Skeletal Muscle Wasting in SARS-CoV-2

NCT ID: NCT04698798

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-02
• Study Completion Date: 2021-04-03

Brief Summary

The SARS-CoV-2 pandemic causes a major burden on patient and staff admitted/working on the intensive care unit (ICU). Short, and especially long admission on the ICU causes major reductions in skeletal muscle mass (3-4% a day) and strength. Since it is now possible to reduce mortality on the ICU, short and long-term morbidity should be considered another principal endpoint after SARS-CoV-2 infection. Cachexia is defined as 'a complex metabolic syndrome associated with underlying illness and characterized by loss of muscle mass'. Its clinical features are weight loss, low albumin, anorexia, increased muscle protein breakdown and inflammation. There is strong evidence that cachexia develops rapidly in patients hospitalized for SARS-CoV-2 infection, especially on the ICU. Several mechanisms are believed to induce cachexia in SARS-CoV-2. Firstly, the virus can interact with muscle cells, by binding to the angiotensin converting enzyme 2 (ACE-2). In vitro studies have shown the virus can cause myofibrillar fragmentation into individual sarcomeres, in addition to loss of nuclear DNA in cardiomyocytes. Similar results were found during autopsies. On a cellular level, nothing is known about the effects of SARS-CoV-2 infection on skeletal muscle cells. However, up to 19.4% of patients present with myalgia and elevated levels of creatine kinases (>200U/l), suggesting skeletal muscle injury. Moreover, patients with SARS-CoV-2 infection are shown to have elevated levels of C-reactive protein and other inflammatory cytokines which can all affect skeletal muscles. The above mentioned factors are not the only mediators by which skeletal muscle mass might be affected in SARS-CoV-2. There are other known factors to affect skeletal muscle mass on the ICU, i.e. immobilization and mechanical ventilation, dietary intake (anorexia) and inflammatory cytokines. SARS-CoV-2 infection in combination with bed rest and mechanical ventilation can lead to severe muscle wasting and functional decline resulting in long-term morbidity.

Until know there are no studies investigating acute skeletal muscle wasting in patients infected with SARS-CoV-2 and admitted to the ICU. As a result, there is a need of more in-depth understanding the effects of SARS-CoV-2 infection on muscle wasting. An optimal characterization of these effects may lead to improvement in morbidity and even mortality in the short and long term by the establishment of evidence-based rehabilitation programs for these patients.

Conditions

Cachexia; Muscle Loss; Muscle Wasting; Muscle Atrophy; Critical Illness

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Skeletal muscle wasting

investigating acute skeletal muscle wasting in patients infected with SARS-CoV-2 and admitted to the ICU

Group Type: EXPERIMENTAL

Muscle Biopsy

Intervention Type: PROCEDURE

Patients will be treated for SARS-CoV-2 symptoms on the intensive care unit. During this treatment two muscle biopsies will be obtained with an interval of seven days between them.

Interventions

Muscle Biopsy

Patients will be treated for SARS-CoV-2 symptoms on the intensive care unit. During this treatment two muscle biopsies will be obtained with an interval of seven days between them.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age >18 years
• SARS-CoV-2 infection
• Expected stay to ICU of > 7 days

Exclusion Criteria

• Spinal cord injury
• Chronic use of corticosteroids before hospital admission

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jessa Hospital

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Frank Vandenabeele

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Vandenabeele, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Sjoerd stevens, drs.

Role: STUDY_CHAIR

Hasselt University

Locations

Jessa Ziekenhuis

Hasselt, , Belgium

Countries

Belgium

Other Identifiers

SMW-CoV-2

Identifier Type: -

Identifier Source: org_study_id