Orange, Calif., 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.
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.
About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
UCI Health comprises the clinical, medical education and research enterprises of the University of California, Irvine. Patients can access UCI Health at physician offices throughout Orange County and at its main campus, UCI Medical Center in Orange, Calif., a 402-bed acute care hospital that provides tertiary and quaternary care, ambulatory and specialty medical clinics, behavioral health and rehabilitation. U.S. News & World Reporthas listed it among America’s Best Hospitals for 19 consecutive years. UCI Medical Center features Orange County’s only National Cancer Institute-designated comprehensive cancer center, high-risk perinatal/neonatal program, combined Level I trauma center and Level II pediatric trauma center, and is the primary teaching hospital for UCI School of Medicine. UCI Health serves a region of more than 3 million people in Orange County, western Riverside County and southeast Los Angeles County. Follow us on Facebook and Twitter.