This study is in progress, not accepting new patients

RCT of Mushroom Based Natural Product to Enhance Immune Response to COVID-19 Vaccination

a study on COVID-19

Summary

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

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, COVID-19, 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...

Location

  • University of California, San Diego
    San Diego California 92093 United States

Lead Scientist at UCSD

  • Gordon Saxe
    Associate Physician Diplomate, Family Medicine and Public Health, Vc-health Sciences-schools. Authored (or co-authored) 7 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT04951336
Study Type
Interventional
Participants
About 90 people participating
Last Updated