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

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

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.

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 and immune response in 45 total subjects.

Inclusion Criteria:

• 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

Exclusion Criteria:

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