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New treatment option for SARS CoV-2 Post-Acute Sequelae
Official title Positron Emission Tomography (PET) Imaging of Neuroinflammation in Patients With Neurological Dysfunction After Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2) Infection
ClinicalTrials.gov ID: NCT05656105
What this study is testing
What is DPA-714 PET/MRI?
DPA-714 PET/MRI is an investigational medicine, being studied as a potential treatment for sars cov-2 post-acute sequelae.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical imaging study will use the small molecule translocator protein (TSPO) ligand, Fluorodeoxyglucose(18F)-labeled DPA-714, to visualize and quantify neuroinflammation in individuals with post-acute sequelae of SARS-CoV-2 (PASC) . The brain uptake of DPA-714 will be contrasted with healthy subjects.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 18 to 65 years of age
- Healthy volunteer OR Clinical diagnosis of post-acute sequelae of SARS-CoV-2 (PASC)
- High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.
- PASC participants must have been previously infected with SARS-CoV-2. Their neurological symptoms must have been present for at least four weeks...
- Healthy control participants must have no neurological symptoms
You likely can't join if
- Contraindication to MRI
- Pregnancy
- Lactation
- Individuals who are unable to participate in the imaging portion due to severity of their medical condition
- Chronic infectious disease (e.g. HIV, HCV)
- Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
See the full eligibility criteria
- 18 to 65 years of age
- Healthy volunteer OR Clinical diagnosis of post-acute sequelae of SARS-CoV-2 (PASC)
- High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.
- PASC participants must have been previously infected with SARS-CoV-2. Their neurological symptoms must have been present for at least four weeks prior to the enrollment.
- Healthy control participants must have no neurological symptoms
- Contraindication to MRI
- Pregnancy
- Lactation
- Individuals who are unable to participate in the imaging portion due to severity of their medical condition
- Chronic infectious disease (e.g. HIV, HCV)
- Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
- Diagnosis of cancer, including leukemia
- Blood or blood clotting disorder
- Except for individuals with Multiple Sclerosis (MS), a diagnosis of autoimmune disease is exclusionary
- Positive urine β-hCG test day of procedure or a serum human chorionic gonadotropin (hCG) test within 48 hours prior to the administration of [18F]DPA-714.11. 11Currently enrolled in a clinical trial utilizing...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.