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

NCT05002179 | Completed Phase 4

• 1 other identifier: 5'000'760
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Tract Infections; Common Cold

Keywords

SARS-CoV2; Prevention of Respiratory tract infections; Prospective; Controlled; Randomized; Open

Outcome Measures

Primary Outcomes (1)

• Incidence of respiratory tract infections "vRTIs" with treatment in comparison to no treatment

  The incidence of respiratory tract infections "vRTIs" with treatment in comparison to no treatment is determined as per study diary entries (acute symptomatic episodes of RTIs), by taking nasal swab samples and blood samples from participants during prevention and acute vRTIs. Swab samples are taken by using validated swab sticks (COPAN) and presence of viral RNA/DNA determined by using the RT-PCR respiratory pathogen panel from VIASURE ®, plus a separate panel for SARS-CoV2. Seroconversion of SARS-CoV2 specific IgG/IgM levels is used to detect additional asymptomatic vRTIs. Analyses are done by a non-parametric Chi-square test

  5 months

Secondary Outcomes (19)

• Changes of viral load and incidence of responder

  5 months

• Development of symptom scores of respiratory tract infections

  5 months

• Duration of respiratory tract infections

  5 months

• Incidence rate of respiratory tract infections complications, recurrences and antibiotic use

  5 months

• Cumulative number of sick days

  5 months

Study Arms (2)

Treatment group

EXPERIMENTAL

Treatment group, 3 x 2 Echinaforce chewable tablets (EC, 3x800mg) daily during prevention and 5 x 2 EC (5x800mg) during acute viral Respiratory tract infection "vRTIs"

Drug: Echinaforce Chewable tablets

Control Group

NO INTERVENTION

No treatment "Comparison group". Participants are free to take none or any preventive measure. Participants are requested not to take any Echinacea products

Interventions

Echinaforce Chewable tablets DRUG

Preventive treatment: 3X2 EC tablets daily during 2 + 2 months of prevention after run-in of 1 week and intermittent treatment break of 1 week without treatment + 1 month of voluntary follow-up prevention. Acute treatment: 5 X 2 EC tablets daily for max. 10 days per individual vRTI or until symptom resolution.

Also known as: Echinacea, Echinaforce, Echinaforce Junior tablets

Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 75 years.
• Written informed consent.
• Good knowledge of respective language.
• Willingness to give swab samples.
• Willingness to give blood and saliva samples.

You may not qualify if:

• ≥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).

Sponsors & Collaborators

• A. Vogel AG: lead
• CONVEX CRO: collaborator
• d.s.h. statistical services GmbH: collaborator
• MediStat Ltd.: collaborator
• Biodome Clinical: collaborator
• Bodimed: collaborator
• PPES lab epigenetic signaling: collaborator

Study Sites (1)

Diagnostics and Consultation Center Convex EOOD

Sofia, 1680, Bulgaria

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Common Cold

Interventions

Echinacea extract; Echinaforce

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Study Officials

• Emil Kolev, Dr. med.

  Diagnostics and Consultation Center Convex

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Monocentric, 2-armed, randomized, open-label, no-treatment-controlled,

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: August 12, 2021
• Study Start: November 20, 2020
• Primary Completion: May 29, 2021
• Study Completion: May 29, 2021
• Last Updated: August 12, 2021

Record last verified: 2021-08

Locations

BU (1)