Drug clinical trials and blood plasma program are in place in multiple KPNC hospitals
By Jan Greene
In the race to find safe and effective treatments for seriously ill patients with COVID-19, Kaiser Permanente Northern California (KPNC) is enrolling patients in nationwide clinical trials and participating in an expanded access program of a novel treatment strategy that uses blood plasma from recovered patients. KPNC is expected to add additional clinical trials in coming weeks.
KPNC is taking a careful approach to choose the most promising investigational treatments to protect patients and produce reliable evidence, explained Alan S. Go, MD, regional medical director of the KPNC Clinical Trials Program based at the Division of Research.
“We get approached almost every other day right now with new treatment ideas,” Go said. “And there’s tremendous pressure. Our treating clinicians are doing the best they can to provide supportive care for people who are really ill, and they’re looking for anything that might help their patients recover and avoid dying from COVID-19. But we also want to make sure we’re supporting the evidence base so that at the end of the day, we have some treatments we can say really work rather than relying on anecdotal reports or uncontrolled studies.”
COVID-19 patients in KPNC hospitals benefit from the systematic integration of patient care with a unique regional Clinical Trials Program established through the Division of Research, Go said. The Clinical Trials Program provides coordination and support across KPNC’s 21 medical centers and hundreds of outpatient offices for clinical trials and emergency access to experimental treatments.
“Our program provides full-service infrastructure and expertise, consisting of regulatory support specialists, coordinators, clinical trial research nurses, and various tools to allow us to be more efficient in our enrollment and to ensure safe implementation of clinical trial protocols,” he said.
KPNC hospitals are participating in clinical trials sponsored by industry that compare patients who receive the new medications with similar patients who do not, considered an important design element to produce reliable results. Some of these trials include:
–Remdesivir, an investigational antiviral drug made by Gilead Sciences. KPNC is taking part in Phase 3 clinical trials, along with more than 150 other medical facilities worldwide, which currently include 6 KPNC hospitals and other Kaiser Permanente regions. Hospitalized patients are being enrolled to receive the intravenous medication in one of two trial protocols, one for severe disease and another for moderate disease.
–Selinexor, a selective inhibitor of nuclear export (SINE) agent being tested by Karyopharm Therapeutics as an antiviral and anti-inflammatory therapy for COVID-19.
KPNC is also participating in an expanded access program to give selected COVID-19 patients convalescent blood plasma, taken from COVID-19 patients who have clinically recovered from the infection. Expanded access programs give sick patients access to a potentially useful but unproven treatment outside of a clinical trial. Researchers believe blood plasma from recovered patients could provide antibodies to attack the virus and help critically ill COVID-19 patients recover more quickly.
People who have recovered from a bout with COVID-19 and meet other eligibility criteria can donate blood plasma through the American Red Cross or other participating blood banks. Kaiser Permanente members should talk with their doctors if they are interested in donating blood plasma for this purpose.
Careful but speedy evaluation
Soon after the COVID-19 crisis began, the Division of Research and The Permanente Medical Group leadership established a COVID-19 Clinical Research Coordinating Team to plan targeted research and prioritize research proposals. It has evaluated more than 120 potential clinical research opportunities and is also tracking non-clinical COVID-19 work by DOR researchers.
The rapidly growing list of COVID-19 research studies at DOR includes:
–A study of the characteristics and clinical trajectory of COVID-19 patients who come through the emergency department by emergency medicine researchers with Kaiser Permanente’s CREST network
–Analysis of hospitalized KPNC patients to learn more about how COVID-19 behaves, who is at risk of complications, and which treatments are effective
–Decision support and risk prediction tools in development for clinicians
–Examinations of COVID-19 in specialized populations such as immunosuppressed people and cancer patients
–A study of mental health services use and outcomes during the COVID-19 pandemic
In addition, the Division of Research’s Vaccine Study Center has funding from the Centers for Disease Control and Prevention to carry out COVID-19 surveillance among KPNC members.
KPNC infectious disease specialist Jacek Skarbinski, MD, cares for patients at Oakland Medical Center all day and spends long hours each night catching up on research literature in his role as the overall principal investigator for several of KPNC’s COVID-19 clinical trials. He describes the search for effective treatments as both urgent and long-term.
“We’re not going to find the absolute best treatment in the next couple of weeks or months,” Skarbinski said. “It’s going to take time. There are no shortcuts to rigorous research. So, we’re working to build a lasting infrastructure to evaluate new therapies that are going to help us in the long run.”