Echinacea Drug for Covid-19

NCT04981314 | Unknown Phase 4 DMC

• 1 other identifier: 2021-000850-24
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 4

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.

Conditions

Covid19

Keywords

Covid-19,; Echinacea

Outcome Measures

Primary Outcomes (1)

• Fever

  Number of days with fever equal or higher to 37 C

  4 weeks since recruitment

Secondary Outcomes (12)

• Dyspnea

  4 weeks since recruitment

• Desaturation

  4 weeks since recruitment

• Disease duration

  4 weeks since recruitment

• Hospitalizations

  4 weeks since recruitment

• Time of hospitalization

  4 weeks since recruitment

Study Arms (2)

Treatment with echinacea

EXPERIMENTAL

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

Drug: Equinacea Arkopharma

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Equinacea Arkopharma DRUG

Echinacea hard caplets

Also known as: Echynacea hard caplets

Treatment with echinacea

Placebo OTHER

Placebo hard caplets

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 99 años, with capacity to provide informed consent.
• Covid-19 diagnose, confirmed by PCR or antigen test
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jesús R. Requena: lead
• IDIS: collaborator
• SALUD: collaborator
• Laboratoires Arkopharma: collaborator

Study Sites (4)

Hospital de Barbastro

Barbastro, Spain

RECRUITING

Hospital do Barbanza

Ribeira, Spain

RECRUITING

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Spain

RECRUITING

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• José Luis Pérez-Albiac

  SALUD (Servicio Aragonés de Salud), Spain

  STUDY CHAIR

Central Study Contacts

Jesús R. Requena

CONTACT

34-605566264; jesus.requena@usc.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Treatments \& placebos are coded. The code will not be revealed to investigators until the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double blind, placebo controlled, randomised.

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: July 29, 2021
• Study Start: June 18, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 31, 2021
• Last Updated: August 10, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: One month after study completion.
• Access Criteria: Biomedical community.

Locations

ES (4)