Gilead Sciences, a biotechnology company that researches, develops and commercializes drugs, has selected MemorialCare Long Beach Medical Center as one of the first expanded access sites on the West Coast to provide the investigational antiviral medication Remdesivir (RDV) as a potential treatment for COVID-19.
MemorialCare officials announced Wednesday, April 15 that the hospital has enrolled its first three patients as part of an international, multicenter clinical study of the medication.
The program began in March with a primary objective to provide expanded access of RDV for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection in adults over the age of 18, according to Gilead.
Remdesivir is a drug that was initially developed by Gilead for the treatment of diseases related to the Ebola and Marburg viruses, but it also showed potential in treating several other single strand RNA viruses– including multiple strains of coronavirus, according to a press release from MemorialCare.
As the coronavirus pandemic expanded and health officials raced to fine a cure or vaccine, Gilead sought and received rapid acceptance from the FDA to launch multiple clinical trials related to RDV, including the recently approved expanded access treatment protocol.
According to the FDA, expanded access, commonly referred to as “compassionate use,” is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
The study is taking place all over the globe, targeting different stages of the virus. In China, their studies will determine the safety and efficacy of Remdesivir as a potential treatment for the coronavirus. In France, health officials are administering Remdesivir while using a master protocol developed by the World Health Organization (WHO).
The results from some studies so far have shown positive results. On April 10, Gilead published a study of 53 COVID-19 patients in the New England Journal of Medicine, which showed that 68% of patients resulted in “clinical improvements.”
“Currently there is no proven treatment for COVID-19. We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received Remdesivir are hopeful,” Jonathan D. Grein, MD, Director of Hospital Epidemiology, Cedars-Sinai Medical Center, Los Angeles, and lead author of the journal article, said. “We look forward to the results of controlled clinical trials to potentially validate these findings.”
Long Beach Medical Center’s research team is led by infectious disease specialist and Principal Investigator Henry Su, M.D.
“Our participation in the Remdesivir expanded access study is consistent with our goal of providing patients with severe COVID-19 infection access to the latest and most potentially efficacious treatment options,” Dr. Su said. “Patients will be closely monitored as part of the study protocol to ensure their safety.”
Kevin Jones, MD, medical director of MemorialCare Office of Research Administration said that it is too early to tell if the medication is working or not, but his staff remains hopeful.
“Anything we have at this early stage would qualify as anecdotal, since we have only a limited number of study participants at this stage,” Dr. Jones said. “However, we remain hopeful that this drug will have a positive impact on these patients.”