Back to resultsEchinaforce COVID-19 Shedding Study
Primary Purpose
COVID-19 Respiratory Infection, SARS-CoV2 Infection
Status
Recruiting
Phase
Phase 4
Locations
Bulgaria
Study Type
Interventional
Intervention
Echinaforce Forte tablets
Echinaforce Chewable tablets
Echinaforce tincture
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Respiratory Infection focused on measuring SARS-CoV2 infectivity, Viral load reduction, antiviral treatment, Oropharynx, Throat
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.
Sites / Locations
- Diagnostics and Consultation Center Convex EOODRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
treatment group 1: Echinaforce Forte (EFF) Tablets (chewed)
treatment gorup 2: Echinaforce Chewable (EFC) Tablets (chewed)
treatment group 3: Echinaforce Tincture (EFT, gargling)
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Absolute and relative viral loads comparing pre- and post EF treatment and in cross comparison of the respective EF-formulations
The viral load reduction as per averages of Cq values and/or genomic read depths (optional) prior any treatment (samples A1 & B1) in comparison to post EF treatment and/or in cross-comparison with the respective time point and/or formulation. Oropharyngeal (OP) Swab samples are taken by using validated swab sticks (Eswab 480CE LQ Amies with Reg. Nylon Flocked applicator, COPAN Int.) and presence and quantity of viral RNA/DNA determined by using the qPCR SARS-CoV2 panel. The viral genomic material is optionally quantified by genomic read depth as per next generation sequencing (NGS). The analysis is done by a two-sided t-test for comparing pre- and post-treatment and ANOVA for cross-comparisons between groups
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.
Residual tissue culture infectious dose per time point: prior any treatment (pre-treatment samples A1 & B1), to post EF treatment and/or in cross-comparison with the respective time point and/or formulation. The analysis is done by a two-sided t-test for comparing pre- and post-treatment and ANOVA for cross-comparisons between groups
Incidence of Treatment responders falling below limit of detection/ threshold value under treatment
The number of subjects per time point that become qPCR negative as per RT-PCR test results and/or reached below threshold genomic read depth value (optional) as per NGS-read out and reach a below threshold residual infectivity as per TCID test result are determined prior and post EF treatment and in cross-comparison of the respective EF formulations. The analysis is done by non-parametric chi-square endpoint analysis].
Incidence of SARS-CoV-2 VOC (variant of concerns)
Absolute and relative frequencies of SARS-CoV2 VOCs is as per identification by optional whole-genome next generation sequencing and automated database annotation to known and unknown SARS-CoV2 strains on pre-treatment samples A1 & A2. The analysis is done by non-parametric chi-square endpoint analysis
Frequency of concomitant medication/therapies
The use of any concomitant medication and/or application of therapies in patients is assessed during home visit as per eCRF entries. The analysis is done by non-parametric chi-square endpoint analysis
Frequency of intake of pre-treatment, Beverage and food-intake prior therapy start.
The use of any relevant pre-treatment, beverage and food consumption in patients is assessed during home visit as per eCRF entries. Any such intake in any case shall be recorded in the eCRF
Frequency of vaccination
The vaccine or prevention status of patients is assessed during home visit as per eCRF entries. Patients are asked if they have obtained SARS-CoV2 vaccination in the past. If yes, which one incl. full product name, number of vaccination shots, time point of vaccination?
Tolerability in view of subjects after treatment.
The treatment tolerability per corresponding study product is assessed by subjects after completion of all study procedures during home visit as per eCRF entries by asking the question how they rate the tolerability of their corresponding study product on a scale: bad = 0, average = 1, good = 2, very good = 3). The analysis is done by Mantel-Haenszel test].
Tolerability in view of Investigators after treatment.
The treatment tolerability per corresponding study product is assessed by the study investigators after completion of all study procedures during home visit as per eCRF entries by asking the question how they rate the tolerability in the subject of the corresponding study product on a scale: bad = 0, average = 1, good = 2, very good = 3). The analysis is done by Mantel-Haenszel test].
Incidence and severity of other symptoms (S/AEs).
S)AE, occurring during home visits are being detected as per e-CRF entries during home visit after study inclusion. Such events are additionally assessed after termination of the study in the form of a compiled safety report. Absolute and relative frequencies are analysed descriptively by non-parametric Fishers-exact/Chi2 test]
Full Information
NCT ID
NCT04999098
First Posted
August 4, 2021
Last Updated
February 2, 2023
Sponsor
A. Vogel AG
Collaborators
Clinical Research Centre CONVEX, Biodome Clinical, MediStat Ltd., Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT04999098
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
A. Vogel AG
Collaborators
Clinical Research Centre CONVEX, Biodome Clinical, MediStat Ltd., Medical University of Graz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Respiratory Infection, SARS-CoV2 Infection
Keywords
SARS-CoV2 infectivity, Viral load reduction, antiviral treatment, Oropharynx, Throat
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized, 3-armed, parallel, active-treatment controlled
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group 1: Echinaforce Forte (EFF) Tablets (chewed)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
treatment gorup 2: Echinaforce Chewable (EFC) Tablets (chewed)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
treatment group 3: Echinaforce Tincture (EFT, gargling)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Echinaforce Forte tablets
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Echinaforce Chewable tablets
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Echinaforce tincture
Other Intervention Name(s)
Echinaforce drops
Intervention Description
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)
Primary Outcome Measure Information:
Title
Absolute and relative differences in Cq values (qPCR) comparing pre- and post EF treatment including all formulations combined.
