Echinaforce COVID-19 Shedding Study

A. Vogel AG

Status and phase: Terminated; Phase 4

Conditions: COVID-19 Respiratory Infection; SARS-CoV2 Infection

Treatments: Drug: Echinaforce Chewable tablets; Drug: Echinaforce tincture; Drug: Echinaforce Forte tablets

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04999098

5'000'820

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• ≥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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 3 patient groups

treatment group 1: Echinaforce Forte (EFF) Tablets (chewed)

Active Comparator group

Description:

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.

Treatment:

Drug: Echinaforce Forte tablets

treatment gorup 2: Echinaforce Chewable (EFC) Tablets (chewed)

Active Comparator group

Description:

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.

Treatment:

Drug: Echinaforce Chewable tablets

treatment group 3: Echinaforce Tincture (EFT, gargling)

Active Comparator group

Description:

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.

Treatment:

Drug: Echinaforce tincture