testing results, disease course, treatment and outcome
| Study group | Role | What they receive |
|---|---|---|
| KD with SARS-COV-2 | Subjects with Kawasaki Disease and presence of concomitant SARS-COV-2 infection Receives: Other: Clinical evaluation | |
| KD without SARS-COV-2 | Subjects with Kawasaki Disease and absence of concomitant SARS-COV-2 infection Receives: Other: Clinical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 4 months
Secondary outcomes (1)
Number of subjects with Kawasaki Disease without concomitant SARS-COV-2 infection
Measured: Through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Jul 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Taddio, MD, Study director, IRCCS materno infantile Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309303
- Sponsor's protocol ID
- RC 12/20
- Acronym
- KAWACOVID
- Status last verified
- Jun 2024
- First submitted
- 29 Mar 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Features and Manifestations of Kawasaki Disease During the SARS-COV-2 Epidemic
- ClinicalTrials.gov ID
- NCT06309303
- Acronym / sponsor ID
- KAWACOVID / RC 12/20
- Conditions
- Kawasaki Disease
- Keywords
- Kawasaki Disease, SARS-COV-2, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KD with SARS-COV-2 | – | Other: Clinical evaluationSubjects with Kawasaki Disease and presence of concomitant SARS-COV-2 infection |
| KD without SARS-COV-2 | – | Other: Clinical evaluationSubjects with Kawasaki Disease and absence of concomitant SARS-COV-2 infection |
Who may qualify
- Ages
- 1 month to 18 months
- Sex
- All
- Age groups
- Child
- Study population
- Children (age 0-17 years) affected by Kawasaki Disease
Key inclusion criteria (3 listed)
- All children with clinical diagnosis of Kawasaki Disease
- age<18 years
- Absence of other underlying chronic diseases
Key exclusion criteria (2 listed)
- Presence of underlying chronic diseases
- Not fulfilling clinical criteria for Kawasaki Disease diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical evaluationEvaluation of clinical manifestation, laboratory ad imaging testing results, disease course, treatment and outcome | Other | KD with SARS-COV-2, KD without SARS-COV-2 |
Primary outcome
Number of subjects with Kawasaki Disease and concomitant SARS-COV-2 infection
Time frame: 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.
1 secondary outcome
Number of subjects with Kawasaki Disease without concomitant SARS-COV-2 infection
Time frame: Through study completion, an average of 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Taddio, MD study director
IRCCS materno infantile Burlo Garofolo
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kawasaki Disease, run by IRCCS Burlo Garofolo at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with Kawasaki Disease and concomitant SARS-COV-2 infection (time frame: Through study completion, an average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.