Echinaforce COVID-19 Shedding Study

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.

Conditions

• COVID-19 Respiratory Infection
• SARS-CoV2 Infection

Interventions

DRUG

Echinaforce Forte tablets

Tincture of fresh Echinacea purpurea (L) MOENCH: Herba rec. T. aerial part DER = 1:12-13 (Drug to extraction solvent ratio) extraction solvent = ethanol 65.1 % (V/V) = 57.3 % (m/m)\* with an approx. dry plant equivalent of 32 mg per tablet Dry weight content in 1 tablet: 5.9 mg Echinacea purpurea: (L) MOENCH: Radix rec. root part DER = 1:11-12 (Drug to extraction solvent ratio) extraction solvent = ethanol 65.1 % (V/V) = 57.3 % (m/m)\* with an approx. dry plant equivalent of 1.8 mg per tablet Dry weight content in1 tablet: 0.3 mg the tablet contain additional excipients

DRUG

Echinaforce Chewable tablets

Tincture of fresh Echinacea purpurea (L) MOENCH: Herba rec. T. aerial part DER = 1:12-13 (Drug to extraction solvent ratio) extraction solvent = ethanol 65.1 % (V/V) = 57.3 % (m/m)\* with an approx. dry plant equivalent of 32 mg per tablet Dry weight content in 1 tablet: 5.9 mg Echinacea purpurea: (L) MOENCH: Radix rec. root part DER = 1:11-12 (Drug to extraction solvent ratio) extraction solvent = ethanol 65.1 % (V/V) = 57.3 % (m/m)\* with an approx. dry plant equivalent of 1.8 mg per tablet Dry weight content in1 tablet: 0.3 mg The tablets contain additional excipients

DRUG

Echinaforce tincture

Tincture of fresh Echinacea purpurea (L) MOENCH: Herba rec. T. aerial part DER = 1:12-13 (Drug to extraction solvent ratio) extraction solvent = ethanol 65.1 % (V/V) = 57.3 % (m/m) Echinacea purpurea: (L) MOENCH: Radix rec. root part DER = 1:11-12 (Drug to extraction solvent ratio) extraction solvent = ethanol 65.1 % (V/V) = 57.3 % (m/m)

Sponsors & Collaborators

• Clinical Research Centre CONVEX

  collaborator UNKNOWN

• Biodome Clinical

  collaborator UNKNOWN

• MediStat Ltd.

  collaborator UNKNOWN

• Medical University of Graz

  collaborator OTHER

• A. Vogel AG

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-15

Primary Completion

2023-05-15

Completion

2023-08-15

Countries

• Bulgaria

Study Locations