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The PsoProtect research database [COVID-19]

  • Research type

    Research Database

  • IRAS ID

    282395

  • Duration of Study in the UK

    years, months, days

  • Research summary

    PsoProtect (Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of Covid-19 infecTion) [COVID-19]

  • REC name

    Yorkshire & The Humber - Leeds West Research Ethics Committee

  • REC reference

    20/YH/0135

  • Date of REC Opinion

    15 Apr 2020

  • REC opinion

    Further Information Favourable Opinion

  • Data collection arrangements

    The rapidly-developing coronavirus disease 2019 (COVID-19) pandemic has created a global public health emergency. There is an urgent need to understand the underlying determinants of the outcome of COVID-19 and how this translates to individuals with immune-mediated inflammatory diseases (IMIDs). This information will be vital for informing assessments of risk of COVID-19 in individuals with IMIDs and for guiding clinical decision making around their treatments. Psoriasis is a common skin IMID affecting 2-4% of the population. It is associated with multimorbidities including obesity, psoriatic arthritis and cardiovascular disease. Moderate-severe disease is often treated with long-term systemic immunosuppressant and immunomodulator therapies, and the impact of these medications on outcomes of COVID-19 is currently unknown. PsoProtect is an international registry for health care providers to report outcomes of COVID-19 in individuals with psoriasis. PsoProtect is the first such registry for psoriasis worldwide. By collecting observational data on cases of COVID-19 in psoriasis on a global scale, PsoProtect has the potential to rapidly improve our understanding of how factors such as systemic immunomodulator/immunosuppressant therapies, comorbidities and demographic variables including age, sex and ethnicity affect outcomes of COVID-19 in psoriasis, for the benefit of the international clinical community. This information will inform clinicians when assessing risk and treating COVID-19 in patients with psoriasis. The data fields of PsoProtect have been closely aligned with that of recently established partner registries for outcomes of COVID-19 in other immune-mediated inflammatory diseases (IMIDs) such as inflammatory bowel disease (www.coviibd.org) and rheumatologic disease (www.rheum-covid.org). PsoProtect will thus facilitate collaborative research and enable valuable cross-IMID analysis of observational clinical data. The primary objective is:\n\nTo uncover the underlying determinants of the outcome of COVID-19 in psoriasis. Specifically, we will determine the impact of immunomodulator/immunosuppressant therapies, comorbidities and demographic variables such as age, sex and ethnicity on outcomes of COVID-19 in psoriasis.\n\nThe secondary objectives are:\n\nTo determine the impact of COVID-19 on the disease course/severity of psoriasis.\n\nTo determine the impact and outcomes of COVID-19 across diseases and therapies, and create a data resource to enrich other allied datasets through cross-disease collaboration.\n\nThe key clinical questions that will be addressed by PsoProtect are:\n\nI. Are patients with psoriasis at a:\n\ni. higher (or lower) risk of COVID-19?\n\nii. higher risk of a more (or less) severe COVID-19 disease course? We will consider proxies such as length of\n\nhospitalisation, total symptom duration, maximum level of care required, complications e.g. sepsis/ARDS/AKI/pneumonia, death.\n\niii. higher (or lower) risk of death due to COVID-19?\n\nII. Are immunosuppressant and immunomodulator therapies for psoriasis (including specific classes and agents) associated with a:\n\ni. higher (or lower) risk of COVID-19?\n\nii. higher risk of a more (or less) severe COVID-19 disease course?\n\niii. higher (or lower) risk of death due to COVID-19?\n\nIII. Are there any predictors (e.g. psoriasis severity, comorbidities, demographic variables such as sex, age, ethnicity) of the following outcomes in psoriasis:\n\ni. higher (or lower) risk of COVID-19?\n\nii. more (or less) severe COVID-19 disease course?\n\niii. higher (or lower) risk of death due to COVID-19?\n\nIV. Are there differences in the signs, symptoms and disease duration of COVID-19 in patients with psoriasis?\n\nV. Does continuing certain systemic psoriasis treatments after COVID-19 onset result in a more or less severe COVID- 19 disease course?\n\nVI. Does COVID-19 affect the disease course/severity of psoriasis?\n\nVII How does the impact and outcomes of COVID-19 in psoriasis compare with other diseases?\n\nWe will provide regular, open access summaries of the reported cases in PsoProtect via our website www.psoprotect.org, for the benefit of the international psoriasis and IMID community.

  • Research database title

    PsoProtect (Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of Covid-19 infecTion) [COVID-19]

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