Multicenter Double Blind, Placebo Controlled RCT of Fomitopsis Officinalis and Trametes Versicolor to Treat COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Total Protein Normal to Abnormal Transition
研究概览
简要总结
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.
详细描述
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 antimalarial options have been explored for later stages of disease, fewer studies have been conducted on medications to reduce the risk of outpatient cases progressing to severe disease. Therefore, it is important that we broaden the search to include agents outside of our usual pharmacopeia. Integrative Medicine offers several promising therapeutics that are available today and warrant investigation.
Some of the botanicals used for their possible immune modulating functions include polypore mushrooms. Among these, Turkey Tail (Trametes versicolor) has a long history of use for its immune supporting properties. An RCT examining the effects of Trametes versicolor in breast cancer patients detected increases in lymphocyte counts and natural killer cell functional activity (Torkelson et al, 2012 and Benson et al, 2019) both of which are key to host COVID-19 response. Further investigations into other relevant mushroom species demonstrated that Agarikon (Fomitopsis officinalis) can strongly induce an array of differential cytokine responses associated with both immune-activation and resolution of host defense- induced inflammatory reactions (unpublished). This homeostatic effect deserves attention for COVID-19 given the high mortality rate associated with cytokine storm.
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. This study aims to establish the safety and feasibility of the use of FoTv vs placebo in 66 total subjects. Subsequent trials will evaluate Chinese herbal medicine as well as the efficacy of FoTv in a larger study population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Mushrooms
Fomitopsis officinalis and Trametes versicolor
干预措施: FoTv (Drug)
Placebo
Organic brown rice
干预措施: FoTv (Drug)
结局指标
主要结局
Total Protein Normal to Abnormal Transition
时间窗: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Albumin Normal to Abnormal Transition
时间窗: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Alkaline Phosphatase Normal to Abnormal Transition
时间窗: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
AST Normal to Abnormal Transition
时间窗: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
ALT Normal to Abnormal Transition
时间窗: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Bilirubin Normal to Abnormal Transition
时间窗: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Adj. EGFR Normal to Abnormal Transition
时间窗: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
Prothrombin Time Normal to Abnormal Transition
时间窗: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
APTT Normal to Abnormal Transition
时间窗: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
ESR Normal to Abnormal Transition
时间窗: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
CRP Normal to Abnormal Transition
时间窗: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
LDH Normal to Abnormal Transition
时间窗: 14 days
We examined participants who were normal at Baseline (Day 1). The Normal to Abnormal proportion reflects the proportion of participants with normal values at Day 1 that became abnormal at Day 14 relative to all participants with normal values at baseline.
次要结局
- Total Bilirubin(14 days)
- Prothrombin Time(14 days)
- Aspartate Aminotransferase (AST)(14 days)
- Alanine Transaminase (ALT)(14 days)
- Albumin(14 days)
- Alkaline Phosphatase(14 days)
- Lactate Dehydrogenase(14 days)
- C-Reactive Protein(14 days)
- Mid-turbinate SARS CoV-2 Viral Load(14 days)
- ESR(14 days)
- Symptom Count(14 days)
- Symptom Severities(14 days)
- Adj. EGFR(14 days)
- APTT(14 days)
- INR(14 days)
研究者
Gordon Saxe
Director, Krupp Center for Integrative Research
University of California, San Diego