Mitochondrial Function in Peripheral Blood Mononuclear Cells, Muscle, and Skin of Long COVID Patients

Официальное название

Mitochondrial Oxygen Consumption and Substrate Utilisation In Vitro in Peripheral Blood Mononuclear Cells, and In Vivo on Muscle and Skin in Long COVID Patients and Convalescent Individuals: A Case-Control and Diagnostic Accuracy Study

Обзор

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.

Первичные конечные точки

• Basal Oxygen Consumption rate (pmol O2/min) [Срок оценки: 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) [Срок оценки: Second study visit (approximately 7 days after the first study visit)]
• Mitochondrial oxygen tension (mitoPO2) (mmHg/s) [Срок оценки: Second study visit (approximately 7 days after the first study visit)]
• Mitochondrial oxygen consumption (mitoVO2) [Срок оценки: Second study visit (minimally 7 days after the first study visit)]

Вторичные конечные точки (12)

• Proportion of participants meeting the criteria for PEM [Срок оценки: Second study visit (minimally 7 days after the first study visit)]
• General fatigue [Срок оценки: Second study visit (approximately 7 days after the first study visit)]
• Physical fatigue [Срок оценки: Second study visit (approximately 7 days after the first study visit)]
• Mental fatigue [Срок оценки: Second study visit (approximately 7 days after the first study visit)]
• Reduced activities [Срок оценки: Second study visit (approximately 7 days after the first study visit)]
• Reduced motivation [Срок оценки: Second study visit (approximately 7 days after the first study visit)]
• Severity and impact of fatigue on daily life [Срок оценки: Second study visit (approximately 7 days after the first study visit)]
• Symptom burden (θ) [Срок оценки: First study visit]
• Resting Energy Expenditure (kcal/kg body weight/day) [Срок оценки: Second study visit (approximately 7 days after the first study visit)]
• Basal Oxygen Consumption rate (pmol O2/min) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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)]

Критерии участия

Individuals with long COVID:

Критерии включения

• 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.

Критерии исключения

• 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

Критерии включения

• 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).

Критерии исключения

• Pre-existing chronic non-communicable diseases (e.g. hypertension, chronic respiratory diseases, diabetes).
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Бельгия · 1 центр

• Laarbeeklaan 101 — Jette

Идентификаторы

NCT: NCT07134673 · EC-2025-071 · G075423N

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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