Covid19NCT04756674
The Impact of Covid-19 on Skeletal Muscle
An observational study of Covid19 and Muscle Loss, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
With the recent worldwide outbreak of the COVID-19 infection and the huge impact it has had upon lives in the UK, it is key to increase knowledge on the impact of the virus on the body. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Covid19, Muscle Loss, Mitochondrial Alteration
- What is being tested?
- No intervetion will be used
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Mar 2021to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population of individuals being treated for COVID-19 infection with a minimum of oxygen therapy. Control population of individuals being treated for non-COVID-19 community acquired pneumonia requiring oxygen therapy
Who may be able to join
- Confirmed COVID-19 infection as confirmed by PCR swab, or being treated for non-COVID-19 community acquired pneumonia
- A minimum of oxygen treatment required for 24hours.
- Capacity to give informed and written consent
Who cannot join
- A BMI <16.5 or >35 kg/m2
- Active cardiovascular disease:
- Significant arrhythmia
- Recent acute coronary event
- Cerebrovascular disease:
- Recent stroke
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Impact of COVID-19 Infection on Skeletal Muscle
With the recent worldwide outbreak of the COVID-19 infection and the huge impact it has had upon lives in the UK, it is key to increase knowledge on the impact of the virus on the body. Certain aspects of the virus' characteristics are also poorly understood: The reason behind the variation in response between individuals, and the long-term impacts of infection upon the body. It is already known from previous research that muscle-health plays an important role in health, with other illnesses known to have an impact upon muscle health. A large number of studies have investigated the relationship between muscle and health, with an increasing focus upon the impact upon the mitochondria within the muscle cells. Mitochondria are the energy-producing component of a cell and are vital not just for the muscle-cells but for the body as a whole.
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.
Read the detailed description
Since the outbreak of the COVID-19 pandemic worldwide, there have been over 50,000 deaths and over 1million infections in the UK alone. It has been widely reported that infection with COVID-19 leads to large variation between individuals, a large number appear asymptomatic or mild flu-like symptoms compared to a percentage requiring intensive care support and for some, the infection is ultimately fatal. The reason behind this variation is not yet fully understood.
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
- Covid19, Muscle Loss, Mitochondrial Alteration
- Being tested
- No intervetion will be used
- Medical subject headings
- COVID-19, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervetion will be usedOther
No intervention will be used
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Non-Covid -19 associated community acquired pneumonia with oxygen therapy required.
n=12 Receives: Other: No intervetion 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 Receives: Other: No intervetion 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 Receives: Other: No intervetion will be used |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in mitochondrial function between COVID-19 infection and control group
Assessment of skeletal muscle mitochondrial oxidative phosphorylation rate between COVID-19 associated illness and Control group (non-covid community-acquired pneumonia).
This will be assessed by measuring oxygen consumption using a high-resolution respirometer and expressed as a ratio of maximal rate.
Measured: This will be assessed in each of the 3 time points: the acute admission assessment, as well as in the recovery period of 6-month and 12-month follow up
The difference in mitochondrial function between levels of ventilation support required in COVID-19 patients
Assessment of skeletal muscle mitochondrial oxidative phosphorylation rate assessed using high-resolution respirometer between the 2 groups of ventilatory support in COVID-19 patients (Oxygen only support, non-invasive ventilation). Expressed as a ratio of maximal oxygen consumption.
Measured: each of the 3 time points assessed: the acute admission, as well as in the recovery phases - 6 month and 12 month follow up
The changes in mitochondrial function during the recovery period from COVID-19
Assessment of skeletal muscle mitochondrial oxidative phosphorylation rate using high-resolution respirometer expressed as a percentage change over the time period in each group
Measured: Comparison over the 3 time periods: acute admission, 6month and 12 month follow up
Secondary outcomes (7)
The difference in muscle macroscopic structure between the groups
Ultrasound will allow the research group to provide an estimate of vastus lateralis size (mm3).
This will be compared between the 3 groups.
Measured: This will be assessed in each of the 3 time points: the acute admission assessment, as well as in the recovery period of 6-month and 12-month follow up
The difference in muscle macroscopic structure between the groups
Ultrasound will allow the research group to provide an estimate of fascicle length (mm) between the 3 groups.
Measured: This will be assessed in each of the 3 time points: the acute admission assessment, as well as in the recovery period of 6-month and 12-month follow up
The difference in muscle macroscopic structure between the groups
Ultrasound will allow the research group to provide an estimate of fascicle angle (degrees) between the 3 groups.
