Study identification

PURI

https://redirect.ema.europa.eu/resource/34501

EU PAS number

EUPAS34437

Study ID

34501

Official title and acronym

USE OF DRUGS ACTING ON RENIN-ANGIOTENSIN SYSTEM (RAS) AND RISK OF COVID-19: A CASE-POPULATION STUDY (SRAA-COVID19)

DARWIN EU® study

No

Study countries

Spain

Study description

The 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.

Study status

Ongoing
Research institution and networks

Institutions

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

Contact details

Francisco José de Abajo Iglesias

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Instituto de Salud Carlos III
Study protocol
Initial protocol

ACE2_COVID-19_V5_2

English (440.28 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable