Despite biomedical advances, medical intervention for COVID-19 is largely limited to
vaccinations and supportive care during the later stages of disease. While antiviral,
anti-inflammatory, and antimalarial options have been explored for later stages of
disease, fewer studies have been conducted on medications to reduce the risk of
outpatient cases progressing to severe disease. Therefore, it is important that we
broaden the search to include agents outside of our usual pharmacopeia. Integrative
Medicine offers several promising therapeutics that are available today and warrant
investigation.

Some of the botanicals used for their possible immune modulating functions include
polypore mushrooms. Among these, Turkey Tail (Trametes versicolor) has a long history of
use for its immune supporting properties. An RCT examining the effects of Trametes
versicolor in breast cancer patients detected increases in lymphocyte counts and natural
killer cell functional activity (Torkelson et al, 2012 and Benson et al, 2019) both of
which are key to host COVID-19 response. Further investigations into other relevant
mushroom species demonstrated that Agarikon (Fomitopsis officinalis) can strongly induce
an array of differential cytokine responses associated with both immune-activation and
resolution of host defense- induced inflammatory reactions (unpublished). This
homeostatic effect deserves attention for COVID-19 given the high mortality rate
associated with cytokine storm.

This is a multi-center, randomized, double blind, placebo-controlled clinical trial to
evaluate two polypore mushrooms, Fomitopsis officinalis and Trametes versicolor (FoTv),
to treat COVID-19-positive outpatients with mild-to-moderate symptoms assigned to
self-quarantined and home management. This study aims to establish the safety and
feasibility of the use of FoTv vs placebo in 66 total subjects. Subsequent trials will
evaluate Chinese herbal medicine as well as the efficacy of FoTv in a larger study
population.