Abstract

Introduction This protocol describes an observational study which set out to assess whether frailty and/or multimorbidity correlates with short-term and medium-term outcomes in patients diagnosed with COVID-19 in a European, multicentre setting.

Methods and analysis Over a 3-month period we aim to recruit a minimum of 500 patients across 10 hospital sites, collecting baseline data including: patient demographics; presence of comorbidities; relevant blood tests on admission; prescription of ACE inhibitors/angiotensin receptor blockers/non-steroidal anti-inflammatory drugs/immunosuppressants; smoking status; Clinical Frailty Score (CFS); length of hospital stay; mortality and readmission. All patients receiving inpatient hospital care >18 years who receive a diagnosis of COVID-19 are eligible for inclusion. Long-term follow-up at 6 and 12 months is planned. This will assess frailty, quality of life and medical complications.

Our primary analysis will be short-term and long-term mortality by CFS, adjusted for age (18–64, 65–80 and >80) and gender. We will carry out a secondary analysis of the primary outcome by including additional clinical mediators which are determined statistically important using a likelihood ratio test. All analyses will be presented as crude and adjusted HR and OR with associated 95% CIs and p values.

Ethics and dissemination This study has been registered, reviewed and approved by the following: Health Research Authority (20/HRA1898); Ethics Committee of Hospital Policlinico Modena, Italy (369/2020/OSS/AOUMO); Health and Care Research Permissions Service, Wales; and NHS Research Scotland Permissions Co-ordinating Centre, Scotland. All participating units obtained approval from their local Research and Development department consistent with the guidance from their relevant national organisation.

Data will be reported as a whole cohort. This project will be submitted for presentation at a national or international surgical and geriatric conference. Manuscript(s) will be prepared following the close of the project.

Rights

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Cite as

Price, A., Barlow-Pay, F., Duffy, S., Pearce, L., Vilches-Moraga, A., Moug, S., Quinn, T., Stechman, M., Braude, P., Mitchell, E., Myint, P., Verduri, A., McCarthy, K., Carter, B., Hewitt, J. & COPE Study Collaborators 2020, 'Study protocol for the COPE study: COVID-19 in Older People: the influence of frailty and multimorbidity on survival. A multi-centre, European observational study', BMJ Open, 10(9), article no: e040569. https://doi.org/10.1136/bmjopen-2020-040569

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Last updated: 06 October 2022
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