Mushroom-based Product for COVID-19

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gordon Saxe
• Collaborators: University of California, Irvine; University of California, Los Angeles

Criteria

Inclusion Criteria:

• Positive COVID-19 diagnosis within the prior 72 hours

• Age 18 years and older

• Women of childbearing potential must have a negative urine or serum hCG. Women of childbearing potential must have a negative serum pregnancy test at screening and agree to use contraception throughout the study period.

• Capable of documenting vitals, symptoms, and study product intake daily and communicating this information to the study team

• Willing to avoid alcohol, cannabis, and dairy products during the study period.

Exclusion Criteria:

• Any of the following symptoms which, according to the CDC, require hospitalization:

1. Trouble breathing

2. Persistent pain or pressure in the chest

3. New confusion or inability to arouse

4. Bluish lips or face

• Current use of investigational agents to prevent or treat COVID-19

• Known liver disease (ALT/AST >3x ULN or diagnosis of cirrhosis)

• Known renal disease (eGFR < 60 ml/min) or acute nephritis.

• Uncontrolled hypertension (SBP>140 or DBP>90 while on medications)

• Pregnant or breastfeeding women