Echinaforce Study to Investigate Explorative Pharmacology and Effectiveness to Prevent From Enveloped Virus Infections

• Status: Completed
• Trial end date: 2021-05-29
• Target enrollment: 0
• Participant gender: All

Summary

It is a single-center, randomized, open-label, phase IV study for the explorative investigation of the pharmacological mode-of-action of Echinaforce® extract in the form of Echinaforce® Chewable tablets"- Further, it is aimed to evaluate the effectiveness of the study product for the prevention and treatment of respiratory tract infections in generally healthy adults following a real-life setting. The study covers 2x2 + 1 month of prevention in 120 randomized participants following a tight sampling set-up for sensitive detection of viral infections by RT-qPCR analysis of nasal swabs and seroconversion of SARS-CoV2 IgG/IgM in serum samples.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: A. Vogel AG
• Collaborators: Biodome Clinical; Bodimed; CONVEX CRO; d.s.h. statistical services GmbH; MediStat Ltd.; PPES lab epigenetic signaling

Criteria

Inclusion Criteria:

• Age 18 - 75 years.

• Written informed consent.

• Good knowledge of respective language.

• Willingness to give swab samples.

• Willingness to give blood and saliva samples.

Exclusion Criteria:

• ≥76 years

• < 18 years.

• Participation in another clinical study in the past 30 days or planned during study conduct.

• Permanent intake of antimicrobial, antiviral, immune suppressive substances.

• Surgical intervention in the 3 months prior enrolment or planned intervention during the study conduct.

• Known diabetes mellitus.

• Known atopy (a constitution to produce an exaggerated immune response to otherwise harmless environmental substances, with clinical manifestation of an allergic disease such as allergic rhinitis, eczema, asthma, atopic dermatitis, etc.)

• Cystic Fibrosis, bronchopulmonary dysfunction, COPD.

• Known immune system disorders and degenerative disorders (autoimmune disorders, AIDS, leukaemia, 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)

• Known allergies to plants of the compositae family (e.g. camomile or dandelion) or one of the compounds in the investigational product

• Known or planned pregnancy during study period (effective contraception is required).