Clinical trial NCT04999098: Echinaforce COVID-19 Shedding Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: COVID-19 Respiratory Infection
SARS-CoV2 Infection
Keywords: SARS-CoV2 infectivity
Viral load reduction
antiviral treatment
Oropharynx
Throat
Lead sponsor: A. Vogel AG
Sponsor class: INDUSTRY
Collaborators: name: Clinical Research Centre CONVEX
name: Biodome Clinical
name: MediStat Ltd.
name: Medical University of Graz
First posted: 2021-08-10
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, 3-armed, parallel, active-treatment controlled
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Absolute and relative differences in Cq values (qPCR) comparing pre- and post EF treatment including all formulations combined.
timeFrame: 2 hours
Secondary outcomes:
measure: Absolute and relative viral loads comparing pre- and post EF treatment and in cross comparison of the respective EF-formulations
timeFrame: 2 hours
measure: 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.
timeFrame: 2 hours
measure: Incidence of Treatment responders falling below limit of detection/ threshold value under treatment
timeFrame: 2 hours
measure: Incidence of SARS-CoV-2 VOC (variant of concerns)
timeFrame: 2 hours
measure: Frequency of concomitant medication/therapies
timeFrame: 3 days
measure: Frequency of intake of pre-treatment, Beverage and food-intake prior therapy start.
timeFrame: 3 days
measure: Frequency of vaccination
timeFrame: 2 hours
measure: Tolerability in view of subjects after treatment.
timeFrame: 2 hours
measure: Tolerability in view of Investigators after treatment.
timeFrame: 2 hours
measure: Incidence and severity of other symptoms (S/AEs).
timeFrame: 2 hours
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Diagnostics and Consultation Center Convex EOOD
Study officials:
References: