Immune Activation Imaging for COVID-19

Recruiting in Palo Alto (17 mi)

Overseen by Timothy J Henrich, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: CellSight Technologies, Inc.

Disqualifiers: Pregnancy, Breastfeeding, Transplant, Autoimmune, others

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team to get a clear answer.

What data supports the effectiveness of the drug [18F]F-AraG, VisAcT, 2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine for COVID-19?

Research on similar imaging agents, like 18F-AzaFol, shows potential in visualizing activated macrophages (immune cells) in lung diseases, which could help identify COVID-19 patients at risk of severe complications. This suggests that [18F]F-AraG might also be useful in monitoring immune responses in COVID-19. ^{1 2 3 4 5}

How does the treatment in the Immune Activation Imaging for COVID-19 trial differ from other treatments for COVID-19?

This treatment uses a novel imaging technique with 124I-iodo-DPA-713, which targets activated macrophages (immune cells involved in inflammation) to visualize the immune response in the lungs of COVID-19 patients. Unlike standard treatments that focus on directly combating the virus or reducing symptoms, this approach aims to provide detailed insights into the immune processes, potentially aiding in identifying patients at risk of severe disease progression. ^{1 2 3 4 5}

Research Team

Timothy J Henrich, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.

Inclusion Criteria

My kidneys are functioning well, with a creatinine clearance rate of 60 mL/min or higher.

I am older than 18 years.

Your absolute neutrophil count is higher than 1000 per cubic millimeter.

Exclusion Criteria

Pregnancy

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

Breastfeeding

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive an intravenous microdose of [18F]F-AraG followed by whole-body PET-CT imaging

4 weeks

1 visit (in-person)

Optional Imaging Extension

Participants may receive a second optional [18F]F-AraG dose and PET-CT imaging

1 month to 1 year

1 visit (in-person, optional)

Follow-up

Participants are monitored for safety and effectiveness after imaging

5 months

Treatment Details

Interventions

• [18F]F-AraG (Virus Therapy)

Trial Overview 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.

Participant Groups

Group I: [18F]F-AraG Experimental Treatment 1 Intervention

Radiofluorinated imaging agent, \[18F\]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine) Trade name: VisAcT

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of California, San Francisco San Francisco, CA

Who Is Running the Clinical Trial?

CellSight Technologies, Inc.

Lead Sponsor

Trials

18

Patients Recruited

320+

University of California, San Francisco

Collaborator

Trials

2636

Patients Recruited

19,080,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Nuclear Imaging of Activated Macrophages with Folic Acid-Based Radiotracers Serve as a Prognostic Means to Identify COVID-19 Patients at Risk? Müller, C., Schibli, R., Maurer, B.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

124I-Iodo-DPA-713 Positron Emission Tomography in a Hamster Model of SARS-CoV-2 Infection. Ruiz-Bedoya, CA., Mota, F., Ordonez, AA., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDG PET/CT imaging features and clinical utility in COVID-19. Yeh, R., Elsakka, A., Wray, R., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune Response Visualized In Vivo by [18F]-FDG PET/CT after COVID-19 Vaccine. Seban, RD., Champion, L., Deleval, N., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel application of [18F]DPA714 for visualizing the pulmonary inflammation process of SARS-CoV-2-infection in rhesus monkeys (Macaca mulatta). Meijer, L., Böszörményi, KP., Bakker, J., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Can Nuclear Imaging of Activated Macrophages with Folic Acid-Based Radiotracers Serve as a Prognostic Means to Identify COVID-19 Patients at Risk? [2020]

2. United States pubmed.ncbi.nlm.nih.gov

124I-Iodo-DPA-713 Positron Emission Tomography in a Hamster Model of SARS-CoV-2 Infection. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

FDG PET/CT imaging features and clinical utility in COVID-19. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Immune Response Visualized In Vivo by [18F]-FDG PET/CT after COVID-19 Vaccine. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Novel application of [18F]DPA714 for visualizing the pulmonary inflammation process of SARS-CoV-2-infection in rhesus monkeys (Macaca mulatta). [2022]