The controversy over hydroxychloroquine will not go away.
The anti-malarial drug gained attention in March when President Trump said he was using it to prevent COVID-19. In May, the medical journal the Lancet published a study saying that the drug was potentially toxic, a study that was retracted in June because its data proved to be fraudulent. The Food and Drug Administration issued an emergency use authorization for the drug in late March and then revoked it in June when new evidence suggested it was ineffective. Then, in late July, a group calling itself America’s Frontline Doctors generated controversy by releasing a video touting hydroxychloroquine as a treatment for COVID-19. The video was pulled by Facebook, YouTube, and Twitter.
Now a new, peer-reviewed study in the International Journal of Antimicrobial Agents may add fuel to a fire that seemed to be burning out. The study finds that outpatients with the coronavirus who were treated with hydroxychloroquine combined with zinc and the antibiotic azithromycin were less likely to be hospitalized. Fewer than 3% of outpatients who took the drug regimen ended up in the hospital versus 15% who did not take it.
A number of studies have found that hydroxychloroquine has no effect on inpatients. But critics have said that patients who are already in the hospital may be too sick for the drug to have any effect. Outpatients, they claim, often present with milder symptoms, and thus, hydroxychloroquine may prove effective.
But the new study has limitations. First is its relatively small sample size of 518 patients. Second, it is a retrospective study, not a randomized controlled trial, often considered the gold standard in medical research. Additionally, one of the authors, Dr. Vladimir Zelenko, has aggressively promoted hydroxychloroquine as a COVID-19 treatment, at one point incorrectly saying that he was conducting an FDA-approved study of the drug.
In June, the New England Journal of Medicine published the results of a randomized controlled trial of hydroxychloroquine on outpatients that found no effect. However, it did not include zinc or azithromycin in its study. Randomized controlled trials examining all three drugs are due out later this year.