Health Canada authorizes the continuation of clinical trials with hydroxychloroquine

Santé Canada autorise la poursuite des essais cliniques sur l’hydroxychloroquine

Photo: John Locher Associated Press
The institution notes that it has approved the different trials of hydroxychloroquine to the condition that”a suitable screening test, and a close monitoring of the participants are put in place”.

Health Canada authorizes the continuation of clinical trials on the hydroxychloroquine is going on in the country, despite the negative results that have been published in the journal The Lancet. The regulatory body argued that no cases of cardiac arrhythmia has not been reported to date in the context of these studies.

Following the publication of the results of an extensive study showing that the administration of chloroquine or hydroxychloroquine alone or in combination with azithromycin, in patients with the COVID-19 who were hospitalized there were no benefits in the treatment of the COVID-19, and even increased the risk of cardiac arrhythmias and mortality, the world Health Organization (WHO) has suspended the clinical trial of SOLIDARITY that they supported.

Health Canada deplores the fact that the authors of this study do not specify “the type of precautions that were taken when prescribing the medication” and that they have not “evaluated the influence of the dose of the drug” on its possible toxicity.

After having read the article in the Lancet, Health Canada has communicated with the heads of the various clinical trials (the number 9) which are carried on the hydroxychloroquine in Canada, including McGill, in order that they provide the list of cases of cardiac arrhythmia which may have been present up to now, as well as a new report of the supervisory committee of safety, which committee is composed of independent experts that regularly review data related to the safety of the treatment studied.

Pending this information, and given the fact that no cases of cardiac arrhythmia have been reported in the context of different clinical trials which are authorized in this country, Health Canada does not recommend interrupting the current studies.

Concerning the canadian component of the trial SOLIDARITY supported by WHO, the ministry has, however, decided to suspend the recruitment of new participants until the receipt of the report of the committee and data monitoring and security.

Health Canada says that it will decide, in the light of the information provided in the reports of the monitoring committees on the safety, if further measures need to be taken with respect to the canadian trials.

In response to the Need, Health Canada recalls that it has endorsed these different clinical trials of hydroxychloroquine to the condition that” a suitable screening test, and a close monitoring of the participants are put in place “. It reiterates its recommendation to only allow access to this drug in the context of clinical trials.

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