LSU Health New Orleans School of Medicine has enrolled its first patient in a randomized clinical trial to evaluate the safety and effectiveness of hydroxychloroquine alone, and in combination, as a treatment for COVID-19.
“We may enroll up to 600 patients with moderate to severe COVID-19,” said Meredith Clement, MD, assistant professor in the Section of Infectious Diseases at LSU Health New Orleans School of Medicine and the trial’s principal investigator.
Hospitalized patients at University Medical Center, one of LSU Health New Orleans’ teaching hospitals, will be enrolled in one of the study’s three arms – treatment with hydroxychloroquine alone, treatment with hydroxychloroquine + azithromycin, or supportive care, which is currently the standard of care.
There is currently no approved treatment for COVID-19. Neither hydroxychloroquine nor azithromycin are approved by the FDA for treatment of COVID-19 in the United States. Hydroxychloroquine is a medication currently approved for the treatment of malaria, certain forms of lupus and rheumatoid arthritis. Azithromycin is an antibiotic currently approved for the treatment of many bacterial infections.
“There is some limited evidence that these medications hold promise in shortening the disease course and decreasing the viral load – the amount of virus in respiratory samples,” added Clement. “But we haven’t really had any reliable data to date.”
“We will closely monitor the participants,” says Yussef Bennani, MD, assistant professor in the Section of Infectious Diseases at LSU Health New Orleans School of Medicine, and co-principal investigator. “The patients’ well-being is paramount. If treating them requires any adjustments to their care, which could include removing the patient from the study, we will work to provide them with the highest-quality care. Participants can also withdraw at any point.”
Possible benefits to participants include an improvement in their symptoms of COVID-19 infection and a shorter recovery time. However, there may be no benefit to an individual participant. Risks to participants include some known side effects of the medications that will be explained before the patients consent to participate.
“We’ll be looking at side effects and outcomes,” Clement explained, “and we’ll be doing regular interim analyses. If it looks like the supportive care arm is not equivalently effective to medication, we’ll drop that arm, so patients won’t receive supportive care only. We’re really trying to find an answer as to how to best treat our patients.”
The research team also includes Jyotsna Fuloria, MD, at University Medical Center.
“Rigorous scientific research will provide the data we need to make appropriate treatment decisions for COVID-19,” said Steve Nelson, MD, dean of LSU Health New Orleans School of Medicine.
“We are so grateful to Louisiana Attorney General Jeff Landry and Senator Fred Mills, Jr. for obtaining the medications we need to conduct this vital clinical trial,” says Larry Hollier, MD, chancellor of LSU Health New Orleans.