Randomized, Controlled, 3-arm, Open, Prospective Clinical Trial to Assess Antiviral Properties of Echinacea Reducing Oropharyngeal Concentration and Infectivity of SARS-CoV-2: The Shedding Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- A. Vogel AG
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Absolute and relative differences in Cq values (qPCR) comparing pre- and post EF treatment including all formulations combined.
研究概览
简要总结
Respiratory viruses pose a permanent threat to humans and society as demonstrated by the current Covid-19 pandemic. Novel drugs and vaccines provide a means for controlling illness. Infections and symptomatic presentation of illness may be reduced, but it remains to be determined to which extent viral shedding and transmission (e.g. by silent transmitters) can be controlled. Lack of such activity may result in continuing viral spread by assumed healthy but asymptomatic spreaders. Echinacea is an established and readily-accessible product with demonstrated in vitro antiviral activity (including coronaviruses). This study aims to estimate the potential of different Echinacea formulations (head-to-head) to reduce concentration infectivity and shedding of SARS-CoV-2 under in vivo conditions.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 - 75 years.
- •Written informed consent.
- •Ability and willingness to give oropharyngeal swab samples.
- •Positive pre-screening SARS-CoV-2 RT-PCR virus test with an above threshold viral load as per qPCR (Cq ≤ 27).
排除标准
- •≥76 years
- •<12 years.
- •Participation in another clinical study in the past 30 days or planned during study conduct.
- •Severe COVID19
- •Intake of antimicrobial, antiviral, immune suppressive substances.
- •Surgical intervention in the 3 months prior enrolment
- •Known diabetes mellitus.
- •Known and medicated atopy or asthma.
- •Cystic Fibrosis, bronchopulmonary dysfunction, COPD.
- •Known immune system disorders and degenerative disorders (autoimmune disorders, AIDS, leukemia, lymphoma, myeloma).
- •Known metabolic or resorption disorders.
- •Known liver or kidney illnesses (chronic hepatitis, liver cirrhosis, chronic kidney insufficiency).
- •Serious health conditions (limited general condition, auto-immune diseases, tumorous diseases, neurological disorders or serious Covid-19)
- •Known allergies to plants of the compositae family (e.g. chamomile or dandelion) or to one of the compounds in the investigational product
- •Known pregnancy.
研究组 & 干预措施
treatment group 1: Echinaforce Forte (EFF) Tablets (chewed)
1st arm (EFF group): Slowly sucking 1 Echinaforce Forte tablet (1 tablet: 1'200mg EF) until dissolution "Dose 1". Another 2 X 1 EF Forte tablets (total of 2 tablets: 2'400 mg EF) is taken one-by-one "Dose 2" after swab sampling, which is repeated after complete dissolution of the second dose of EF Forte tablets.
干预措施: Echinaforce Forte tablets (Drug)
treatment gorup 2: Echinaforce Chewable (EFC) Tablets (chewed)
2nd arm (EFC group): Slowly sucking 1 x 3 Echinaforce Chewable tablets (total 3 tablets: 1'200mg EF) until dissolution "Dose 1". Another dose of 2 x 2 & 1 x 3 EF Chewable tablets (total 7 tablets: 2'800mg EF) are slowly sucked "Dose 2" after swab sampling, which is repeated after complete dissolution of the second dose of EF Chewable tablets.
干预措施: Echinaforce Chewable tablets (Drug)
treatment group 3: Echinaforce Tincture (EFT, gargling)
3rd arm (EFT group): Gargling of 2 x 19 drops of Echinaforce tincture (1'200 mg EF) is diluted in 2 x35 mL water "Dose 1". Another dose of 3 x 30 drops of Echinaforce tincture (2'800 mg EF) diluted in 3 x35 mL water for 15 sec each "Dose 2", gargled for 15 sec and swallowed after swab sampling, which is repeated after gargling of the second dose of EF Tincture.
干预措施: Echinaforce tincture (Drug)
结局指标
主要结局
Absolute and relative differences in Cq values (qPCR) comparing pre- and post EF treatment including all formulations combined.
时间窗: 2 hours
The average Cq values as per qPCR analysis by means of qPCR values prior any treatment (samples A1 \& B1) in comparison to post EF treatment. Oropharyngeal (OP) Swab samples are taken by using validated swab sticks (Eswab 480CE LQ Amies with Reg. Nylon Flocked applicator, COPAN Int.) and presence of viral RNA/DNA determined by using the qPCR SARS-CoV2 panel. The analysis is done by a two-sided t-test
次要结局
- Frequency of concomitant medication/therapies(3 days)
- Frequency of intake of pre-treatment, Beverage and food-intake prior therapy start.(3 days)
- Frequency of vaccination(2 hours)
- Incidence and severity of other symptoms (S/AEs).(2 hours)
- Incidence of Treatment responders falling below limit of detection/ threshold value under treatment(2 hours)
- Incidence of SARS-CoV-2 VOC (variant of concerns)(2 hours)
- Tolerability in view of Investigators after treatment.(2 hours)
- Absolute and relative viral loads comparing pre- and post EF treatment and in cross comparison of the respective EF-formulations(2 hours)
- Absolute and relative tissue infective dose (TCID) of recovered life viruses comparing pre- and post EF treatment results and/or in cross-comparison of the respective EF formulations.(2 hours)
- Tolerability in view of subjects after treatment.(2 hours)