Fred Hutchinson Cancer Research Center announced the opening of the COVID-19 Clinical Research Center, or CCRC. Funded by philanthropic donations and public/private partnerships, the CCRC is one of the first facilities in the nation designed to test novel interventions to treat and prevent COVID-19.
The stand-alone facility in the renovated Minor Building on Fred Hutch’s South Lake Union campus in Seattle will provide a collaborative space for scientists and clinicians to partner with study volunteers, health care providers, research institutes, foundations and the biotech/pharmaceutical industry on Phase 1 through 3 clinical trials (observational and interventional) for COVID-19-positive participants, and in the future, participants with other infectious diseases. Other capabilities include blood draws, infusions, injections, physical exams and administration of oral drugs. Pharmacy access will be provided by Fred Hutch’s clinical care partner, the Seattle Cancer Care Alliance, or SCCA.
Newly renovated facility is among the first stand-alone centers specifically designed to test novel interventions such as monoclonal antibodies and antivirals to treat and prevent COVID-19
For more information on referring volunteers, joining a trial or partnering with Fred Hutch to conduct a trial, visit the COVID-19 Clinical Research Center website.
The CCRC will open with two studies underway. One is a Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of remdesivir (GS-5734TM) treatment of those individuals with COVID-19 who are not ill enough to be hospitalized.
In this study, infectious disease doctors at Fred Hutch and the University of Washington School of Medicine are testing whether remdesivir can reduce symptoms and the need for hospitalization in individuals with early stage COVID-19. Remdesivir has been shown to help patients recover faster in the hospital, and this study will determine whether it is also beneficial in less-sick patients who are not hospitalized.
The other study is a Phase 2/3 randomized, double-blind, placebo-controlled trial examining REGN-COV2, Regeneron's investigational double antibody cocktail, in non-hospitalized patients with SARS-CoV-2, the virus that causes COVID-19. Initial study results suggest the monoclonal antibody treatment reduced the amount of virus and the duration of symptoms in non-hospitalized patients with COVID-19. In this study, which is for people diagnosed with COVID-19 with or without symptoms of the disease, researchers at Fred Hutch and UW Medicine will further test REGN-COV2 and help determine whether it can provide immediate antiviral activity, lasting several weeks.
“Previous studies demonstrated that remdesivir can hasten recovery in COVID-19 hospitalized patients, and that drugs like REGN-COV2 may reduce the length of illness and the risk of hospitalization overall,” said Dr. Julie McElrath, senior vice president and director of Fred Hutch’s Vaccine and Infectious Disease Division and holder of the Joel D. Meyers Endowed Chair. “We’re eager to examine these therapies through Fred Hutch’s scientific lens in partnership with COVID-19 volunteers in our region to help determine if these medicines can also keep people out of the hospital, prevent serious medical complications and reduce the duration of their illness.”
Dr. Rachel Bender Ignacio will serve as the medical director of the new CCRC.
Bender Ignacio is an assistant professor in the Division of Allergy & Infectious Diseases in the University of Washington Department of Medicine and an associate in the Hutch's Vaccine and Infectious Disease Division, or VIDD. She is an attending physician at the Harborview Medical Center/UW Medicine system on the HIV and infectious disease, or ID, consult service and the solid organ transplant ID services. Her research interests include HIV co-infections, including tuberculosis and viruses, HIV-associated malignancies, and immune activation during early HIV.
Fred Hutch News sat down with Bender Ignacio to learn more about the goals for the facility and the urgent mission to control and prevent the spread of SARS-CoV-2 and COVID-19.
There’s a major need to test novel interventions to treat and prevent COVID-19. The CCRC will offer an opportunity for investigators interested in testing experimental treatments and interventions that can be safely given and evaluated in an alternative setting from a hospital or traditional medical facility.
In her role as senior vice president of VIDD, Dr. Julie McElrath will oversee the CCRC along with input from Dr. Larry Corey, who had the initial vision for the dedicated center.
I’ll be the medical director of the CCRC in addition to overseeing a team of on-site clinical and support staff with Fatima Ranjbaran, our new operations director. I’ll also be responsible for ensuring that the trials are conducted safely and with the best clinical and scientific practices. Kristi Stiffler [Fred Hutch's associate vice president for Clinical Research Support] and Clinical Research Support are providing operational support for the center.
The facility will be funded by a mix of public and private partnerships including some generous donor contributions to Fred Hutch's COVID-19 Research Response Fund. Clinical trials will be independently funded by a sponsor, which is either the federal government or a biotechnology or pharmaceutical company. The studies will also contribute to funding the staffing and operational costs.
The facility can accommodate interventional and observational Phase 1-3 clinical trials. The infrastructure allows our experts to perform blood draws, infusions, injections and physical exams and to administer oral drugs. All participants must be ambulatory with mild to moderate COVID-19 disease or may also be healthy volunteers. Pharmacy access will be provided by SCCA and investigational treatments will be couriered to the CCRC. The center will only administer interventions according to study protocols. Because the CCRC is not a hospital or routine medical clinic, we will only be providing medical care within the bounds of research protocols for participants who meet eligibility for one of the trials.
The center is a stand-alone building not directly connected to any other part of Fred Hutch or SCCA. It’s designed to support active COVID-19 research participants outside a hospital setting. It’s important to remember that not all participants will have COVID-19; some will be healthy volunteers and others will have recovered from COVID-19 illness and are enthusiastic about sharing their body’s response to the virus to help further science.
Safety measures to protect everyone from transmission include:
We don’t have any formal plans at this time, but we are exploring ideas to repurpose the space to investigate other infectious diseases.