COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-8h7q82

Allex;ruy Fonseca;silveira

allex.jardim@bol.com.br; ruysouza28@gmail.com

2020-10-02

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Treatment

laboratory test confirming infection by SARS-CoV-2 (positive serologic test IgM or rt-PCR), hospitalized with a clinical, epidemiological and radiological picture compatible with COVID-19, over 18 years old, present a severe form of the disease characterized by one of the following clinical signs: dyspnea, tachypnea (more than 30 irpm), peripheral oxygen saturation less than 93% (pulse oximeter evaluation), PaO2 / FiO2 ratio less than 300, or infiltrate pulmonary more than 50% of the parenchyma seen on chest tomography or chest radiography

under 18 years old, indigenous people, patients not fluent in Portuguese, unable to understand the objectives and methods of the study, critically ill patients who are not accompanied by legal representatives, those who reject participation in the study, patients with cardiac arrhythmia that include prolongation of the QT interval, previous use of any of the medications surveyed for more than 24 hours

3

Universidade Federal de Roraima

18

100

Brazil

Severe disease at enrollment

6: Severe disease at enrollment

0

The study end points were: need for supplemental oxygen; ;need for invasive ventilation; ;need for admission to the intensive care unit (ICU);

Phase 2

[{"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}]