Muscle Weakness in COVID-19 Patients

NCT04959773 | Completed

• 1 other identifier: UPavia-MIOCOVID
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Although the Covid-19 infection mainly manifests itself with respiratory symptoms, as early as two months after the onset of the pandemic, the presence of other symptoms, including muscle ones, became clear. With the disappearance of the emergency and the advancement of knowledge, medium- and long-term effects have been reported at the level of different organs and systems. Many patients, after several months from infection, report intolerance to exercise and many suffer from pain and muscle weakness. No studies has been carried out on the muscular consequences of the infection and on their possible contribution to intolerance to exercise. Since skeletal muscle possesses the ACE2 receptor (Angiotensin converting enzyme 2) to which SARS-Cov-2 binds, it follows that the involvement of the skeletal muscle could be due not only to the secondary effects of the infection (e.g. reduced oxygen supply from persistent lung disease, perfusion defects from cardiovascular defects and vascular damage), but also to the direct action of virus (SARS-Cov-2 myositis). The general purpose of the research is to quantify the spread of symptoms and signs of muscle weakness and pain among the patient population welcomed at the Cardiorespiratory Rehabilitation Department of the Alexandria Hospital which have been suffering from SARS-CoV-2, being discharged and healed for more than two months, and define the possible contribution of muscular modifications to exercise intolerance.

Conditions

SARS-CoV Infection; Covid19; Muscle Weakness; Exercise Intolerance

Outcome Measures

Primary Outcomes (5)

• Functional status

  Post-COVID-19 Functional Status scale

  at least 2 months after infection

• Perceived quality of life by EQ-5D-5L

  The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

  at least 2 months after infection

• Exercise intolerance

  Maximal oxygen consumption during incremental test

  at least 2 months after infection

• Muscle weakness

  Reduced muscle force during isometric contraction

  at least 2 months after infection

• Pulmonary function

  Spirometry and DLCO capacity

  at least 2 months after infection

Secondary Outcomes (4)

• Muscle fatiguability

  at least 2 months after infection

• Histology and morphology of skeletal muscle

  at least 2 months after infection

• Single muscle fiber mechanics

  at least 2 months after infection

• Ex-vivo muscle oxidative function

  at least 2 months after infection

Study Arms (3)

COVID+ with exercise intolerance

Patients of both sexes who have contracted SARS-COV-2 infection (swab positive and positive serological test (IgG)) and who suffer from muscle weakness after more than two months from infection. The presence of cardiovascular or internal pathologies or in any case of serious disease will be considered an exclusion criterion. general conditions.

COVID+ without exercise intolerance

Patients of both sexes who have contracted SARS-COV-2 infection (swab positive and positive serological test (IgG)) and who recovered and came to their normal life. The presence of cardiovascular or internal pathologies or in any case of serious disease will be considered an exclusion criterion.

Control healthy subjects (CTRL)

Subjects of both sexes who do not have contracted SARS-COV-2 infection (swab negative and negative serological test (IgG)). The presence of cardiovascular or internal pathologies or in any case of serious disease will be considered an exclusion criterion.

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be divided into three Groups : * COVID+ with exercise intolerance Patients of both sexes who have contracted SARS-COV-2 infection (swab positive and positive serological test (IgG)) and who suffer from muscle weakness after more than two months from infection. * COVID+ without exercise intolerance Patients of both sexes who have contracted SARS-COV-2 infection (swab positive and positive serological test (IgG)) and who recovered and came to their normal life. * CTRL Subjects of both sexes who do not have contracted SARS-COV-2 infection (swab negative and negative serological test (IgG)).

You may not qualify if:

• presence of cardiovascular, neurological and metabolic disorders.

Sponsors & Collaborators

• University of Pavia: lead
• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: collaborator

Study Sites (1)

Azienda Ospedaliera

Alessandria, AL, 15121, Italy

Location

MeSH Terms

Conditions

Severe Acute Respiratory Syndrome; COVID-19; Muscle Weakness

Condition Hierarchy (Ancestors)

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

Study Officials

• Biagio Polla, MD

  AO SS Alessandria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: July 13, 2021
• Study Start: November 15, 2020
• Primary Completion: May 15, 2022
• Study Completion: January 30, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)