Status: Ongoing First registered on: 10/04/2020
Last updated on: 18/05/2020
1. Study identification
EU PAS Register NumberEUPAS34663
Official titlePharmacological risk factors for COVID-19 infection: a matched prospective cohort study of patients in primary care
Study title acronym
Study typeObservational study
Brief description of the studyBackground: There has been speculation that drugs used to manage chronic conditions such as type 2 diabetes and hypertension could lead to increased risk of both COVID-19 infection 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 these effects. 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 and hydroxychloroquine on COVID-19 infection rates and related 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 50 years and above with a diagnosis of hypertension, type 2 diabetes mellitus, rheumatoid arthritis and osteoarthritis as of 30th Jan 2020. 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
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 nameInstitute of applied health research, University of birmingham
Centre locationBirmingham, UK
Details of (Primary) lead investigator
Title Dr
Last name Krishnarajah
First name Nirantharakumar
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

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed17/04/2020
Start date of data collection17/04/202015/05/2020
Start date of data analysis17/04/202015/05/2020
Date of interim report, if expected17/05/2020
Date of final study report17/06/2020
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
OtherTBC100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Krishnarajah
First name Nirantharakumar
Address line 1Institute of applied health research
Address line 2 
Address line 3 
CityBirmingham 
PostcodeB152TT 
CountryUnited Kingdom
Phone number (incl. country code)441214148344 
Alternative phone number 
Fax number (incl. country code) 
Email address k.nirantharan@bham.ac.uk
Public Enquiries
Title Dr 
Last name Krishnarajah 
First name Nirantharakumar 
Address line 1Institute of applied health research 
Address line 2 
Address line 3 
CityBirmingham 
PostcodeB152TT 
CountryUnited Kingdom 
Phone number (incl. country code)441214148344 
Alternative phone number 
Fax number (incl. country code) 
Email address k.nirantharan@bham.ac.uk 
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