STIMULATE-ICP
Research type
Research Study
Full title
A pragmatic, multi-centre, cluster-randomised trial of an integrated care pathway with a nested, Phase III, open label, adaptive platform randomised drug trial in individuals with Long COVID.
IRAS ID
1004698
Contact name
Amitava Banerjee
Contact email
Sponsor organisation
University College London
Eudract number
2021-006598-47
ISRCTN Number
ISRCTN10665760
Research summary
Long COVID affects over a million people in the UK, with wide-ranging disabling symptoms. We need to better understand, diagnose, and treat this new disease. To do this effectively we need to join up services including specialists, hospitals, and community care, creating a care pathway. Over 80 long COVID clinics have been established but care is different in different areas and there is no one pathway shown to be effective.
We will be working out what Long COVID is, how to diagnose it and how best to manage it: creating a Long COVID care pathway supporting recovery and improving outcomes.
Current care involves basic investigations, blood tests and a self-management rehabilitation website (https://www.yourcovidrecovery.nhs.uk/ ). We will compare current care to a new pathway including a community-based, comprehensive MRI scan (CoverscanTM) with decision support for health professionals, and digitally enhanced community rehabilitation (Living with COVID RecoveryTM).
Primary care networks scored by deprivation index and grouped together as clusters with even scores (groups contain the same mix of people ensuring fairness in accessing the pathways) will be randomised to different "usual care" to compare the new parts of the pathway with current care. We will also be comparing selected drugs against usual care (no drugs) starting with a combination of loratadine and famotidine, adding further prioritised drugs in future. Eligible participants may take part in the drug study or for data collection only as per their choice. Using initial clinic assessment, clinical record and detailed patient reported questionnaires, and repeating measures at 12 weeks we will assess effects of treatment on symptoms (particularly fatigue), mental health, return to work and other important outcomes. We will repeat this at 24 weeks to see if any changes have been sustained.We will recruit over 4,500 individuals to this largest long-COVID trial to-date.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0416
Date of REC Opinion
10 Jan 2022
REC opinion
Further Information Favourable Opinion