SOM Enrolls First Patient in COVID-19 Clinical Trial
Leslie Capo, Director of Information Services
Editor's Note: This was originally released on April 13, 2020.
The 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,” says Meredith
Clement, MD, Assistant Professor in the Section of Infectious Diseases 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 the current 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,” adds Dr. 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 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. But 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 explains, “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,” notes Steve Nelson, MD, Dean of the LSU 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.