Source: Le Devoir Canada
Following the publication of the results of a large study indicating that administration of chloroquine or hydroxychloroquine alone or in combination with azithromycin to patients with COVID-19 who were hospitalized provided no benefit in the treatment of COVID-19, and even increased the risk of cardiac arrhythmia and mortality, the World Health Organization (WHO) suspended the SOLIDARITY clinical trial it was supporting.
Health Canada deplores the fact that the authors of this study do not specify “the type of precautions that were taken when prescribing the drug”, and that they did not “assess the influence of the dose of the drug” on its possible toxicity.
After having read the Lancet article , Health Canada contacted the persons in charge of the various clinical trials (9 in number) which are being conducted on hydroxychloroquine in Canada, including notably at McGill, so that they can provide it with the list of cardiac arrhythmia cases that may have occurred to date, as well as a new report from the Safety Oversight Committee, which is made up of independent experts who regularly review safety related data of the treatment studied.
Pending receipt of this information and given the fact that no cases of cardiac arrhythmia have been reported in the various authorised clinical trials in the country, Health Canada does not recommend that the studies in progress be discontinued.
Regarding the Canadian component of the SOLIDARITY trial supported by the WHO, the department has however decided to suspend the recruitment of new participants until receipt of the report from the data and security surveillance committee.
Health Canada says it will decide, based on the information provided in the safety oversight committee reports, whether further action is required on the Canadian trials.
In its response to Le Devoir , Health Canada recalls that it approved these various clinical trials on hydroxychloroquine on the condition that “adequate screening and close monitoring of participants be put in place”. He reiterates his recommendation to allow access to this drug only in the context of clinical trials.