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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/35861
• EU PAS number:
  EUPAS35860
• Study ID:
  35861
• Official title and acronym:
  The PsoProtect Research Database (Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of Covid-19 infecTion)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Australia

  Austria

  Belgium

  Brazil

  Canada

  Chile

  Colombia

  France

  Germany

  India

  Iran, Islamic Republic of

  Italy

  Luxembourg

  Malaysia

  Mauritius

  Netherlands

  Norway

  Peru

  Philippines

  Poland

  Spain

  Sweden

  Thailand

  Türkiye

  United Arab Emirates

  United Kingdom

  United States
• Study description:
  PsoProtect (Psoriasis Patient Registry for Outcomes, Therapy and Epidemiology of Covid-19 infecTion) is an international registry for reporting outcomes of COVID-19 in individuals with psoriasis and related IMIDs (rheumatic diseases and atopic dermatitis). By collecting observational data on cases of COVID-19 in psoriasis and related IMIDs 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 IMIDs, for the benefit of the international clinical community.PsoProtect is closely aligned with recently established partner databases for clinician-reported outcomes to COVID-19 in other IMIDs (such as www.coviibd.org and www.rheum-covid.org). We will continue to collaborate closely with these research teams in order to facilitate valuable cross-disease analyses. The primary objective is to uncover the underlying determinants of the outcome of COVID-19 in psoriasis and the related IMIDs rheumatic diseases and atopic dermatitis. 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 IMIDs.The secondary objectives are to determine the impact of COVID-19 on the disease course/severity of psoriasis and related IMIDs (rheumatic diseases and atopic dermatitis), and 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.This is an observational cohort study of outcomes to COVID-19 in psoriasis and related IMIDs. Real-world observational clinical data is collected using the web-based clinician and patient facing PsoProtect case report forms (designed using the REDCap platform).
• Study status:
  Planned

Research institutions and networks

Institutions

St John's Institute of Dermatology

Study timelines

Date when funding contract was signed

Planned: 27/03/2020

Study start date

Planned: 27/03/2020

Date of final study report

Planned: 31/03/2025

Sources of funding

Other

More details on funding

NIHR Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London, The Psoriasis Association (UK)

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

IRAS Reference: 282395REC reference: 20/YH/0135https://psoprotect.org/https://psoprotectme.org/