Study Results
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Basic Information
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WITHDRAWN
OBSERVATIONAL
2021-03-10
2022-10-01
Brief Summary
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The researchers hope that by investigating the impact of COVID-19 infection upon human skeletal muscle, the question of why individuals have different responses to the infection and the mechanism of the longer-term impact of infection can be answered. This added knowledge will then, hopefully, be able to guide therapy targets in the future.
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Detailed Description
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With COVID-19 likely to have a lasting impact within the UK and on the NHS, any research that improves our knowledge upon the effect of the infection has the possibility to improve therapy targets and hopefully improve patient outcomes.
With how novel the COVID-19 pathogen is, little is currently known about the potential long-term impacts of infection upon individuals. There are currently many reports of longer-term syndromes following infection with COVID-19 including loss of smell and myalgia. The researchers hope that investigating the impact upon patients over the 12-months following their infection will gather information on the long-term impacts and potentially find evidence of the reason for these longer-term symptoms.
With skeletal muscle being one of the largest components of the human body, any impact upon its function is likely to have a significant impact upon an individual. With it being vital for not only locomotion but also in energy production for the body. The researchers hypothesize that changes within the skeletal muscle may account for some of the impacts of COVID-19 infection. The investigators hope that by investigating changes in muscle structure, muscle mitochondrial function, and neurological supply to the muscle they can identify a future therapy target to improve outcomes from COVID-19 infection.
To investigate this, this study plans to recruit participants with confirmed COVID-19 infection requiring varying levels of oxygen support (Oxygen therapy only n=12, Non-invasive ventilation n=12) and a control group of non-covid community-acquired pneumonia requiring oxygen therapy (n=12).
All groups will undergo the same investigations, and no interventions will form part of the study. Investigations will be carried out at 24-72hours of acute hospital admission, with follow-up assessments at 6-months and 12-months post-discharge.
The assessments performed will include: muscle biopsy of the vastus lateralis muscle, an ultrasound scan of the vastus lateralis muscle, voluntary and stimulated iEMG of VL, and hand-grip strength analysis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Control Group
Non-Covid -19 associated community acquired pneumonia with oxygen therapy required.
n=12
No intervetion will be used
No intervention will be used
Oxygen Therapy
Confirmed COVID-19 infection via PCR swab, with a new oxygen therapy requirement. NB the researchers will not be involved in the clinical decision of if the participant requires oxygen, this will be the clinical-teams decision.
n=12
No intervetion will be used
No intervention will be used
Non-Invasive ventilation therapy
Confirmed COVID-19 infection via PCR Swab, with a clinical need for non-invasive ventilation.
NB the researchers will not be involved in the clinical decision if the participant requires non-invasive ventilation, this will be the clinical-teams decision.
n=12
No intervetion will be used
No intervention will be used
Interventions
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No intervetion will be used
No intervention will be used
Eligibility Criteria
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Inclusion Criteria
* A minimum of oxygen treatment required for 24hours.
* Capacity to give informed and written consent
Exclusion Criteria
* Active cardiovascular disease:
Significant arrhythmia
Recent acute coronary event
* Cerebrovascular disease:
Recent stroke
* Respiratory disease including:
Pulmonary hypertension
Significant COPD
Uncontrolled asthma
* Clotting dysfunction or current use of anticoagulants (eg Warfarin/Clopidogrel/ Rivaroxaban)
* Significant musculoskeletal or neurological disorders
40 Years
ALL
No
Sponsors
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University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Beth Phillips, BSc PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
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Royal Derby Hospital
Derby, Derbyshire, United Kingdom
Countries
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Other Identifiers
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Sponsor ID: 20065
Identifier Type: OTHER
Identifier Source: secondary_id
20065
Identifier Type: -
Identifier Source: org_study_id
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