Echinaforce COVID-19 Shedding Study

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

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.

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.