TY - JOUR
T1 - Therapies for Long COVID in non-hospitalised individuals
T2 - from symptoms, patient-reported outcomes and immunology to targeted therapies (The TLC Study)
AU - Haroon, Shamil
AU - Nirantharakumar, Krishnarajah
AU - Hughes, Sarah
AU - Subramanian, Anuradhaa
AU - Aiyegbusi, Olalekan Lee
AU - Davies, Elin Haf
AU - Myles, Puja R
AU - Williams, Tim
AU - Turner, Grace
AU - Chandan, Joht
AU - McMullan, Christel
AU - Lord, Janet
AU - Wraith, David
AU - McGee, Kirsty
AU - Denniston, Alastair
AU - Taverner, Thomas
AU - Jackson, Louise
AU - Sapey, Elizabeth
AU - Gkoutos, Georgios
AU - Gokhale, Krishna
AU - Leggett, Edward
AU - Iles, Clare
AU - Frost, Christopher
AU - McNamara, Gary
AU - Bamford, Amy
AU - Marshall, Tom
AU - Zemedikun, Dawit
AU - Price, Gary
AU - Marwaha, Steven
AU - Simms-Williams, Nikita
AU - Brown, Kirsty
AU - Walker, Anita
AU - Matthews, Karen
AU - Camaradou, Jennifer
AU - Saint-Cricq , Michael
AU - Kumar, Sumita
AU - Alder , Yvonne
AU - Stanton, David E.
AU - Agyen , Lisa
AU - Baber , Megan
AU - Blaize , Hannah
AU - Calvert, Melanie
N1 - © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.
PY - 2022/4/26
Y1 - 2022/4/26
N2 - 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.
AB - 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.
KW - COVID-19 Testing
KW - COVID-19/complications
KW - Humans
KW - Patient Reported Outcome Measures
KW - Quality of Life
KW - Syndrome
UR - http://www.scopus.com/inward/record.url?scp=85128941705&partnerID=8YFLogxK
U2 - 10.1136/ bmjopen-2021-060413
DO - 10.1136/ bmjopen-2021-060413
M3 - Article
C2 - 35473737
SN - 2044-6055
VL - 12
JO - BMJ open
JF - BMJ open
IS - 4
M1 - e060413
ER -