1. Study identification
EU PAS Register NumberEUPAS34469
Official titleDescription of the cutaneous manifestations of Covid-19
Study title acronymCOVID-PIEL
Study typeObservational study
Brief description of the studyObservational transversal descriptive study with the main objective to describe the clinical characteristics and symptoms of the cutaneous manifestations associated with COVID-19.
The secondary objectives are:
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.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableACG-CLO2020-01
Agencia Española del Medicamento
2. Research centres and Investigator details
Coordinating study entity
Centre nameHospital de Móstoles
Centre locationMóstoles. Madrid. Spain
Details of (Primary) lead investigator
Title Ms
Last name Galvan Casas
First name Cristina
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres
In total how many centres are involved in this Study?3
Hospital Plato, Barcelona
Hospital Universitario de Gran Canaria Doctor Negrín, Las Palmas de Gran Canaria
Countries in which this study is being conducted
National study
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed31/03/2020
Start date of data collection06/04/2020
Start date of data analysis21/04/2020
Date of interim report, if expected21/04/2020
Date of final study report30/04/2020
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherPrincipal Investigators100
5. Contact details for enquiries
Scientific Enquiries
Title Ms
Last name Galvan Casas
First name Cristina
Address line 1PINTOR ZULOAGA, 15
Address line 2
Address line 3
CityVILLANUEVA DE LA CAÑADA
Postcode28691
CountrySpain
Phone number (incl. country code)0034649578784
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Ms
Last name Galvan Casas
First name Cristina
Address line 1PINTOR ZULOAGA, 15
Address line 2
Address line 3
CityVILLANUEVA DE LA CAÑADA
Postcode28691
CountrySpain
Phone number (incl. country code)0034649578784
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Rash erythematous
8. Population under study
Age
Preterm newborns
Term newborns (0-27 days)
Infants and toddlers (28 days - 23 months)
Children (2 - 11 years)
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
Other population
Renal impaired
Hepatic impaired
Immunocompromised
Pregnant women
9. Number of subjects
Estimated total number of subjects60
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Spontaneous reporting
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
To describe the clinical characteristics and symptoms of the cutaneous manifestations associated with COVID-19.
Are there primary outcomes?No
Are there secondary outcomes?Yes
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
13. Study design
What is the design of the study?
Cross-sectional study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
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.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Available when the study ends
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted