LOS ANGELES–(BUSINESS WIRE)–Researchers at The Lundquist Institute began Thursday a randomized, double-blind, placebo-controlled clinical trial designed to find out whether hydroxychloroquine and azithromycin reduce hospitalization and/or death in individuals suffering from COVID-19, the disease caused by the novel coronavirus, SARS-CoV-2.
This trial, sponsored by the National Institutes for Health, will include 2,000 adults with symptomatic SARS-CoV-2 infections. Under the direction of Dr. Eric Daar, The Lundquist Institute will be one of 25 to 30 sites nationwide, each looking to enroll about 100 patients over the next six weeks.
“The Lundquist Institute has delivered life-saving innovations for decades, and we are pleased to be selected as one of the sites for this crucial trial,” said David Meyer, PhD, President and CEO of The Lundquist Institute. “COVID-19 is the single greatest public health challenge of my lifetime, and we must act fast to find, as well as to do the needed studies to verify a potential treatment such as this.”
During the trial, patients will receive seven days of treatment with drugs or placebo, with a follow-up appointment at 20 days. A randomized selection of participants will receive oral doses of hydroxychloroquine or placebo twice daily for seven days, as well as a daily dose of azithromycin or placebo for five days. This combination of medications has been used to treat a few COVID-19 patients and is advocated by some in the medical and political communities, but its efficacy, as well as its safety, is unproven at this point, which is why this trial is required.
The initial endpoint of the study would be to evaluate the levels of hospitalization and/or death within 20 days following enrollment in the study. Nonetheless, subjects will continue to be monitored at 12 and 24 weeks post-enrollment.
A Data Safety Monitoring Board (DSMB), the impartial jury of the study, will be reviewing results weekly to determine safety and efficacy of the treatment. Subjects will be interviewed by phone seven times during the 20 days to determine if any potentially harmful side effects are experienced. These would be reported immediately to the DSMB. Release of study results will be up to the DSMB or after all participants have completed the study and data is fully analyzed.
A randomized clinical trial is the only effective way to determine if a treatment such as this can safely benefit those suffering from COVID-19. The disease, which was discovered late last year, has already killed more than 70,000 Americans since late February. The Lundquist Institute, with its extensive background and history in clinical studies on viruses, such as HIV, is ideally prepared to hit the ground running in this study.