CISCO-21 Prevent and Treat Long COVID-19. (CISCO-21)
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|ClinicalTrials.gov Identifier: NCT04900961|
Recruitment Status : Recruiting
First Posted : May 25, 2021
Last Update Posted : September 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Other: Resistance Exercise||Not Applicable|
The rationale for our study has two main parts. The first (primary) addresses a gap in therapy, notably, for a non-pharmacological intervention. To address this gap, the investigators have set out to develop a lifestyle intervention that may be helpful to patients with persisting symptoms in the recovery (or convalescence) phase after COVID-19. Specifically, the investigators will train participants to undertake a pragmatic resistance-based exercise intervention that they can learn and apply according to their circumstances in-hospital or in the community. The rationale is predicated on providing patients with a personalised therapy option and empowering them in the self-management of their recovery following illness due to COVID-19 infection.
The second area of need is the general lack of evidence-based medicines for patients who have persisting symptoms after COVID-19. To address this gap, there is a need for rapid trials to evaluate multiple therapeutic candidates to urgently provide doctors (and their patients) with clinical evidence to inform treatment decisions. To address this gap, the investigatorsaim to create a platform for rapid trials of new treatments after COVID-19. The investigators wish to seize the opportunity afforded by this trial to set-up a transferable framework for future trials in COVID-19. The rationale is to provide a low-cost trials resource to facilitate the rapid set-up and cost-efficient delivery of multiple other trials. This will be a parallel work strand during the trial. The investigators will develop a Working Group of stakeholders from across the National Health Service (NHS) and Universities in Scotland and our COVID-19 patient and public invovlement (PPI) group (which includes co-applicants and collaborators). Key considerations include repurposing novel therapy, potential for efficacy, safety, endpoint, sample size, feasibility interim analyses, power, the Medicines and Healthcare products Regulatory Agency (MHRA) and costs. As part of the plan of work in application (Aim 3), the researchers and PPI Group will scope these potential interventions within the context of a platform trial with a view to identifying candidates to follow-on after the exercise intervention trial. This will cut the costs of doing future trials and allow more patients the opportunity to contribute to medical research that will improve outcomes for people recovering from COVID-19.
Our team is multidisciplinary, multi-ethnic, gender-balanced and drawn from across NHS Scotland, and the University of Glasgow. The investigators are leading the CISCO-19 study (ClinicalTrials.gov Identifier: NCT04403607), funded by the Chief Scientist Office (CSO), in the West of Scotland, using medical imaging of the hearts, lungs, and kidneys of patients, to understand the impact of COVID-19. The investigators have consulted with members of the public, including people with COVID-19, in designing this study.
The investigators will also undertake exploratory research into the vascular biology of COVID-19 infection. This work will be undertaken in collaboration with scientists in the University of Glasgow, including the British Heart Foundation Centre for Research Excellence and the Medical Research Council (MRC) Centre for Virus Research. A blood sample at 3 months will be collected and stored in the NHS Biorepository.
In order to assess the natural history, longer-term follow-up for health outcomes will be undertaken using electronic record linkage to patient records omitting the need for participants to undergo further research visits after the end of the trial. If after initial analysis longer term, follow up via national records is felt to be worthwhile additional funding will be sought for this.
Alignment with other national / international initiatives Our proposal will link with other prioritised studies in the United Kingdom. In general, co-enrolment would be desirable to synergise the studies. Our study will bring in new resource to enhance enrolment into existing studies, specifically, by engaging more sites, and more research staff.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention and Early Treatment of the Long-term Physical Effects of Coronarvirus-19 (COVID-19): a Randomised Clinical Trial of Resistance Exercise.|
|Actual Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||July 31, 2033|
Active Comparator: Intervention
A personalised, resistance-based exercise intervention for patients during the convalescence phase in-hospital through to 3-months post-discharge, a duration reflecting chronic, maintenance treatment studies. To maximise enrolment of eligible patients, the intervention may be initiated in-hospital or in the community post-discharge. Resistance bands may be used according to the exercise guideline.
Other: Resistance Exercise
The exercise regimens are generic and designed not to require expert physiotherapy input, therefore, the availability of NHS physiotherapists, which may be at times limited, will not be a barrier to implementation
No Intervention: Control
Standard of care treatment
- Incremental Shuttle Walk Test [ Time Frame: at 3 months ]This is a validated measure of functional capacity, with test-retest reliability and evidence of being responsive to rehabilitation interventions.
- Spirometry [ Time Frame: at 3 months ]The basic spirometry measurement will be forced vital capacity (FVC).
- Handgrip Strength [ Time Frame: at 3 months ]Handgrip strength will be recorded using a handheld dynamometer. For handgrip strength, measurements are performed until 3 measurements are within 5% of each other. Typically, 3 - 6 manoeuvres in each hand are performed. Responses in the dominant hand will be recorded.
- Short Physical Performance Battery [ Time Frame: at 3 months ]The Short Physical Performance Battery (SPPB) is a series of brief, simple physical tests including of the ability to stand for 10 seconds with the feet in 3 different positions (together side-by-side (score 0 - 1), semi-tandem (score 0 - 1), and tandem (score 0 - 2)), two timed trials of a 3m or 4m walk (fastest recorded) and the time to rise from a chair 5 times. The score ranges from 0 to 12 (higher scores reflect better extremity function). The gait and chair subtests score from 0 to 4.
- EuroQol-5 dimension (EQ)-5D [ Time Frame: at 3 months ]EuroQol-5 dimension (EQ)-5D, a patient reported outcome measure.
- Patient Health Questionnaire-4 (PHQ4) [ Time Frame: at 3 months ]Patient Health Questionnaire-4 (PHQ4), a patient reported outcome measure.
- Brief Illness Perception Questionnaire (IPQ) [ Time Frame: at 3 months ]Brief Illness Perception Questionnaire (IPQ), a patient reported outcome measure.
- Duke Activity Status Index (DASI) [ Time Frame: at 3 months ]Duke Activity Status Index (DASI), a patient reported outcome measure.
- International Physical Activity Questionnaires Short Form (IPAQ-SF) [ Time Frame: at 3 months ]International Physical Activity Questionnaires Short Form (IPAQ-SF), a patient reported outcome measure.
- Fatigue questionnaire [ Time Frame: at 3 months ]Fatigue questionnaire, a patient reported outcome measure.
- Fried Frailty phenotype [ Time Frame: 3 months ]Weight loss; exhaustion; grip strength; low physical activity; and slow walking pace
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04900961
|Contact: Diann Taggart||44 141 314 4407||Diann.Taggart@ggc.scot.nhs.uk|
|Queen Elizabeth University Hospital||Recruiting|
|Glasgow, United Kingdom|
|Glasgow, United Kingdom|
|Principal Investigator:||Colin Berry, BSc MBChB PhD||University of Glasgow|