RCT of Fomitopsis Officinalis and Trametes Versicolor to Treat COVID-19

NCT04667247 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: 200633-1a
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (12)

• Total Protein Normal to Abnormal Transition

  We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

  14 days

• Albumin Normal to Abnormal Transition

  We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

  14 days

• Alkaline Phosphatase Normal to Abnormal Transition

  We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

  14 days

• AST Normal to Abnormal Transition

  We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

  14 days

• ALT Normal to Abnormal Transition

  We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

  14 days

• Bilirubin Normal to Abnormal Transition

  We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

  14 days

• Adj. EGFR Normal to Abnormal Transition

  We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

  14 days

• Prothrombin Time Normal to Abnormal Transition

  We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

  14 days

• APTT Normal to Abnormal Transition

  We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

  14 days

• ESR Normal to Abnormal Transition

  We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

  14 days

• CRP Normal to Abnormal Transition

  We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

  14 days

• LDH Normal to Abnormal Transition

  We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.

  14 days

Secondary Outcomes (15)

• Total Bilirubin

  14 days

• Prothrombin Time

  14 days

• Aspartate Aminotransferase (AST)

  14 days

• Alanine Transaminase (ALT)

  14 days

• Albumin

  14 days

Study Arms (2)

Mushrooms

EXPERIMENTAL

Fomitopsis officinalis and Trametes versicolor

Drug: FoTv

Placebo

PLACEBO COMPARATOR

Organic brown rice

Drug: FoTv

Interventions

FoTv DRUG

8 capsules three times a day for 14 consecutive days.

Also known as: Fomitopsis officinalis and Trametes versicolor

Mushrooms; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gordon Saxe: lead
• University of California, Los Angeles: collaborator
• University of California, Irvine: collaborator

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Gordon Saxe, M.D./Ph.D.
• Organization: Krupp Center for Integrative Research, University of California San Diego

gsaxe@health.ucsd.edu

6195435765

Study Officials

• Andrew Shubov, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Krupp Center for Integrative Research

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 14, 2020
• Study Start: December 23, 2020
• Primary Completion: March 21, 2022
• Study Completion: May 4, 2022
• Last Updated: August 19, 2025
• Results First Posted: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)