CISCO-21 Prevent and Treat Long COVID-19. (CISCO-21)

February 21, 2025 updated by: NHS Greater Glasgow and Clyde

Prevention and Early Treatment of the Long-term Physical Effects of Coronarvirus-19 (COVID-19): a Randomised Clinical Trial of Resistance Exercise.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 (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

Enrollment (Actual)

233

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom
        • Queen Elizabeth University Hospital
      • Glasgow, United Kingdom
        • Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Patients will be classified according by clinical presentation:

A) Non-hospitalised - Positive diagnosis with persisting symptoms for at least 4 weeks from symptoms onset leading to medical review (A&E, Community COVID Hub) but not admission (Treatment group), B) Hospitalised, positive diagnosis, and with post-discharge, persistent symptoms for at least 4 weeks from symptoms onset (Treatment group), C) Hospitalised, positive diagnosis, and in convalescent phase in-hospital (Prevention group).

Groups A & B = target population for treatment of persisting symptoms post-COVID i.e. Long-COVID; Group C = Target population for prevention of Long COVID.

Inclusion Criteria:

  1. Virology PCR positive laboratory diagnosis and/or point of care test positive for COVID-and/or
  2. Positive Lateral Flow Test (confirmation from notes or by participant) and/or
  3. Positive COVID antibody test
  4. Persistent symptoms for at least 4 weeks from symptoms onset (Groups A & B only)
  5. Presentation type - one of group A, B or C.

Exclusion Criteria:

  1. Physiotherapy as part of standard care e.g. post intensive care unit (ICU), post high dependency unit (HDU),
  2. No expectation of being able to walk within 3 months
  3. Unable to provide informed consent,
  4. Unable to comply with the protocol.
  5. Known pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spirometry
Time Frame: at 3 months
The basic spirometry measurement will be forced vital capacity (FVC).
at 3 months
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.
at 3 months
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.
at 3 months
EuroQol-5 dimension (EQ)-5D
Time Frame: at 3 months
EuroQol-5 dimension (EQ)-5D, a patient reported outcome measure.
at 3 months
Patient Health Questionnaire-4 (PHQ4)
Time Frame: at 3 months
Patient Health Questionnaire-4 (PHQ4), a patient reported outcome measure.
at 3 months
Brief Illness Perception Questionnaire (IPQ)
Time Frame: at 3 months
Brief Illness Perception Questionnaire (IPQ), a patient reported outcome measure.
at 3 months
Duke Activity Status Index (DASI)
Time Frame: at 3 months
Duke Activity Status Index (DASI), a patient reported outcome measure.
at 3 months
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.
at 3 months
Fatigue questionnaire
Time Frame: at 3 months
Fatigue questionnaire, a patient reported outcome measure.
at 3 months
Fried Frailty phenotype
Time Frame: 3 months
Weight loss; exhaustion; grip strength; low physical activity; and slow walking pace
3 months
Episodes of care
Time Frame: at 3 months
Episodes of healthcare care (primary, secondary, physiotherapy, rehabilitation)
at 3 months
Hospitalisation
Time Frame: at 3 months
Hospitalisation for any reason, representing a serious adverse event
at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

University of Glasgow
Chief Scientist Office of the Scottish Government

Investigators

  • Principal Investigator: Colin Berry, BSc MBChB PhD, University of Glasgow

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

February 21, 2025

Study Registration Dates

First Submitted

May 10, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN20CA537

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The Investigator may share individual participant data (IPD) with bone fide researchers, subject to Sponsor approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe