Echinaforce COVID-19 Shedding Study

NCT04999098 | Terminated Phase 4

• 1 other identifier: 5'000'820
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Respiratory Infection; SARS-CoV2 Infection

Keywords

SARS-CoV2 infectivity; Viral load reduction; antiviral treatment; Oropharynx; Throat

Outcome Measures

Primary Outcomes (1)

• Absolute and relative differences in Cq values (qPCR) comparing pre- and post EF treatment including all formulations combined.

  The average Cq values as per qPCR analysis by means of qPCR values prior any treatment (samples A1 \& B1) in comparison to post EF treatment. Oropharyngeal (OP) Swab samples are taken by using validated swab sticks (Eswab 480CE LQ Amies with Reg. Nylon Flocked applicator, COPAN Int.) and presence of viral RNA/DNA determined by using the qPCR SARS-CoV2 panel. The analysis is done by a two-sided t-test

  2 hours

Secondary Outcomes (10)

• Absolute and relative viral loads comparing pre- and post EF treatment and in cross comparison of the respective EF-formulations

  2 hours

• 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.

  2 hours

• Incidence of Treatment responders falling below limit of detection/ threshold value under treatment

  2 hours

• Incidence of SARS-CoV-2 VOC (variant of concerns)

  2 hours

• Frequency of concomitant medication/therapies

  3 days

Study Arms (3)

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

ACTIVE COMPARATOR

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.

Drug: Echinaforce Forte tablets

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

ACTIVE COMPARATOR

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.

Drug: Echinaforce Chewable tablets

treatment group 3: Echinaforce Tincture (EFT, gargling)

ACTIVE COMPARATOR

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.

Drug: Echinaforce tincture

Interventions

Echinaforce Forte tablets DRUG

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

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

Echinaforce Chewable tablets DRUG

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

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

Echinaforce tincture DRUG

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)

Also known as: Echinaforce drops

treatment group 3: Echinaforce Tincture (EFT, gargling)

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• ≥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.

Sponsors & Collaborators

• A. Vogel AG: lead
• Clinical Research Centre CONVEX: collaborator
• Biodome Clinical: collaborator
• MediStat Ltd.: collaborator
• Medical University of Graz: collaborator

Study Sites (1)

Diagnostics and Consultation Center Convex EOOD

Sofia, 1680, Bulgaria

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, 3-armed, parallel, active-treatment controlled

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 10, 2021
• Study Start: November 15, 2021
• Primary Completion: May 15, 2023
• Study Completion: August 15, 2023
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

BU (1)