Researchers recruiting patients for Regeneron antibody trial
UW Medicine, Fred Hutch scientists will jointly test whether the monoclonal drug can prevent infection among people exposed to COVID-19.
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Researchers at UW Medicine and the Fred Hutchinson Cancer Research Center are jointly testing monoclonal antibodies created by Regeneron Pharmaceuticals to prevent COVID-19, and are starting to recruit patients.
The scientists are testing a double antibody cocktail called REGN-COV2 (REGN10933+REGN10987), which had favorable results in mouse models and a positive review of the Phase I safety evaluation in an initial cohort of 30 hospitalized and non-hospitalized patients with COVID-19. President Trump received a higher dose for treatment that was delivered through an IV infusion.
Last week, the company announced favorable first data from a descriptive analysis showing the antibody cocktail reduced viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19. REGN-COV2 also showed positive trends in reducing medical visits.
“Monoclonal antibodies are very promising,” said co-principal investigator Dr. Ruanne Barnabas, associate professor of global health and allergy and infectious diseases at the University of Washington School of Medicine.
The prevention trial is recruiting 2,000 people at more than 100 sites across the United States.The medicine will be delivered through a pin prick in the skin.
The trial will evaluate REGN-COV2’s ability to prevent infection among uninfected people who have had close exposure to COVID-19 from a housemate or family member.
“As the globe surpasses 1 million reported deaths from COVID-19, it is clear that we need better tools to fight this infection,” said co-investigator Dr. Shelly Karuna with the HIV Vaccine Trials Network at Fred Hutch. “Monoclonal antibodies could help us achieve an end to the pandemic.”
Monoclonal antibodies are intended to provide immediate antiviral activity that lasts several weeks. A number of U.S. trials are testing monoclonal antibodies for the prevention and treatment of COVID-19, including an early treatment trial of the REGN-COV2 antibody cocktail at the Fred Hutch COVID-19 Clinical Research Center (REGN 2067) -- the same treatment President Trump received. UW Medicine’s AIDS Clinical Trial Unit is already conducting a treatment trial of other monoclonal antibodies.
To qualify for the prevention study, participants must have a confirmed household member test positive for SARS-CoV-2, the virus that causes COVID-19. Participation involves at least 10 follow-up visits. Visits will be in-person and will include collection of blood and respiratory swab samples, medical history and exams, and monitor and report symptoms and temperature. Participants will be reimbursed at the completion of each visit. For enrollment details or see website to see if you qualify. If you are outside Seattle, go to this website and complete a form to be contacted by a site.
“This is an exciting opportunity to get an investigational monoclonal antibody at Harborview Medical Center that could prevent COVID-19,” said Barnabas.
The Phase III trial is being run by Regeneron Pharmaceuticals. The COVID-19 Prevention Network (CoVPN), funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is participating in the trial. UW Medicine and Fred Hutch are sites part of the CoVPN, which is composed of existing NIAID-supported clinical research networks with infectious disease expertise and is designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodies for the prevention of COVID-19. The NIH grant number is 3UM1AI068614.
For more information on the trial, go here.