UMMC staff support HCQ COVID-19 ineffectiveness findings

Published on Monday, November 23, 2020

By: Bruce Coleman

Clinician-scientists at the University of Mississippi Medical Center were among those at 34 health care institutions nationwide to have participated in a study that concluded, when compared to an inactive placebo, hydroxychloroquine did not significantly improve clinical outcomes of patients hospitalized for respiratory illness related to COVID-19.

Funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health, the “Outcomes Related to COVID-19 Treated with Hydroxychloroquine among Inpatients with Symptomatic Disease” (ORCHID) study was conducted at hospitals in the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network. Its findings were published in the Nov. 9 issue of the Journal of the American Medical Association.

According to Dr. Alan E. Jones, UMMC assistant vice chancellor for clinical affairs, the study represents an important step forward in the scientific effort to find effective treatments for COVID-19-related illnesses.

“In patients hospitalized with COVID-19 early in their illness, the study found no evidence that hydroxychloroquine prevented death or helped patients recover from COVID-19 more quickly,” Jones said. “There has been a lot of controversy about HCQ, and this study provides the highest quality data to show that the use of HCQ in the treatment of COVID-19 is not helpful.

“This will allow clinicians to make evidence-based best choices for the treatment of their patients.”

Dr. Utsav Nandi, UMMC assistant professor of emergency medicine, said the study represented “one of the first major clinical trials the Medical Center initiated that was focused on COVID-19 therapeutics.

“The PETAL network had redirected its entire efforts to COVID-19 and the ORCHID trial was one of the first studies,” said Nandi, associate director of research in the Department of Emergency Medicine at UMMC.

Between April and June, 479 patients hospitalized for respiratory illnesses from COVID-19 at the participating institutions were enrolled in the blinded, placebo-controlled randomized clinical trial. UMMC enrolled 34 of the patients - the fourth-highest among all participating institutions - from April 14 through June 19.

Patients who were acutely ill and hospitalized with COVID-19 received 10 doses of HCQ or a placebo for five days. For a month after the medication was first administered, investigators followed the patients’ clinical status, including their hospital discharge, oxygen usage, mechanical ventilator usage and death.

“This effort was spearheaded by the Emergency Department research team,” Nandi said. “The ED team would screen admitted COVID-19 patients for eligibility and then an investigator would approach eligible patients for the informed consent process. If a patient expressed interest in participating in this trial, our coordinators would then randomize them to receive either the medication or placebo.

“Since this was designed to be a double-blinded trial to provide the highest quality of evidence, the patients and investigators would both be unaware of which arm the patient was assigned to (medication or placebo). The research team would continue monitoring the patient both in-hospital and virtually upon discharge to document any adverse reactions.”

One month after starting the study, 10.4 percent of patients who received HCQ had died, while 10.6 percent of patients who received a placebo had died. In June, the NHLBI stopped the study after it determined HCQ was not likely to be of benefit to hospitalized patients with COVID-19.

“Confronted with a novel pathogen, scientists and clinical trialists around the world have been working extremely hard to investigate potential treatment modalities that may help us prevent, lessen the severity of and, hopefully, save the lives of those infected with SARS-CoV-2,” Nandi said. “HCQ was promoted as a potential therapeutic option during the early period of the pandemic, both due to its potential antiviral and anti-inflammatory effects as well as it being cheap and readily available due to its use for other FDA-approved diseases.

“While it was adopted into clinical practice at many hospitals, the medical and scientific community lacked evidence regarding its efficacy and safety as it pertained to COVID-19. The results of this ORCHID trial show us that it was not efficacious in a U.S. patient population.”

Jones credited UMMC’s scientists, clinical staff and patients for helping lead to this important discovery.

“This was a team effort from the study staff, to the physicians and nurses, to the patients, and we are grateful to all who pulled together and made this study a success,” he said.