Pharmacological risk factors for COVID-19 infection: a matched prospective cohort study of patients in primary care

Study type
Protocol
Date of Approval
Study reference ID
20_070
Lay Summary

In the UK, the widespread infection of the novel coronavirus – COVID-19 – has created great attention and there is a clear need for effective interventions. Individuals who are at high risk of this infection have been identified. They include patients who have underlying conditions such as type 2 diabetes, hypertension and patients on immune modifying medications (e.g. rheumatoid arthritis patients). For management of these underlying conditions, these patients take anti-hypertensives and glucose lowering medications.

There has been speculation that these drugs could lead to increased risk of both the infection itself and deaths related to the infection. On the other hand there is also belief that some medications may be protective (e.g. HCQ). This has been amplified on social media and there is no current evidence to support these hypotheses.

In order to provide appropriate guidance for these high risk patients, it is essential that we conduct a pharmaco-epidemiological study to investigate the effects of these drugs on COVID-19 infection rates, hospitalisation due to COVID-19, and related deaths.

Technical Summary

Aim:
This study will aim to identify the effect of current use of various antihypertensive treatments (ACE inhibitors, ARAs and calcium channel blockers), therapies for type 2 diabetes (SGLT2 inhibitors), NSAIDs, hydroxychloroquine, statins, anticoagulants, metformin, memantine and amantadine on COVID-19 infection rates and mortality. We will compare the rates and severity (hospitalisation due to COVID-19, mortality) of COVID-19 infection among patients prescribed with the above-mentioned drugs (with an underlying condition indicating a necessity for their prescription) compared to propensity score matched patients prescribed with comparator drugs (with the same underlying condition).

Design:
Propensity score matched cohort study with active comparators.

Target population:
Adults aged 18 years and above with a diagnosis of hypertension, type 2 diabetes mellitus, rheumatoid arthritis, osteoarthritis, low cardiovascular risk, AF and low CHA2DS2-VASc score, PCOS, dementia, or dementia/Parkinson's disease as of 30th Jan 2020. In each of these 9 cohorts, subcohorts with current use of the exposure and comparator drugs as a monotherapy will be identified.

Health Outcomes to be Measured

Primary Outcomes:
(1) Composite of confirmed, suspected or probable diagnosis of COVID-19
(2) Confirmed diagnosis of COVID-19
(3) COVID-19 associated mortality
(4) Hospitalization due to COVID-19

Collaborators

Krishnarajah Nirantharakumar - Chief Investigator - University of Birmingham
Krishnarajah Nirantharakumar - Corresponding Applicant - University of Birmingham
Alastair Denniston - Collaborator - University of Birmingham
Anuradhaa Subramanian - Collaborator - University of Birmingham
Christopher Sainsbury - Collaborator - University of Birmingham
Dipak Kotecha - Collaborator - University of Birmingham
Elizabeth Sapey - Collaborator - University of Birmingham
Georgios Gkoutos - Collaborator - University of Birmingham
Intikhab Alam - Collaborator - King Abdullah University of Science and Technology
Jamie Coleman - Collaborator - University of Birmingham
Jingya Wang - Collaborator - University of Birmingham
Joht Singh Chandan - Collaborator - University of Birmingham
KK Cheng - Collaborator - University of Birmingham
Konstantinos Toulis - Collaborator - University of Birmingham
Krishna Gokhale - Collaborator - University of Birmingham
Neeraj Bhala - Collaborator - University Hospitals Birmingham
Nicola Adderley - Collaborator - University of Birmingham
Roberto Incitti - Collaborator - King Abdullah University of Science and Technology
Shamil Haroon - Collaborator - University of Birmingham
Takashi Gojobori - Collaborator - King Abdullah University of Science and Technology
Tom Marshall - Collaborator - University of Birmingham
Tom Taverner - Collaborator - University of Birmingham
Wiebke Arlt - Collaborator - University of Birmingham

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Townsend Score;Practice Level Index of Multiple Deprivation