Ruminations

Blog dedicated primarily to randomly selected news items; comments reflecting personal perceptions

Thursday, June 04, 2020

Verdict No.1 on Hydroxychlooquine

"We conducted an international, randomized controlled trial to look at whether the use of hydroxychloroquine in patients who'd had a high-risk exposure to COVID-19 would prevent the development of symptomatic disease compared to placebo."
"The approach was if we could load the patient with hydroxychloroquine in the tissues before the incubation period was over, then maybe we could prevent those people who've been exposed from getting sick."
"There was some observational, anecdotal stories suggesting that this was going to be effective, and the purpose of the randomized controlled trial was to demonstrate whether that was true or not true."
"We found that there was no statistical difference between patients who got the placebo -- which was a vitamin pill -- versus those who received the active drug hydroxychloroquine."
"I would have loved to have a positive study, but in circumstances like this you need the negative studies too so you can redirect attention."
Dr.Todd Lee, Research Institute of the McGill University Health Centre
The drug hydroxychloroquine, pushed by U.S. President Donald Trump and others in recent months as a possible treatment to people infected with COVID-19, is displayed by a pharmacist at the Rock Canyon Pharmacy in Provo, Utah, U.S., May 27, 2020.   George Frey/Reuters
Conclusion: Hydroxychloroquine is ineffective in preventing the development in people exposed to the novel coronavirus, according to a new study whose results were published in the New England Journal of Medicine. The clinical trial, led in Canada by Dr.Todd Lee and Dr.Emily McDonald, both with the McGill University Health Centre, took place in conjunction with partners at the University of Manitoba and University of Alberta.This was a study co-ordinated within a larger one by Dr.David Boulware of the University of Minnesota.

As the first double-blind, randomized, placebo-controlled trial in completion to assess the possible effectiveness of the malaria drug in preventing COVID-19, its results will, without doubt, be a disappointment to many. Recruits for the study came from Quebec, Manitoba, Alberta and across the United States, for a total of 821 asymptomatic adult participants, exposed at home or in a health-care setting to an individual diagnosed with COVID-19. Within the group, 719 of the participants reported an unprotected, prolonged encounter with a confirmed case of COVID.

Most of the participants were healthy young adults with an average age of 40. Participants were sent either the placebo or hydroxychloroquine by mail, within four days of exposure; the protocol requiring the substances received to be taken for a five-day period, the first day starting with a higher dose of the medication. Neither researchers nor participants were informed which treatment was being administered to whom; the spirit of a double-blind protocol.

Hydroxychloroquine
Hydroxychloroquine is often used to treat arthritis. (AFP)
Of the 821 participants, COVID-19 was developed by 107 people, confirmed by a test or compatible symptoms throughout the 14 days of followup. Of those who received hydroxychloroquine, 49 developed the disease with accompanying symptoms (symptoms such as fever and cough) in comparison to 58 in the group which had taken the placebo. Statistically, in other words, the drug was no more effective than the placebo turned out to be. Two of those diagnosed with COVID, one from each group, were hospitalized, though no one among the entire group died of the disease.

Those who took the malaria drug experienced side effects, such as nausea and abdominal discomfort -- more commonly than those receiving the placebo. The drug continues to be studied around the world. Hope remains that it could reduce the risk of infection during exposure, or lower the risk of hospitalization in infected patients. However, from the outcome of this controlled trial, it appears remote that any other, more successful trial will conclude that the drug could be useful against COVID-10.

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