Drug touted as COVID treatment by Trump has no benefit, USC, Dorn VA research shows
An anti-malaria drug that has been touted by President Donald Trump as a possible treatment for COVID-19 showed no clear benefits in treating nearly 400 coronavirus patients in military veteran hospitals around the country, according to a new study by researchers from South Carolina and Virginia.
In fact, patients who were treated with hydroxychloroquine, the drug in question, died at a higher rate than other COVID-19 patients observed by researchers.
The study, which involved research by Columbia’s William Jennings Bryan Dorn VA Medical Center and the University of South Carolina, was published online this week at www.medrxiv.org, which houses preliminary reports of work that has not yet been reviewed by scientific peers.
The study observed data from 368 male military veteran patients — representing only about 0.04% of the total cases of coronavirus that have been diagnosed so far in the United States — and has not yet been peer-reviewed. Some patients had been treated with the anti-malaria drug only while others were given the drug along with an antibiotic, azithromycin. Others were given neither drug.
“In this study, we found no evidence that use of hydroxychloroquine, either with or without azithromycin, reduced the risk of mechanical ventilation in patients hospitalized with Covid-19,” the study’s authors wrote. “An association of increased overall mortality was identified in patients treated with hydroxychloroquine alone. These findings highlight the importance of awaiting the results of ongoing prospective, randomized, controlled studies before widespread adoption of these drugs.”
A spokesperson for Dorn cautioned, however, that because these conclusions were drawn from a retroactive analysis of patient data, rather than from a controlled clinical trial, they should not be considered “definitive.”
“The findings should not be viewed as definitive because the analysis doesn’t adjust for patients’ clinical status and showed that hydroxychloroquine alone was provided to VA’s sickest COVID-19 patients, many times as a last resort,” Dorn spokesman Bob Hall said in an email Wednesday.
The study was co-authored by researchers from the Dorn Research Institute as part of the Columbia Veterans Affairs Health System, the USC College of Pharmacy, USC’s Department of Epidemiology and Biostatistics and the University of Virginia School of Medicine.
In spite of its preliminary scope, the study’s results bring additional scrutiny to the president’s claims that the drug, or a combination of hydroxychloroquine and azithromycin, could be “one of the biggest game changers in the history of medicine.” That claim already has been minimized by medical experts, who say much more data is needed to draw conclusions.
The Medical University of South Carolina health care system, based in Charleston, announced Wednesday it would begin participating in a national clinical trial studying the effectiveness of the drug in treating COVID-19 patients. The trial aims to enroll 550 patients who will be treated with either hydroxychloroquine or a placebo.
“There’s so much uncertainty in the public as to whether hydroxychloroquine helps or harms,” Dr. Andrew Goodwin, a specialist in treating acute respiratory distress syndrome, said in an MUSC news release. “There have been a lot of people in the media, as well as the government, who have been strongly supportive of this medication, really without sufficient data to prove that it actually helps.”
The newly published study retroactively analyzed the health outcomes of military veterans treated for coronavirus at Veterans Affairs hospitals across the country. The study report does not specify whether patients at Columbia’s Dorn VA hospital were among those observed for COVID-19 treatment.
The data showed that 27.8% of patients who were treated with hydroxychloroquine alone died, compared to 22.1% of those treated with the combination of drugs and 11.4% of those who were not treated with hydroxychloroquine.
In addition to the death rates, the data also showed that 13.3% of patients treated with hydroxychloroquine required the use of a mechanical ventilator, compared to 6.9% of those treated with the combination and 14.1% of those with no hydroxychloroquine treatment.
Based on this data, the researchers concluded that hydroxychloroquine, either alone or in combination with azithromycin, did not reduce the risk for either ventilation or death for these patients.
The researchers noted that “multiple prospective, randomized trials of hydroxychloroquine are now underway and will, in due course, provide valuable information about safety and efficacy.”
The novel coronavirus that has swept the globe had infected more than 826,000 Americans as of Wednesday. In South Carolina, at least 4,608 cases have been confirmed, and at least 135 people have died as a result of COVID-19, the disease caused by the coronavirus.
This story was originally published April 22, 2020 at 2:12 PM.
