Description of the cutaneous manifestations of Covid-19 (COVID-PIEL)

02/04/2020
11/09/2024
EU PAS number:
EUPAS34469
Study
Planned
Study type

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Non-interventional study

Non-interventional study design

Cross-sectional
Study drug and medical condition

Medical condition to be studied

Rash erythematous
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

Hepatic impaired
Immunocompromised
Pregnant women
Renal impaired

Estimated number of subjects

60
Study design details

Main study objective

To describe the clinical characteristics and symptoms of the cutaneous manifestations associated with COVID-19.

Outcomes

o Identify the chronology of the cutaneous manifestations associated with COVID-19.o Evaluate the eventual relationship of skin manifestations with current COVID-19 treatments.o Evaluate the relationship of cutaneous manifestations associated with analytical parameters

Data analysis plan

The statistical analysis includes descriptive statistics using absolute frequencies and percentages. The chi-square test and odds ratio calculation will be used to test the association between skin manifestations, COVID-19 treatments and analytical parameters indicating severity.