Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Diego, California
Dates
study started
estimated completion
Principal Investigator
by Gordon Saxe, MD

Description

Summary

This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of two polypore mushrooms, Fomitopsis officinalis and Trametes versicolor (FoTv), for use as an adjunct to vaccination for COVID-19 in a general population at the time of COVID-19 vaccination.

Official Title

Multicenter Double-Blind, Placebo-Controlled RCT of Fomitopsis Officinalis/Trametes Versicolor for COVID-19

Details

This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of two polypore mushrooms, Fomitopsis officinalis and Trametes versicolor (FoTv), for use as an adjunct to vaccination for COVID-19 in a general population at the time of COVID-19 vaccination. Fo and Tv have immunomodulatory properties which may increase antibody titers in response to vaccination more than vaccination alone. However, because they are also immunomodulatory - not purely immune-stimulating - they may have the added benefit of simultaneously decreasing vaccine-related side effects following COVID-19 vaccination. The study aims to establish the safety and feasibility of the use of FoTv vs placebo; evaluate the effect on post-vaccination clinical symptoms, neutralizing antibody, and immune response in 45 total subjects

Keywords

COVID-19 Vaccination FoTv Mushrooms

Eligibility

You can join if…

Open to people ages 18 years and up

  • Scheduled for or planning on scheduling COVID-19 vaccination
  • Age 18 years and older
  • Willing to avoid alcohol, cannabis, and dairy products during the study product in-take period.
  • Capable of documenting vitals, symptoms, and study product intake daily and communicating this information to the study team

You CAN'T join if...

  • Known liver disease (or diagnosis of cirrhosis)
  • Known renal disease or acute nephritis.
  • Pregnant or breastfeeding women

Location

  • University of California, San Diego accepting new patients
    San Diego California 92093 United States

Lead Scientist at UCSD

  • Gordon Saxe, MD
    Associate Physician, Family Medicine and Public Health. Authored (or co-authored) 7 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04951336
Phase
Phase 2
Study Type
Interventional
Last Updated