What side effects are associated with this type of intervention?

Common treatments for COVID-19 include corticosteroids and Chinese herbal medicine. Corticosteroids, such as prednisolone, can cause side effects like increased blood sugar levels, weight gain, and a higher risk of infections. Inhaled corticosteroids may also lead to ocular issues like cataracts and glaucoma. Chinese herbal medicines, including formulations like Jinhua Qinggan, have shown some promise in symptom relief but can cause mild-to-moderate adverse effects. More rigorous studies are needed to fully understand their safety and efficacy.

What prior FDA approvals exist?

The FDA has approved several treatments for COVID-19, including antiviral drugs like remdesivir, monoclonal antibodies such as bamlanivimab and etesevimab, and immunomodulators like baricitinib. These treatments target different aspects of the virus and the body's response to infection. While [18F]F-AraG is a tracer used for PET-CT imaging to study immune activation, it is not a treatment but rather a diagnostic tool. There are no FDA-approved treatments specifically similar to [18F]F-AraG, as it is used for imaging rather than direct therapeutic intervention.

What other types of research exist?

A promising novel alternative to [18F]F-AraG for PET-CT imaging in coronavirus patients could be FAP-targeted tracers. These tracers offer better tumor-to-background ratios and do not require exhausting preparations, making them a potential option for improved imaging.

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Immune Activation Imaging for COVID-19

Phase 2

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

No Placebo-Only Group

Summary

This trial involves injecting a special substance into people who have recovered from COVID-19 and then taking detailed body scans to see where the substance goes. This helps doctors understand how different parts of the body are affected after recovering from COVID-19.

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.

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.

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:

Select...

I have had a stem cell or organ transplant from another person.

Select...

I have been diagnosed with myelodysplasia syndrome or had lymphoproliferative disease before joining the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the anatomical distribution of [18F]F-AraG in participant with convalescent COVID-19 greater than 4 weeks (N = 80). Tracer activity will be compared with sex and age-matched uninfected historical control participants enrolled in prior studies.

Secondary study objectives

Determine if [18F]F-AraG PET-CT is able to detect differences in T cell activation between convalescent COVID-19 participants and age-matched uninfected historical control participants.

[18F]F-AraG uptake in participants with convalescent COVID-19 over time

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met

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].