Status:
COMPLETED
RCT of Fomitopsis Officinalis and Trametes Versicolor to Treat COVID-19
Lead Sponsor:
Gordon Saxe
Collaborating Sponsors:
University of California, Los Angeles
University of California, Irvine
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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-positiv...
Detailed Description
Despite biomedical advances, medical intervention for COVID-19 is largely limited to vaccinations and supportive care during the later stages of disease. While antiviral, anti-inflammatory, and antima...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT04667247
Start Date
December 23 2020
End Date
May 4 2022
Last Update
August 19 2025
Active Locations (2)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095
2
University of California, San Diego
San Diego, California, United States, 92093