N/A
Completed N=90
RCT of Mushroom Based Natural Product to Enhance Immune Response to COVID-19 Vaccination
COVID-19 Vaccination
Source: ClinicalTrials.gov NCT04951336 ↗
Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: AST Normal to Abnormal Transition — 2.0; 2.6 % of participants who transitioned — p=1.000
Summary
This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of two polypore mushrooms, Fomitopsis officinalis and Trametes versicolor (FoTv), for use as an adjunct to vaccination for COVID-19 in a general population at the time of COVID-19 vaccination.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AST Normal to Abnormal Transition |
2.0; 2.6 | 1.000 |
| PRIMARY ALT Normal to Abnormal Transition |
4.7; 5.9 | 1.000 |
| PRIMARY ALP Normal to Abnormal Transition |
1.9; 0 | 1.000 |
| PRIMARY eGFR Normal to Abnormal Transition |
10.5; 2.9 | 0.359 |
| SECONDARY SARS-CoV-2 Receptor Binding Domain (RBD) |
355.02881; 1.29801; 206.22357; 1.35671; 541.90950; 289.80001 | 0.002 sig |
| SECONDARY SARS-CoV-2 Spike Protein ("Spike"). |
247.56807; 0.47756; 149.40025; 0.78453; 380.70020; 205.36409 | 0.002 sig |
| SECONDARY Side-Effect Number |
0.6333; 0.2632; 0.5200; 0.4545; 2.9333; 1.4737 | 0.060 |
| SECONDARY Side-Effect Severity |
1.0333; 0.2632; 0.6800; 0.4545; 3.7600; 2.4000 | 0.326 |
Eligibility Criteria
Inclusion Criteria
- Scheduled for or planning on scheduling COVID-19 vaccination
- Age 18 years and older
- Willing to avoid alcohol, cannabis, and dairy products during the study product in-take period.
- Capable of documenting vitals, symptoms, and study product intake daily and communicating this information to the study team
Exclusion Criteria
- Known liver disease (or diagnosis of cirrhosis)
- Known renal disease or acute nephritis.
- Pregnant or breastfeeding women
Data sourced from ClinicalTrials.gov (NCT04951336). 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.