Trial NCT04420247
Publication Rea-Neto A, Scientific Reports, 2021 (published paper)
Dates: 2020-04-16 to 2020-08-06
Funding: Not reported/unclear
Conflict of interest: No
Methods | |
RCT Blinding: Unblinded | |
Location :
Multicenter / Brazil Follow-up duration (days): 28 | |
Inclusion criteria | Patients admitted to the ICU or acute care rooms; 18 years or more; flu symptoms (runny nose, dry or productive cough, sore throat and/or fever) associated with one of the following manifestations: clinical need for supplemental oxygen for dyspnea, pulse oxygen saturation ≤ 94% on room air, pulmonary computed tomography findings compatible with COVID-19 or the necessity of mechanical ventilation (MV); diagnosis of SARS-CoV-2 infection confirmed by molecular analysis or RT-PCR performed at admission |
Exclusion criteria | Patients with a significant history of cardiopathy or any kind of arrhythmia; psoriasis; seizure; G6PD deficiency; myasthenia gravis; ALT/AST > 5 times the normal values; creatinine clearance < 30 ml/min/1.73 m2; pregnancy or lactation; known Clq/HClq allergy; arrhythmia or abnormally prolonged QT interval (from ECG at admission); clinical history of arrhythmia |
Interventions | |
Treatment
Chloroquine/Hydroxychloroquine Initial dose: 450 mg (CQ) or 400 mg (HCQ) twice on day 1 - Maintenance dose 450 mg (CQ) or 400 mg (HCQ) once daily on days 2 to 5 |
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Control
Standard care ( / ) Definition of Standard care: Each study site was encouraged to follow the best practice guidelines for the care of critically ill patients with COVID-19. The use of glucocorticoids, antibiotics and antiviral agents was allowed. All clinical interventions, such as ventilatory support, laboratory testing, and hemodynamic management, were left at the discretion of the ICU team for both groups. Other therapeutic strategies, such as remdesivir, tocilizumab and convalescent plasma, were not available for any participant in the study. | |
Participants | |
Randomized 142 participants (n1=71 / n2= 71) | |
Characteristics of participants N=142 Mean age : 53.8 70 males Severity : Mild: n=0 / Moderate: n=5/ Severe: n=81 Critical: n=19 | |
Primary outcome | |
In the register World Health Organization (WHO) 9-levels ordinal scale (from 0-8) [ Time Frame: 14 days after randomization ] | |
In the report Clinical status measured on day 14 after randomization with a 9-point ordinal scale | |
Documents available |
Protocol NR Statistical plan NR 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 | In addition to the published article, the retrospective study registry was used in data extraction and risk of bias assessment. The report mentioned a protocol, but it was not accessible at the time of data extraction. The intervention group received either chloroquine or hydroxychloroquine depending on type of hospital: chloroquine is available to patients in public hospitals in Brazil whereas patients in private centers received hydroxychloroquine because chloroquine was not available to them. The report presents an interim analysis; the trial was stopped before reaching the planned sample size due to safety reasons. Consequently, the target sample size was not reached. |