COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-88bs9x

Patricia Rocco

prmrocco@biof.ufrj.br

2020-08-24

Recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

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.

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.

2

Ministério da Ciência; Tecnologia; Inovações e Comunicações (MCTIC)

18

100

Brazil

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

0

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.

Phase 3

[{"arm_notes": "", "treatment_id": 447, "treatment_name": "Ef168", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]