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Mushroom-based Product
Mushroom-based Product for COVID-19 (MACH19 Trial)
Phase 1 & 2
Waitlist Available
Led By Andrew Shubov, MD
Research Sponsored by Gordon Saxe
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
MACH19 Trial Summary
This trial will compare two types of mushrooms to see if they help treat mild-to-moderate symptoms of COVID-19 in people who are self-quarantining at home. A total of 66 people will be in the study.
Who is the study for?
Adults over 18 with a recent COVID-19 diagnosis can join this trial. They must be able to track and report their health daily, not consume alcohol, cannabis, or dairy during the study, and use contraception if they're women of childbearing potential. People with severe symptoms needing hospitalization or those with liver disease, uncontrolled high blood pressure, kidney disease, pregnant or breastfeeding are excluded.Check my eligibility
What is being tested?
The trial is testing FoTv—a combination of two mushrooms—against a placebo in people managing mild-to-moderate COVID-19 at home. It's randomized (participants are put into groups by chance) and double-blind (neither participants nor researchers know who gets what treatment), involving 66 individuals to assess safety and feasibility.See study design
What are the potential side effects?
Since this is a study for safety and feasibility, specific side effects of FoTv aren't listed but could include typical reactions to supplements such as digestive discomfort or allergic reactions.
MACH19 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
Alanine transaminase
Aspartate transaminase
+3 moreSecondary outcome measures
C-Reactive Protein
D-Dimer
Mental disorders
+10 moreMACH19 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MushroomsExperimental Treatment1 Intervention
Fomitopsis officinalis and Trametes versicolor
Group II: PlaceboPlacebo Group1 Intervention
Organic brown rice
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Gordon SaxeLead Sponsor
University of California, Los AngelesOTHER
1,538 Previous Clinical Trials
10,266,977 Total Patients Enrolled
21 Trials studying COVID-19
873,021 Patients Enrolled for COVID-19
University of California, IrvineOTHER
546 Previous Clinical Trials
1,923,147 Total Patients Enrolled
6 Trials studying COVID-19
2,010 Patients Enrolled for COVID-19
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Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have any of these serious symptoms, you need to go to the hospital: difficulty breathing, ongoing chest pain or pressure, confusion or difficulty waking up, or a bluish color on your lips or face.Your blood pressure is not well controlled, even with medication.You agree not to consume alcohol, cannabis, or dairy products during the study.You are currently taking experimental medications to prevent or treat COVID-19.
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Mushrooms
- Group 2: Placebo
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