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Neuroinflammation and post-infectious fatigue in individuals with and without Covid-19

Neuroinflammation and post-infectious fatigue in individuals with and without Covid-19 - COVFATI

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54244
Enrollment
85
Registered
2021-07-01
Start date
2022-02-03
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

corona

Interventions

None listed

Sponsors

Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Group 1. In order to participate in this study, individuals with a previous COVID-19 infection and with post-infectious fatigue or cognitive complaints should meet the following criteria: 1) The patient 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; 2) The patient is 3 months after being diagnosed with COVID-19 or after hospital discharge in case the patient was admitted. 3) 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 4) The patient reports physical/social disability (= 10 on the Work and Social Adjustment Scale [WSAS]10; 5) The patient is in the range 30-65 years of age (to ensure radiation safety) 6) The patient has sufficient command of the Dutch language 7) Genotyping of rs6971 must show that patient is a mixed or high affinity binder Group 2. In order to participate in this study, individuals with a previous COVID-19 infection and without post-infectious fatigue or cognitive complaints should meet the following criteria: 1) The patient was diagnosed with symptomatic COVID-19, confirmed by a positive PCR for SARS-CoV-2, positive SARS-CoV-2 serology or CO-RADS 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; 2) The patient is 3 months after being diagnosed with COVID-19 or after hospital discharge in case the patient was admitted. 3) The patient experiences no significant levels of fatigue ( 65 on the Rand36 physical functioning subscale or a score of < 10 on the Work and Social Adjustment Scale [WSAS]10; 5) The patient is in the range 30-65 years of age (to ensure radiation safety) 6) The patient has sufficient command of the Dutch language 7) Genotyping of rs6971 must show that patient is a mixed or high affinity binder Group 3. Healthy controls should meet the following criteria: 1) Should be negatively tested for COVID-19 trough PCR, serology, antibodies, or via antigen quicktest 2) 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 aver

Exclusion criteria

Exclusion criteria: 1) Rs6971 shows low affinity binding 2) Patients who are unable to lay still for scanning due to claustrophobia or severe back pain or trypanophobia (fear of needles) 3) Gross neurological pathology (strategic or lobar infarcts) on MRI or CT that may interfere with the interpretation of the PET scan. 4) Post-infectious complaints before COVID-19 or any other current disease of infection that is known to cause substantial fatigue

Design outcomes

Primary

MeasureTime frame
The primary parameter is the measurement of neuro-inflammation in vivo with the [18F]DPA-714 (±286MBq, 4,9mSv) 70 minutes PET scan, alternately capturing brain (60 minutes) and body (10 minutes; pelvic to head) with both continuous on-line and manual arterial blood sampling for full quantification ([18F]DPA-714 volume of distribution).15,16. Brain MRI will be performed for functional and anatomical information.

Secondary

MeasureTime frame
Secondary parameters include whole-body inflammation as measured with 60-70 min body PET. In adddition, we will use CIS, BDI, GAD7 and neuropsychological evaluation to assess chronic fatigue, depressive, anxiety and cognitive symptoms, partially for descriptive purposes. In addition, questionnaires to evaluate smell and taste complaints will be evaluated.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)