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COVID-19Phase 2/3COVFATINCT05371522

Neuro-inflammation and Post-infectious Fatigue in Individuals With and Without COVID-19

A Phase 2/3 study testing [18F]DPA-714 positron emission tomography (PET) scan in people with COVID-19, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Neuroinflammation can be an important regulator of long COVID, specifically fatigue and cognitive complaints. There is evidence that peripheral inflammation and neuro-inflammation are involved in fatigue and cognitive complaints, but precise pathophysiological mechanisms and causal relationship with viral infections… Read more about this study

Who is it for?
Ages 40 to 60 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
[18F]DPA-714 positron emission tomography (PET) scan
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteNetherlands
Study dates
3 Feb 2022to Sep 2023
Phase
Phase 2/3
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 40 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • The individual was diagnosed with symptomatic COVID-19, confirmed by a positive PCR for SARS-CoV-2, positive SARS-CoV-2 serology or CO-RADS (COVID-19 Reporting and Data System) 4 or 5 on CT-scan, or antigen quicktest, or had typical symptoms and was part of a household in which another person was tested positive by PCR 2 weeks before or after the first day of illness;
  • The individual is 3 months after being diagnosed with COVID-19 or after hospital discharge in case the patient was admitted.
  • The individual is in the range 40-60 years of age (to ensure radiation safety)
  • The individual has sufficient command of the Dutch language
  • Genotyping of rs6971 must show that the individual is a mixed or high affinity binder
  • Additional Inclusion criteria for patients with post-COVID-19 complaints:
Show all 16Show fewer
  • The patient experiences severe levels of fatigue (≥ 40) on the fatigue subscale of the Checklist Individual Strength [CIS-fatigue]) and/or cognitive complaints (≥ 15) on the concentration subscale of the Checklist Individual Strength [CIS-concentration].The severe fatigue or cognitive complaints started with or increased substantially directly after the onset of symptoms of COVID-19;
  • The patient reports physical/social disability (≤ 65 on the Rand36 physical functioning subscale or a score of ≥ 10 on the Work and Social Adjustment Scale [WSAS];
  • Additional Inclusion criteria for individuals without post-COVID-19 complaints:
  • The individual experiences no significant levels of fatigue (< 35 on the fatigue subscale of the Checklist Individual Strength [CIS-fatigue]) or cognitive complaints (<15 on the concentration subscale of the Checklist Individual Strength [CIS-concentration]) and does not subjectively major symptoms of fatigue or cognitive complaints. Based upon average of normal population +1SD.
  • The individual reports no physical/social disability (> 65 on the Rand36 physical functioning subscale or a score of < 10 on the Work and Social Adjustment Scale [WSAS]
  • Should be negatively tested for COVID-19 trough PCR, serology, antibodies, or via antigen quicktest
  • No evidence for substantial fatigue or cognitive complaints as evidenced by the CIS subscale fatigue (<35) and CIS subscale concentration (<15) and does not subjectively major symptoms of fatigue or cognitive complaints. Based upon average of normal population +1SD
  • The individual is in the range 40-60 years of age (to ensure radiation safety)
  • The individual has sufficient command of the Dutch language
  • Genotyping of rs6971 must show that the individual is a mixed or high affinity binder

Who cannot join

  • Rs6971 shows low affinity binding
  • Individuals who are unable to lay still for scanning due to claustrophobia or severe back pain or trypanophobia (fear of needles)
  • Gross neurological pathology (strategic or lobar infarcts or stroke or neurotrauma) on MRI or CT that may interfere with the interpretation of the PET scan.
  • Have a hemoglobin test (Hb) result of < to 8 in males and < to 7 in females;
  • Are females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Females of childbearing potential must not be pregnant (negative serum β-HCG at the time of screening and negative urine β-HCG within 24 hours prior to injection) or breastfeeding at screening.
  • Have donated blood within 6 months prior to the [18F]DPA-714 PET scan day;
  • The individual has an already known psychiatric or somatic condition that can explain his/her fatigue or major psychiatric disorder other than somatic-symptom disorder (chronic fatigue) as a main diagnosis. We will also screen for the presence of Post-Traumatic Stress Disorder PTSD as a main diagnosis] (PCL-5) which prevalence may be high in this patient group because of traumatic experiences during the acute phase of COVID-19. We will also screen for the presence of depressive disorder as a main diagnosis. To screen for PTSD and depressive disorder we will use the Diagnostic and Statistical Manual of Mental Disorders version 5 and verbally check if (any) symptoms do not meet the requirements for a PTSS or depression diagnostic/classification;
  • Current use of benzodiazepines11brg

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • VU University Medical Center

    Amsterdam, 1081 HV

Other trials in Netherlands

About this study

Neuroinflammation can be an important regulator of long COVID, specifically fatigue and cognitive complaints. There is evidence that peripheral inflammation and neuro-inflammation are involved in fatigue and cognitive complaints, but precise pathophysiological mechanisms and causal relationship with viral infections are still unknown. The primary aim of this study is to quantify neuroinflammation with [18F]DPA-714 (TSPO-binding) PET scans in post-COVID-19 patients with and without post-infectious fatigue and cognitive complaints and relate it to cognitive, psychiatric and post-infectious fatigue symptoms.

