Results from a study at a large medical center in New York City did not associate hydroxychloroquine with either a greatly lowered or an increased risk of intubation or death in hospitalized patients with coronavirus disease 2019 (COVID-19) .
Hydroxychloroquine is currently approved for treatment of malaria and rheumatoid arthritis; the FDA granted the drug Emergency Use Authorization in March for the treatment of hospitalized patients with severe acute respiratory syndrome coronavirus 2, the virus that causes COVID-19, on the basis of antiinflammatory and antiviral effects. However, the study pointed to the fact that to date, there are no robust clinical trials that have shown the efficacy of hydroxychloroquine for the treatment for COVID-19.
Of the 1376 hospitalized participants included in the observational study, 811 (58.9%) received hydroxychloroquine as treatment for their infection, whereas 565 (41.1%) did not.
The investigators found that hospitalized patients who were treated with hydroxychloroquine expressed more severe illness at baseline than those who were not treated with the drug; 45.8% of hydroxychloroquine-treated patients were administered the drug within 24 hours after presentation to the emergency department and 85.9% were treated within 48 hours.
Those who were administered hydroxychloroquine received 600 mg twice on day 1, and then 400 mg each day for a median of 5 days.
Results of the study showed no significant association between hydroxychloroquine treatment and intubation or death. The study’s authors added that multiple sensitivity analyses showed similar results. However, they noted that the results should not be taken to rule out either benefit or harm of hydroxychloroquine treatment, given the observational design.
Overall, the authors recommended randomized studies to evaluate hydroxychloroquine for treatment of COVID-19: “In this observational study involving patients with COVID-19 who had been admitted to the hospital, hydroxychloroquine administration was not associated with either a greatly lowered or an increased risk of the composite end point of intubation or death. Randomized, controlled trials of hydroxychloroquine in patients with COVID-19 are needed,” the authors wrote.
1. Geleris J, Sun Y, Platt J, et al. Observational study of hydroxychloroquine in hospitalized patients with Covid-19. New England Journal of Medicine. 2020. doi: 10.1056/NEJMoa2012410