Evidence map›Paper›PMID 36791116›Full record

ArticlePloS one2023

STIMULATE-ICP: 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: A structured protocol.

Denise Forshaw, Emma C Wall, Gordon Prescott, Hakim-Moulay Dehbi, Angela Green, Emily Attree, Lyth Hismeh, William D Strain, Michael G Crooks, Caroline Watkins and 6 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
6.0field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 29 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
  6. Neurological, psychological, psychosocial complications of long-COVID and their management.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
    Review
  7. Translating insights into therapies for Long Covid.Science translational medicine · 2024
    Review
  8. Article
  9. Cardiovascular effects of the post-COVID-19 condition.Nature cardiovascular research · 2024
    Review
  10. Review
  11. The immunology of long COVID.Nature reviews. Immunology · 2023
    Review
  12. Thromboinflammation in long COVID-the elusive key to postinfection sequelae?Journal of thrombosis and haemostasis : JTH · 2023
    Review
  13. Article
  14. Article
  15. Review
  16. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 8 institutions in 2 countries.

Denise ForshawLancashire Clinical Trials Unit, University of Central Lancashire, Preston, United Kingdom.
Emma C WallFrancis Crick Institute, London, United Kingdom.ORCID 0000-0003-2732-4497
Gordon PrescottLancashire Clinical Trials Unit, University of Central Lancashire, Preston, United Kingdom.ORCID 0000-0002-9156-2361
Hakim-Moulay DehbiComprehensive Clinical Trials Unit, University College London, London, United Kingdom.
Angela GreenDepartment of Physiotherapy, Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom.ORCID 0000-0003-2047-0352
Emily AttreeSTIMULATE-ICP PPI Team.
Lyth HismehSTIMULATE-ICP PPI Team.
William D StrainUniversity of Exeter Medical School, Exeter, United Kingdom.
Michael G CrooksAcademic Respiratory Medicine, Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom.
Caroline WatkinsLancashire Clinical Trials Unit, University of Central Lancashire, Preston, United Kingdom.
Chris RobsonLiving With, London, United Kingdom.
Rajarshi BanerjeePerspectum, Oxford, United Kingdom.
Paula LorgellySchool of Population Health, University of Auckland, Auckland, New Zealand.
Melissa HeightmanDepartment of Respiratory Medicine, University College London Hospitals NHS Trust, London, United Kingdom.
Amitava BanerjeeInstitute of Health Informatics, University College London, London, United Kingdom.ORCID 0000-0001-8741-3411
STIMULATE-ICP trial team
University of Lancashire · GBUniversity College London Hospitals NHS Foundation Trust · GBUniversity of Hull · GBLiving Streets · GBThe Francis Crick Institute · GBUniversity College London · GBUniversity of Auckland · NZUniversity of Exeter · GB

Funding

Department of Health COV-LT2-0043
6 · The paper itself

Abstract

introductionLong COVID (LC), the persistent symptoms ≥12 weeks following acute COVID-19, presents major threats to individual and public health across countries, affecting over 1.5 million people in the UK alone. Evidence-based interventions are urgently required and an integrated care pathway approach in pragmatic trials, which include investigations, treatments and rehabilitation for LC, could provide scalable and generalisable solutions at pace. METHODS AND ANALYSIS: This is a pragmatic, multi-centre, cluster-randomised clinical trial of two components of an integrated care pathway (Coverscan™, a multi-organ MRI, and Living with COVID Recovery™, a digitally enabled rehabilitation platform) with a nested, Phase III, open label, platform randomised drug trial in individuals with LC. Cluster randomisation is at level of primary care networks so that integrated care pathway interventions are delivered as "standard of care" in that area. The drug trial randomisation is at individual level and initial arms are rivaroxaban, colchicine, famotidine/loratadine, compared with no drugs, with potential to add in further drug arms. The trial is being carried out in 6-10 LC clinics in the UK and is evaluating the effectiveness of a pathway of care for adults with LC in reducing fatigue and other physical, psychological and functional outcomes at 3 months. The trial also includes an economic evaluation which will be described separately. ETHICS AND DISSEMINATION: The protocol was reviewed by South Central-Berkshire Research Ethics Committee (reference: 21/SC/0416). All participating sites obtained local approvals prior to recruitment. Coverscan™ has UK certification (UKCA 752965). All participants will provide written consent to take part in the trial. The first participant was recruited in July 2022 and interim/final results will be disseminated in 2023, in a plan co-developed with public and patient representatives. The results will be presented at national and international conferences, published in peer reviewed medical journals, and shared via media (mainstream and social) and patient support organisations. TRIAL REGISTRATION NUMBER: ISRCTN10665760.

Indexed as

COVID-19Delivery of Health Care, IntegratedAdultClinical Trials, Phase III as TopicHumansMulticenter Studies as TopicPost-Acute COVID-19 SyndromePragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicSARS-CoV-2Treatment Outcome

Identifiers

PMID36791116
PMCPMC9931100
OpenAlexW4320857196

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.