DROPLET Study [COVID-19]
Research type
Research Study
Full title
DiRect effects of COVID-19 On Paediatric Liver disease and Transplantation – DROPLET Study
IRAS ID
286544
Contact name
Deirdre A Kelly
Contact email
Sponsor organisation
Birmingham Women's and Children's NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Coronaviruses are a family of viruses that cause disease primarily in animals, however a number of these viruses have the ability to infect humans, including the current virus COVID-19 responsible for the severe acute respiratory syndrome (SARS) presentation seen during the current pandemic. Since its first detection in China at the end of 2019, nearly every country in the world has now been affected. It is widely believed that there is more than one strain of virus and this is making development of a vaccine challenging.
Adults appear to be at higher risk, especially males, those of ethnic minority backgrounds and those with pre-existing illnesses. Children on the other hand appear to be affected to a lesser degree1 and current evidence suggests the illness symptoms and signs they show are less severe.
In order to understand this further we plan to study our unique population of children with who are immunocompromised e.g. Autoimmune diseases; rheumatology; oncology; liver disease, both with and without liver transplantation, in order to establish the disease burden and rate of asymptomatic carriage.
We will: a) establish the prevalence of symptomatic and asymptomatic COVID-19 in immunocompromised patients; b) estimate viral persistence in infected patients or family members c) assess the development and persistence of antibody to inform the need for vaccination d) link with established databases to identify long term outcome.
The study will recruit immunocomprsed patients and families and those taking part in the ImmunoCOVID Study [Ethics/IRAS number: 281544]. This UK wide study allows parents of immunocompromised children, or children and teenagers themselves, to self-record their experiences of viral illnesses including COVID-19 using web-based online weekly questionnaire.
We will collect data on these immunocompromised children, their healthy siblings and family members from August 2020 in order to determine the direct effects of SARS-CoV-2 infection on this cohort. This will involve collecting nasal and saliva swabs to determine active infection; identifying persistence of virus after infection; validating antibody response in serum, dried blood spots and saliva; determining numbers of symptomatic and asymptomatic patients and documenting their outcome.
We will develop a web based core dataset for the study, using CASTOR, containing the essential clinical data and demographics needed to establish the diagnosis and outcome of COVID-19, linking with established databases (ImmunoCOVID, ISARIC, PHE mandatory reporting).
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0199
Date of REC Opinion
26 Aug 2020
REC opinion
Further Information Favourable Opinion