Characterisation of the Immune Response to SARS-CoV-2 Infection / COVID-19 in Type 1 Diabetes

Brief summary (registry, in English)

Emerging clinical details of the current SARS-CoV-2 pandemic have illustrated that there are multiple clinical presentations and outcomes of this viral infection. People with an infection have been reported to have a spectrum of disease from severe acute respiratory distress requiring ventilation, to mild respiratory or gastrointestinal symptoms and asymptomatic presentations. The SARS-CoV-2 pandemic has been accompanied with a substantial increase in the number of individuals presenting with new onset type 1 diabetes \[1\]. Most individuals presenting with type 1 diabetes since the start of the COVID-19 pandemic are SARS-CoV-2 antibody positive. These findings suggest that SARS-CoV-2 infection can cause type 1 diabetes. Investigators have identified that many individuals presenting with type 1 diabetes since the start of the COVID-19 pandemic are SARS-CoV-2 positive by swab or blood test. Researchers have also observed that T cells in patients who have had COVID recognise some of the peptides in the pancreatic islet cells, which are responsible for production of insulin. These findings suggest that SARS-CoV-2 infection may be associated with new onset of type 1 diabetes. The aim of this project is to understand the host immune response to infection with SARS-CoV-2 and other common pathogens over time in convalescent newly diagnosed patients with type 1 diabetes, including acquired immune responses, gene expression profiling in peripheral blood and to identify host genetic variants associated with disease progressions or severity. Participants will have Type 1 diabetes and will have had a diagnosis of COVID-19 (confirmed by a positive nasopharyngeal swab PCR test and/or SARS-CoV-2 antibody test) and have recovered from COVID-19. Samples will be processed and analysed to explore the molecular mechanisms by which SARS-CoV-2 and other common infections might precipitate immune attack on insulin-producing cells resulting in autoimmune diabetes.

What you commit to

• Study type: Observational
• Participants enrolled: 30
• From 1 Jan 2021 to the primary completion date, 1 Jul 2024
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 8 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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