Echinacea and Covid-19 (Acronym: ECCO-2)

Phase 1

• Conditions: COVID-19; MedDRA version: 23.1Level: LLTClassification code 10084355Term: COVID-19 virus test positiveSystem Organ Class: 100000004848; MedDRA version: 23.1Level: LLTClassification code 10084437Term: COVID-19 PCR test positiveSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2021-000850-24-ES
• Lead Sponsor: Jesús Rodríguez Requena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-01
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Age between 18 and 99. Capacity to provide informed consent.
• Presentation with a predominantly respiratory involvement.
• Body temperature of 37ºC, at some point in the course of the disease,
• Being between days 1 and 8 of disease course, counted from inception of symptoms
• Npt being vaccinated against SARS_COV-2.
• Being able to complete the treatment, in particular, swallowing the caplets.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

• Patients without a PCR or antigen test-based diagnosis.
• Asymptomatic patients.
• Patients with a disease course of more than 9 days
• Patients with a predominantly digestive presentation.
• Patients with a formal counterindication to take echinacea.
• Patients that have previously received oxygen therapy.
• Non collaborative patients, patients under 18, or unable to provide informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate whether the drug Equinacea Arkopharma, consisting of root of Echinacea purpurea, diminishes symptoms and improves disease course in covid-19 positive patients when administered along the standard treatment of the disease.;Secondary Objective: To determine that incidence of adverse effects is not higher than those associated to the standard treatment.;Primary end point(s): The main variable is the number of days of fever (temperature equal to or greater than 37ºC at some point during the day).;Timepoint(s) of evaluation of this end point: Over the study, and reported on Visits at 7 days, 12 days y 28 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Adverse events;Timepoint(s) of evaluation of this end point: Over the study, and reported on Visits at 7 days, 12 days y 28 days