The Impact of Covid-19 on Skeletal Muscle

NCT04756674 | Withdrawn

• 2 other identifiers: 20065Sponsor ID: 20065
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Covid19; Muscle Loss; Mitochondrial Alteration

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  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

  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

  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

  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

  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

  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

Study Arms (3)

Control Group

Non-Covid -19 associated community acquired pneumonia with oxygen therapy required. n=12

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

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

Other: No intervetion will be used

Interventions

No intervetion will be used OTHER

No intervention will be used

Control Group; Non-Invasive ventilation therapy; Oxygen Therapy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• A BMI \<16.5 or \>35 kg/m2
• 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

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Royal Derby Hospital

Derby, Derbyshire, DE223NE, United Kingdom

Location

MeSH Terms

Conditions

COVID-19; Muscular Atrophy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Beth Phillips, BSc PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: February 16, 2021
• Study Start: March 10, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: June 2, 2023

Record last verified: 2021-07

Locations

GB (1)