A study on the effect of an Echinacea formulation on the clinical manifestations and evolution of Covid-19.

INTERVENTION: Trade Name: EQUINÁCEA ARKOPHARMA cápsulas duras Product Name: Echinacea purpurea Pharmaceutical Form: Capsule, hard INN or Proposed INN: ECHINACEA PURPUREA ROOT, CRYOGROUND Other descriptive name: ECHINACEA PURPUREA ROOT, CRYOGROUND Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: COVID‐19 ; MedDRA version: 23.1 Level: LLT Classification code 10084355 Term: COVID‐19 virus test positive System Organ Class: 100000004848 ; MedDRA version: 23.1 Level: LLT Classification code 10084437 Term: COVID‐19 PCR test positive System Organ Class: 100000004848 Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: 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. 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). Secondary Objective: To determine that incidence of adverse effects is not higher than those associated to the standard treatment. 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: 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 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