We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04900961
Recruitment Status : Recruiting
First Posted : May 25, 2021
Last Update Posted : September 5, 2021
Sponsor:
Collaborators:
University of Glasgow
Chief Scientist Office of the Scottish Government
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

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.

Condition or disease Intervention/treatment Phase
Covid19 Other: Resistance Exercise Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Spirometry [ Time Frame: at 3 months ]
    The basic spirometry measurement will be forced vital capacity (FVC).

  2. 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.

  3. 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.

  4. EuroQol-5 dimension (EQ)-5D [ Time Frame: at 3 months ]
    EuroQol-5 dimension (EQ)-5D, a patient reported outcome measure.

  5. Patient Health Questionnaire-4 (PHQ4) [ Time Frame: at 3 months ]
    Patient Health Questionnaire-4 (PHQ4), a patient reported outcome measure.

  6. Brief Illness Perception Questionnaire (IPQ) [ Time Frame: at 3 months ]
    Brief Illness Perception Questionnaire (IPQ), a patient reported outcome measure.

  7. Duke Activity Status Index (DASI) [ Time Frame: at 3 months ]
    Duke Activity Status Index (DASI), a patient reported outcome measure.

  8. 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.

  9. Fatigue questionnaire [ Time Frame: at 3 months ]
    Fatigue questionnaire, a patient reported outcome measure.

  10. Fried Frailty phenotype [ Time Frame: 3 months ]
    Weight loss; exhaustion; grip strength; low physical activity; and slow walking pace



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Virology plymerase chain reaction (PCR) positive laboratory diagnosis of COVID-19,
  2. Within 6 months of diagnosis,
  3. Persistent symptoms for at least 4 weeks from symptoms onset (Groups A & B only)
  4. 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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Diann Taggart 44 141 314 4407 Diann.Taggart@ggc.scot.nhs.uk

Locations
Layout table for location information
United Kingdom
Queen Elizabeth University Hospital Recruiting
Glasgow, United Kingdom
Royal Infirmary Recruiting
Glasgow, United Kingdom
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Chief Scientist Office of the Scottish Government
Investigators
Layout table for investigator information
Principal Investigator: Colin Berry, BSc MBChB PhD University of Glasgow
  Study Documents (Full-Text)

Documents provided by NHS Greater Glasgow and Clyde:
Study Protocol  [PDF] March 30, 2021

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT04900961    
Other Study ID Numbers: GN20CA537
First Posted: May 25, 2021    Key Record Dates
Last Update Posted: September 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The Investigator may share individual participant data (IPD) with bone fide researchers, subject to Sponsor approval.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NHS Greater Glasgow and Clyde:
COVID-19
Clinical trial
Graded resistance exercise
Personalised medicine
Post-COVID-19 syndrome
Long COVID
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases