A clinical trial in Manitoba to test the possible benefits of a controversial drug in the fight against COVID-19 will continue despite a published study strongly suggesting that there is none.
The study, led by Professor Mandeep Mehra of Harvard Medical School and published Friday in The Lancet medical journal found no evidence of any benefit when treating coronavirus patients with chloroquine and hydroxychloroquine. The findings linked drug use to an increased risk of death and arrhythmia.
Researchers led by Mehra analyzed data from more than 96,000 patients confirmed to have COVID-19 from 671 hospitals on six continents. All were hospitalized from late December to mid-April and died or were discharged on April 21. Just under 15,000 patients were treated with hydroxychloroquine or chloroquine, or one of these drugs combined with an antibiotic.
These four treatments were linked to a higher risk of dying in hospital.
About one in 11 patients in the control group – who did not receive any of the drugs – died in hospital. About one in six patients treated with chloroquine or hydroxychloroquine alone died in hospital.
About one in five treated with chloroquine and an antibiotic died and almost one in four treated with hydroxychloroquine and an antibiotic died.
But the results will not derail a clinical trial based on the University of Minnesota, the University of Manitoba and McGill University which will examine whether hydroxychloroquine is an effective prophylactic drug for use by healthcare workers who may enter in contact with COVID -19 patients.
Lauren MacKenzie, a senior researcher at the University of Manitoba and an assistant professor of infectious diseases, said that the Harvard-led study looked at very different drug use under very different circumstances.
This research is what is called an observational study, which means that researchers observe the effect of treatment without trying to change which is or is not exposed, MacKenzie told Free press in an email on Friday.
This type of study is known to be subject to selection bias, “in that the control group and the intervention group are generally not the same, which is why the intervention group receives the intervention. “
Those who received the treatment were probably much sicker at the start, she said.
The Minnesota-Manitoba-McGill study is a randomized controlled trial and will only follow healthy individuals who have not acquired COVID-19.
“A conclusion from this Lancet The study by the author and the editors of the review said that “urgent randomized controlled trials are needed,” which is precisely our trial, “said MacKenzie.
She said her clinical trial did not allow anyone with a known cardiac arrhythmia to participate, which was not the case in the study released on Friday.
And the doses used in The Lancet the study was also much higher, she said.
The drugs gained notoriety when US President Donald Trump approved them as treatment options before their effectiveness against COVID-19 was tested by researchers.
Chloroquine is used to prevent or treat malaria. Hydroxychloroquine, a related drug, is used to treat autoimmune diseases such as lupus and arthritis.
Sarah Lawrynuik reports on climate change for the Winnipeg Free Press. Funding for the Free Press reporter on climate change comes from the Government of Canada through the Local Journalism Initiative.
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