A study published in the International Journal of Infectious Diseases investigated the controversial drug hydroxychloroquine in patients with severe COVID-19 disease. The malaria drug has been discussed repeatedly through the pandemic, touted by President Trump and Brazil’s President Jair Bolsonaro, and even given Emergency Use Authorization by the U.S. FDA.
The FDA revoked the authorization in mid-June due to concerns of the efficacy and possible adverse cardiac events.
The new study, a retrospective observational study conducted at the Henry Ford Medical System in Detroit, Michigan titled “Treatment with Hydroxychloroquine, Azithromycin, and Combination in Patients Hospitalized with COVID-19”, reported a 50% reduced mortality for patients who received hydroxychloroquine early in treatment compared with those who were not given the treatment. .
Mortality in the group given hydroxychloroquine was about 13%, while those who received no hydroxychloroquine or azithromycin died in 26.4% of cases.
The study has not gained as much traction as one might expect from reading the article’s topline results. This is in part due to all of the evidence that has accrued regarding the use of hydroxychloroquine since the pandemic began, as well as concerns with the study itself.
Critics of the study point out an imbalance in the treatment and control arms regarding risk factors. For example, steroids were given to the treatment group at a rate twice that of the control group. Dexamethasone has previously been shown to be effective in reducing COVID-19 severity.
The treatment group consisted of an almost equal number of patients over and under 65 years old, while nearly two-thirds of the control group were over 65. Additionally, only about one quarter of the treated patients were white, while nearly half of untreated patients were white. The study itself identified advanced age and white race as a risk factor, suggesting that at least some of the reduction in mortality in the treatment group is attributable to these factors.
Despite these concerns with the complete study group, the investigators provided a sub analysis with a propensity matched group and found hazard ratio reduction of 51%. The study authors also found no adverse cardiac signs in any patients, which they attributed to early medical intervention, and telemetry with strict electrolyte protocols, and monitoring for dysrhythmias.
The report’s publication comes on the heels of the FDA’s July 1 warning of safety issues in using chloroquine and hydroxychloroquine including cardiac arrhythmias, blood and lymph disorders, kidney injury, and liver failure. Whether or not hydroxychloroquine is effective in treating COVID-19 patients is unfortunately likely to take a backseat due to politicized atmosphere surrounding the drug.
