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New treatment option for Covid19
Official title Imaging Immune Activation in COVID-19
ClinicalTrials.gov ID: NCT04815096
What this study is testing
What is [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine)?
[18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for covid19.
Also referred to as VisAcT.
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 is a single center, single arm exploratory imaging study involving up to two intravenous microdoses of [18F]F-AraG (the second tracer dose is optional) followed by whole-body PET-CT imaging in participants with convalescent COVID-19. Up to 80 participants will be enrolled over an accrual period of approximately 48 months.
- Phase 2: a mid-size study of how well it works
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
You may be able to join if
- Age \>18 years
- Ability to read and understand written informed consent document
- Have a recent diagnosis of SARS-CoV-2 infection as defined by a prior positive SARS-CoV-2 nucleic acid-based diagnostic test performed in a clinical...
- \> 14 days since onset of COVID-19 symptoms (or if no symptoms, from time of initial nucleic acid based diagnostic test).
- Laboratory evaluations obtained within 60 days prior to entry.
You likely can't join if
- Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator
- Participants who are pregnant (female participants of childbearing age will be tested prior to injection of imaging agent at entry visit/initial...
- Participants who are breastfeeding
- Female participants of reproductive potential (defined as women who have not been post-menopausal for at least 24 consecutive months (i.e., who have...
- Participants who have had prior allogeneic stem cell or solid organ transplant.
- Screening absolute neutrophil count \ 3 x ULN, alanine aminotransferase \>3 x ULN.
See the full eligibility criteria
- Age \>18 years
- Ability to read and understand written informed consent document
- Have a recent 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...
- \> 14 days since onset of COVID-19 symptoms (or if no symptoms, from time of initial nucleic acid based diagnostic test).
- Laboratory evaluations obtained within 60 days prior to entry.
- Platelet count ≥75,000/mm3
- ANC \>1000/mm3
- Aspartate aminotransferase (AST) \<3 x ULN
- Alanine aminotransferase (ALT) \<3 x ULN
- Calculated creatinine clearance (CrCl) ≥60 mL/min as estimated by the Cockcroft-
- Gault equation
- Any medical condition that would compromise the imaging acquisition, in the opinion of the investigator
- Participants who are pregnant (female participants of childbearing age will be tested prior to injection of imaging agent at entry visit/initial visit - positive test will exclude from further participation in the study)
- Participants who are breastfeeding
- Female participants of reproductive potential (defined as women 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...
- Participants who have had prior allogeneic stem cell or solid organ transplant.
- Screening absolute neutrophil count \ 3 x ULN, alanine aminotransferase \>3 x ULN.
- Known SARS-CoV-2 shedding within 5 days of PET imaging.
- Previously diagnosed myelodysplasia syndrome or history of lymphoproliferative disease prior to study entry
- Active systemic autoimmune diseases not related to COVID-19.
- COVID-19 vaccine prior to the first PET imaging session. Participants may receive COVID-19 vaccination after the first PET imaging session and the optional second PET scan, with the scan being performed at least 2 weeks...
- Prior PET scan or therapeutic radiation within 1 year of study enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- 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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.