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Mushroom-based Product for COVID-19

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 1/Phase 2

Eligibility

Gender
All
Healthy Volunteers
Yes
Minimum Age
18 Years
Maximum Age
N/A

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:
    • Trouble breathing
    • Persistent pain or pressure in the chest
    • New confusion or inability to arouse
    • 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

Join this Trial

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Study Stats
Protocol No.
20-001928
Contact
Andrew Shubov
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04667247
For detailed technical eligibility, visit ClinicalTrials.gov.