MedPath

Mechanical ventilator for use in patients with respiratory failure due to Covid-19 (VExCO)

Not Applicable
Conditions
Respiration, Artificial
C02.782.600.550.200
Registration Number
RBR-2dxyx4
Lead Sponsor
Hospital Universitário Clementino Fraga Filho
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
Not specified
Target Recruitment
Not specified
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

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

Study & Design

Study Type
Intervention
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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<br><br>Clinically assess efficacy for the presence of uncontrolled asthma after 5 or more days of medication initiation through telephone contact by trained staff
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath