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MONITOR-PEM

Mitochondrial Oxygenation as ambulatory Non-Invasive Test for Objective Recognition of Post Exertional Malaise (MONITOR-PEM) - MONITOR-PEM

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57921
Enrollment
200
Registered
2025-03-24
Start date
2025-10-30
Completion date
Unknown
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long COVID, mitochondrial dysfunction, post-exertional malaise (PEM), microcirculation LONG COVID, reduced cell energy, crash after effort (PEM), Blood flow in the tiniest blood vessels

Interventions

To measure mitoPO2 and mitoVO2, a 5-ALA patch is applied to the skin of the upper arm. This substance is converted into PPIX within the mitochondria, which reacts with oxygen. This reaction allows us

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 64 Years

Inclusion criteria

Inclusion criteria: Long - COVID patients (group 1, 2 and 4) Age:Group 1 and 2: >18 years and <65 yearsGroup 4: >6 years and <65 yearsLong COVID-19 diagnosis, based on   Positive PCR  Positive Sars-Cov2 serology   Positive rapid antigen testTypical clinical syndrome during the first pandemic wave, when testing was not possible Long COVID/Post-COVID-19 diagnosis based on World Health Organisation (WHO) consensus diagnosis: (“Long COVID-19 condition occurs in individuals with a history of probable or confirmed SARS CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms and that last for at least 2 months and cannot be explained by an alternative diagnosis. Symptoms may be new onset following initial recovery from an acute COVID-19 episode or persist from the initial illness. Symptoms may also fluctuate or relapse over time)”  Bell's Disability Scale score 30 - 60 (group 1) or =30 (group 2)  Long COVID duration > 6 months Reduced school attendance, more than 20% absence (group 4) Presence of post-exertional malaise (self-reported)  Provided written informed consent  Convalescent Controls Age:Group 1 and 2: >18 years and <65 yearsGroup 4: >6 years and <65 yearsPast COVID-19 diagnosis, based on   Positive PCR  Positive Sars-Cov2 serology   Positive rapid antigen test  Typical clinical syndrome during the first pandemic wave, when testing was not possible  No diagnosis of long COVID, good recovery. Overall functioning >95% compared to functioning prior COVID-19 infection  Self-reported general good wellbeing  Provided written informed consent   MIS-C patients (Group 3) Age >6 years and <65 years  PICU admission in acute fase of illness related to COVID-19 infection Post COVID-19 diagnosis, based on   Positive PCR  Positive Sars-Cov2 serology   Positive rapid antigen test  Typical clinical syndrome during the first pandemic wave, when testing was not possible Self-reported complaints resulting in a varying impact on daily life (including PEM, saltered school attendance) 

Exclusion criteria

Exclusion criteria: Long COVID and MIS-C patients  Unable or not willing to provide written informed consent  Unable to complete written questionnaires in Dutch  Alternative diagnosis that may explain clinical symptoms   Active treatment with hyperbaric oxygen treatment during study start  Diagnosis of dementia  Suffering from any immune-driven disease or structural use of anti-inflammatory therapy of any kind (including NSAIDs and steroids) during the last 3 months  Re-infection with SARS-CoV-2 or a booster vaccination in the past 3 months Suffering from uncontrolled hypertension, diabetes mellitus Use of anticoagulants in last 4 weeks  Convalescent Controls Unable or not willing to provide written informed consent  Unable to complete written questionnaires in Dutch  Diagnosis of dementia  Suffering from any immune-driven disease or structural use of anti-inflammatory therapy of any kind (including NSAIDs and steroids), including during the last 3 months  Re-infection with SARS-CoV-2 or a booster vaccination in the past 3 months.  Suffering from uncontrolled hypertension, diabetes mellitus Use of anticoagulants in last 4 weeks

Design outcomes

Primary

MeasureTime frame
Changes in mitoPO2 and mitoVO2 before and after sub-maximal exercise and during a follow-up visit (after 24-72 hours) during a consecutive PEM-episode.  

Secondary

MeasureTime frame
As secondary objectives, we aim to explore the underlying mechanisms of PEM in long COVID by investigating potential contributors such as tissue hypoxia, microvascular dysfunction, and impaired oxygen utilization. This includes examining the roles of inflammation, endothelial dysfunction, altered angiogenesis and in vivo mitochondrial testing.

Countries

Netherlands

Contacts

Public ContactF.A. Harms

Erasmus MC, Universitair Medisch Centrum Rotterdam

f.harms@erasmusmc.nl010 7033458

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Sep 19, 2026