Evidence map›Paper›PMID 41620671›Full record

Trial reportBMC immunology2026

Polypore mushroom mycelia as an adjunct to COVID-19 vaccination: a randomized clinical trial.

Gordon Saxe, Christine N Smith, Shahrokh Golshan, Tatyana Shekhtman, Zolton J Bair, Chase Beathard, Renee A Davis, Lauray MacElhern, Andrew Shubov, Daniel Slater and 3 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04951336 (Multicenter Double-Blind, Placebo-Controlled RCT of Fomitopsis Officinalis/Trametes Versicolor for COVID-19), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04951336 nacompletednot on this map

Multicenter Double-Blind, Placebo-Controlled RCT of Fomitopsis Officinalis/Trametes Versicolor for COVID-19

TypeinterventionalSponsorUniversity of California, San DiegoRan2021 to 2022Enrolled90ConditionsCOVID-19 VaccinationArmsFoTv
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Gordon SaxeDepartment of Family Medicine, University of California San Diego, San Diego, CA, USA. gsaxe@health.ucsd.edu.
Christine N SmithKrupp Center for Integrative Research, Centers for Integrative Health, University of California San Diego, San Diego, CA, USA.
Shahrokh GolshanKrupp Center for Integrative Research, Centers for Integrative Health, University of California San Diego, San Diego, CA, USA.
Tatyana ShekhtmanDepartment of Family Medicine, University of California San Diego, San Diego, CA, USA.
Zolton J BairDepartment of Research and Development, Fungi Perfecti, LLC, Washington, Olympia, USA.
Chase BeathardDepartment of Research and Development, Fungi Perfecti, LLC, Washington, Olympia, USA.
Renee A DavisDepartment of Research and Development, Fungi Perfecti, LLC, Washington, Olympia, USA.
Lauray MacElhernDepartment of Family Medicine, University of California San Diego, San Diego, CA, USA.
Andrew ShubovDepartment of Medicine, Center for East-West Medicine, University of California Los Angeles, Los Angeles, CA, USA.
Daniel SlaterDepartment of Family Medicine, University of California San Diego, San Diego, CA, USA.
Lan K KaoDepartment of Medicine, Center for East-West Medicine, University of California Los Angeles, Los Angeles, CA, USA.
Phoebe SenowitzDepartment of Family Medicine, University of California San Diego, San Diego, CA, USA.
Stephen WilsonBotnar Institute of Immune Engineering, Basel, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUse of fungal mycelium as a vaccination adjunct may constitute a novel antiviral strategy to address newly emerging viruses. We evaluated safety and feasibility of a fungal mycelium-based natural product (Fomitopsis officinalis and Trametes versicolor, FoTv) as an adjunct to human COVID-19 vaccination, as well as its impact on vaccine side-effects and anti-SARS-CoV-2 antibodies (Abs).

methodsRandomized, double-blind, placebo-controlled clinical trial involving adjunctive treatment with FoTv or visually-identical Placebo (dosage: eight 500-mg capsules TID orally for four days) in combination with COVID-19 vaccination. Main outcomes included: Safety (adverse events, renal and hepatic function [Days 1–14]); Feasibility (completion rate and treatment adherence); Side-effects (number and severity, self-reported on days 1 [vaccination] to 5); and anti-SARS-CoV-2 Ab levels (receptor-binding domain and Spike, collected from blood drawn on days 1, 3, 14, and 28/42, and at 6 months).

resultsNinety participants receiving COVID-19 vaccination were randomized to either FoTv (N = 52) or Placebo (N = 38) groups. There were no adverse events and the groups had overlapping 95% confidence intervals for the percentage of participants transitioning from normal to abnormal renal/hepatic function when comparing Days 1 and 14. All participants (100%) completed the study and treatment adherence was greater than 95%. Participants with detectable anti-SARS-CoV-2 Abs (from prior COVID antigen exposure) were classified as “COVID-Exposed” and those with undetectable anti-SARS-CoV-2 Abs as “COVID-Naive.” FoTv, versus Placebo, significantly reduced side-effects in COVID-Naive individuals, specifically on days 3 and 5, but not in COVID-Exposed individuals. In the COVID-Naive FoTv group, Ab responses were preserved across 6 months (and possibly increased), an effect not observed among other groups.

conclusionsAfter COVID-19 vaccination, adjunctive FoTv was safe, feasible, and reduced vaccine side-effects without compromising (and possibly increasing) Ab levels up to 6 months in participants without previous SARS-CoV-2 exposure. Use of fungal mycelia was successfully tested as a unique approach to prevent a novel pandemic virus (SARS-CoV-2), with potential application to H5N1/Bird Flu and other emerging viruses.

trial registrationTrial registered on ClinicalTrials.gov NCT04951336 on June 30, 2021.

Indexed as

COVID-19COVID-19 VaccinesSARS-CoV-2AdultAgedAntibodies, ViralDouble-Blind MethodFemaleHumansMaleMiddle AgedMyceliumPolyporaceaeVaccinationAntibodies, ViralCOVID-19 VaccinesAdjunctAntibodiesBird fluCOVIDFungiMushroomMyceliumSARS-CoV-2Side effectsVaccine

Identifiers

PMID41620671
PMCPMC12955250

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.