Covid19 Clinical Trial
— MIOCOVIDOfficial title:
Potential Mechanisms of Long-term Muscle Weakness and Decreased Exercise Tolerance in Patients Infected by SARS-COV-2
Verified date | May 2023 |
Source | University of Pavia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | January 30, 2023 |
Est. primary completion date | May 15, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 35 Years to 70 Years |
Eligibility | Inclusion Criteria: - Exclusion Criteria: - presence of cardiovascular, neurological and metabolic disorders. |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera | Alessandria | AL |
Lead Sponsor | Collaborator |
---|---|
University of Pavia | Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional status | Post-COVID-19 Functional Status scale | at least 2 months after infection | |
Primary | 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 | |
Primary | Exercise intolerance | Maximal oxygen consumption during incremental test | at least 2 months after infection | |
Primary | Muscle weakness | Reduced muscle force during isometric contraction | at least 2 months after infection | |
Primary | Pulmonary function | Spirometry and DLCO capacity | at least 2 months after infection | |
Secondary | Muscle fatiguability | Central and peripheral indexes of fatigue after an isotonic exercise | at least 2 months after infection | |
Secondary | Histology and morphology of skeletal muscle | The muscle sections will be stained with: 1) Hoechst nuclear dye for evaluating the presence of nucleated center cells and 2) Hematoxylin and Eosin (H&E) for measuring the area of the cross section of the individual muscle fibers (CSA) and to reveal morphological alterations. The morphological analysis should first demonstrate the presence of atrophy of individual muscle fibers. From the morphological analysis it will also be possible to highlight the presence of inflammatory infiltrates, the presence of core nucleated cells and other signs of structural alteration. | at least 2 months after infection | |
Secondary | Single muscle fiber mechanics | Functional analyzes will be performed on single muscle fibers and on isolated myosin.
The absolute isometric force (Po), the specific isometric force (Po / CSA) and the no-load shortening rate (Vo) of the individual muscle fibers will be determined with the slack test technique. The fibers, chemically deprived of the cell membrane through exposure to detergent (Triton X 100), will be stimulated by exposure to a solution containing Ca2 + and ATP ions. At the end of the functional experiment, the fibers will be collected and typed through the analysis of the isoform content of the myosin heavy chain (MHC). |
at least 2 months after infection | |
Secondary | Ex-vivo muscle oxidative function | Through molecular analyzes it will be possible to investigate the mechanisms underlying the possible myopathic condition. The following molecular investigations will be performed with Real Time-PCR (RT-PCR) and Western Blot (WB) techniques: activation of the signaling pathways of synthesis and protein degradation (IGF-1 / Akt / mTOR; ubiquitin proteosome system, autophagy ); apoptosis; mitochondrial dynamics; redox state. | at least 2 months after infection |
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