The University of Minnesota has published results from its COVID-19 hydroxychloroquine trial that show the anti-malaria drug is ineffective at preventing coronavirus infection, echoing negative results from other recent studies.
The study, the first randomized placebo trial to evaluate the drug’s effectiveness in preventing infection in healthy patients following exposure, found that the drug didn’t prevent development of the virus any better than a placebo.
The researchers noted, however, that they found no serious side effects or cardiac complications from the use of hydroxychloroquine, although 40 percent of participants had mild side effects, such as diarrhea, nausea and upset stomach.
The FDA and European Medicines Agency issued warnings last month about potential risks posed by the drug for patients with heart disease, noting multiple reports of heart-related adverse events and deaths in COVID-19 patients given hydroxychloroquine or chloroquine alone or alongside azithromycin (DID, April 27).
The trial launched on March 17 and enrolled 821 non-hospitalized adults in the U.S. and Canada who had been exposed to COVID-19 by a housemate, healthcare worker or first responder.
Overall, approximately 12 percent of the patients on hydroxychloroquine developed COVID-19 as opposed to 14 percent who took a placebo. The two-percentage point difference between the participants was not statistically significant, the researchers said. “Even if there was a statistical difference, this would equate to treating 42 persons with hydroxychloroquine in order to prevent one infection.” — James Miessler