Echinaforce COVID-19 Shedding Study

SARS-CoV2 Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04999098
• Other study ID #: 5'000'820
• Status: Recruiting
• Phase: Phase 4
• Start date: November 15, 2021
• Est. completion date: August 2023

Study information

• Verified date: February 2023
• Source: A. Vogel AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: August 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• Infections
• Respiratory Tract Infections
• SARS-CoV2 Infection

Intervention

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
• 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
• 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)

Locations

Country	Name	City	State
Bulgaria	Diagnostics and Consultation Center Convex EOOD	Sofia

Sponsors (5)

Lead Sponsor	Collaborator
A. Vogel AG	Biodome Clinical, Clinical Research Centre CONVEX, Medical University of Graz, MediStat Ltd.

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	2 hours
Secondary	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	2 hours
Secondary	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].	2 hours
Secondary	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	2 hours
Secondary	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	3 days
Secondary	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	3 days
Secondary	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?	2 hours
Secondary	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].	2 hours
Secondary	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].	2 hours
Secondary	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]	2 hours