Mushroom-based Product for COVID-19 (MACH19 Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen ByAndrew Shubov, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Gordon Saxe

Trial Summary

What is the purpose of this trial?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. The study aims to establish the safety and feasibility of the use of FoTv vs placebo in 66 total subjects.

Eligibility Criteria

Adults over 18 with a recent COVID-19 diagnosis can join this trial. They must be able to track and report their health daily, not consume alcohol, cannabis, or dairy during the study, and use contraception if they're women of childbearing potential. People with severe symptoms needing hospitalization or those with liver disease, uncontrolled high blood pressure, kidney disease, pregnant or breastfeeding are excluded.

Participant Groups

The trial is testing FoTv—a combination of two mushrooms—against a placebo in people managing mild-to-moderate COVID-19 at home. It's randomized (participants are put into groups by chance) and double-blind (neither participants nor researchers know who gets what treatment), involving 66 individuals to assess safety and feasibility.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MushroomsExperimental Treatment1 Intervention

Fomitopsis officinalis and Trametes versicolor

Group II: PlaceboPlacebo Group1 Intervention

Organic brown rice