COVID-19 Respiratory InfectionPhase 4NCT04999098
Echinaforce COVID-19 Shedding Study
A Phase 4 study testing Echinaforce Forte tablets, Echinaforce Chewable tablets and Echinaforce tincture in people with COVID-19 Respiratory Infection and SARS-CoV2 Infection, run by A. Vogel AG at 1 site in Bulgaria.
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. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- COVID-19 Respiratory Infection, SARS-CoV2 Infection
- What is being tested?
- Echinaforce Forte tablets, Echinaforce Chewable tablets and Echinaforce tincture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBulgaria
- Study dates
- 15 Nov 2021to 15 Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- ≥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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this 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
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.
- Being tested
- Echinaforce Forte tablets, Echinaforce Chewable tablets, Echinaforce tincture
- Keywords
- SARS-CoV2 infectivity, Viral load reduction, antiviral treatment, Oropharynx, Throat
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echinaforce Forte tabletsDrug
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 tabletsDrug
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 tinctureDrug
Also called Echinaforce drops
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Echinaforce tincture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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.
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
Measured: 2 hours
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].
Measured: 2 hours
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
Measured: 2 hours
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
Measured: 3 days
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
Measured: 3 days
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?
Measured: 2 hours
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].
Measured: 2 hours
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].
Measured: 2 hours
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]
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start15 Nov 2021
- Primary completion15 May 2023
- Study completion15 Aug 2023
Why it stopped: insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, 3-armed, parallel, active-treatment controlled
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- A. Vogel AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinical Research Centre CONVEX, Biodome Clinical, MediStat Ltd., Medical University of Graz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999098
- Sponsor's protocol ID
- 5'000'820
- Status last verified
- Aug 2024
- First submitted
- 4 Aug 2021
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is no plan yet
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04999098
- Acronym / sponsor ID
- 5'000'820
- Keywords
- SARS-CoV2 infectivity, Viral load reduction, antiviral treatment, Oropharynx, Throat
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient recruitment
- Enrolment
- 40 participants (actual)
- Lead sponsor
- A. Vogel AGIndustry (pharma, biotech, devices)
- Collaborators
- Clinical Research Centre CONVEX, Biodome Clinical, MediStat Ltd., Medical University of Graz
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, 3-armed, parallel, active-treatment controlled
| Arm | Type | Receives |
|---|---|---|
| treatment group 1: Echinaforce Forte (EFF) Tablets (chewed) | Active comparator | Drug: Echinaforce Forte tablets1st 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. |
| treatment gorup 2: Echinaforce Chewable (EFC) Tablets (chewed) | Active comparator | Drug: Echinaforce Chewable tablets2nd 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. |
| treatment group 3: Echinaforce Tincture (EFT, gargling) | Active comparator | Drug: Echinaforce tincture3rd 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. |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (15 listed)
- ≥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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echinaforce Forte tabletsTincture 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 | Drug | treatment group 1: Echinaforce Forte (EFF) Tablets (chewed) |
| Echinaforce Chewable tabletsTincture 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 | Drug | treatment gorup 2: Echinaforce Chewable (EFC) Tablets (chewed) |
| Echinaforce tinctureAlso: Echinaforce dropsTincture 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) | Drug | treatment group 3: Echinaforce Tincture (EFT, gargling) |
Primary outcome
Absolute and relative differences in Cq values (qPCR) comparing pre- and post EF treatment including all formulations combined.
Time frame: 2 hours
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
10 secondary outcomes
Absolute and relative viral loads comparing pre- and post EF treatment and in cross comparison of the respective EF-formulations
Time frame: 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.
Time frame: 2 hours
Incidence of Treatment responders falling below limit of detection/ threshold value under treatment
Time frame: 2 hours
Incidence of SARS-CoV-2 VOC (variant of concerns)
Time frame: 2 hours
Frequency of concomitant medication/therapies
Time frame: 3 days
Frequency of intake of pre-treatment, Beverage and food-intake prior therapy start.
Time frame: 3 days
Frequency of vaccination
Time frame: 2 hours
Tolerability in view of subjects after treatment.
Time frame: 2 hours
Tolerability in view of Investigators after treatment.
Time frame: 2 hours
Incidence and severity of other symptoms (S/AEs).
Time frame: 2 hours
Results and safety
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: Undecided. There is no plan yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Echinaforce Forte tablets, Echinaforce Chewable tablets and Echinaforce tincture in people with COVID-19 Respiratory Infection and SARS-CoV2 Infection, run by A. Vogel AG at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute and relative differences in Cq values (qPCR) comparing pre- and post EF treatment including all formulations combined. (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.