Trial RBR-95yjmq
Publication Rodrigues C, Int J Antimicrob Age (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
HCQ+AZM
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
participants :
HCQ+AZM=42
Placebo=42
Characteristics of participants
N= 84
Mean age : NR
50 males
Severity : Mild: n= 84/ Asymptomatic: n=0
Number of vaccinated participants: NR
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 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
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).
Risk of bias assessment was updated on May 15th 2022 after quality control.