A National Institutes of Health funded observational study conducted by investigators at New York-Presbyterian Hospital and Columbia University Irvine Medical Center revealed that hydroxychloroquine failed to help hospitalized patients with COVID-19.
First, it should be noted that as recently reported by Columbia University, the study was far larger than most comparable observational studies that included no more than 100 patients. However, this is not a randomized, controlled study.
In this study, a total of 1,376 patients were included in this observational study at participating research sites including New York-Presbyterian Hospital and Columbia University Irvine Medical Center in New York City. Set in the emergency room, study investigators observed the effects of hydroxychloroquine, an antimalaria medication on patients showing SARS-CoV-2 symptoms. The observational study team administered the drug to 811 patients within 48 hours of entry. 565 patients didn’t receive the study drug.
The researchers sought to observe the relationship between the use of the antimalaria study drug and the development of respiratory failure leading to intubation or death. Of the total patient population in this study, 346 patients developed respiratory failure, 180 were intubated and 166 died without intubation.
The researchers employed what is described in Columbia University’s website as “sophisticated statistical techniques to account for known differences between patients in the two groups, including age, sex, and initial vital signs” led to a finding that those patients receiving hydroxychloroquine actually fared no better when it came to the probability of risk associated with intubation or death as patients who did not receive the drug.
Published in the New England Journal of Medicine, the research team concluded that those patients hospitalized with SARS-CoV-2, the virus behind the COVID-19 pandemic, should not be routinely treated with hydroxychloroquine.
This study was conducted as an observational study—hence, it was not randomized and controlled and therefore there are inherent limitations to such a study. A superior way to understand the true benefit of a drug involves the proper use of the randomized controlled trial. As Neil Schluger, corresponding study author noted, “There are currently many such studies of hydroxychloroquine that are planned or already enrolling in the United States and elsewhere.” TrialSite News is monitoring these studies and will offer updates as they appear.
On the other hand, Dr. Schluger suggests although not a randomized and controlled study the findings nonetheless establish a clear directive, at least for the study sponsor and investigators, not to use hydroxychloroquine outside of randomized controlled trials.
Neil Schluger, MD, chief of the Division of Pulmonary, Allergy and Critical Care Medicine, New York Presbyterian/Columbia University Irvine Medical Center, professor of medicine, environmental health sciences, and epidemiology at Columbia University Vagelos College of Physicians and Surgeons
Other authors include Joshua Geleris, Yifei Sun, Jonathan Platt, Jason Zucker, Matthew Baldwin, George Hripcsak, Angelena Labella, Daniel Manson, Christine Kubin, R. Graham Barr, and Magdalena Sobieszczyk (all from New York-Presbyterian/Columbia University Irving Medical Center).
Call to Action: TrialSite News will be monitoring and tracking ongoing clinical trials involving hydroxychloroquine and COVID-19.Source: Columbia University Irving Medical Center