NCT07134673

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:

  • 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

June 25, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 21, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

January 21, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

April 22, 2026

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

June 25, 2025

Last Update Submit

April 21, 2026

Conditions

Keywords

mitochondrial dysfunction

Outcome Measures

Primary Outcomes (4)

  • 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)

Secondary Outcomes (16)

  • Proportion of participants meeting the criteria for PEM

    Second study visit (minimally 7 days after the first study visit)

  • General fatigue

    Second study visit (approximately 7 days after the first study visit)

  • Physical fatigue

    Second study visit (approximately 7 days after the first study visit)

  • Mental fatigue

    Second study visit (approximately 7 days after the first study visit)

  • Reduced activities

    Second study visit (approximately 7 days after the first study visit)

  • +11 more secondary outcomes

Other Outcomes (1)

  • Weight (kg)

    Second study visit (approximately 7 days after the first study visit)

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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).
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laarbeeklaan 101

Jette, Brussels Capital, 1090, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood Mononuclear Cells

MeSH Terms

Conditions

Post-Acute COVID-19 SyndromeMitochondrial Diseases

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • 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

Central Study Contacts

Berenice G. Jimenez Garcia, Master of Science

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Clinical Nutrition, Co-director of Vitality Research Group

Study Record Dates

First Submitted

June 25, 2025

First Posted

August 21, 2025

Study Start

January 21, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

April 22, 2026

Record last verified: 2025-08

Locations