Covid19Phase 4ECCO-2NCT04981314
Echinacea Drug for Covid-19
A Phase 4 study testing Equinacea Arkopharma in people with Covid19, run by Jesús R. Requena at 4 sites in Spain.
Trial summary
The main objectives of ECCO-2 are: 1) Efficacy: to study whether EQUINACEA ARKOPHARMA, hard caplets containing cryogenized root of the plant Echinacea purpurea, show an improvement of the clinical manifestations and disease course in ambulatory patients with covid-19 with a respiratory presentation and not requiring… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Covid19
- What is being tested?
- Equinacea Arkopharma
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 4 sitesSpain
- Study dates
- 18 Jun 2021to 31 Oct 2021
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 99 años, with capacity to provide informed consent.
- Covid-19 diagnose, confirmed by PCR or antigen test
- Predominantly respiratory presentation. Additional minor digestive or/and neurological clinical manifestations will not lead to exclusion.
- Axillary temperature equal to or higher than 37ºC, at some point during the evolution of clinical signs prior to recruitment, or at the moment of recruitment.
- Being between days 1 and 9 of evolution of the disease, counting from the inception of symptoms.
- Not having received any Covid-19 vaccine.
- Capacity to complete the treatment, i.e., not having any swallowing difficulties, or any physical or psychiatric condition that would prevent the patient from taking caplets.
- Patients that after being evaluated at the emergency room are deemed to be in a condition to follow treatment at home, with follow up by their family doctor, i.e., that will not be hospitalized.
Who cannot join
- Patients under 18.
- Patients without a PCR or antigen test-based diagnose.
- Asymptomatic patients.
- Patients with an evolution higher than 9 days after the inception of symptoms
- Patients with a predominantly digestive presentation.
- Patients with a hypersensitivity to the active principle, any of the excipients of the drug or to the Asteraceae family of plants.
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- Patients with systemic progressive diseases such as tuberculosis, diseases of the immune system, collagenosis, multiple sclerosis múltiple, AIDS, VIH infections and other immune diseases
- Patients previously treated at home with oxygen therapy.
- Non-collaborating patients.
- Patients without capacity to provide informed consent.
- Pregnant or nursing patients.
- Patients with an active immunosupressive treatment.
- Women in a potentially fertile age will need to provide a negative pregnancy test before being including in the study. Subsequently, they will be instructed about the convenience of not becoming pregnant during the study. Only women using reliable birth control measures will be included. WOCBPs unable to guarantee reliable birth control during the study, or using unreliable methods such as coitus interruptus, nursing or just spermicides, will be excluded.
Trial locations and contacts
4 sites in 1 country.
Spain4 sites, 4 recruiting
- Recruiting
Hospital de Barbastro
Barbastro
Juan Eito, M.D.
- Recruiting
Hospital do Barbanza
Ribeira
Azucena Prieto, M.D.
- Recruiting
Hospital Clínico Universitario de Santiago
Santiago de Compostela
Cristina Rúa, M.D.
- Recruiting
Hospital Clínico Universitario Lozano Blesa
Zaragoza
Marta Jordán, M.D.
About this study
Official title: Study on the Effect of an Echinacea Formulation on the Clinical Manifestations and Evolution of Covid-19
The main objectives of ECCO-2 are: 1) Efficacy: to study whether EQUINACEA ARKOPHARMA, hard caplets containing cryogenized root of the plant Echinacea purpurea, show an improvement of the clinical manifestations and disease course in ambulatory patients with covid-19 with a respiratory presentation and not requiring hospitalization (i.e., mild covid-19). The drug being evaluated will be added as a supplement of the standard treatment, with its current recommended dose for treatment of the common cold. 2) Safety: to determine that the incidence of adverse events is not higher than that seen with the standard treatment applied in each case.
Read the detailed description
Different presentations of the plant Echinacea purpurea are widely prescribed and used for the treatment of upper respiratory tract viral infections. The plant is known to contain an array of active principles including alkylamides, cichoric acid, glucoproteins resulting in stimulation of the innate immune system, in particular, an activation of macrophages and an increase of phagocytic activity (Nagoor Meeran et al. 2019. Heliyon, 7(2):e05990). It has also been recently shown to exert a direct antiviral effect against SARS-CoV-II in vitro (Signer et al. 2020. Virol J 17:136). EQUINACEA ARKOPHARMA is a pharmaceutical preparation of Echinacea purpurea prepared by controlled cryo-processing roots of the plant and packing the powder thus obtained in hard caplets. The product is a medicine approved by the European Medicines Agency for the treatment of common cold. In this study, 230 patients presenting with mild Covid-19 at the emergency room of 4 participating hospitals, with an eminently respiratory presentation, fever, and not requiring hospitalization, will be randomly assigned to two branches to receive EQUINACEA ARKOPHARMA or placebo, in a double-blind manner. Patients will be followed up for 4 weeks and the effect of treatment vs. placebo on clinical manifestations, duration of fever and of total disease and percentage of return to the emergency room and/or hospitalization will be assessed.
- Conditions
- Covid19
- Being tested
- Equinacea Arkopharma, Placebo
- Keywords
- Covid-19,, Echinacea
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equinacea ArkopharmaDrug
Also called Echynacea hard caplets
Echinacea hard caplets
PlaceboOther
Placebo hard caplets
| Study group | Role | What they receive |
|---|---|---|
| Treatment with echinacea | Experimental | EQUINÁCEA ARKOPHARMA, 2 caplets at breakfast, 2 caplets at lunch and 2 caplets at dinner with a glass of water, for 10 days. Receives: Drug: Equinacea Arkopharma |
| Placebo | Placebo comparator | Hard caplets indistinguishable from EQUINÁCEA ARKOPHARMA, 2 caplets at breakfast, 2 caplets at lunch and 2 caplets at dinner with a glass of water, for 10 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fever
Number of days with fever equal or higher to 37 C
Measured: 4 weeks since recruitment
Secondary outcomes (12)
Dyspnea
Number of days with subjective dyspnea
Measured: 4 weeks since recruitment
Desaturation
Number of days with desaturation (equal or less than 96%, measured with pulseoximeter provided)
Measured: 4 weeks since recruitment
Disease duration
Days of disease duration
Measured: 4 weeks since recruitment
Hospitalizations
Percentage of hospitalizations
Measured: 4 weeks since recruitment
Time of hospitalization
Number of hospitalization days
Measured: 4 weeks since recruitment
Home sick leave days
Number of home sick leave days
Measured: 4 weeks since recruitment
Emergency room visits
Number of additional emergency room visits
Measured: 4 weeks since recruitment
Intensive Care Unit incoming
Percentage of incoming to ICU
Measured: 4 weeks since recruitment
Deaths
Percentage of deaths
Measured: 4 weeks since recruitment
Recruiter´s subjective improvement impression
Score of recruiter´s subjective improvement impression
Measured: 4 weeks since recruitment
Patient´s subjective improvement impression
Score of patient´s subjective improvement impression
Measured: 4 weeks since recruitment
Adverse events
Adverse events
Measured: 4 weeks since recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start18 Jun 2021
- Primary completion1 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Double blind, placebo controlled, randomised.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jesús R. Requena
- Sponsor type
- University, hospital or other
- Collaborators
- IDIS, SALUD, Laboratoires Arkopharma
- Responsible party
- Sponsor-investigator, Jesús R. Requena, University of Santiago de Compostela
- Investigators
- José Luis Pérez-Albiac, Study chair, SALUD (Servicio Aragonés de Salud), Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981314
- Sponsor's protocol ID
- 2021-000850-24
- Other IDs
- 2021-000850-24
- Acronym
- ECCO-2
- Status last verified
- Aug 2021
- First submitted
- 26 Jul 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Main results will be submitted for publication in a biomedical journal. The remaining IPD will be made availble to researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of an Echinacea Formulation on the Clinical Manifestations and Evolution of Covid-19
- ClinicalTrials.gov ID
- NCT04981314
- Acronym / sponsor ID
- ECCO-2 / 2021-000850-24
- Conditions
- Covid19
- Keywords
- Covid-19,, Echinacea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Jesús R. RequenaUniversity, hospital or other
- Collaborators
- IDIS, SALUD, Laboratoires Arkopharma
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 29 Jul 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.
The main objectives of ECCO-2 are: 1) Efficacy: to study whether EQUINACEA ARKOPHARMA, hard caplets containing cryogenized root of the plant Echinacea purpurea, show an improvement of the clinical manifestations and disease course in ambulatory patients with covid-19 with a respiratory presentation and not requiring hospitalization (i.e., mild covid-19). The drug being evaluated will be added as a supplement of the standard treatment, with its current recommended dose for treatment of the common cold. 2) Safety: to determine that the incidence of adverse events is not higher than that seen with the standard treatment applied in each case.
