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

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 85

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 (<= 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 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 (< 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
4) The patient 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]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

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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