Ignite Creation Date:
2024-05-06 @ 4:12 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04900961
Status:
RECRUITING
Last Update Posted:
2021-09-05
First Post:
2021-05-10
Brief Title:
CISCO-21 Prevent and Treat Long COVID-19
Sponsor:
NHS Greater Glasgow and Clyde
Organization:
NHS Greater Glasgow and Clyde
Study Overview
Official Title:
Prevention and Early Treatment of the Long-term Physical Effects of Coronarvirus-19 COVID-19 a Randomised Clinical Trial of Resistance Exercise
Status:
RECRUITING
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CISCO-21
Brief Summary:
Many people have long-lasting symptoms after COVID-19 such as breathlessness fatigue and chest pain So far research studies of treatments for COVID-19 have focused on the life-threatening acute illness few studies look at treatments to improve long-term health after COVID-19 COVID-19 particularly when this requires a hospital admission can lead to weight loss and muscle wasting contributing to worse outcomes Muscle strengthening resistance-based exercise could improve outcomes in the long-term
Detailed Description:
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 ClinicalTrialsgov 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
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 ClinicalTrialsgov 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None