Researchers from Intermountain Healthcare and University of Utah Health in Salt Lake City have launched two vital clinical trials to test the effectiveness and safety of two drugs — hydroxychloroquine and azithromycin — to treat patients with COVID-19 (infection with the novel coronavirus).
Researchers from the two health systems plan to enroll nearly 2,300 patients who are COVID-19 positive or suspected of being positive for the virus.
“Results from these studies will help us to understand the value of hydroxychloroquine in treatment of COVID-19 as we seek ways to fight the virus effectively and reduce the human cost of this pandemic,” said Dr. Samuel Brown, principal investigator of one of the studies and a critical care researcher at Intermountain Healthcare.
Hydroxychloroquine, an anti-malarial drug typically used to treat some autoimmune diseases, and azithromycin, an antibiotic typically used for sinusitis or pneumonia, have been suggested as potential treatments for COVID-19, but whether they actually help is unknown.
“Because COVID-19 is a new disease, we’re all starting from scratch,” said Dr. Adam M. Spivak, principal investigator of the second clinical trial and an infectious disease physician at University of Utah Health. “The only way to answer the key question of ‘does this drug work?’ is to perform an unbiased clinical trial where we study its effects.”
In the first trial, patients hospitalized with suspected or confirmed COVID-19 will be given either hydroxychloroquine or azithromycin to determine whether either drug affects the severity of COVID-19 and saves lives. Researchers plan to enroll 300 patients in the clinical trial from across all Intermountain Healthcare hospitals and University of Utah Health hospitals that are treating COVID-19 patients.
“The main question we’re looking to answer in this trial is, 'Does hydroxychloroquine improve the severity of illness and save lives for patients hospitalized with COVID-19?'” said Brown.
In the second set of trials, patients with confirmed COVID-19 who are being treated as outpatients will be given hydroxychloroquine or azithromycin to determine if either drug can prevent hospitalization. The trials will also determine whether hydroxychloroquine impacts viral shedding and prevents infection of household contacts as compared to a placebo.
For the outpatient trials, researchers will enroll 2,000 patients across Utah from all Intermountain Healthcare and University of Utah Health System hospitals that are treating COVID-19 patients. Patients will receive treatment and be monitored via telehealth.
Researchers acknowledge there may be pressure on clinicians to use hydroxychloroquine for COVID-19 patients outside of a clinical trial. While it may feel reassuring to prescribe this medication in the midst of a pandemic, it may be counter-productive or even harmful until physicians better understand their impact, they say.
