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: Participants, outcome assessor and health care pro
Location : Single center / Brazil
Follow-up duration (days): 90
Inclusion criteria
  • Laboratory 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 criteria
  • Under 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
Hydroxychloroquine
Initial dose: 400 mg orally twice on day 0 - Maintenance dose: 400 mg orally once daily twice on day 1, and once daily from day 2 to day 5

Chloroquine
Initial dose: 450 mg orally twice on day 0 -Maintenance dose: 450 mg orally twice on day 1, and once daily from day 2 to day 5
Control
Ivermectin
14 mg orally once from day 1 to day 3 (+ placebo tablets on days 1, 4 & 5 to maintain blinding)

Participants
Randomized
participants :
Hydroxychloroquine=54
Chloroquine=61
Ivermectin=53
Characteristics of participants
N= 168
Mean age : NR
95 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
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 willing stated in the publication:

Not reported
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.