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

Abstract

IntroductionIndividuals 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 analysisA 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 disseminationEthical 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 number1567490.

COVID-19 long-term sequelae: Omicron versus Alpha and Delta variants

“…Although the health costs derived from COVID-19 have been extensively studied [42] , [43] , new studies are needed to assess the costs of treating subsequent sequelae (physician consultations, pharmacotherapy, secondary care referrals, etc.) [37] , [44] . In addition to healthcare costs, many patients have been left out of the labor force due to long COVID, further noting that many of them disproportionately worked in service jobs, including health care, social care, and retail trade [37] .…”

Co-production of a feasibility trial of pacing interventions for Long COVID

“…The work reported is part of the Therapies for Long COVID (TLC) programme of research (National Institute for Health and Care Research (NIHR): COV-LT-0013) [ 8 ]. The key work packages and objectives are summarised in Fig.…”

Non-Pharmacological Therapies for Post-Viral Syndromes, Including Long COVID: A Systematic Review

“…The Patient and Public Involvement and Engagement (PPIE) Group for the Therapies for Long COVID Study [ 29 ] was involved in the co-development of the research question, helped determine the review’s scope and commented on the findings. The patient and public contribution was recorded using the GRIPP-2 short form checklist ( Supplementary Table S2 ) [ 30 ].…”