U-COVID study

  • Research type

    Research Study

  • Full title

    A single-centre, prospective evaluative study to investigate the potential presence of SARS-CoV-2 (COVID19) in ulcer lesions

  • IRAS ID

    312345

  • Contact name

    Matt Phillips

  • Contact email

    matt.phillips@ncic.nhs.uk

  • Sponsor organisation

    North Cumbria Integrated Care NHS Foundation Trust

  • Duration of Study in the UK

    1 years, 0 months, 30 days

  • Research summary

    Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a RNA-based coronavirus that can cause Coronavirus Disease 2019 (COVID-19); in the last two years it has been associated with high levels of morbidity and mortality throughout the world’s population. After a series of mutations, the current Omicron variant (as of April 2022) is more infectious than the previous dominant strains, though it is less lethal. The development and rollout of particularly RNA-based vaccines has further decreased mortality rates. In the literature and in clinics, a potential association has been found between the SARS-CoV-2 infection and the development of mouth and anogenital ulcers in people with no known risk factors for these lesions. Single cases have been reported on this phenomenon and in one case SARS was screened for and could be detected by reverse transcriptase Polymerase Chain Reaction (RT-PCR) when the ulcer was swabbed. In males, post-infection erectile dysfunction and reduced sperm count have been reported. However, to our knowledge no series of cases has been investigated to determine how common it is for ulcers to be present after SARS-CoV-2 and for the virus to be present in the ulcers. This study is a first effort at obtaining further information by inviting people with ulcer(s) to volunteer for the lesion to be screened for SARS-CoV-2. Provided it is feasible to enrol sufficient participants, the results of this study may ultimately inform public health bodies and healthcare professionals, plus the specific treatment required.

  • REC name

    London - Dulwich Research Ethics Committee

  • REC reference

    22/LO/0425

  • Date of REC Opinion

    20 Oct 2022

  • REC opinion

    Further Information Favourable Opinion