Measured: This will be assessed in each of the 3 time points: the acute admission assessment, as well as in the recovery period of 6-month and 12-month follow up
Difference in the neurological supply of skeletal muscle
Measuring iEMG activity from voluntary and involuntary contractions will allow a detailed examination of the nerve-muscle relationship assessed by nerve firing rate (hz)
Measured: This will be assessed in each of the 3 time points: the acute admission assessment, as well as in the recovery period of 6-month and 12-month follow up
Difference in the neurological supply of skeletal muscle
Measuring iEMG activity from voluntary and involuntary contractions will allow a detailed examination of the nerve-muscle relationship encompassing the neuromuscular junction transmission stability (assessed using MUP (uv.ms)
Measured: This will be assessed in each of the 3 time points: the acute admission assessment, as well as in the recovery period of 6-month and 12-month follow up
Difference in the neurological supply of skeletal muscle
Measuring iEMG activity from voluntary and involuntary contractions will allow a detailed examination of the nerve-muscle relationship allowing us to assess nerve conduction time (ms)
Measured: This will be assessed in each of the 3 time points: the acute admission assessment, as well as in the recovery period of 6-month and 12-month follow up
Difference in muscle function
This will be analysed according to handgrip strength performance (measured in kg)
Measured: This will be assessed in each of the 3 time points: the acute admission assessment, as well as in the recovery period of 6-month and 12-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start10 Mar 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Why it stopped: Failure to recruit due to high use of anticoagulants in COVID-19 patients and rapid declining rates of COVID-19 thanks to the vaccine implementation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beth Phillips, BSc PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756674
- Sponsor's protocol ID
- 20065
- Other IDs
- Sponsor ID: 20065
- Status last verified
- Jul 2021
- First submitted
- 2 Nov 2020
- Last updated
- 2 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of COVID-19 Infection on Skeletal Muscle
- ClinicalTrials.gov ID
- NCT04756674
- Acronym / sponsor ID
- 20065
- Conditions
- Covid19, Muscle Loss, Mitochondrial Alteration
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Failure to recruit due to high use of anticoagulants in COVID-19 patients and rapid declining rates of COVID-19 thanks to the vaccine implementation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the recent worldwide outbreak of the COVID-19 infection and the huge impact it has had upon lives in the UK, it is key to increase knowledge on the impact of the virus on the body. Certain aspects of the virus' characteristics are also poorly understood: The reason behind the variation in response between individuals, and the long-term impacts of infection upon the body. It is already known from previous research that muscle-health plays an important role in health, with other illnesses known to have an impact upon muscle health. A large number of studies have investigated the relationship between muscle and health, with an increasing focus upon the impact upon the mitochondria within the muscle cells. Mitochondria are the energy-producing component of a cell and are vital not just for the muscle-cells but for the body as a whole.
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.
Detailed description
Since the outbreak of the COVID-19 pandemic worldwide, there have been over 50,000 deaths and over 1million infections in the UK alone. It has been widely reported that infection with COVID-19 leads to large variation between individuals, a large number appear asymptomatic or mild flu-like symptoms compared to a percentage requiring intensive care support and for some, the infection is ultimately fatal. The reason behind this variation is not yet fully understood.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Other: No intervetion will be usedNon-Covid -19 associated community acquired pneumonia with oxygen therapy required. n=12 |
| Oxygen Therapy | – | Other: No intervetion will be usedConfirmed 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 |
| Non-Invasive ventilation therapy | – | Other: No intervetion will be usedConfirmed 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population of individuals being treated for COVID-19 infection with a minimum of oxygen therapy. Control population of individuals being treated for non-COVID-19 community acquired pneumonia requiring oxygen therapy
Key inclusion criteria (3 listed)
- Confirmed COVID-19 infection as confirmed by PCR swab, or being treated for non-COVID-19 community acquired pneumonia
- A minimum of oxygen treatment required for 24hours.
- Capacity to give informed and written consent
Key exclusion criteria (12 listed)
- A BMI <16.5 or >35 kg/m2
- Active cardiovascular disease:
- Significant arrhythmia
- Recent acute coronary event
- Cerebrovascular disease:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervetion will be usedNo intervention will be used | Other | Control Group, Non-Invasive ventilation therapy, Oxygen Therapy |
Primary outcome
The difference in mitochondrial function between COVID-19 infection and control group
Time frame: This will be assessed in each of the 3 time points: the acute admission assessment, as well as in the recovery period of 6-month and 12-month follow up
Assessment of skeletal muscle mitochondrial oxidative phosphorylation rate between COVID-19 associated illness and Control group (non-covid community-acquired pneumonia). This will be assessed by measuring oxygen consumption using a high-resolution respirometer and expressed as a ratio of maximal rate.
The difference in mitochondrial function between levels of ventilation support required in COVID-19 patients
Time frame: each of the 3 time points assessed: the acute admission, as well as in the recovery phases - 6 month and 12 month follow up
Assessment of skeletal muscle mitochondrial oxidative phosphorylation rate assessed using high-resolution respirometer between the 2 groups of ventilatory support in COVID-19 patients (Oxygen only support, non-invasive ventilation). Expressed as a ratio of maximal oxygen consumption.
The changes in mitochondrial function during the recovery period from COVID-19
Time frame: Comparison over the 3 time periods: acute admission, 6month and 12 month follow up
Assessment of skeletal muscle mitochondrial oxidative phosphorylation rate using high-resolution respirometer expressed as a percentage change over the time period in each group
7 secondary outcomes
The difference in muscle macroscopic structure between the groups
Time frame: This will be assessed in each of the 3 time points: the acute admission assessment, as well as in the recovery period of 6-month and 12-month follow up
The difference in muscle macroscopic structure between the groups
Time frame: This will be assessed in each of the 3 time points: the acute admission assessment, as well as in the recovery period of 6-month and 12-month follow up
The difference in muscle macroscopic structure between the groups
Time frame: This will be assessed in each of the 3 time points: the acute admission assessment, as well as in the recovery period of 6-month and 12-month follow up
Difference in the neurological supply of skeletal muscle
Time frame: This will be assessed in each of the 3 time points: the acute admission assessment, as well as in the recovery period of 6-month and 12-month follow up
Difference in the neurological supply of skeletal muscle
Time frame: This will be assessed in each of the 3 time points: the acute admission assessment, as well as in the recovery period of 6-month and 12-month follow up
Difference in the neurological supply of skeletal muscle
Time frame: This will be assessed in each of the 3 time points: the acute admission assessment, as well as in the recovery period of 6-month and 12-month follow up
Difference in muscle function
Time frame: This will be assessed in each of the 3 time points: the acute admission assessment, as well as in the recovery period of 6-month and 12-month follow up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Phillips, BSc PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Muscle Loss, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in mitochondrial function between COVID-19 infection and control group (time frame: This will be assessed in each of the 3 time points: the acute admission assessment, as well as in the recovery period of 6-month and 12-month follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.