Therapies for Long COVID in non-hospitalised individuals: from symptoms, patient-reported outcomes and immunology to targeted therapies (The TLC Study)

Shamil Haroon, Krishnarajah Nirantharakumar, Sarah Hughes, Anuradhaa Subramanian, Olalekan Lee Aiyegbusi, Elin Haf Davies, Puja R Myles, Tim Williams, Grace Turner, Joht Chandan, Christel McMullan, Janet Lord, David Wraith, Kirsty McGee, Alastair Denniston, Thomas Taverner, Louise Jackson, Elizabeth Sapey, Georgios Gkoutos, Krishna GokhaleEdward Leggett, Clare Iles, Christopher Frost, Gary McNamara, Amy Bamford, Tom Marshall, Dawit Zemedikun, Gary Price, Steven Marwaha, Nikita Simms-Williams, Kirsty Brown, Anita Walker, Karen Jones, Karen Matthews, Jennifer Camaradou, Michael Saint-Cricq , Sumita Kumar, Yvonne Alder , David E. Stanton, Lisa Agyen , Megan Baber , Hannah Blaize , Melanie Calvert

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Abstract

INTRODUCTION: Individuals with COVID-19 frequently experience symptoms and impaired quality of life beyond 4-12 weeks, commonly referred to as Long COVID. Whether Long COVID is one or several distinct syndromes is unknown. Establishing the evidence base for appropriate therapies is needed. We aim to evaluate the symptom burden and underlying pathophysiology of Long COVID syndromes in non-hospitalised individuals and evaluate potential therapies.

METHODS AND ANALYSIS: A cohort of 4000 non-hospitalised individuals with a past COVID-19 diagnosis and 1000 matched controls will be selected from anonymised primary care records from the Clinical Practice Research Datalink, and invited by their general practitioners to participate on a digital platform (Atom5). Individuals will report symptoms, quality of life, work capability and patient-reported outcome measures. Data will be collected monthly for 1 year.Statistical clustering methods will be used to identify distinct Long COVID-19 symptom clusters. Individuals from the four most prevalent clusters and two control groups will be invited to participate in the BioWear substudy which will further phenotype Long COVID symptom clusters by measurement of immunological parameters and actigraphy.We will review existing evidence on interventions for postviral syndromes and Long COVID to map and prioritise interventions for each newly characterised Long COVID syndrome. Recommendations will be made using the cumulative evidence in an expert consensus workshop. A virtual supportive intervention will be coproduced with patients and health service providers for future evaluation.Individuals with lived experience of Long COVID will be involved throughout this programme through a patient and public involvement group.

ETHICS AND DISSEMINATION: Ethical approval was obtained from the Solihull Research Ethics Committee, West Midlands (21/WM/0203). Research findings will be presented at international conferences, in peer-reviewed journals, to Long COVID patient support groups and to policymakers.

TRIAL REGISTRATION NUMBER: 1567490.

Original languageEnglish
Article numbere060413
Number of pages9
JournalBMJ open
Volume12
Issue number4
DOIs
Publication statusPublished - 26 Apr 2022

Bibliographical note

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.

Keywords

  • COVID-19/complications
  • COVID-19 Testing
  • Humans
  • Patient Reported Outcome Measures
  • Quality of Life
  • Syndrome

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