Long COVID, Post-COVID-19 Condition
Conditions
Keywords
mitochondrial dysfunction
Brief summary
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: 1. To compare the oxygen use between people with long COVID and people who completely recovered after COVID-19, using three techniques that measure the oxygen use in blood cells, on the skin and in the muscle 2. To test how similar these three techniques are in measuring the oxygen used in the three different tissues Participants will: * Complete surveys, * Wear an activity tracker (7 days), * Undergo several non-invasive tests, and * Donate a blood sample The study will take place in UZ Brussel hospital and will take 2 study visits, approximately 7 days apart.
Interventions
None listed
Sponsors
Universitair Ziekenhuis Brussel
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Individuals with long COVID: Inclusion criteria: * Long COVID diagnosis, based on the WHO definition; * Presence of long COVID symptoms for a minimum of 6 months. * History of confirmed or documented SARS-CoV-2 infection. * Adult (≥18 years of age). * Post-COVID-19 Functional Status Scale grade 2-4, while they had a grade 0 before the SARS-CoV-2 infection.
Exclusion criteria
* Pre-existing chronic diseases potentially affecting the functional status scale. * Treatment with metabolism altering drugs. * \> 10 standard units of alcohol (10 grams of alcohol/glass) per week. * Unable to understand oral and written instructions in Dutch, French or English. * Allergies to medical adhesive bandages. * Porphyria and other skin conditions aggravated by sunlight. Convalescent individuals Inclusion criteria: * History of confirmed or documented SARS-CoV-2 infection. * Complete recovery after the SARS-CoV-2 infection, no history of long COVID based on the WHO definition; * Post-COVID-19 Functional Status Scale \[2\] grade 0 both before the infection and currently. * Adult (≥18 years of age).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Basal Oxygen Consumption rate (pmol O2/min) | 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) | Seahorse XF Substrate Oxidation Stress test analysis of the peripheral blood mononuclear cells (PBMCs) |
| Tissue Saturation Index (TSI) | Second study visit (approximately 7 days after the first study visit) | Near-infrared spectroscopy |
| Mitochondrial oxygen tension (mitoPO2) (mmHg/s) | Second study visit (approximately 7 days after the first study visit) | Cellular Oxygen Metabolism monitoring |
| Mitochondrial oxygen consumption (mitoVO2) | Second study visit (minimally 7 days after the first study visit) | Cellular Oxygen Metabolism monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants meeting the criteria for PEM | Second study visit (minimally 7 days after the first study visit) | De Paul Symptom Questionnaire - Post-exertional malaise (DSQ-PEM) |
| General fatigue | Second study visit (approximately 7 days after the first study visit) | Multidimensional Fatigue Inventory (MFI-20) |
| Physical fatigue | Second study visit (approximately 7 days after the first study visit) | Multidimensional Fatigue Inventory (MFI-20) |
| Mental fatigue | Second study visit (approximately 7 days after the first study visit) | Multidimensional Fatigue Inventory (MFI-20) |
| Reduced activities | Second study visit (approximately 7 days after the first study visit) | Multidimensional Fatigue Inventory (MFI-20) |
| Reduced motivation | Second study visit (approximately 7 days after the first study visit) | Multidimensional Fatigue Inventory (MFI-20) |
| Severity and impact of fatigue on daily life | Second study visit (approximately 7 days after the first study visit) | 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. |
| Symptom burden (θ) | First study visit | 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. |
| Resting Energy Expenditure (kcal/kg body weight/day) | Second study visit (approximately 7 days after the first study visit) | 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. |
| Basal Oxygen Consumption rate (pmol O2/min) | 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) | Seahorse XF Substrate Oxidation Stress test analysis of the peripheral blood mononuclear cells (PBMCs) after substrate pathway inhibitor Etomoxir is used |
| Maximal Oxygen Consumption rate (pmol O2/min) | 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) | Seahorse XF Substrate Oxidation Stress Test analysis of the peripheral blood mononuclear cells (PBMCs) after substrate pathway inhibitor Etomoxir is used |
| Respiratory Quotient | Second study visit (approximately 7 days after the first study visit) | Indirect calorimetry |
Countries
Belgium
Contacts
CONTACTBerenice G. Jimenez Garcia, Master of Science
PRINCIPAL_INVESTIGATORElisabeth De Waele, MD. PhD.
Vitality Research Group, Metabolism and Nutrition, Vrije Universiteit Brussel (VUB), Clinical Nutrition Department, Universitair Ziekenhuis Brussel (UZ Brussel)
Outcome results
None listed