In the largest study to date, hydroxychloroquine failed to show benefits when treating COVID patients. Of interest, as compared to some other reports, it also did not show harm. The study was funded by the NIH, conducted by researchers at New York-Presbyterian Hospital and Columbia University Irving Medical Center in New York City, and published in the New England Journal of Medicine.
The investigators examined the association between hydroxychloroquine use and either intubation or death. Patients were excluded if they were intubated, died, or discharged within 24 hours after presentation to the emergency department (presumed to be too short a time to assess ). The primary end point was an analysis of a combination of a time to either intubation or death. In other words, the end points were the percent of patients who got ill enough to be put on a ventilator or die from the infection, but only after 24 hours of being in the study.
Of 1446 consecutive patients, 70 patients were excluded from the analysis (event within 24 hours). In the remaining 1376 patients, during a median follow-up of 22.5 days, 811 (58.9%) received hydroxychloroquine (600 mg twice on day 1, then 400 mg daily for a median of 5 days); 45.8% of the patients were treated within 24 hours after presentation to the emergency department, and 85.9% within 48 hours.
Hydroxychloroquine-treated patients were more severely ill at baseline than those who did not receive the drug. Overall, 346 patients (25.1%) had a primary end-point event (180 patients were intubated, of whom 66 subsequently died, and 166 died without intubation). In the main analysis, there was no significant association, positive or negative, between hydroxychloroquine use and intubation or death (hazard ratio, 1.04, 95% confidence interval, 0.82 to 1.32).
The study’s findings didn’t find any potential benefit or harm from the drug, and the authors suggested that a rigorous, randomized clinical trial is needed. It is interesting that most news outlets simply reported the drug did not work. I certainly don’t think this is a positive outcome for the use of the drug, but the randomized trials need to be finished. As per the FDA, I would also not give the drug outside of a trial.