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 148 participants (n1=111 / n2= 37) | |
| Characteristics of participants N=148 Mean age : 46.8 82 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0 | |
| 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 stated
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| 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). |