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The study of the drug -- touted by U.S. President Donald Trump as a COVID-19 treatment -- included 368 male patients in U.S. veterans hospitals, the Associated Press reported.
About 28% of the patients who received hydroxychloroquine plus usual care died, compared with 11% of those who received usual care alone.
About 22% of patients who received hydroxychloroquine plus the antibiotic azithromycin died, but the researchers didn't consider the difference between that group and the usual care group significant enough to rule out other factors that could have affected survival, according to the AP.
The study also found that treatment with hydroxychloroquine made no difference in patients' chances of needing to be placed on a breathing machine.
The study is the largest so far to assess the use of hydroxychloroquine with or without the antibiotic azithromycin in treating COVID-19. It's posted on an online site for researchers and has been submitted to the New England Journal of Medicine, but hasn't been reviewed by other scientists, the AP reported.
Earlier this month, part of a hydroxychloroquine study in Brazil was halted after heart rhythm problems developed in one-quarter of patients given the higher of two doses.
Many doctors are skeptical of the drug's potential for treating COVID-19.
"I think we're all rather underwhelmed" at the results among the few patients who've received it, Dr. Nasia Safdar, medical director of infection control and prevention, University of Wisconsin, Madison, told the AP.
After Trump started promoting the use of hydroxychloroquine, patients asked about it, "but now I think that people have realized we don't know if it works or not" and that morre research is needed, said Safdar, who was not involved in the VA study.
Other clinical trials of hydroxychloroquine in COVID-19 patients are continuing.
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