Trial RBR-8h7q82
Publication Galan L ,Pathog Glob Health, 2021 (published paper)

Funding: Public/non profit (Universidade Federal de Roraima)
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Single center / Brazil
Follow-up duration (days): 90
Inclusion criteriaLaboratory test confirming infection by SARS-CoV-2 (positive serologic test IgM or rt-PCR); hospitalized with a clinical, epidemiological, and radiological picture compatible with COVID-19; over 18 years old; present a severe form of the disease characterized by one of the following clinical signs: dyspnea, tachypnea (>30 bpm), peripheral oxygen saturation <93% (pulse oximeter evaluation), PaO2/FiO2 ratio <300, or infiltrate pulmonary>50% of the parenchyma seen on chest tomography or chest radiography.
Exclusion criteriaUnder 18 years old; indigenous people; patients not fluent in Portuguese; unable to understand the objectives and methods of the study; critically ill patients who are not accompanied by legal representatives; those who reject participation in the study; patients with cardiac arrhythmia that include prolongation of the QT interval; previous use of any of the medications surveyed for more than 24 h.
Interventions
Treatment 1
Ivermectin
Control
Hydroxychloroquine
Control
Chloroquine
Participants
Randomized
168 participants n1=53/ n2=54/ n3=61
Characteristics of participants
N=168
Mean age : 53.2
95 males
Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=*
Primary outcome
In the register
Need for supplemental oxygen, need for invasive ventilation, need for admission to the intensive care unit (ICU)
In the report
Overall survival
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated
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
*
General comment The prospective trial registry was available. There were no differences between the published article and the registry in population or interventions. The study achieved its target sample size. No study protocol or statistical analysis plan was available. Outcomes reported were no relevant for the COVID-19 NMA. Consequently, no outcome data have been extracted for this study.