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Kawasaki Disease clinical trials

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NCT ID: NCT06309303 Completed - Kawasaki Disease Clinical Trials

Kawasaki Disease During the COVID-19 Epidemic

KAWACOVID
Start date: July 1, 2020
Phase:
Study type: Observational

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.

NCT ID: NCT04003844 Completed - Kawasaki Disease Clinical Trials

Study of Combined Therapy IVIG-SN 10% and Acetylsalicylic Acid in Kawasaki Disease

Start date: February 1, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of high-dose human Immunoglobulin G Intravenous (IGIV) 10% in subjects with Kawasaki diseases (KD).

NCT ID: NCT03915795 Completed - Kawasaki Disease Clinical Trials

Statins Study in Kawasaki Disease Children With Coronary Artery Abnormalities

Start date: August 20, 2019
Phase:
Study type: Observational

The aim of this study is to investigate the effects of statins on chronic inflammation, coronary artery abnormalities and clinical cardiac events in long-term KD children complicated with severe coronary artery abnormalities, and the feasibility and safety of statins in treatment of KD children.

NCT ID: NCT03902262 Completed - Appendicitis Clinical Trials

Acute Abdomen in Kawasaki Disease

Start date: April 14, 2016
Phase:
Study type: Observational

Clinical and histopathological description of three cases of Kawasaki disease with acute abdomen.

NCT ID: NCT02439996 Completed - Kawasaki Disease Clinical Trials

Different Doses of IVIG for Kawasaki Disease

Start date: January 2014
Phase: Phase 3
Study type: Interventional

The objective of this study is to investigate the effect of different doses of intravenous immunoglobulin (IVIG) (1g/kg once, 1g/kg twice, 2g/kg once) for Kawasaki disease (KD) in a multicentre, prospective,randomised trial.

NCT ID: NCT02390596 Completed - Children Clinical Trials

Anakinra and Kawasaki Disease

KAWAKINRA
Start date: February 5, 2016
Phase: Phase 2
Study type: Interventional

The study is designed to assess the efficacy and safety of anakinra, an interleukin 1 receptor antagonist, in patients with Kawasaki disease who failed to respond to standard treatment:e.g. one infusion of 2g/kg of intravenous immunoglobulins.

NCT ID: NCT02317913 Completed - Kawasaki Disease Clinical Trials

Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012

Start date: April 2013
Phase: N/A
Study type: Observational

To investigate the epidemiological pictures of Kawasaki disease (KD) in Shanghai from 2008 through 2012, and illustrate the risk factors of coronary arterial lesions .

NCT ID: NCT02298062 Completed - Kawasaki Disease Clinical Trials

Infliximab for Kawasaki Disease Patients Resistant to IVIG : a Multicentre, Prospective, Randomised Trial

Start date: January 2013
Phase: Phase 3
Study type: Interventional

The objective of this study is to investigate the effect of infliximab to the children who don't respond to the first dose of intravenous immunoglobulin (IVIG) (2g/kg) in Kawasaki disease.

NCT ID: NCT02179853 Completed - Kawasaki Disease Clinical Trials

Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease

Start date: November 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that may lead to complications later in life, including heart attack. Although the investigators can identify children with KD that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that lead to inflammation during acute KD, has been shown in the KD mouse model to prevent the development of coronary artery damage. Therefore, the investigators propose to study the safety and activity of anakinra in infants and children < 2 years old with coronary artery abnormalities from KD.

NCT ID: NCT02176070 Completed - Clinical trials for Giant Cell Arteritis

Reproductive Health in Men and Women With Vasculitis

Start date: February 2011
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to learn about reproductive health, including fertility and pregnancies, in people with vasculitis.