Effect of drug consumption before and during the SARS-COV-2 infection on the evolution of patients with COVID-19. A population-based study (COVIDrug)

Study identification

• EU PAS number:
  EUPAS44587
• Study ID:
  44588
• Official title and acronym:
  Effect of drug consumption before and during the SARS-COV-2 infection on the evolution of patients with COVID-19. A population-based study (COVIDrug)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  This project aims to generate knowledge from a population-based cohort study to improve the scientific evidence about susceptibility to infection by SARS-COV-2 and the severity of COVID-19 associated with different therapeutic groups. A population-based retrospective cohort study (Autonomous Community of Galicia) will be carried out, which will involve the 2.5 million subjects covered by the Galician Public Health System. A nested case-control study will be designed in this population-based retrospective cohort. All patients diagnosed with COVID-19 in the C.A. of Galicia during the study period will be considered as cases. Two groups will be used as controls, a sample from the rest of the cohort (objective G1.A) and the COVID + patients by PCR not admitted (objective G1.B). We will consider: i) exposure variables all drugs prescribed to cases and controls in the cohort, during the study period, ii) effect variables the case or control condition, iii) covariates: Age, sex, comorbidities (diabetes mellitus, obesity, history of active neoplasms, chronic obstructive pulmonary disease (COPD), asthma, hypertension, ischemic heart disease) identified through ICD-10 codes for subjects admitted to hospital and Classification International Primary Care (CIAP) in the rest. To assess the exposure to the drug or therapeutic group under study (ARBs, ACE inhibitors, NSAIDs…) we will assess the consumption of these drugs in the 6 months before the index day. Multilevel logistic regression analysis will be performed, considering each stratum (a case and the controls with the matching variables) as an aggregation unit to estimate the odds ratio, and its 95% confidence interval (CI) for the risk of Covid- 19 associated with exposures of interest.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Health Research Institute of Santiago de Compostela (IDIS)

Study timelines

Date when funding contract was signed

Actual: 29/09/2020

Study start date

Actual: 01/10/2020

Data analysis start date

Actual: 01/09/2021

Date of final study report

Planned: 30/12/2022

Sources of funding

Other

More details on funding

Instituto de Salud Carlos III

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable