Status: Ongoing First registered on: 31/03/2020
Last updated on: 02/04/2020
1. Study identification
EU PAS Register NumberEUPAS34437
Official titleUSE OF DRUGS ACTING ON RENIN-ANGIOTENSIN SYSTEM (RAS) AND RISK OF COVID-19: A CASE-POPULATION STUDY
Study title acronymSRAA-COVID19
Study typeObservational study
Brief description of the studyThe coronavirus SARS-CoV-2 uses the protein ACE2 (angiotensin converting enzyme 2) as the receptor binding domain for its protein S (spike) to gain entry into cells and replicate. Blockers of the renin-angiotensin system (RAS) have been reported to upregulate the expression of ACE2 and this observation has raised the hypothesis that the use of these drugs could facilitate COVID-19 infection and/or make it more serious. Yet, the epidemiological evidence is lacking. The aim of this project is to carry out a quick case-population study using patients admitted to hospital with a diagnosis of COVID-19 as cases and a random sample of patients from a primary care database as the control series matched with cases for exact age, sex, and month-day (10 controls per case). Information on comorbidities and drugs used in the last month (current use) will be extracted from the clinical records in both cases and controls. We will examine the association of COVID-19 with the current use of RAS blockers as compared to non-use and as compared to current use of other antihypertensive drugs by computing the adjusted Odds Ratio through a conditional logistic regression model. The feasibility of selecting a secondary series of COVID-19+ cases who were not admitted to hospital (milder cases) will be assessed.
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 nameHospital Universitario Príncipe de Asturias
Centre locationAlcalá de Henares, Madrid. Spain
Details of (Primary) lead investigator
Title Professor
Last name de Abajo Iglesias
First name Francisco José
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?8

AEMPS
Hospital Universitario Ramón y Cajal, Madrid
Hospital Central de la Defensa, Madrid
Hospital Clínico San Carlos, Madrid
Hospital Universitario de la Princesa, Madrid
Hospital Universitario Puerta de Hierro-Majadahonda, Madrid
Hospital Universitario de Getafe, Madrid
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 signed18/03/202018/03/2020
Start date of data collection18/03/202018/03/2020
Start date of data analysis13/04/2020
Date of interim report, if expected06/04/2020
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 councilsInstituto de Salud Carlos III100
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name de Abajo Iglesias
First name Francisco José
Address line 1Ctra. Alcalá-Meco s/n.
Address line 2 
Address line 3 
CityAlcalá de Henares 
Postcode28805 
CountrySpain
Phone number (incl. country code)34918878100 
Alternative phone number 
Fax number (incl. country code) 
Email address francisco.abajo@uah.es
Public Enquiries
Title Professor 
Last name de Abajo Iglesias 
First name Francisco José 
Address line 1Ctra. Alcalá-Meco s/n. 
Address line 2 
Address line 3 
CityAlcalá de Henares 
Postcode28805 
CountrySpain 
Phone number (incl. country code)34918878100 
Alternative phone number 
Fax number (incl. country code) 
Email address francisco.abajo@uah.es 
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