NCT05371522

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

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 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.

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

Interventions

Type	Name	Description
RADIATION	[18F]DPA-714 positron emission tomography (PET) scan	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

Timeline

• Start date: 2022-02-03
• Primary completion: 2023-09-01
• Completion: 2023-09-01
• First posted: 2022-05-12
• Last updated: 2022-05-12

Locations

1 site across 1 country: Netherlands