World Health Organization to restart hydroxychloroquine study as risk data questioned

Henrietta Brewer
June 4, 2020

U.S. President Donald Trump has said he is taking hydroxychloroquine even though he has not tested positive for the coronavirus.

Approximately 12% of those given hydroxychloroquine developed Covid-19, compared to 14% who were given the vitamin folate as a placebo.

The key finding is that hydroxychloroquine, the most common preparation of drugs typically used to prevent malaria and to help those with autoimmune conditions such as lupus and rheumatoid arthritis, "was not able to prevent the development of COVID-19 any better than a placebo".

"We conducted an global, 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", Lee said in an interview.

A week after the World Health Organization (WHO) paused the hydroxychloroquine arm of a clinical trial of experimental COVID-19 drugs, its chief Tedros Adhanom Ghebreyesus today said experts had reviewed the safety data and were now recommending the trial continue as planned.

The WHO announced Wednesday the resumption of its hydroxychloroquine trials after The Lancet cast doubt over a large-scale study it published last month that led to temporary suspension of testing of the drug.

The study found that hospitalized Covid-19 patients who were treated with the anti-malaria drugs hydroxychloroquine or chloroquine, either alone or in combination with a macrolide, were associated with an increased risk of death and increased risk of developing ventricular arrhythmias.

"I think both sides - one side who is saying "this is a risky drug" and the other side that says "this works" -neither is correct", said Boulware.

In Wednesday's issue of the New England Journal of Medicine, medical researchers reported on testing the use of hydroxychloroquine in 821 adults throughout the USA and in Quebec, Manitoba and Alberta.

WHO officials said they were especially anxious about outbreaks in Latin America and Haiti, one of the world's poorest nations, where infections have been spreading rapidly. Of those who developed COVID-19, 49 had received hydroxychloroquine, while 58 people who received the placebo developed it.

"Our objective was to answer the question of whether hydroxychloroquine worked to prevent disease or did not work", said David Boulware, the lead researcher at the University of Minnesota.

Last week, Italy, France and Germany banned the use of the drug to treat Covid-19 patients, citing new clinical evidence indicating that there was "an increased risk for adverse reactions with little or no benefit." .

The results are published today in the New England Journal of Medicine. But while he said that the safety results are encouraging, he anxious that the study, because of size and other limitations, might not completely rule out such issues.

The Solidarity trial includes participants and researchers in Canada. Researchers said the subjects were by and large healthy and young, with an average age of 40.

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