Coronavirus as the cause of diseases classified to other chapters
Conditions
Interventions
Experimental group: 250 patients will receive EF168 * orally, 3 x daily, for 5 days, orally.
* Confidential treatment
Control group: 250 patients will receive oral placebo, 3 times a day, for 5 days,
Drug
Sponsors
Ministério da Ciência, Tecnologia, Inovações e Comunicações (MCTIC)
Coordenação Geral de Recursos Logísticos (CGLOG)
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients who meet the requirements for the diagnosis of Coronavirus infection [Characteristic respiratory symptoms (dry cough, fever) associated with a tomographic image of pneumonia compatible with COVID-19 without acute respiratory failure (Oxygen Saturation less than 93% with nasal oxygen catheter at 5 liters / minute); Patients who meet the requirements for the diagnosis of Coronavirus infection [Characteristic respiratory symptoms (dry cough, fever) associated with a confirmatory molecular test for COVID-19 without acute respiratory failure (Oxygen Saturation less than 93% with a 5 liter nasal oxygen catheter /minute); Age greater than or equal to 18 years old man or woman; In women with negative pregnancy test and commitment to the use of contraception throughout the study (provided by the researcher); Willing to take study medication; Able to provide written, informed and / or informed consent even to a family member.
Exclusion criteria
Exclusion criteria: It is not possible to take drugs orally or through a gastroenteric feeding tube; With significantly abnormal liver function (Child Pugh C); Previous renal failure: patients who previously underwent dialysis, or patients with GFR less than or equal to 30 mL / min / 1.73 m2; NYHA (New York Heart Association) heart failure 3 or 4; COPD GOLD 3 and 4; Neoplasia; Autoimmune disease; Individuals with known hypersensitivity to study drugs; People who have already been treated with the study drug during the last 30 days; Clinical or radiological suspicion of tuberculosis and bacterial pneumonia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the rate of tracheal intubation and the number of days under mechanical ventilation of patients with severe SARS-CoV-2 pneumonia treated with EF168 or placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the number of days in the ICU and hospital for patients with COVID-19-derived pneumonia submitted to the EF168 therapeutic protocol with patients with COVID-19-derived pneumonia treated with placebo.;Compare the number of days on intranasal oxygen of patients with COVID-19-derived pneumonia undergoing the EF168 therapeutic protocol with patients with COVID-19-derived pneumonia treated with placebo.;Compare the mortality rate of patients with COVID-19-derived pneumonia undergoing the EF168 therapeutic protocol with patients with COVID-19-derived pneumonia treated with placebo.;Compare the mortality rate of patients with COVID-19-derived pneumonia submitted to the EF168 therapeutic protocol with patients with COVID-19-derived pneumonia in the general population. | — |
Countries
Brazil
Contacts
Public ContactPatricia Rocco
Universidade Federal do Rio de Janeiro-UFRJ
Outcome results
None listed