Echinacea Drug for Covid-19

Covid19 Clinical Trial

— ECCO-2  

Official title:

Study on the Effect of an Echinacea Formulation on the Clinical Manifestations and Evolution of Covid-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04981314
• Other study ID #: 2021-000850-24
• Secondary ID: 2021-000850-24
• Status: Recruiting
• Phase: Phase 4
• Start date: June 18, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: August 2021
• Source: University of Santiago de Compostela
• Contact: Jesús R. Requena
• Phone: 34-605566264
• Email: jesus.requena[@]usc.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: October 31, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• Equinacea Arkopharma
Echinacea hard caplets

Other:
• Placebo
Placebo hard caplets

Locations

Country	Name	City	State
Spain	Hospital de Barbastro	Barbastro
Spain	Hospital do Barbanza	Ribeira
Spain	Hospital Clínico Universitario de Santiago	Santiago De Compostela
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza

Sponsors (4)

Lead Sponsor	Collaborator
Jesús R. Requena	IDIS, Laboratoires Arkopharma, SALUD

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fever	Number of days with fever equal or higher to 37 C	4 weeks since recruitment
Secondary	Dyspnea	Number of days with subjective dyspnea	4 weeks since recruitment
Secondary	Desaturation	Number of days with desaturation (equal or less than 96%, measured with pulseoximeter provided)	4 weeks since recruitment
Secondary	Disease duration	Days of disease duration	4 weeks since recruitment
Secondary	Hospitalizations	Percentage of hospitalizations	4 weeks since recruitment
Secondary	Time of hospitalization	Number of hospitalization days	4 weeks since recruitment
Secondary	Home sick leave days	Number of home sick leave days	4 weeks since recruitment
Secondary	Emergency room visits	Number of additional emergency room visits	4 weeks since recruitment
Secondary	Intensive Care Unit incoming	Percentage of incoming to ICU	4 weeks since recruitment
Secondary	Deaths	Percentage of deaths	4 weeks since recruitment
Secondary	Recruiter´s subjective improvement impression	Score of recruiter´s subjective improvement impression	4 weeks since recruitment
Secondary	Patient´s subjective improvement impression	Score of patient´s subjective improvement impression	4 weeks since recruitment
Secondary	Adverse events	Adverse events	4 weeks since recruitment