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| ID | Type | Description | Link |
|---|---|---|---|
| G075423N | Other Identifier | Vrije Universiteit Brussel, Universitair Ziekenhuis Brussel |
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Mitochondria are structures inside cells that are responsible for producing energy from nutrients through a series of steps, using oxygen. To have an idea of how well the mitochondria can produce energy, we can measure how much oxygen they use. The goal of this study is to:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals with long COVID | History of a confirmed or documented SARS-CoV-2 infection and long COVID according to the World Health Organisation's clinical case definition | ||
| Convalescent individuals | History of a confirmed or documented SARS-CoV-2 infection, complete recovery after the SARS-CoV-2 infection, no history of long COVID according to the World Health Organisation's clinical case definition |
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| Measure | Description | Time Frame |
|---|---|---|
| Basal Oxygen Consumption rate (pmol O2/min) | Seahorse XF Substrate Oxidation Stress test analysis of the peripheral blood mononuclear cells (PBMCs) | Blood sample is taken during the second study visit (approximately 7 days after the first study visit) and the PBMCs are cryopreserved until analysis (after all participants have been recruited, estimated to be within 1 year of the start of the study) |
| Tissue Saturation Index (TSI) | Near-infrared spectroscopy | Second study visit (approximately 7 days after the first study visit) |
| Mitochondrial oxygen tension (mitoPO2) (mmHg/s) | Cellular Oxygen Metabolism monitoring | Second study visit (approximately 7 days after the first study visit) |
| Mitochondrial oxygen consumption (mitoVO2) | Cellular Oxygen Metabolism monitoring | Second study visit (minimally 7 days after the first study visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants meeting the criteria for PEM | De Paul Symptom Questionnaire - Post-exertional malaise (DSQ-PEM) | Second study visit (minimally 7 days after the first study visit) |
| General fatigue |
| Measure | Description | Time Frame |
|---|---|---|
| Weight (kg) | Body weight (kg) in light indoor clothes without shoes. | Second study visit (approximately 7 days after the first study visit) |
Individuals with long COVID:
Inclusion criteria:
Exclusion criteria:
Convalescent individuals
Inclusion criteria:
Exclusion criteria:
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Study participants will be recruited in the Universitair Ziekenhuis Brussel, from the general population in Belgium through traditional and social media, as well as in the vicinity of the study site through leaflets and posters.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Berenice G. Jimenez Garcia, Master of Science | Contact | +3224749624 | berenice.gabriela.jimenez.garcia@vub.be |
| Name | Affiliation | Role |
|---|---|---|
| Elisabeth De Waele, MD. PhD. | Vitality Research Group, Metabolism and Nutrition, Vrije Universiteit Brussel (VUB), Clinical Nutrition Department, Universitair Ziekenhuis Brussel (UZ Brussel) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laarbeeklaan 101 | Recruiting | Jette | Brussels Capital | 1090 | Belgium |
Based on the guidelines and regulations of the Vrije Universiteit Brussel, the IPD will be shared. Plan is yet to be determined.
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D028361 | Mitochondrial Diseases |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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Peripheral Blood Mononuclear Cells
Multidimensional Fatigue Inventory (MFI-20)
| Second study visit (approximately 7 days after the first study visit) |
| Physical fatigue | Multidimensional Fatigue Inventory (MFI-20) | Second study visit (approximately 7 days after the first study visit) |
| Mental fatigue | Multidimensional Fatigue Inventory (MFI-20) | Second study visit (approximately 7 days after the first study visit) |
| Reduced activities | Multidimensional Fatigue Inventory (MFI-20) | Second study visit (approximately 7 days after the first study visit) |
| Reduced motivation | Multidimensional Fatigue Inventory (MFI-20) | Second study visit (approximately 7 days after the first study visit) |
| Severity and impact of fatigue on daily life | The Fatigue Severity Scale (FSS) contains nine statements that rate the severity of the fatigue symptoms. The statements are rated from 1 to 7, with a low value indicating strong disagreement with the statement and a high value indicating strong agreement with the statement. The total score is the sum of the individual scores, with a higher score indicating a greater impact of fatigue on daily life. | Second study visit (approximately 7 days after the first study visit) |
| Symptom burden (θ) | Item Response Theory (IRT) will be applied to estimate a latent trait representing symptom burden, using Section 2.6 of the WHO Post-COVID-19 Case Report Form. Symptoms will be coded as binary variables (1 = symptom present, 0 = symptom absent). IRT modeling will be used to derive a latent trait estimate (θ) for each individual, reflecting the overall severity or burden of symptoms. | First study visit |
| Resting Energy Expenditure (kcal/kg body weight/day) | Indirect calorimetry will be used to measure the Resting Energy Expenditure (kcal/day). This value will be divided by the body weight (kg) on that same day. | Second study visit (approximately 7 days after the first study visit) |
| Basal Oxygen Consumption rate (pmol O2/min) | Seahorse XF Substrate Oxidation Stress test analysis of the peripheral blood mononuclear cells (PBMCs) after substrate pathway inhibitor Etomoxir is used | Blood sample is taken during the second study visit (approximately 7 days after the first study visit) and the PBMCs are cryopreserved until analysis (after all participants have been recruited, estimated to be within 1 year of the start of the study) |
| Basal Oxygen Consumption rate (pmol O2/min) | Seahorse XF Substrate Oxidation Stress test analysis of the peripheral blood mononuclear cells (PBMCs) after substrate pathway inhibitor UK5099 is used | Blood sample is taken during the second study visit (approximately 7 days after the first study visit) and the PBMCs are cryopreserved until analysis (after all participants have been recruited, estimated to be within 1 year of the start of the study) |
| Basal Oxygen Consumption rate (pmol O2/min) | Seahorse XF Substrate Oxidation Stress test analysis of the peripheral blood mononuclear cells (PBMCs) after substrate pathway inhibitor BPTES is used | Blood sample is taken during the second study visit (approximately 7 days after the first study visit) and the PBMCs are cryopreserved until analysis (after all participants have been recruited, estimated to be within 1 year of the start of the study) |
| Maximal Oxygen Consumption rate (pmol O2/min) | Seahorse XF Substrate Oxidation Stress Test analysis of the peripheral blood mononuclear cells (PBMCs) after substrate pathway inhibitor Etomoxir is used | Blood sample is taken during the second study visit (approximately 7 days after the first study visit) and the PBMCs are cryopreserved until analysis (after all participants have been recruited, estimated to be within 1 year of the start of the study) |
| Maximal Oxygen Consumption rate (pmol O2/min) | Seahorse XF Substrate Oxidation Stress Test analysis of the peripheral blood mononuclear cells (PBMCs) after substrate pathway inhibitor UK5099 is used | Blood sample is taken during the second study visit (approximately 7 days after the first study visit) and the PBMCs are cryopreserved until analysis (after all participants have been recruited, estimated to be within 1 year of the start of the study) |
| Maximal Oxygen Consumption rate (pmol O2/min) | Seahorse XF Substrate Oxidation Stress Test analysis of the peripheral blood mononuclear cells (PBMCs) after substrate pathway inhibitor BPTES is used | Blood sample is taken during the second study visit (approximately 7 days after the first study visit) and the PBMCs are cryopreserved until analysis (after all participants have been recruited, estimated to be within 1 year of the start of the study) |
| Respiratory Quotient | Indirect calorimetry | Second study visit (approximately 7 days after the first study visit) |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |