Long COVID / PASC en ME/CFS Long COVID and Myalgic encephalomyelitis/chronic fatigue syndrome
Conditions
Interventions
Not applicable.
Sponsors
Vrije Universiteit
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject with PASC must meet all of the following criteria: * Non-hospitalized individuals with prior confirmed diagnosis of severe acute respiratory coronavirus 2 (SARS-CoV-2) infection by reverse transcription-polymerase chain reaction testing or serology (wantai) testing * Individuals with diagnosed PASC by a post-covid physician * >3 months of symptoms * Post exertional malaise, according to the DSQ-PEM questionnaire or 1:1 interview with post-covid physician * No symptoms present before confirmed diagnosis of severe acute respiratory coronavirus 2 * Aged between 18-65 years In order to be eligible to participate in this study, a subject with ME/CFS must meet all of the following criteria: * Fulfill the Canadian Consensus Criteria (CCC) * Post exertional malaise, according to the DSQ-PEM questionnaire or 1:1 interview with post-covid physician * >3 months of symptoms * ME/CFS diagnosis
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * History of asthma, stroke, chronic obstructive pulmonary disease, congestive heart failure, heart surgery, or congenital heart diseases * Severe illness (e.g., cancer, CHD, uncontrolled diabetes) * Current treatment with drugs known to interfere with metabolism e.g. systemic corticosteroids, statins, SGLT2 inhibitors, GLP1 receptor agonists or immune modulatory drugs in the last three months. * Severe psychiatric or mood disorders * Are current smokers or have been a regular smoker within the last 12 months * Insulin pump therapy * Symptomatic autonomic or distal neuropathy * BMI >35 due to adiposity, since this is known to cause difficulties in obtaining muscle biopsies. * Pregnancy * Recent acute myocardial infarction (150 mmHg and Diastolic Blood Pressure > 100 mmHg on repeated measurements) * Active infection, anaemia, severe renal dysfunction (estimated Glomerular filtration rate 6 alcohol units per day or >14 alcohol units per week * Use of anticoagulants or anti platelet therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study parameters are listed below. A detailed description of the methodology to determine these parameters is written in the section on data and statistical analysis (section 10). The primary outcome parameters are skeletal muscle and blood determinants (see 5.1.1). Secondary outcome parameters include exercise tolerance, maximal and submaximal parameters of aerobic function (i.e. VO2max and lactate threshold), intracellular metabolite concentrations derived from biopsies, heart rate variability and measures of muscle oxygenation derived via near-infrared spectroscopy (NIRS). 4.6 Main study parameter/endpoint Primary outcome parameters of this study are markers for local and systemic inflammation, mitochondrial respiratory function and myokine concentrations. Each of these variables will be assessed via muscle biopsy of the vastus lateralis muscle and venous blood samples. The following primary parameters will be evaluated: Markers of local (muscle) and systemic (venous blood) inflammation: • macrophage count and infiltration into skeletal muscle • IL-6, creatine kinase, troponin Mitochondrial function: • markers for OXPHOS subunits, mitochondrial fission/fusion and mitophagy • Mitochondrial ROS production • Electron microscopy: mitochondrial ultrastructure, intramuscular glycogen deposits and lipid storage Myokine concentrations: • IL-6, GDF15, FGF-21, and other newly discovered myokines | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters of this study involve other parameters of exercise tolerance and aerobic function. The peak work rate attained during ramp incremental exercise (WRpeak) will be used to measure exercise tolerance. The key parameters of aerobic function that will be assessed include: VO2max, the gas exchange threshold, the respiratory compensation point, the gain (i.e. efficiency) of the oxygen uptake (VO2) response to ramp incremental exercise, and the mean response time of the VO2 response. Other secondary outcome measures include the non-invasive measurements of muscle oxidative metabolism (i.e. tissue saturation index [TSI], oxygenated hemoglobin [O2Hb] and deoxygenated hemoglobin [HHb], measured by NIRS) during ramp incremental exercise, the heart rate variability (HRV), and daily activity. Relationships between these parameters and the parameters of exercise tolerance, aerobic function, muscle biopsy, proteomics, metabolomics, transcriptomics and auto-immunity will also be explored. Measured through heart rate monitoring during 14 consecutive days, to establish the total time spent in low, moderate and vigorous intensity activities. Activity monitors will be used to determine the total step count during the 14 day period and subjects will also be asked to keep an activity diary. | — |
Countries
Netherlands
Contacts
Public ContactR.C.I. Wüst
Vrije Universiteit
Outcome results
None listed