PET/CT Imaging Agent for COVID-19

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of California, Davis

Disqualifiers: Pregnancy, Breast-feeding, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

10 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How does the drug [18F]Favipiravir differ from other COVID-19 treatments?

[18F]Favipiravir is unique because it combines the antiviral properties of Favipiravir, originally used for influenza, with a radioactive label for PET/CT imaging, allowing researchers to study its distribution and behavior in the body. This imaging capability is not a feature of standard COVID-19 treatments, which typically focus solely on antiviral effects. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a PET/CT study using the 18F-αvβ6-binding-peptide.The goal of this study is to evaluate this peptide in patients after infection with SARS CoV2.

Eligibility Criteria

This trial is for men and women over 18 who had COVID-19 but are now negative, with no prior lung diseases. They must have had a lung image taken during their infection and be able to stay still for up to an hour per scan. It's not for those with other respiratory infections, pregnant or breastfeeding women, patients too heavy for PET/CT scans (>350lbs), or anyone unlikely to attend follow-up sessions.

Inclusion Criteria

You had a chest X-ray or CT scan while being diagnosed with an infection.

I have been diagnosed with COVID-19.

I can stay still for up to an hour.

Exclusion Criteria

I do not have any active infections in my lungs.

Lack of availability for follow-up assessments

You are expected to live for less than 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive a 10 mCi (±20%) intravenous injection of 18F-αvβ6-BP, followed by PET/CT imaging to detect lung damage

6 months

Up to 3 PET/CT scans

Follow-up

Participants are monitored for safety and effectiveness after imaging

6 months

Treatment Details

Interventions

• 18F-αvβ6-BP

Trial Overview The study tests a new imaging agent called 18F-αvβ6-binding-peptide in PET/CT scans on patients who've recovered from COVID-19. The goal is to see how well this peptide works in detecting changes in the lungs after SARS-CoV-2 infection.

Participant Groups

Group I: 18F-αvβ6-BP Experimental Treatment 1 Intervention

Following a 10 mCi (±20%) intravenous injection (IV) of 18F-αvβ6-BP, PET/CT images will be acquired at 60 minutes. Baseline blood samples will be drawn and banked. Vital sign (VS) measurements (heart rate, respiratory rate, blood pressure and temperature) monitored throughout. Region-of-interest analysis (ROI) will be performed in the lung. Each participant will undergo up to 3 18F- αvβ6-BP PET/CT scans over a 6-month timeframe.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

References

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

Evaluation of [18F]Favipiravir in Rodents and Nonhuman Primates (NHP) with Positron Emission Tomography. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Clinicopathological Correlation: Dopamine and Amyloid PET Imaging with Neuropathology in Three Subjects Clinically Diagnosed with Alzheimer's Disease or Dementia with Lewy Bodies. [2023]

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

In vivo imaging of amyloid deposition in Alzheimer disease using the radioligand 18F-AV-45 (florbetapir [corrected] F 18). [2022]

4. England pubmed.ncbi.nlm.nih.gov

Amyloid imaging in Alzheimer's disease: comparison of florbetapir and Pittsburgh compound-B positron emission tomography. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Correlation of Early-Phase F-18 Florapronal PET with F-18 FDG PET in Alzheimer's Disease and Normal Brain. [2022]