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Immune Activation Imaging for COVID-19

Phase < 1
Recruiting
Led By Timothy Henrich, MD
Research Sponsored by CellSight Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Calculated creatinine clearance (CrCl) ≥60 mL/min as estimated by the Cockcroft-Gault equation
Age >18 years
Must not have
Prior allogeneic stem cell or solid organ transplant
Previously diagnosed myelodysplasia syndrome or history of lymphoproliferative disease prior to study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial is studying a new imaging method to track the spread of the coronavirus in the body.

Who is the study for?
This trial is for adults over 18 who've recently had COVID-19, with symptoms starting at least 14 days ago or a positive test if asymptomatic. They must have certain blood cell counts and organ function levels, not be pregnant or breastfeeding, and agree to use two forms of birth control if applicable.Check my eligibility
What is being tested?
The study tests an imaging agent called [18F]F-AraG using PET-CT scans to see how it distributes in the body after COVID-19 infection. Participants will receive up to two microdoses of the tracer; one mandatory scan followed by an optional second scan four months later.See study design
What are the potential side effects?
As this is an exploratory imaging study involving a tracer used in PET-CT scans, specific side effects are not detailed but may include reactions related to intravenous injection and exposure to radiation from the imaging process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or higher.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a stem cell or organ transplant from another person.
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I have been diagnosed with myelodysplasia syndrome or had lymphoproliferative disease before joining the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
[18F]F-AraG uptake in participants with convalescent COVID-19
Secondary outcome measures
[18F]F-AraG uptake in female versus male participants
[18F]F-AraG uptake in participants with convalescent COVID-19 over time
[18F]F-AraG uptake in participants with mild to severe COVID-19 symptoms

Trial Design

1Treatment groups
Experimental Treatment
Group I: [18F]F-AraGExperimental Treatment1 Intervention
Radiofluorinated imaging agent, [18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine) Trade name: VisAcT

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for COVID-19 include antiviral medications, corticosteroids, and supportive care. Antiviral drugs like remdesivir inhibit viral replication by targeting the viral RNA polymerase. Corticosteroids such as dexamethasone reduce inflammation by suppressing the immune response, which is crucial in severe cases to prevent cytokine storms. Supportive care, including oxygen therapy and mechanical ventilation, helps manage symptoms and maintain oxygen levels. The imaging study using [18F]F-AraG focuses on tracking immune activation, which is important for understanding the body's response to infection and the effectiveness of treatments aimed at modulating the immune system.
Chinese herbal medicine ("3 medicines and 3 formulations") for COVID-19: rapid systematic review and meta-analysis.[COVID-19 pneumonia].

Find a Location

Who is running the clinical trial?

CellSight Technologies, Inc.Lead Sponsor
17 Previous Clinical Trials
264 Total Patients Enrolled
University of California, San FranciscoOTHER
2,528 Previous Clinical Trials
15,242,612 Total Patients Enrolled
Timothy Henrich, MDPrincipal InvestigatorUniversity of California, San Francisco
3 Previous Clinical Trials
102 Total Patients Enrolled
~1 spots leftby Oct 2024