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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000850-24 | EudraCT Number |
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| Name | Class |
|---|---|
| IDIS | UNKNOWN |
| SALUD | UNKNOWN |
| Laboratoires Arkopharma | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Equinacea Arkopharma | Drug | Echinacea hard caplets |
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| Measure | Description | Time Frame |
|---|---|---|
| Fever | Number of days with fever equal or higher to 37 C | 4 weeks since recruitment |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea | Number of days with subjective dyspnea | 4 weeks since recruitment |
| Desaturation | Number of days with desaturation (equal or less than 96%, measured with pulseoximeter provided) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jesús R. Requena | Contact | 34-605566264 | jesus.requena@usc.es |
| Name | Affiliation | Role |
|---|---|---|
| José Luis Pérez-Albiac | SALUD (Servicio Aragonés de Salud), Spain | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Barbastro | Recruiting | Barbastro | Spain |
Main results will be submitted for publication in a biomedical journal. The remaining IPD will be made availble to researchers upon request.
One month after study completion.
Biomedical community.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Double blind, placebo controlled, randomised.
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Treatments & placebos are coded. The code will not be revealed to investigators until the end of the study.
| Placebo | Other | Placebo hard caplets |
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| 4 weeks since recruitment |
| Disease duration | Days of disease duration | 4 weeks since recruitment |
| Hospitalizations | Percentage of hospitalizations | 4 weeks since recruitment |
| Time of hospitalization | Number of hospitalization days | 4 weeks since recruitment |
| Home sick leave days | Number of home sick leave days | 4 weeks since recruitment |
| Emergency room visits | Number of additional emergency room visits | 4 weeks since recruitment |
| Intensive Care Unit incoming | Percentage of incoming to ICU | 4 weeks since recruitment |
| Deaths | Percentage of deaths | 4 weeks since recruitment |
| Recruiter´s subjective improvement impression | Score of recruiter´s subjective improvement impression | 4 weeks since recruitment |
| Patient´s subjective improvement impression | Score of patient´s subjective improvement impression | 4 weeks since recruitment |
| Adverse events | Adverse events | 4 weeks since recruitment |
| Hospital do Barbanza | Recruiting | Ribeira | Spain |
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| Hospital Clínico Universitario de Santiago | Recruiting | Santiago de Compostela | Spain |
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| Hospital Clínico Universitario Lozano Blesa | Recruiting | Zaragoza | Spain |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |