Chronic fatigue after COVID-19 infection
Conditions
Interventions
Product Name: [18F]DPA-714
Pharmaceutical Form: Radiopharmaceutical precursor, solution
Sponsors
Amsterdam UMC VUmc
Eligibility
Sex/Gender
All
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 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 up to and including 16 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])9. The severe fatigue 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 40-60 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 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 up to and including 16 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 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 or stroke or neurotrauma) on MRI or CT that may interfere with the interpretation of the PET scan. 4) Have a hemoglobin test (Hb) result of < to 8 in males and < to 7 in females; 5) 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 ß-HCG at the time of screening and negative urine ß-HCG within 24 hours prior to injection) or breastfeeding at screening. 6) Have donated blood within 6 months prior to the [18F]DPA-714 PET scan day; 7) The patient 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; 8) Current use of benzodiazepines
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to quantify neuroinflammation and whole-body inflammation with [18F]DPA-714 whole-body PET scans in post-COVID-19 infection;Secondary Objective: To relate neuroinflammation and whole-body inflammation to cognitive, psychiatric and post-infectious fatigue symptoms.;Primary end point(s): Main study parameter/endpoint Differences in spatial-temporal TSPO binding capacity between 3 groups: 1) Patients with post-infectious fatigue (of COVID-19 infection) 2) Patients without post-infectious fatigue (of COVID-19 infection) 3) Controls without evidence of COVID-19 and not severely fatigued. ;Timepoint(s) of evaluation of this end point: After all participants have completed their study visits (2 visits per participant) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary study parameters/endpoints Correlation between TSPO binding capacity and degree of post-infectious fatigue and brain damage measured with MRI. ;Timepoint(s) of evaluation of this end point: After all participants have completed their study visits. | — |
Countries
Netherlands
Contacts
Public Contactdept. Radiology & Nuclear Medicine
Amsterdam UMC VUmc
Outcome results
None listed