non specified coronavirus infection/ coronavirus
Conditions
Interventions
1. Control group - 210 participants
Control group will recieve proper COVID19 treatment but will not recieve hydroxychloroquine, chloroquine, azythromicyn or other macrolide.
2. HCQA - 210 participan
Drug
Sponsors
Hospital do Coração
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients admitted to the ICU or Hospital with suspected or confirmed COVID-19
Exclusion criteria
Exclusion criteria: Presence of any of the following: Need to supplement oxygen more than 4L; Use of high flow nasal catheter; Use of non-invasive ventilation; Use of mechanical ventilation; Use of hidroxichoroquine, chloroquine, azithromycin or other macrolide over 24 hours; History of severe ventricular or QTC equal or grater than 48 ms cardiac arrithmia; History of hepatic desease (cirrosis); Renal dysfunction (estimated glomerular filtration rate [eGFR] less than 30ml/min/1.73m2, using MDRD or CKD-EPI method); Patients with retinopathy or macular degeneration; Children under 18 years;Pregnancy; Allergy to chloroquine and derivatives; Allergy to azythromicyn; Patients in hospital over 48hr; Patients with symptoms over 14 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate patient's health condition after 15 days. The primary outcome is based on seven possible patient's health conditions whithin 15 days: ;Outpatient, without activity limitation;Patient in hospital, without supplemental oxygen;Patient in hospital, with supplemental oxygen;Patient in hospital with non-invasive ventilation or high flow cannula;Patient in mechanical ventilation;Death;Outpatient, with limited activities | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate patient's health conditions as an ordinal outcome in 7 days ;Need for intubation and mechanical ventilation in 15 days;Need of non-invasive ventilation or high flow cannula in 15 days;Hospital stay;In-hospital mortality;Occurence of hromboembolic complications;Occurrence of renal dysfunction, defined as an increase in creatinine above 1.5 times the baseline value;Respiratory support free days in 15 days | — |
Countries
Brazil
Contacts
Public ContactAlexandre;Fernando Cavalcanti;Zampieri
Hospital do Coração;Hospital do Coração
Outcome results
None listed