Detailed description
Different presentations of the plant Echinacea purpurea are widely prescribed and used for the treatment of upper respiratory tract viral infections. The plant is known to contain an array of active principles including alkylamides, cichoric acid, glucoproteins resulting in stimulation of the innate immune system, in particular, an activation of macrophages and an increase of phagocytic activity (Nagoor Meeran et al. 2019. Heliyon, 7(2):e05990). It has also been recently shown to exert a direct antiviral effect against SARS-CoV-II in vitro (Signer et al. 2020. Virol J 17:136). EQUINACEA ARKOPHARMA is a pharmaceutical preparation of Echinacea purpurea prepared by controlled cryo-processing roots of the plant and packing the powder thus obtained in hard caplets. The product is a medicine approved by the European Medicines Agency for the treatment of common cold. In this study, 230 patients presenting with mild Covid-19 at the emergency room of 4 participating hospitals, with an eminently respiratory presentation, fever, and not requiring hospitalization, will be randomly assigned to two branches to receive EQUINACEA ARKOPHARMA or placebo, in a double-blind manner. Patients will be followed up for 4 weeks and the effect of treatment vs. placebo on clinical manifestations, duration of fever and of total disease and percentage of return to the emergency room and/or hospitalization will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double blind, placebo controlled, randomised.
| Arm | Type | Receives |
|---|---|---|
| Treatment with echinacea | Experimental | Drug: Equinacea ArkopharmaEQUINÁCEA ARKOPHARMA, 2 caplets at breakfast, 2 caplets at lunch and 2 caplets at dinner with a glass of water, for 10 days. |
| Placebo | Placebo comparator | Other: PlaceboHard caplets indistinguishable from EQUINÁCEA ARKOPHARMA, 2 caplets at breakfast, 2 caplets at lunch and 2 caplets at dinner with a glass of water, for 10 days. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 99 años, with capacity to provide informed consent.
- Covid-19 diagnose, confirmed by PCR or antigen test
- Predominantly respiratory presentation. Additional minor digestive or/and neurological clinical manifestations will not lead to exclusion.
- Axillary temperature equal to or higher than 37ºC, at some point during the evolution of clinical signs prior to recruitment, or at the moment of recruitment.
- Being between days 1 and 9 of evolution of the disease, counting from the inception of symptoms.
Key exclusion criteria (13 listed)
- Patients under 18.
- Patients without a PCR or antigen test-based diagnose.
- Asymptomatic patients.
- Patients with an evolution higher than 9 days after the inception of symptoms
- Patients with a predominantly digestive presentation.
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 |
|---|---|---|
| Equinacea ArkopharmaAlso: Echynacea hard capletsEchinacea hard caplets | Drug | Treatment with echinacea |
| PlaceboPlacebo hard caplets | Other | Placebo |
Primary outcome
Fever
Time frame: 4 weeks since recruitment
Number of days with fever equal or higher to 37 C
12 secondary outcomes
Dyspnea
Time frame: 4 weeks since recruitment
Desaturation
Time frame: 4 weeks since recruitment
Disease duration
Time frame: 4 weeks since recruitment
Hospitalizations
Time frame: 4 weeks since recruitment
Time of hospitalization
Time frame: 4 weeks since recruitment
Home sick leave days
Time frame: 4 weeks since recruitment
Emergency room visits
Time frame: 4 weeks since recruitment
Intensive Care Unit incoming
Time frame: 4 weeks since recruitment
Deaths
Time frame: 4 weeks since recruitment
Recruiter´s subjective improvement impression
Time frame: 4 weeks since recruitment
Patient´s subjective improvement impression
Time frame: 4 weeks since recruitment
Adverse events
Time frame: 4 weeks since recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: Yes. Main results will be submitted for publication in a biomedical journal. The remaining IPD will be made availble to researchers upon request.
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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.
José Luis Pérez-Albiac study chair
SALUD (Servicio Aragonés de Salud), Spain
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Equinacea Arkopharma in people with Covid19, run by Jesús R. Requena at 4 sites in Spain.
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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesús R. Requena (34-605566264, jesus.requena@usc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fever (time frame: 4 weeks since recruitment). 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 10 Aug 2021.