UCI Health launches therapeutic clinical trial for COVID-19
March 23, 2020
UCI Health clinicians have launched a clinical trial to test the efficacy of the antiviral drug remdesivir as a potential therapy for COVID-19, the disease caused by the novel coronavirus (SARS-CoV-2) that has reached pandemic levels across the globe.
There are no specific therapeutics approved by the Food and Drug Administration (FDA) to treat people with COVID-19. The infection can cause mild to severe respiratory illness, and symptoms can include fever, cough and shortness of breath. In older adults and immunocompromised patients with the condition can develop into severe pneumonia.
“There is currently no safe, effective treatment for COVID-19,” said Alpesh N. Amin, MD, MBA, chair of the Department of Medicine, UCI School of Medicine and executive director, UCI Health Hospitalist Program. “While remdesivir has shown some promise, we need solid clinical data that indicates it improves outcomes for infected patients.”
Amin and infectious disease specialist Lanny Hsieh, MD, are principal investigators at UCI and will oversee the randomized, placebo-controlled trial. UCI, along with UC San Diego and UC Davis, are designated sites for the first NAIAD-sponsored remdesivir clinical trials in California. The trial enrolled its first patients in late February at the University of Nebraska Medical Center.
As Orange County’s only academic health system, UCI Health and UCI Medical Center are well-equipped to manage the care of patients with infectious diseases. UCI experts have planned since early January to prepare the medical center’s staff and facilities to treat patients infected with SARS-CoV-2.
The Orange County Health Care Agency has reported 125 confirmed cases of COVID-19.
Remdesivir, developed by Gilead Sciences Inc., is an investigational broad-spectrum antiviral treatment. It was previously tested in humans with Ebola virus disease and has shown promise in animal models for treating Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), which are caused by other coronaviruses.
COVID-19 was first detected in December 2019 in Wuhan, Hubei Province, China. SARS emerged in China and infected more than 8,000 people in 2002 and 2003. MERS emerged in Saudi Arabia in 2012. Through December 2019, the World Health Organization had confirmed 2,499 MERS-CoV cases and 861 deaths (or about 1 in 3), according to the NIAID.
According to the NIAID, participants in the NIH-sponsored trial must have laboratory-confirmed SARS-CoV-2 infection and evidence of lung involvement, including rattling sounds when breathing (rales) with a need for supplemental oxygen or abnormal chest X-rays, or illness requiring mechanical ventilation. Individuals with confirmed infection who have mild, cold-like symptoms or no apparent symptoms will not be included in the study. In accordance with standard clinical research protocols, eligible patients will provide informed consent to participate in the trial.
For more information, visit ClinicalTrials.gov and search identifier NCT04280705.