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

Who is this study for? Adult patients with COVID-19
What treatments are being studied? Equinacea Arkopharma
Status: Unknown
Location: See all (4) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital de Barbastro
RECRUITING
Barbastro
Hospital do Barbanza
RECRUITING
Ribeira
Hospital Clínico Universitario de Santiago
RECRUITING
Santiago De Compostela
Hospital Clínico Universitario Lozano Blesa
RECRUITING
Zaragoza
Contact Information
Primary
Jesús R. Requena
jesus.requena@usc.es
34-605566264
Time Frame
Start Date: 2021-06-18
Completion Date: 2021-10-31
Participants
Target number of participants: 230
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Jesús R. Requena
Collaborators: SALUD, Laboratoires Arkopharma, IDIS

This content was sourced from clinicaltrials.gov