Description
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
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Absolute and relative viral loads comparing pre- and post EF treatment and in cross comparison of the respective EF-formulations
Description
The viral load reduction as per averages of Cq values and/or genomic read depths (optional) prior any treatment (samples A1 & B1) in comparison to post EF treatment and/or in cross-comparison with the respective time point and/or formulation. Oropharyngeal (OP) Swab samples are taken by using validated swab sticks (Eswab 480CE LQ Amies with Reg. Nylon Flocked applicator, COPAN Int.) and presence and quantity of viral RNA/DNA determined by using the qPCR SARS-CoV2 panel. The viral genomic material is optionally quantified by genomic read depth as per next generation sequencing (NGS). The analysis is done by a two-sided t-test for comparing pre- and post-treatment and ANOVA for cross-comparisons between groups
Time Frame
2 hours
Title
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.
Description
Residual tissue culture infectious dose per time point: prior any treatment (pre-treatment samples A1 & B1), to post EF treatment and/or in cross-comparison with the respective time point and/or formulation. The analysis is done by a two-sided t-test for comparing pre- and post-treatment and ANOVA for cross-comparisons between groups
Time Frame
2 hours
Title
Incidence of Treatment responders falling below limit of detection/ threshold value under treatment
Description
The number of subjects per time point that become qPCR negative as per RT-PCR test results and/or reached below threshold genomic read depth value (optional) as per NGS-read out and reach a below threshold residual infectivity as per TCID test result are determined prior and post EF treatment and in cross-comparison of the respective EF formulations. The analysis is done by non-parametric chi-square endpoint analysis].
Time Frame
2 hours
Title
Incidence of SARS-CoV-2 VOC (variant of concerns)
Description
Absolute and relative frequencies of SARS-CoV2 VOCs is as per identification by optional whole-genome next generation sequencing and automated database annotation to known and unknown SARS-CoV2 strains on pre-treatment samples A1 & A2. The analysis is done by non-parametric chi-square endpoint analysis
Time Frame
2 hours
Title
Frequency of concomitant medication/therapies
Description
The use of any concomitant medication and/or application of therapies in patients is assessed during home visit as per eCRF entries. The analysis is done by non-parametric chi-square endpoint analysis
Time Frame
3 days
Title
Frequency of intake of pre-treatment, Beverage and food-intake prior therapy start.
Description
The use of any relevant pre-treatment, beverage and food consumption in patients is assessed during home visit as per eCRF entries. Any such intake in any case shall be recorded in the eCRF
Time Frame
3 days
Title
Frequency of vaccination
Description
The vaccine or prevention status of patients is assessed during home visit as per eCRF entries. Patients are asked if they have obtained SARS-CoV2 vaccination in the past. If yes, which one incl. full product name, number of vaccination shots, time point of vaccination?
Time Frame
2 hours
Title
Tolerability in view of subjects after treatment.
Description
The treatment tolerability per corresponding study product is assessed by subjects after completion of all study procedures during home visit as per eCRF entries by asking the question how they rate the tolerability of their corresponding study product on a scale: bad = 0, average = 1, good = 2, very good = 3). The analysis is done by Mantel-Haenszel test].
Time Frame
2 hours
Title
Tolerability in view of Investigators after treatment.
Description
The treatment tolerability per corresponding study product is assessed by the study investigators after completion of all study procedures during home visit as per eCRF entries by asking the question how they rate the tolerability in the subject of the corresponding study product on a scale: bad = 0, average = 1, good = 2, very good = 3). The analysis is done by Mantel-Haenszel test].
Time Frame
2 hours
Title
Incidence and severity of other symptoms (S/AEs).
Description
S)AE, occurring during home visits are being detected as per e-CRF entries during home visit after study inclusion. Such events are additionally assessed after termination of the study in the form of a compiled safety report. Absolute and relative frequencies are analysed descriptively by non-parametric Fishers-exact/Chi2 test]
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Diagnostics and Consultation Center Convex EOOD
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lilyana Mircheva, Msc
Phone
+ 359 2 9863 109
Email
lilly@convex.bg
First Name & Middle Initial & Last Name & Degree
Kamelia Kafeva
Phone
+ 359 2(0)896578201
Email
kamelia@convex.bg
First Name & Middle Initial & Last Name & Degree
Alexandar Buchkov, Dr. med
First Name & Middle Initial & Last Name & Degree
Emil Kolev, Dr.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
There is no plan yet
Learn more about this trial
Echinaforce COVID-19 Shedding Study
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