Read the detailed description

In this study we will include 20 post-COVID-19 patients (>3 months after diagnosis or discharge from hospital) (50% with post-infectious fatigue and/or cognitive complaints) and 50% without post-infectious fatigue/cognitive complaints; matched for disease severity). We will also include 10 age/sex-matched healthy controls without history of COVID-19 or severe fatigue/cognitive complaints. RS6971 polymorphism of the TSPO receptor will be determined and low affinity binders will be excluded from this study.

The main study parameter is the measurement of in vivo neuroinflammation with a [18F]DPA-714 90 minutes PET scan, alternately capturing brain (60 minutes) and body (30 minutes) with both continuous on-line and manual arterial blood sampling for full quantification ([18F]DPA-714 volume of distribution). The 30-minutes body scan will be performed to examine whole-body inflammation. Brain MRI will be performed for functional and anatomical information. We will use questionnaires and neuropsychological evaluation to assess chronic fatigue, depressive, anxiety and cognitive symptoms, partially for descriptive purposes.

Conditions
COVID-19
Being tested
[18F]DPA-714 positron emission tomography (PET) scan
Keywords
long COVID, imaging, (neuro)inflammation
Medical subject headings
COVID-19, Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]DPA-714 positron emission tomography (PET) scanRadiation

    60 minute dynamic brain [18F]DPA-714 positron emission tomography (PET) scan followed by a 30 minute static whole body positron emission tomography (PET) scan

Study groups in NCT05371522
Study groupRoleWhat they receive
[18F]DPA-714ExperimentalAll individuals included will undergo a [18F]DPA-714 positron emission tomography (PET) scan, irrespective of the existence of post-COVID-19 complaints.
Receives: Radiation: [18F]DPA-714 positron emission tomography (PET) scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quantitative neuroinflammation as measured with [18F]DPA-714 positron emission tomography (PET)

    Measured: 60 minute dynamic brain scan

  2. Whole-body inflammation as measured with [18F]DPA-714 positron emission

    Measured: 30 minute static whole-body scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2022
  2. Study start3 Feb 2022
  3. Primary completionSep 2023 (estimated)
  4. Study completionSep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
All individuals included will undergo a \[18F\]DPA-714 positron emission tomography (PET) scan
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05371522
Sponsor's protocol ID
2021.0333
Other IDs
2021-000781-15
Acronym
COVFATI
Status last verified
May 2022
First submitted
11 May 2022
Last updated
12 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Visser D, Golla SSV, Palard-Novello X, Verfaillie SCJ, Verveen A, Koch DW, Rikken RM, van de Giessen E, Nieuwkerk PT, den Hollander ME, Horn J, van Heugten CM, de Jong MD, van den Wijngaard CC, van der Maaden T, van Os YMG, Prins M, Visser-Meily JMA, Schober P, Schuit RC, Kassiou M, Windhorst AD, Biere-Rafi S, Appelman B, van Vugt M, Barkhof F, van Berckel BNM, Boellaard R, Knoop H, Tolboom N. Varying Levels of Inflammatory Activity in Brain and Body of Patients with Persistent Fatigue and Difficulty Concentrating After COVID-19: A TSPO PET Study. J Nucl Med. 2025 Nov 3;66(11):1787-1794. doi: 10.2967/jnumed.124.269297.

    PubMed 40935606

  • Palard-Novello X, Visser D, Yaqub M, van de Giessen E, den Hollander ME, Windhorst AD, Verfaillie SCJ, Knoop H, van Berckel BNM, Golla SSV, Tolboom N, Boellaard R. Whole-Body [18F]DPA-714 Kinetic Assessment Using PET/CT Scanner with Long Axial Field of View. J Nucl Med. 2025 Jul 1;66(7):1142-1148. doi: 10.2967/jnumed.124.268979.

    PubMed 40441893

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing [18F]DPA-714 positron emission tomography (PET) scan in people with COVID-19, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

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 16 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 12 May 2022. 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 Netherlands. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Quantitative neuroinflammation as measured with [18F]DPA-714 positron emission tomography (PET) (time frame: 60 minute dynamic brain scan). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05371522, which also lists 2 linked publications.

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 May 2022.

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