Phase 2
Completed N=54
RCT of Fomitopsis Officinalis and Trametes Versicolor to Treat COVID-19
Source: ClinicalTrials.gov NCT04667247 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Total Protein Normal to Abnormal Transition — 0; 0 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Protein Normal to Abnormal Transition |
0; 0 | — |
| PRIMARY Albumin Normal to Abnormal Transition |
4; 0 | 1.000 |
| PRIMARY Alkaline Phosphatase Normal to Abnormal Transition |
0; 0 | — |
| PRIMARY AST Normal to Abnormal Transition |
0; 0 | — |
| PRIMARY ALT Normal to Abnormal Transition |
4.3; 0 | 1.000 |
| PRIMARY Bilirubin Normal to Abnormal Transition |
0; 0 | — |
| PRIMARY Adj. EGFR Normal to Abnormal Transition |
28.6; 0 | 0.061 |
| PRIMARY Prothrombin Time Normal to Abnormal Transition |
0; 14.3 | .100 |
| PRIMARY APTT Normal to Abnormal Transition |
4.5; 5.0 | 1.000 |
| PRIMARY ESR Normal to Abnormal Transition |
0; 14.3 | .162 |
| PRIMARY CRP Normal to Abnormal Transition |
0; 0 | — |
| PRIMARY LDH Normal to Abnormal Transition |
46.2; 37.5 | 1.00 |
| SECONDARY Total Bilirubin |
0.4215; 0.3650; 0.5469; 0.4216 | .174 |
| SECONDARY Prothrombin Time |
11.515; 11.448; 11.342; 11.342 | .846 |
| SECONDARY Aspartate Aminotransferase (AST) |
23.50; 22.92; 20.73; 20.54 | .841 |
| SECONDARY Alanine Transaminase (ALT) |
28.15; 22.92; 22.62; 19.79 | 0.612 |
| SECONDARY Albumin |
4.565; 4.517; 4.638; 4.558 | .690 |
| SECONDARY Alkaline Phosphatase |
75.64; 76.29; 68.50; 77.54 | 0.109 |
| SECONDARY Lactate Dehydrogenase |
186.08; 195.38; 195.77; 207.70 | 0.844 |
| SECONDARY C-Reactive Protein |
0.9437; 0.5452; 0.3325; 0.3686 | 0.044 sig |
| SECONDARY Mid-turbinate SARS CoV-2 Viral Load |
15.2895; 14.9429; 27.7164; 32.3462; 37.7235; 37.4067 | .989 |
| SECONDARY Adj. EGFR |
111.93848626354; 101.72611717162; 104.27777159545; 103.86989833636 | 0.010 sig |
| SECONDARY APTT |
32.377; 32.233; 32.108; 31.513 | .560 |
| SECONDARY INR |
1.073; 1.048; 1.054; 1.033 | 0.707 |
| SECONDARY ESR |
12.54; 14.89; 11.13; 12.68 | 0.765 |
| SECONDARY Symptom Count |
7.2308; 6.8750; 6.2692; 6.7083; 5.6154; 6.1667 | 0.005 sig |
| SECONDARY Symptom Severities |
13.6538; 11.0833; 10.4615; 10.4167; 8.8077; 9.1667 | <0.001 sig |
Eligibility 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:
- 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 140 or DBP>90 while on medications)
- Pregnant or breastfeeding women
Data sourced from ClinicalTrials.gov (NCT04667247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.