COMET: Covid Medication Study [COVID-19]
Research type
Research Study
Full title
COMET: Covid Medication Study
IRAS ID
282899
Contact name
Michael Scott
Contact email
Sponsor organisation
Erasmus Medisch Centrum
Clinicaltrials.gov Identifier
282899, IRAS project ID
Duration of Study in the UK
0 years, 3 months, 0 days
Research summary
This study examines the relationship of the use of certain drugs on the clinical outcomes of patients with COVID-19. The overall aim is to identify risk factors for COVID-19 with the primary analysis focusing on correlation between drugs and clinical outcome (specifically Angiotensin Converting Enzyme inhibitors and Angiotensin II Receptor Blockers) and if possible development of a risk prediction model.\n\nData from patients with proven COVID-19 will be included in this study. These data are collected during normal care (without the intention to use it for research at the time of collection). Hospital pharmacists (direct care team) will be asked to log this information on a database. The information will be pseudonymized so that the research team will not be able to identify patients. The hospital will be required to keep their own hospital coding list to be able to track patients if necessary. The identifiers on the case report form will include the study number and year of birth.\nAdditional data collected includes: age (years); gender; ICPC/ICD10 medical history; Laboratory data (ALAT/INR/eGFR/Potassium/Sodium); BMI; Medication use at presentation; Smoking history; Logistic course (presentation at Emergency Department/transmission from/to another hospital); Survival.
Summary of study results:
This study was led by researchers in The Netherlands and has collected pseudonymised data on patients hospitalised with COVID-19. Participants did not receive any changes to treatment or interventions, this study was only concerned with analysing previously collected data on patients diagnosed with COVID.
The primary aim of the study was to establish whether certain medications, primarily ACE inhibitors and angiotensin II receptor blockers, adversely affected clinical outcome. No association between use of ACE inhibitors or angiotensin II receptor blockers prior to hospital admission and the clinical course of COVID-19 was identified.
A secondary finding describing an association between Clinical Frailty Scale score and hospital mortality was explored. The results suggested that a Clinical Frailty Score was a suitable risk marker for hospital mortality in adult patients with COVID-19. However, treatment decisions based on the Clinical Frailty Scale in patients younger than 65 years should be made with caution.
Long-term follow up data suggested that the Clinical Frailty Score was a suitable risk marker for mortality 24-months after hospitalisation in COVID-19 patients.Data was collected from up to 63 hospitals in 11 countries in Europe.
The Northern Health and Social Care Trust contributed the data for 94 patients to this study. We were also the coordinating site for the UK and as such facilitated the opening of Norfolk and Norwich University Hospitals NHS Foundation Trust and Royal Brompton & Harefield NHS Foundation Trust (RBHT). . Previously participating UK sites Norfolk & Norwich University Hospital Foundation Trust and Royal Brompton & Harefield Hospitals have closed the study at their sites.
REC name
East of England - Essex Research Ethics Committee
REC reference
20/EE/0129
Date of REC Opinion
30 Apr 2020
REC opinion
Favourable Opinion