Not-for-profit Sutter Health Launches Clinical Trials with Gilead Sciences
Sutter Health, together with health systems across Northern California has teamed up with Foster City-based Gilead Sciences on clinical trials for a promising treatment for COVID-19. The COVID-19 vaccine is at least a year away and now scientists across the globe are investigating existing medicines that might work as treatments.
In April 2020, Sutter began participating in two of Gilead Sciences’ Phase 3, randomized clinical trials to evaluate the use of the company’s drug, remdesivir, in adults diagnosed with COVID-19, the disease caused by the novel coronavirus.
The studies test the clinical efficacy and safety of remdesivir in patients with moderate or severe COVID-19, compared with standard-of-care treatment. The U.S. Food and Drug Administration (FDA) reviews results from Phase 3 trials when considering a drug approval.
Promising Treatment
Remdesivir is an antiviral, intravenous drug made by Gilead Sciences. It’s been available as an experimental compound for years, but has not been approved by the FDA for use in clinical treatment.
Jamey Schmidt, Director of Clinical Research at Sutter’s California Pacific Medical Center (CPMC), quickly saw the potential benefit to patients in partnering drug manufacturers (in this case, Gilead Sciences) with Sutter researchers and physicians skilled in clinical trial start-up and ready to help tackle the infectious disease outbreak.
“Sutter research is committed to bring this investigational treatment to Sutter physicians caring for patients infected with the novel coronavirus,” says Schmidt, who collaborated with Greg Tranah, Ph.D., CPMC’s Scientific Director, and Jennifer Ling, M.D., infectious disease specialist at CPMC and principal investigator of the remdesivir clinical trials at CPMC.
CPMC, Sutter Santa Rosa Regional Hospital, Sutter Roseville Medical Center and Sutter Medical Center Sacramento are participating in the clinical trials of remdesivir, and other Sutter sites may enroll to the studies later this month.
“In response to this global health crisis, we’re proud that Sutter is helping lead efforts across Northern California and seeking new tools to combat this novel infection and lessen the virus’s impact,” says Dr. Ling. “Through research at Sutter, new discoveries will help determine the potential of remdesivir to help individual patients with COVID-19.”
Some patients who have been infected by the novel coronavirus and are severely ill may not meet the study criteria for enrollment in the clinical trials of remdesivir. Instead, they may qualify for treatment via Gilead Sciences’ expanded access program (EAP) for remdesivir. The EAP provides alternative access to the investigational drug for severely ill patients with COVID-19 who do not meet the clinical trials study criteria.
First developed in 2009 and used during the Ebola outbreak in 2014, remdesivir is being studied in multiple clinical trials worldwide to see if it is safe and effective against the coronavirus in humans. The drug was previously tested in animals infected by other coronaviruses like SARS and MERS, and is now being tested in humans to determine if it can reduce the intensity and duration of COVID-19.
“Research at Sutter is helping deliver safe, high-quality care to our patients during this unprecedented pandemic,” says Leon Clark, Vice President, Chief Research and Health Equity Officer, Sutter Health. “By bringing innovation to the forefront of how we can best care for Sutter patients who acquire COVID-19, Sutter’s talented researchers are stepping up to the challenge presented by this global health crisis.”
April 29 Update:
Results from a clinical trial of remdesivir, an antiviral manufactured by Gilead Sciences, led by the U.S. National Institutes of Health (NIH) were reported April 29, 2020. The findings suggest that hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than patients who received placebo, according to a preliminary data analysis from a randomized, controlled trial involving 1063 patients. The trial (known as the Adaptive COVID-19 Treatment Trial, or ACTT), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, was the first clinical trial launched in the United States to evaluate remdesivir as an experimental treatment for COVID-19.
Additionally, Gilead Sciences also shared preliminary results today from the company’s open-label, Phase 3 SIMPLE trial evaluating five- and 10-day dosing durations of remdesivir in hospitalized patients with severe COVID-19. The study results demonstrated that patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those patients who were administered a five-day treatment course of the drug.
Sutter is not participating in the ACTT treatment trial nor the SIMPLE clinical trial. However, as described in the above article posted on April 8, Sutter is participating in the two Phase 3, randomized, controlled clinical trials that are testing remdesivir. Gilead Sciences has not yet disclosed when results of these clinical trials will be published. Clinical trials at Sutter testing investigational use of remdesivir will close to enrollment May 29, 2020.
May 4 Update:
On May 1, 2020, remdesivir received FDA Emergency Use Authorization for the treatment of COVID-19. The authorization enables the potential use of remdesivir to treat hospitalized patients suffering from severe COVID-19 disease in the U.S., outside of the context of an established clinical trial of the drug. Based on patients’ severity of disease, the authorization allows for five- and 10-day treatment durations.
Learn more about Sutter research and clinical trials.
