“I don’t think this gets us anywhere closer to an answer. It’s another muddy study,” she said.
Similarly, Christopher V. Plowe, MD, MPH, director of the Global Health Institute at Duke University in Durham, North Carolina, told Medscape Medical News he sees no convincing answers in this study.
Plowe, professor of medicine, molecular genetics, microbiology, and global health at Duke, also noted differences between the two groups at enrollment.
For example, the HCQ group had more than three times the number of patients with shortness of breath (22.1% vs 5.9%); more with sputum production (16.2 vs 5.9%); and more with cough (51.5% vs 38.2%). In addition, the average age was 4 years higher in the HCQ group.
“It makes me wonder whether the randomization was truly random,” Plowe said.
Plowe also questioned the authors’ statement that they didn’t see cardiac arrhythmia events, such as prolonged QT intervals. “I can’t see any evidence that they did an EKG on anybody,” he said.
“This study leaves the door open to the possibility that hydroxychloroquine may have a clinical benefit. If there is a benefit, it seems to be related to the drug’s anti-inflammatory properties. If that’s the case, I’m not sure this particular drug, as opposed to others, would be the way to go,” Plowe said.
Mixed Results in Other Studies
“Our negative results on the anti-viral efficacy of HCQ obtained in this trial are on the contrary to the encouraging in-vitro results and to the recently reported promising results from a non-randomized trial with 36 COVID-19 patients,” the authors write.
However, the 36-patient trial to which they refer has since been called into question, as previously reported by Retraction Watch.
Despite lack of clear evidence of benefit, HCQ is recommended off label for the treatment of COVID-19 by the Chinese National guideline, and the US Food and Drug Administration has issued an emergency-use authorization for the treatment of adult patients with COVID-19.
By contrast, the Infectious Diseases Society of America recently concluded that because of insufficient data, they could not recommend any particular treatment for patients with COVID-19.