Mitochondrial Function in Peripheral Blood Mononuclear Cells, Muscle, and Skin of Long COVID Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
54 Participants
are grouped into 2 trial groupsGroup A: Individuals with long COVID
Group B: Convalescent individuals
Trial outcomes
Primary outcomes
1
Basal Oxygen Consumption rate (pmol O2/min)
Seahorse XF Substrate Oxidation Stress test analysis of the peripheral blood mononuclear cells (PBMCs)
Time frame
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)2
Tissue Saturation Index (TSI)
Near-infrared spectroscopy
Time frame
Second study visit (approximately 7 days after the first study visit)3
Mitochondrial oxygen tension (mitoPO2) (mmHg/s)
Cellular Oxygen Metabolism monitoring
Time frame
Second study visit (approximately 7 days after the first study visit)4
Mitochondrial oxygen consumption (mitoVO2)
Cellular Oxygen Metabolism monitoring
Time frame
Second study visit (minimally 7 days after the first study visit)Secondary outcomes
1
Proportion of participants meeting the criteria for PEM
De Paul Symptom Questionnaire - Post-exertional malaise (DSQ-PEM)
Time frame
Second study visit (minimally 7 days after the first study visit)2
General fatigue
Multidimensional Fatigue Inventory (MFI-20)
Time frame
Second study visit (approximately 7 days after the first study visit)3
Physical fatigue
Multidimensional Fatigue Inventory (MFI-20)
Time frame
Second study visit (approximately 7 days after the first study visit)4
Mental fatigue
Multidimensional Fatigue Inventory (MFI-20)
Time frame
Second study visit (approximately 7 days after the first study visit)Other outcomes
1
Weight (kg)
Body weight (kg) in light indoor clothes without shoes.
Time frame
Second study visit (approximately 7 days after the first study visit)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov