Trial RBR-95yjmq
Publication Rodrigues C, Int J Antimicrob Agents, 2021 (published paper)
Dates: 2020-04-12 to 2020-05-13
Funding: Private (Diagnósticos da América S.A. (Dasa), Ímpar Serviços Hospitalares S.A., and DNA Capital Foundation.)
Conflict of interest: No
Methods | |
RCT Blinding: double blinding | |
Location :
Single center / Brazil Follow-up duration (days): 21 | |
Inclusion criteria | 1) Aged between 18 and 65 years; 2) mild symptoms suggestive of COVID-19 (two or more of the following: cough, fever, shortness of breath, nausea/vomiting, diarrhea, body aches, weakness/fatigue, headache, sore throat, runny nose/congestion, sudden gustatory or olfactory loss) with an interval from symptoms onset to enrollment of 2 to 5 days; 3) detection of viral RNA in naso/oropharyngeal swabs through a real-time reverse-transcription polymerase chain reaction;4) Not requiring hospital admittance; 5) Consenting to study participation |
Exclusion criteria | 1) known hypersensitivity to HCQ or azithromycin (AZT); 2) pre-existing pulmonary disease, history of immunosuppression, active cancer diagnosis; 3) pregnancy or lactation; 4) history of cardiac abnormalities or QTc prolongation (QTc > 480 ms); 5) known glucose-6-phosphate dehydrogenase (G6PD) deficiency; 6) patients requiring hospital admittance; 7) patients with inadequate hematological parameters, heart, renal, or liver function |
Interventions | |
Treatment
Hydroxychloroquine + Azithromycin HCQ: two 200 mg capsules twice a day for seven days + AZM: Initial dose: one 500 mg capsule on day 1 - Maintenance dose: one 250m mg capsule/day for 4 days |
|
Control
Placebo | |
Participants | |
Randomized 84 participants (n1=42 / n2= 42) | |
Characteristics of participants N=84 Mean age : 36.6 50 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
Primary outcome | |
In the register Time to negative viral load from the beginning of treatment and up to 9 days | |
In the report Time (days) to viral clearance within a 9-day evaluation period following enrollment following the onset of symptoms and the study enrollment dates. | |
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 |
Some concerns |
General comment | “In addition to the published article, the retrospective study registry was used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available There is no change from the trial registration in the intervention and control treatments. The primary outcome indicated in registry reflects the primary outcome reported in the paper. Some secondary outcomes in the registry (radiographic response, concomitant medication to manage symptoms, adverse events) were not reported or not fully reported. The study achieved the target sample size declared in the methods (n = 84), but not that in the registry (n = 108)." |