Trial NCT04329611
Publication Schwartz I, CMAJ Open (2021) (published paper)
Dates: 2020-04-15 to 2020-05-22
Funding: Mixed (Calgary Health Trust, the University of Calgary, Alberta Innovates Health Solutions, Alberta Health Services and the Alberta Government provided funding. Hydroxychloroquine and matching placebo were provided by Apotex.)
Conflict of interest: No

Methods
RCT
Blinding: double blinding
Location : Multicenter / Canada
Follow-up duration (days): 30
Inclusion criteria
  • Adults with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal or pharyngeal swab within the previous 4 days
  • symptom onset within the previous 12 days
  • with at least 1 risk factor for severe disease.
Exclusion criteria
  • Hospitalized
  • pregnant or breastfeeding
  • unable to swallow pills or unable to comply with the medical regimen
  • used hydroxychloroquine, chloroquine, lumefantrine, mefloquine or quinine within the previous 30 days
  • at higher risk for arrhythmia secondary to hydroxychloroquine, including those concurrently using a drug that prolonged the corrected QT interval (QTc) and those with a modified Tisdale Risk Score of 7 or greater.
Interventions
Treatment
Hydroxychloroquine
Initial dose: 200 mg orally 4 times a day for one day - Maintenance dose: 200 mg 2 times a day for 4 days.
Control
Placebo

Participants
Randomized
participants :
Hydroxychloroquine=111
Placebo=37
Characteristics of participants
N= 148
Mean age : NR
82 males
Severity : Mild: n= 148/ Asymptomatic: n=*
Number of vaccinated participants: NR
Primary outcome
In the register
Composite of hospitalization, invasive mechanical ventilation or death within 30 days [ Time Frame: Within 30 days of randomization ]
In the report
Development of severe disease defined as the composite of hospitalization, invasive mechanical ventilation, or death within 30 days
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing willing stated in the publication:

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 trial registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. There were some changes to secondary outcome measures during the conduct of the trial, but prior to its termination. Some secondary outcomes reported in the article (ICU admission, SAEs, emesis) were not included in the registry but were in the retrospective protocol. Recruitment to the trial was stopped due to a since-retracted publication raised safety concerns for hydroxychloroquine and was not restarted due to decreasing cases in the community and slow recruitment. Thus the study (n = 148) did not achieve its target sample size (n = 1446).