Trial NCT04322123
Publication Cavalcanti AB, N Engl J Med, 2020 (published paper)
Dates: 3/29/2020 to 5/17/2020
Funding: Mixed (Hospitals and research institutes participating in Coalition Covid-19 Brazil; EMS Pharma)
Conflict of interest: Yes
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / Brazil Follow-up duration (days): 15 | |
Inclusion criteria | 1. Patients who were 18 years of age or older and were hospitalized with suspected or confirmed
COVID-19.
2. Fewer than 14 days since symptom onset. |
Exclusion criteria | 1. Need for oxygen supplementation >4 L/min via nasal cannula or 40% via Venturi mask;
2. Need for oxygen supplementation via high-flow nasal cannula; 3. Need for non-invasive ventilation; 4. Need for invasive mechanical ventilation; 5. Previous use of chloroquine, hydroxychloroquine, azithromycin, or any other macrolide for more than 24 hours before enrollment; 6. History of severe ventricular cardiac arrhythmia or electrocardiogram with corrected QT interval (QTc) ≥480 ms; 7. History of liver cirrhosis; 8. Chronic renal failure (estimated glomerular filtration rate <30 mL/min/1.73 m2); 9. Known retinopathy or macular degeneration; 10. History of pancreatitis; 11. Less than 18 years of age; 12. Known allergy to chloroquine or hydroxychloroquine; 13. Known allergy to azithromycin; 14. Pregnancy or breastfeeding. |
Interventions | |
Treatment 1 Hydroxychloroquine (400mg) Co-Intervention: Standard care Duration : 7 days | |
Control Standard care | |
Treatment 3 Hydroxychloroquine + Azithromycin (400mg/500mg) Co-Intervention: Standard care Duration : 7 days | |
Participants | |
Randomized 667 participants n1=221/ n2=229/ n3=217 | |
Characteristics of participants N=667 Mean age : 50.1 388 males Severity : Mild: n=387 / Moderate: n=278/ Severe: n=0 Critical: n=0 | |
Primary outcome | |
In the register Evaluation of the clinical status of patients on the 15th day after randomization defined by the Ordinal Scale of 7 points. | |
In the report Clinical status at 15 days, evaluated with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) | |
Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated Yes |
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
General comment |