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New treatment option for PASC Post Acute Sequelae of COVID-19
Official title Multiparametric [18F]F-AraG Imaging in Post-Acute Sequelae of COVID-19 (PASC)
ClinicalTrials.gov ID: NCT07076862
What this study is testing
What is A.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static)?
A.1 - [¹⁸F]F-AraG PET/CT (90-min dynamic + 4-h static) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pasc post acute sequelae of covid-19.
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 study uses total-body [¹⁸F]F-AraG PET/CT imaging to investigate immune activation and vascular changes in individuals with post-acute sequelae of SARS-CoV-2 infection (PASC), also known as Long COVID. Participants will undergo dynamic PET/CT imaging along with blood biomarker assessments and symptom evaluations.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Age ≥ 18 years
- Ability to understand the purposes and risks of the trial and willingness to sign an IRB-approved informed consent form.
- Willingness and ability to comply with all protocol required procedures.
- For participants of reproductive potential, defined as individuals who have not been post-menopausal for at least 24 consecutive months (i.e., who...
- Previous diagnosis of SARS-CoV-2 infection as defined by a prior positive SARS-CoV-2 nucleic acid-based diagnostic test performed in a clinical...
You likely can't join if
- Serious comorbidities (nonmalignant disease or other conditions) that in the opinion of the investigator could compromise protocol objectives.
- Any condition that alters the function of their immune system or any conditions caused by malfunction of their immune system and would interfere with...
- Received vaccination of any type, including a SARS-CoV-2 vaccine, within 30 days of imaging
- Pregnant or nursing individuals. A urine or HCG serum pregnancy test with a sensitivity of at least 25 mIU/mL will be performed at screening and on...
- Participants who have had prior allogeneic stem cell or solid organ transplant.
- Previously diagnosed myelodysplasia syndrome or history of lymphoproliferative disease prior to study entry.
See the full eligibility criteria
- Age ≥ 18 years
- Ability to understand the purposes and risks of the trial and willingness to sign an IRB-approved informed consent form.
- Willingness and ability to comply with all protocol required procedures.
- For participants of reproductive potential, defined as individuals who have not been post-menopausal for at least 24 consecutive months (i.e., who have had menses within the preceding 24 months), or women who have not...
- Previous diagnosis of SARS-CoV-2 infection as defined by a prior positive SARS-CoV-2 nucleic acid-based diagnostic test performed in a clinical laboratory on one or more nasopharyngeal or respiratory secretion samples...
- Onset of COVID-19 symptoms (or if no symptoms, time of initial nucleic acid or antigen-based diagnostic test) at least 3 months prior to the baseline study visit.
- Ability to travel to our research sites in San Francisco and Sacramento.
- Laboratory evaluations obtained within 60 days prior to entry:
- Hemoglobin ≥ 8g/dL
- Platelet count ≥ 75,000 cells/mm3
- Absolute neutrophil count (ANC) \> 1000 cells/mm3
- Aspartate aminotransferase (AST) \< 3 × ULN units/L
- Alanine aminotransferase (ALT) \< 3 × ULN units/L
- Calculated creatinine clearance (CrCl) ≥ 60mL/min as estimated by the Cockcroft-Gault equation: For men, (140 - age in years) × (body weight in kg) ÷ (serum creatinine in mg/dL × 72) = CrCl (mL/min)\ \ For women...
- For PASC participants only: Reporting at least 2 unexplained symptoms, with at least 1 symptom in the fatigue domain and at least 1 symptom in either cardiopulmonary or neurocognitive domains, that last for at least 2...
- For control participants only: Individuals who have made full clinical recovery within 4-12 weeks of acute COVID-19 infection with no newly developed symptoms or changes in health after recovery.
- Serious comorbidities (nonmalignant disease or other conditions) that in the opinion of the investigator could compromise protocol objectives.
- Any condition that alters the function of their immune system or any conditions caused by malfunction of their immune system and would interfere with imaging, including known underlying inflammatory or immune disorders...
- Received vaccination of any type, including a SARS-CoV-2 vaccine, within 30 days of imaging
- Pregnant or nursing individuals. A urine or HCG serum pregnancy test with a sensitivity of at least 25 mIU/mL will be performed at screening and on the day of PET/CT imaging at no charge to all participants of...
- Participants who have had prior allogeneic stem cell or solid organ transplant.
- Previously diagnosed myelodysplasia syndrome or history of lymphoproliferative disease prior to study entry.
- Active systemic autoimmune diseases not related to COVID-19.
- Self-reported history of dysphoria or anxiety in closed spaces (i.e., uncontrolled claustrophobia).
- Concurrent or prior enrollment in a separate research study involving a PET scan performed within the last 12 months for research purposes only.
- Body weight is more than 240 kg (529 pounds)
- Prisoners
- Life expectancy \< 24 months
- Recent use of medication including guanosine or cysteine analogs.
- Any other criteria which would make the participant unsuitable for enrollment to this study, as determined by the Principal Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- San Francisco, California, 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 and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States; San Francisco, California, 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.