BATS [COVID-19]
Research type
Research Study
Full title
Best Available Treatment Study for inflammatory syndromes temporally associated with SARS-CoV-2
IRAS ID
284825
Contact name
Michael Levin
Contact email
Sponsor organisation
Imperial College London
ISRCTN Number
ISRCTN69546370
Clinicaltrials.gov Identifier
ISRCTN69546370, ISRCTN registry
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Paediatricians worldwide are seeing rapidly increasing numbers of children with a wide spectrum of paediatric inflammatory syndromes temporally associated with the COVID-19 pandemic. These emerging disorders appear to represent unusual responses to SARS-CoV-2 infection driven by children’s immune systems, with overlapping features with Kawasaki Disease (KD), a rare paediatric inflammatory disorder. Currently, paediatricians around the world are managing these patients with treatments that they judge to be best for their patients with the resources they have available; these include a range of anti-inflammatory and immunomodulatory treatments. Furthermore, many centres will not have certain treatments available due to worldwide shortage of many agents as a result of their use in COVID-19 patients. This has raised urgent questions for children, families and their clinicians, including: \n-\tAre there early clinical or laboratory features which predict disease severity, progression and poorer outcomes?\n-\tDo the available anti-inflammatory and immunomodulatory treatments improve the outcomes including reducing risk of coronary artery aneurysms? \n-\tWhat levels of inflammation define need for treatment?\n-\tWhat are the risks and benefits of these treatments? \n-\tWhat is the risk of long-term complications, e.g. coronary artery aneurysm, and how does this relate to syndrome and severity?\nWe invite paediatricians in any country to join a study which we term “Best Available Treatment Study”. We aim to systematically collect anonymised data on all patients with this emerging condition, retrospectively, using an online case report form. Capturing the patient’s clinical findings, inflammatory markers, treatments and outcomes will allow careful analysis of these data to advance our understanding of these disorders and rapidly provide answers on the questions as to which patients to treat, which treatments work and which may be harmful.
REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
20/HRA/2957
Date of REC Opinion
8 Jun 2020
REC opinion
Favourable Opinion