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

Last updated on 21 Apr 2020

Research type

Research database


Title

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


Contact name

Professor Catherine Smith


Sponsor



Funder



New study or amendment to existing study

New


Research summary 

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:

To 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.

The secondary objectives are:

To determine the impact of COVID-19 on the disease course/severity of psoriasis.

To 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.

The key clinical questions that will be addressed by PsoProtect are:

I. Are patients with psoriasis at a:

i. higher (or lower) risk of COVID-19?

ii. higher risk of a more (or less) severe COVID-19 disease course? We will consider proxies such as length of

hospitalisation, total symptom duration, maximum level of care required, complications e.g. sepsis/ARDS/AKI/pneumonia, death.

iii. higher (or lower) risk of death due to COVID-19?

II. Are immunosuppressant and immunomodulator therapies for psoriasis (including specific classes and agents) associated with a:

i. higher (or lower) risk of COVID-19?

ii. higher risk of a more (or less) severe COVID-19 disease course?

iii. higher (or lower) risk of death due to COVID-19?

III. Are there any predictors (e.g. psoriasis severity, comorbidities, demographic variables such as sex, age, ethnicity) of the following outcomes in psoriasis:

i. higher (or lower) risk of COVID-19?

ii. more (or less) severe COVID-19 disease course?

iii. higher (or lower) risk of death due to COVID-19?

IV. Are there differences in the signs, symptoms and disease duration of COVID-19 in patients with psoriasis?

V. Does continuing certain systemic psoriasis treatments after COVID-19 onset result in a more or less severe COVID- 19 disease course?

VI. Does COVID-19 affect the disease course/severity of psoriasis?

VII How does the impact and outcomes of COVID-19 in psoriasis compare with other diseases?

We 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.


IRAS ID

282395


Registry entries



REC name

Yorkshire & The Humber - Leeds West Research Ethics Committee


REC reference

 20/YH/0135


Date approved

15/04/2020


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