CHR Rapidly Launches COVID-19 Studies
Clinical Trial and Surveillance Studies Underway
By Jill Pope, Senior Technical Writer/Editor
As Kaiser Permanente doctors, nurses, and other hospital staff work on the front lines caring for our members with COVID-19, research teams at the KP Northwest Center for Health Research (CHR) are testing new treatments to combat the virus and monitoring its effects.
Potential Treatment Being Tested
Richard M. Mularski, MD, MSHS, MCR
Stephen P. Fortmann, MD
In March, CHR began conducting a randomized clinical trial to test Gilead Sciences’ remdesivir. Remdesivir is an antiviral drug that was developed as a possible treatment for the Ebola virus. In animal studies, the drug has held promise against the viruses that cause both Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS). The new clinical trial is studying remdesivir’s effectiveness against the virus that causes COVID-19, which is similar to SARS and MERS.
Leading the study are Richard Mularski, MD, MSHS, MCR, a CHR Senior Investigator who also practices pulmonary and critical care medicine at Kaiser Permanente Northwest (KPNW), and Stephen Fortmann, MD, Senior Director, Science Programs at CHR.
“Thanks to Dr. Mularski and the highly experienced research nurses and clinical trial staff in CHR’s Clinical Research Support Services, this trial started recruiting a week after Gilead approved our site,” said Fortmann. “This is lightning speed in the world of clinical trials and reflects the urgency created by the COVID-19 pandemic and the dedication of Kaiser Permanente physicians and staff to provide their patients with the best possible care while still learning as we go.”
In addition, CHR Investigators are partnering with a group of doctors and pharmacists from KPNW’s Infectious Disease Department to conduct this work. They are:
- Tracy Barton, PharmD
- Katherine Gazlay, PharmD
- Andrew Leitz, MD, PhD
- Jocelyn Mason, PharmD
- Keith Riley, MD
- Molly Stenzel, MD
- Diana Antoniskis, MD
- Peter Alex Leahey, MD
- Hien Minh Nguyen, MD
- Katie Sharff, MD
- Steven Spindel, MD
Under the clinical trial, hospitalized adults with moderate or severe COVID-19 infection at KPNW’s Sunnyside Medical Center and Westside Medical Center may be eligible to join. As of publication, more than a dozen patients are enrolled. Any adult patient admitted to either hospital who meets the clinical trial criteria can participate, including patients who are not KP members.
Technically, two separate clinical trials are underway. The first trial, for patients with severe COVID-19 illness, is comparing patients who receive a 5-day course of the drug to patients who receive a 10-day course of the drug—both groups will get the drug in addition to their usual care. The second trial, for patients with moderate COVID-19 illness, is comparing patients who receive these same 5- and 10-day dosing regimens in addition to their usual care with patients who receive usual care alone.
There are no proven treatments for COVID-19, so most patients are receiving supportive care, which may include oxygen and ventilator support. Enrolling in a clinical trial can allow patients to get access to a drug that is not approved yet. Prior to the new clinical trials, remdesivir was available only to a limited number of COVID-19 patients through the “compassionate use” or expanded access process. This process offers a way for patients with serious or life-threatening conditions to try a drug that is not yet approved when clinical trials and other treatments are not available.
Clinical trials are also needed to establish safety and efficacy before approval by the Food and Drug Administration (FDA). The new studies are Phase 3 clinical trials. Phase 1 trials focus on drug safety, phase 2 trials gather effectiveness data, and Phase 3 trials study both safety and effectiveness.
Allison Naleway, PhD
CHR is also working closely with the Centers for Disease Control and Prevention (CDC) to better understand COVID-19. Distinguished Investigator Allison Naleway, PhD and her team have begun a weekly surveillance project in partnership with the CDC that leverages our existing Vaccine Safety Datalink (VSD) collaboration. The VSD includes five KP regions: KPNW, KP Washington, KP Northern California, KP Southern California, and KP Colorado. This project will describe the epidemiology of COVID-19 in our KP member populations, focusing on testing patterns, severity indicators (hospitalization, ICU, ventilator use), and underlying illnesses and medication use. For this project, data from the five KP regions will be combined with data from two other health care systems: the Marshfield Clinic in Wisconsin and HealthPartners in Minnesota.
Dr. Naleway also hopes to launch two more CDC-funded studies in May that seek to better understand how COVID-19 is affecting specific population groups. Both studies would initially involve weekly symptom reporting and collection of medical records data and would then expand to mucosal swab and blood specimen collection in the summer and fall. One study would focus on health care personnel and first responders; the other would focus on pregnant women and their infants.
“We have prior experience working with these two priority groups because of our long history of flu and flu vaccine research,” says Dr. Naleway. “We’re able to get out into the field quickly because the CDC made investments in influenza pandemic planning and we can rapidly convert those existing protocols and data collection tools and methods to work with COVID.” Both studies would increase our understanding of symptoms, testing, recovery, viral shedding, transmission, and patient health outcomes.