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}

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

University of California, San Francisco Collaborator

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] Herein, we discuss the potential role of folic acid-based radiopharmaceuticals for macrophage imaging to support clinical decision-making in patients with COVID-19. Activated macrophages play an important role during coronavirus infections. Exuberant host responses, i.e., a cytokine storm with increase of macrophage-related cytokines, such as TNFα, IL-1β, and IL-6 can lead to life-threatening complications, such as acute respiratory distress syndrome (ARDS), which develops in approximately 20% of the patients. Diverse immune modulating therapies are currently being tested in clinical trials. In a preclinical proof-of-concept study in experimental interstitial lung disease, we showed the potential of 18F-AzaFol, an 18F-labeled folic acid-based radiotracer, as a specific novel imaging tool for the visualization and monitoring of macrophage-driven lung diseases. 18F-AzaFol binds to the folate receptor-beta (FRβ) that is expressed on activated macrophages involved in inflammatory conditions. In a recent multicenter cancer trial, 18F-AzaFol was successfully and safely applied (NCT03242993). It is supposed that the visualization of activated macrophage-related disease processes by folate radiotracer-based nuclear imaging can support clinical decision-making by identifying COVID-19 patients at risk of a severe disease progression with a potentially lethal outcome.

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] Label="PURPOSE">Molecular imaging has provided unparalleled opportunities to monitor disease processes, although tools for evaluating infection remain limited. Coronavirus disease (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is mediated by lung injury that we sought to model. Activated macrophages/phagocytes have an important role in lung injury, which is responsible for subsequent respiratory failure and death. We performed pulmonary PET/CT with 124I-iodo-DPA-713, a low-molecular-weight pyrazolopyrimidine ligand selectively trapped by activated macrophages cells, to evaluate the local immune response in a hamster model of SARS-CoV-2 infection.

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

FDG PET/CT imaging features and clinical utility in COVID-19. [2022] To determine the imaging findings and potential clinical utility of FDG PET/CT in patients with laboratory-confirmed COVID-19.

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

Immune Response Visualized In Vivo by [18F]-FDG PET/CT after COVID-19 Vaccine. [2021] Worldwide deployment of COVID-19 vaccines is in progress. Recent immune activation following vaccination can sometimes be seen in fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography ([18F]-FDG PET/CT). As previously evidenced, FDG-avid axillary lymph node(s) are common in patients receiving vaccines against SARS-CoV-2, influenza virus, or human papillomavirus, and reflect a regional immune response. In addition, these findings may also be accompanied by an increased spleen glucose metabolism after the COVID-19 vaccine, which captures a systemic immune response. Hence, we provide here a clinical example demonstrating that immune response could be associated with increased glucose metabolism in lymphoid organs such as lymph nodes and the spleen, which are critical modulators of T cell immunity. We believe that it is of paramount importance that nuclear physicians should be able to recognize clinical and imaging features of such immune responses upon vaccination for COVID-19 and beyond.

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] Label="RATIONALE">The aim of this study was to investigate the application of [18F]DPA714 to visualize the inflammation process in the lungs of SARS-CoV-2-infected rhesus monkeys, focusing on the presence of pulmonary lesions, activation of mediastinal lymph nodes and surrounded lung tissue.