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Echinacea Drug for Covid-19 (ECCO-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04981314
Recruitment Status : Recruiting
First Posted : July 29, 2021
Last Update Posted : August 10, 2021
Sponsor:
Collaborators:
IDIS
SALUD
Laboratoires Arkopharma
Information provided by (Responsible Party):
Jesús R. Requena, University of Santiago de Compostela

Brief 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 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.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Equinacea Arkopharma Other: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind, placebo controlled, randomised.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Treatments & placebos are coded. The code will not be revealed to investigators until the end of the study.
Primary Purpose: Treatment
Official Title: Study on the Effect of an Echinacea Formulation on the Clinical Manifestations and Evolution of Covid-19
Actual Study Start Date : June 18, 2021
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Echinacea

Arm Intervention/treatment
Experimental: Treatment with echinacea
EQUINÁCEA ARKOPHARMA, 2 caplets at breakfast, 2 caplets at lunch and 2 caplets at dinner with a glass of water, for 10 days.
Drug: Equinacea Arkopharma
Echinacea hard caplets
Other Name: Echynacea hard caplets

Placebo Comparator: Placebo
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.
Other: Placebo
Placebo hard caplets




Primary Outcome Measures :
  1. Fever [ Time Frame: 4 weeks since recruitment ]
    Number of days with fever equal or higher to 37 C


Secondary Outcome Measures :
  1. Dyspnea [ Time Frame: 4 weeks since recruitment ]
    Number of days with subjective dyspnea

  2. Desaturation [ Time Frame: 4 weeks since recruitment ]
    Number of days with desaturation (equal or less than 96%, measured with pulseoximeter provided)

  3. Disease duration [ Time Frame: 4 weeks since recruitment ]
    Days of disease duration

  4. Hospitalizations [ Time Frame: 4 weeks since recruitment ]
    Percentage of hospitalizations

  5. Time of hospitalization [ Time Frame: 4 weeks since recruitment ]
    Number of hospitalization days

  6. Home sick leave days [ Time Frame: 4 weeks since recruitment ]
    Number of home sick leave days

  7. Emergency room visits [ Time Frame: 4 weeks since recruitment ]
    Number of additional emergency room visits

  8. Intensive Care Unit incoming [ Time Frame: 4 weeks since recruitment ]
    Percentage of incoming to ICU

  9. Deaths [ Time Frame: 4 weeks since recruitment ]
    Percentage of deaths

  10. Recruiter´s subjective improvement impression [ Time Frame: 4 weeks since recruitment ]
    Score of recruiter´s subjective improvement impression

  11. Patient´s subjective improvement impression [ Time Frame: 4 weeks since recruitment ]
    Score of patient´s subjective improvement impression

  12. Adverse events [ Time Frame: 4 weeks since recruitment ]
    Adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04981314


Contacts
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Contact: Jesús R. Requena 34-605566264 jesus.requena@usc.es

Locations
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Spain
Hospital de Barbastro Recruiting
Barbastro, Spain
Contact: Juan Eito, M.D.         
Hospital do Barbanza Recruiting
Ribeira, Spain
Contact: Azucena Prieto, M.D.         
Hospital Clínico Universitario de Santiago Recruiting
Santiago De Compostela, Spain
Contact: Cristina Rúa, M.D.         
Hospital Clínico Universitario Lozano Blesa Recruiting
Zaragoza, Spain
Contact: Marta Jordán, M.D.         
Sponsors and Collaborators
Jesús R. Requena
IDIS
SALUD
Laboratoires Arkopharma
Investigators
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Study Chair: José Luis Pérez-Albiac SALUD (Servicio Aragonés de Salud), Spain
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Responsible Party: Jesús R. Requena, Associate Professor, University of Santiago de Compostela
ClinicalTrials.gov Identifier: NCT04981314    
Other Study ID Numbers: 2021-000850-24
2021-000850-24 ( EudraCT Number )
First Posted: July 29, 2021    Key Record Dates
Last Update Posted: August 10, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Main results will be submitted for publication in a biomedical journal. The remaining IPD will be made availble to researchers upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: One month after study completion.
Access Criteria: Biomedical community.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jesús R. Requena, University of Santiago de Compostela:
Covid-19,
Echinacea
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases