An anti-malaria drug that has been trumpeted as a therapy for COVID-19 was unable in a University of Minnesota clinical trial to prevent the onset of the infectious disease.
The results of the nation’s first randomized trial with the drug, hydroxychloroquine, against COVID-19 will disappoint doctors who had hoped for new therapies amid the pandemic. Many prescribers had given it off-label to COVID-19 patients — in the absence of other options — and President Donald Trump had been an early champion of the drug and said in mid-May that he was taking it for the preventive benefit, a benefit that the U study could not verify.
“While we are disappointed that this did not prevent COVID-19, we are pleased that we were able to provide a conclusive answer,” said Dr. David Boulware, leader of the U trial. “Our objective was to find an answer.”
Results published online Wednesday by the New England Journal of Medicine showed little difference in the onset of COVID-19 in 414 people who took hydroxychloroquine and a comparison group of 407 that took only folic acid vitamins. All participants had at least moderate risk for COVID-19 after being exposed to others in their homes or workplaces who had the illness.
There was a small difference, as 11.8% of people taking the drug developed COVID-19, compared with 14.3% of those taking vitamins, the study showed. However, that difference was considered statistically insignificant.
Even if valid, the small difference means that 42 people would have to take the drug prophylactically to prevent one COVID-19 case. That would be costly and expose people to drug side effects. The study showed that 40% experienced mild side effects such as nausea, but it allayed fears that widespread use of the drug could result in cardiac and other complications.
The study provides evidence only of whether the drug is effective in preventing COVID-19 onset following exposure to someone with the infection.
A separate U trial is examining whether it benefits patients after early onset of symptoms, but results haven’t been published.
Enthusiasm for the drug has already cooled after open-label trials and case reports that found little benefit, but the U results are a significant advance.
Minnesota as of Wednesday reported 25,870 lab-confirmed cases and 1,086 deaths from COVID-19, which is caused by a novel coronavirus for which there is no vaccine.
While COVID-19 case numbers have ebbed, state health officials suspect another wave after protests over the death of George Floyd brought thousands of people together.
Chanting and shouting could hasten the spread of the virus, said Jan Malcolm, state health commissioner, along with police use of tear gas to break up protests that could cause infected people to breathe heavily.
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