EXCOVIR V1.0 [COVID-19]

  • Research type

    Research Study

  • Full title

    Exploring COVID19 specific Immune Responses in acute and convalescent phases of infection (EXCOVIR)

  • IRAS ID

    283457

  • Contact name

    Anthony Rowbottom

  • Contact email

    anthony.rowbottom@lthtr.nhs.uk

  • Sponsor organisation

    Lancashire Teaching Hospitals NHS Foundation Trust

  • ISRCTN Number

    ISRCTN12345678

  • Clinicaltrials.gov Identifier

    NCT12345678

  • Clinicaltrials.gov Identifier

    n/a, n/a

  • Duration of Study in the UK

    1 years, 6 months, 0 days

  • Research summary

    SARS-CoV-2, the coronavirus causing COVID-19 is causing an unprecedented fast-spreading worldwide pandemic. The disease can have dramatically different effects on different people, with some patients having very mild or no symptoms, and others suffering from severe lung problems requiring intensive care treatment. When a new virus emerges, it is often difficult to predict how our immune systems will react to it, both immediately and over time. This study aims to improve understanding of the host adaptive immune responses in a range of COVID-19 patients during different stages in their illness and recovery. \nThere are currently no tests to predict how severe the disease will be in individual patients. We aim to identify predictors of disease severity through the detection of circulating levels of immune signalling molecules, the evaluation of immune cell surface markers and specific immune cell populations in people with varying severities of COVID-19 disease. If successful, this can be applied to clinical practice as a sensitive and objective marker of disease activity, and, potentially serve as a predictive determinant of disease severity in SAR-CoV-2 infected patients. These findings could inform the future care of COVID-19 patients, rapidly identifying those at risk of developing a severe disease requiring immediate treatment and management. Further to this, we aim to provide additional evidence towards identifying an appropriate correlate of immunity to SARS-CoV-2.\nWithin this piece of work, we will also to undertake a feasibility study, investigating a new testing method to identify whether or not people had been previously infected with SARS-CoV-2. This test would look at SARS-CoV-2 specific immune cells and is a different approach to the detection of SARS-CoV-2 antibodies. This approach will be particularly useful in the future for those patients and staff members with a clinical history consistent with COVID-19 but not supported by antibody levels. The findings from this study would inform a larger programme of work towards the development of new tests that would be useful in the diagnosis and management of patients with COVID-19. We propose that if used together, the two platforms will provide a highly accurate test to determine whether an individual had previously been exposed to the virus, and importantly, had successfully developed a protective ‘memory’ immune response. \n

  • REC name

    Social Care REC

  • REC reference

    20/IEC08/0020

  • Date of REC Opinion

    9 Jun 2020

  • REC opinion

    Favourable Opinion