Post-Acute COVID-19 SyndromeNCT05758558
Cognitive, Psychological, and Physical Functioning in Long-COVID Patients With Different Levels of Fatigue.
An observational study of Post-Acute COVID-19 Syndrome, run by Hasselt University at 1 site in Belgium.
Trial summary
Post COVID-19 usually occurs 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Patients report a range of disabling symptoms such as fatigue, shortness of breath, cognitive impairment, memory loss and mental health and employment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Acute COVID-19 Syndrome
- How many people
- 69 participants
- Where
- 1 siteBelgium
- Study dates
- 5 May 2023to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants that match the criteria of the recently published definition of the post-COVID-19 condition will be considered eligible to participate in the study.[8] Post-COVID-19 has been defined as a condition that occurs in individuals with a history of confirmed SARS-CoV-2 infection, and that occurs usually within three months from the onset of COVID-19 with symptoms that last for at least two months and cannot be explained by an alternative diagnosis. Consequently, participants that either have or have not been hospitalized will both be allowed to participate in this study. COVID infection will be self-reported by the participant. Participants will be encouraged to show any test certificate but they are not obligated to do so.
Who may be able to join
- The participant must report current persisting symptoms (such as brain fog, anxiety, shortness of breath, headaches but also others) and indicate on the Post COVID-19 Functional Status Scale that these have an impact on everyday functioning (grade 2, 3, and 4). These symptoms need to be present for more than two months.
- Further inclusion criteria are:
- Fatigue Severity Scale (FSS) score > 4
- Aged over 18 years old
- Willing to sign the digital informed consent
- Dutch speaking and Dutch understanding
- Be tested positive for COVID-19, i.e. by reverse transcription polymerase chain reaction (RT-PCR), computed tomography (CT) of the lungs, or symptom-based diagnosis by the general practitioner.
Who cannot join
- Pregnant women
- Pacemaker, defibrillator
- Brain or nerve disorders
- Epilepsy
- A copper spiral or recent bone fracture
Trial locations and contacts
1 site in 1 country.
About this study
Post COVID-19 usually occurs 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Patients report a range of disabling symptoms such as fatigue, shortness of breath, cognitive impairment, memory loss and mental health and employment issues. This clinical heterogeneity complicates the identification of the appropriate needs and care.
The aim of this cross-sectional study is to identify subgroups (clusters) of post COVID patients based on clinical symptoms, demographic characteristics, levels of fatigue and physical, cognitive and psychological functioning of the individuals.
- Conditions
- Post-Acute COVID-19 Syndrome
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical evaluation
Hand grip strength (Jamar hand dynamometer) \& Six Minute Walk Test (6MWT)
Measured: Day 1
Fatigue severity
Fatigue severity scale (FSS)
Measured: Day 1
Psychological evaluation
Anxiety and depression Scale (HADS); MINI-S, MINI International Neuropsychiatric Interview - Simplified (Overbeek \& Schruers 2019)
Measured: Day 1
Cognitive evaluation
Multi-modal Evaluation of Sensory Sensitivity (MESSY); Montreal Cognitive Assessment (MoCA)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start5 May 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Acute COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stef Feijen, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758558
- Sponsor's protocol ID
- CME2022/021 S66200
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2023
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive, Psychological, and Physical Functioning in Long-COVID Patients With Different Levels of Fatigue.
- ClinicalTrials.gov ID
- NCT05758558
- Acronym / sponsor ID
- CME2022/021 S66200
- Conditions
- Post-Acute COVID-19 Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post COVID-19 usually occurs 3 months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot be explained by an alternative diagnosis. Patients report a range of disabling symptoms such as fatigue, shortness of breath, cognitive impairment, memory loss and mental health and employment issues. This clinical heterogeneity complicates the identification of the appropriate needs and care.
The aim of this cross-sectional study is to identify subgroups (clusters) of post COVID patients based on clinical symptoms, demographic characteristics, levels of fatigue and physical, cognitive and psychological functioning of the individuals.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants that match the criteria of the recently published definition of the post-COVID-19 condition will be considered eligible to participate in the study.[8] Post-COVID-19 has been defined as a condition that occurs in individuals with a history of confirmed SARS-CoV-2 infection, and that occurs usually within three months from the onset of COVID-19 with symptoms that last for at least two months and cannot be explained by an alternative diagnosis. Consequently, participants that either have or have not been hospitalized will both be allowed to participate in this study. COVID infection will be self-reported by the participant. Participants will be encouraged to show any test certificate but they are not obligated to do so.
Key inclusion criteria (7 listed)
- The participant must report current persisting symptoms (such as brain fog, anxiety, shortness of breath, headaches but also others) and indicate on the Post COVID-19 Functional Status Scale that these have an impact on everyday functioning (grade 2, 3, and 4). These symptoms need to be present for more than two months.
- Fatigue Severity Scale (FSS) score > 4
- Aged over 18 years old
- Willing to sign the digital informed consent
- Dutch speaking and Dutch understanding
Key exclusion criteria (5 listed)
- Pregnant women
- Pacemaker, defibrillator
- Brain or nerve disorders
- Epilepsy
- A copper spiral or recent bone fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical evaluation
Time frame: Day 1
Hand grip strength (Jamar hand dynamometer) \& Six Minute Walk Test (6MWT)
Fatigue severity
Time frame: Day 1
Fatigue severity scale (FSS)
Psychological evaluation
Time frame: Day 1
Anxiety and depression Scale (HADS); MINI-S, MINI International Neuropsychiatric Interview - Simplified (Overbeek \& Schruers 2019)
Cognitive evaluation
Time frame: Day 1
Multi-modal Evaluation of Sensory Sensitivity (MESSY); Montreal Cognitive Assessment (MoCA)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Acute COVID-19 Syndrome, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical evaluation (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.