Respiration, Artificial
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adults age greater than or equal to 18 years ;patients assisted in the ER with probable or confirmed infection by COVID-19; time between symptoms and inclusion less than or equal to 7 days; present mild symptoms, with no indication of hospitalization; present at least 1 risk factor for complication (age more than 65 years; hypertension; diabetes mellitus; bronchial asthma; COPD or other chronic lung diseases; smoking ; immunosuppression; obesity
Exclusion criteria
Exclusion criteria: Patients under 18 years old, hospitalization in the first care; positive test for influenza in the first visit; known hypersensitivity hydroxychloroquine / chloroquine; previous diagnosis of retinopathy or macular degeneration; previous diagnosis of QT-long syndrome; history of sudden death in close family members (parents and siblings), use of anti-arrhythmic drugs or others that may increase the bioavailability of hydroxychloroquine or enhance its effect, decompensated heart failure, symptomatic coronary artery disease; evidence of known liver disease, reported by the patient; evidence of known chronic kidney disease, reported by the patient, patients with pancreatitis, baseline ECG with QT interval greater than or equal to 480ms; chronic use of hydroxychloroquine / chloroquine for other reasons; pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess need for hospitalization due to a COVID-19 compatible cause within 30 days after hospitalization through telephone contact by a trained professional, as it is believed that 90% of hospital admissions due to SARS-Cov2 occur within the first 15 sick days. The outcome period of 30 days was chosen to capture the 10% of the remaining hospitalizations, which are outliers, which will happen between 15 and 30 days of illness.;Secondary Outcome Clinically assess efficacy for the presence of uncontrolled asthma after 5 or more days of medication initiation through telephone contact by trained staff | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinically assess the effectiveness of pneumonia through telephone contact by trained staff;Clinically evaluate the efficacy of otitis media through telephone contact by trained staff;Clinically assess efficacy for fever resolution time through telephone contact by trained staff;Clinically assess the effectiveness of the time to resolve respiratory symptoms (cough, runny nose) through telephone contact by trained staff;Clinically assess efficacy for fever resolution time through telephone contact by trained staff;Check if there was an admission to the Intensive Care Unit through telephone contact by trained staff;Check if there is a need for orotracheal intubation;Check mechanical ventilation time;Assess mortality;To evaluate hypoglycemia through questioning by telephone contact by trained starff to verify changes in the frequency of hypoglycemic episodes in diabetic patients using hypoglycemic medication, perceived by clinical conditions or measured in a capillary or blood glucose device.;To evaluate the presence of cardiac arrhythmias in patients with no known history of prolongation in the QT interval or pre-existing heart disease, through telephone contact, questioning the need to seek medical attention and detect adverse events resulting from treatment;Check if there is a reduction in visual acuity: Change in visual acuity or a new diagnosis of retinal disease not previously known, through telephone contact questioning the need to seek medical attention and detection of adverse event resulting from treatment;Check if there is a change in intestinal habit greater than three (3) diarrheal episodes a day during the use of hydroxychloroquine medication and after 3 days after the end of it, through telephone contact questioning the need to seek medical attention and detection of adverse event resulting from treatment;Check if there is a change in appetite (anorexia) during the use of the hydroxychloroquine medication and 3 days after the end of it, through telephone | — |
Countries
Brazil
Contacts
Hospital Universitário Clementino Fraga Filho;Hospital Alemão Oswaldo Cruz