Status: Finalised First registered on: 15/04/2020
Last updated on: 15/09/2020
1. Study identification
EU PAS Register NumberEUPAS34753
Official titleEFFECTIVENESS AND SAFETY OF CORTICOSTEROIDS IN SARS-COV-2 INFECTION (COVID-19): COHORT STUDY
Study title acronymCORTICOV-19
Study typeActive surveillance
Brief description of the studyThis is a retrospective cohort post-authorization drug study. From the patients admitted to the hospital for COVID-19 with a diagnosis of interstitial pneumonia, two cohorts will be selected based on their exposure (or not) to treatment with corticosteroids. The study will be carried out under real healthcare conditions, Data will be collected from days 1, 3 and 7 post inclusion (or treatment)
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 applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsClinical Pharmacology Service HUPHM
Department/Research groupClinical Pharmacology Service
Organisation/affiliation
Website/Homepage
Details of (Primary) lead investigator
Title Dr
Last name Ruiz-Antoran
First name Belen
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

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 signed13/04/202013/04/2020
Start date of data collection14/04/202014/04/2020
Start date of data analysis24/04/202027/04/2020
Date of interim report, if expected30/04/202004/05/2020
Date of final study report15/05/202008/05/2020
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
OtherOwn funds100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Ruiz-Antoran
First name Belen
Address line 1Manuel de Falla 1.
Address line 2 
Address line 3 
CityMadrid 
Postcode28222 
CountrySpain
Phone number (incl. country code)0034911916481 
Alternative phone number 
Fax number (incl. country code) 
Email address bruiz.hpth@salud.madrid.org
Public Enquiries
Title Dr 
Last name Ruiz-Antoran 
First name Belen 
Address line 1Manuel de Falla 1. 
Address line 2 
Address line 3 
CityMadrid 
Postcode28222 
CountrySpain 
Phone number (incl. country code)0034911916481 
Alternative phone number 
Fax number (incl. country code) 
Email address bruiz.hpth@salud.madrid.org 
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