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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Psoriasis
• Additional medical condition(s):
  Clinicians enter the details of their cases of COVID-19 in psoriasis using the online PsoProtect case report form.Patients with psoriasis, rheumatic disease or atopic dermatitis are able to self-report using the patient-facing case report forms.

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  5000

Study design details

• Main study objective:
  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.
• Outcomes:
  Hospitalization due to COVID-19, Death due to COVID-19Change in psoriasis/IMID severity during COVID-19
• Data analysis plan:
  1) Univariable analysis (unadjusted) to compare demographic /disease characteristics according to hospitalisation status Summarise N (%) or Median (IQR) for categorical/continuous respectively.For each variable (e.g. age, ethnicity, sex, treatment, comorbidities), compare hospitalised vs non-hospitalised groups and report p-value, using:o Chi-square test for each categorical variableo Mann Whitney U test for each continuous variable2) Multivariable-adjusted logistic regression to assess the associations between demographic/disease specific features and hospitalisation from COVID-19 - Table 2• Report:o Unadjusted/univariable model: odds ratios (95% CI)o Adjusted/joint model: odds ratios (95% CI) and P-value