Newswise — SEATTLE — Oct. 5, 2020 — 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 stand-alone facilities in the nation designed to test novel interventions to treat and prevent COVID-19.
The 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.
“The ability to safely deliver therapies to people with COVID-19 early in their disease course is critical to limiting spread, reducing hospitalizations and death, and reopening our society,” said Dr. Rachel Bender Ignacio, an associate in the Vaccine and Infectious Disease Division at Fred Hutch and the medical director of the CCRC. “For more than 40 years, Fred Hutch researchers have made fundamental discoveries and breakthroughs relating to viruses and the body’s immune response to cancer, HIV and other infections. Our team of clinical researchers is committed to applying our expertise to determine which therapies are the safest and most effective in treating COVID-19 and saving and improving lives.”
Multiple measures are in place to address the safety of study participants and those who are on-site. They include:
· Air circulation that meets or exceeds standards in medical facilities, including dedicated air handling/circulation and HEPA filters for each enclosed room.
· Separate entry/exits and restrooms for study volunteers with known or potential COVID-19 as well as separate entry/exits and restrooms for healthy volunteers who do not have infectious diseases.
· Restricted and secure access to the facility to prevent unauthorized/accidental access.
· Appropriate personal protective equipment for all CCRC staff and participants.
· Extensive cleaning and disinfecting protocols.
The CCRC is opening 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 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.”
For more information on referring volunteers, joining a trial or partnering with Fred Hutch to conduct a trial, please visit the COVID-19 Clinical Research Center website.
Fred Hutch researchers are playing a leading role in an international scientific response to the pandemic — tracking the virus's global spread, developing diagnostic tests and monoclonal antibodies that neutralize the virus, designing and evaluating COVID-19 vaccines in early and late-phase clinical trials, and working to better understand how the human immune system can provide durable protection and prevent future outbreaks. Even as the scientific community rapidly works towards vaccines and treatments, we can all do our part to keep our communities safe right now by wearing face coverings and maintaining physical distancing. For more information, visit Fred Hutch’s coronavirus overview.
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At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first National Cancer Institute-funded cancer prevention research program, as well as the clinical coordinating center of the COVID-19 Prevention Network and the Women’s Health Initiative.
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