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Echinacea Drug for Covid-19 (ECCO-2)

Primary Purpose

Covid19

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Equinacea Arkopharma
Placebo
Sponsored by
Jesús R. Requena
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Covid-19,, Echinacea

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de BarbastroRecruiting
  • Hospital do BarbanzaRecruiting
  • Hospital Clínico Universitario de SantiagoRecruiting
  • Hospital Clínico Universitario Lozano BlesaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment with echinacea

Placebo

Arm Description

EQUINÁCEA ARKOPHARMA, 2 caplets at breakfast, 2 caplets at lunch and 2 caplets at dinner with a glass of water, for 10 days.

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.

Outcomes

Primary Outcome Measures

Fever
Number of days with fever equal or higher to 37 C

Secondary Outcome Measures

Dyspnea
Number of days with subjective dyspnea
Desaturation
Number of days with desaturation (equal or less than 96%, measured with pulseoximeter provided)
Disease duration
Days of disease duration
Hospitalizations
Percentage of hospitalizations
Time of hospitalization
Number of hospitalization days
Home sick leave days
Number of home sick leave days
Emergency room visits
Number of additional emergency room visits
Intensive Care Unit incoming
Percentage of incoming to ICU
Deaths
Percentage of deaths
Recruiter´s subjective improvement impression
Score of recruiter´s subjective improvement impression
Patient´s subjective improvement impression
Score of patient´s subjective improvement impression
Adverse events
Adverse events

Full Information

First Posted
July 26, 2021
Last Updated
August 3, 2021
Sponsor
Jesús R. Requena
Collaborators
IDIS, SALUD, Laboratoires Arkopharma
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1. Study Identification

Unique Protocol Identification Number
NCT04981314
Brief Title
Echinacea Drug for Covid-19
Acronym
ECCO-2
Official Title
Study on the Effect of an Echinacea Formulation on the Clinical Manifestations and Evolution of Covid-19
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jesús R. Requena
Collaborators
IDIS, SALUD, Laboratoires Arkopharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
Covid-19,, Echinacea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Double blind, placebo controlled, randomised.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Treatments & placebos are coded. The code will not be revealed to investigators until the end of the study.
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment with echinacea
Arm Type
Experimental
Arm Description
EQUINÁCEA ARKOPHARMA, 2 caplets at breakfast, 2 caplets at lunch and 2 caplets at dinner with a glass of water, for 10 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Equinacea Arkopharma
Other Intervention Name(s)
Echynacea hard caplets
Intervention Description
Echinacea hard caplets
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo hard caplets
Primary Outcome Measure Information:
Title
Fever
Description
Number of days with fever equal or higher to 37 C
Time Frame
4 weeks since recruitment
Secondary Outcome Measure Information:
Title
Dyspnea
Description
Number of days with subjective dyspnea
Time Frame
4 weeks since recruitment
Title
Desaturation
Description
Number of days with desaturation (equal or less than 96%, measured with pulseoximeter provided)
Time Frame
4 weeks since recruitment
Title
Disease duration
Description
Days of disease duration
Time Frame
4 weeks since recruitment
Title
Hospitalizations
Description
Percentage of hospitalizations
Time Frame
4 weeks since recruitment
Title
Time of hospitalization
Description
Number of hospitalization days
Time Frame
4 weeks since recruitment
Title
Home sick leave days
Description
Number of home sick leave days
Time Frame
4 weeks since recruitment
Title
Emergency room visits
Description
Number of additional emergency room visits
Time Frame
4 weeks since recruitment
Title
Intensive Care Unit incoming
Description
Percentage of incoming to ICU
Time Frame
4 weeks since recruitment
Title
Deaths
Description
Percentage of deaths
Time Frame
4 weeks since recruitment
Title
Recruiter´s subjective improvement impression
Description
Score of recruiter´s subjective improvement impression
Time Frame
4 weeks since recruitment
Title
Patient´s subjective improvement impression
Description
Score of patient´s subjective improvement impression
Time Frame
4 weeks since recruitment
Title
Adverse events
Description
Adverse events
Time Frame
4 weeks since recruitment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesús R. Requena
Phone
34-605566264
Email
jesus.requena@usc.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Luis Pérez-Albiac
Organizational Affiliation
SALUD (Servicio Aragonés de Salud), Spain
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de Barbastro
City
Barbastro
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Eito, M.D.
Facility Name
Hospital do Barbanza
City
Ribeira
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Azucena Prieto, M.D.
Facility Name
Hospital Clínico Universitario de Santiago
City
Santiago De Compostela
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Rúa, M.D.
Facility Name
Hospital Clínico Universitario Lozano Blesa
City
Zaragoza
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Jordán, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Main results will be submitted for publication in a biomedical journal. The remaining IPD will be made availble to researchers upon request.
IPD Sharing Time Frame
One month after study completion.
IPD Sharing Access Criteria
Biomedical community.

Learn more about this trial

Echinacea Drug for Covid-19

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