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

NCT05002179 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2021-08-12

No results posted yet for this study

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

Interventions

DRUG

Echinaforce Chewable tablets

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.

Sponsors & Collaborators

  • CONVEX CRO

    collaborator UNKNOWN

  • d.s.h. statistical services GmbH

    collaborator UNKNOWN

  • MediStat Ltd.

    collaborator UNKNOWN

  • Biodome Clinical

    collaborator UNKNOWN

  • Bodimed

    collaborator UNKNOWN

  • PPES lab epigenetic signaling

    collaborator UNKNOWN

  • A. Vogel AG

    lead INDUSTRY

Principal Investigators

  • Emil Kolev, Dr. med. · Diagnostics and Consultation Center Convex

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-20
Primary Completion
2021-05-29
Completion
2021-05-29

Countries

  • Bulgaria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05002179 on ClinicalTrials.gov