UW Medicine is one of a network of U.S. sites testing a new treatment for COVID-19 that involves monoclonal antibodies, which are intended to provide immediate antiviral activity that lasts several weeks.
The drug is part of the ACTIV-2 Outpatient Monoclonal Antibodies and Other Therapies Trial, sponsored by the National Institute of Allergy and Infectious Diseases. The trial is also receiving support from Operation Warp Speed, the U.S. government's multi-agency effort to help end the pandemic.
The first part of the trial is enrolling 220 people nationwide - half will get a placebo and half will receive the drug known as LY3819253, an experimental monoclonal antibody treatment made by Lilly Research Laboratories in partnership with AbCellera Biologics. AbCellera and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases identified the antibody from a blood sample of one of the first people in the United States to recover from COVID-19. The purpose of the study is to test the safety and antiviral activity of the drug.
"We need a treatment that is effective," said infectious disease physician Ann Collier, director of the AIDS Clinical Trial Unit (ACTU) and professor of medicine at the University of Washington School of Medicine. "People living in the Seattle area who have recently been diagnosed with COVID-19 and are not hospitalized have the opportunity to make a huge contribution by participating in this study."
The UW Medicine ACTU is one of 25 initial sites conducting ACTIV-2, which will include phase 2 and phase 3 evaluations of many promising investigational agents for treating early COVID-19 in a single trial.
The ACTU is committed to enrolling individuals from populations most impacted by COVID-19. The project will work closely with community partners to make participation in the trial available to those who are often underrepresented in clinical research.
There is currently no approved vaccine or therapeutic to prevent or treat COVID-19.
To qualify for the study, participants must be at least 18 years old with confirmed SARS-CoV-2 from a respiratory sample collected within seven days of study entry plus at least one symptom of COVID-19 within 48 hours of entry. There will be 28 days of intensive follow-up after the first visit where participants will be given an infusion of LY3819253. Visits will be in-person and will include blood collection and saliva and nasal swab samples, medical history and exams, and completing a study diary to record symptoms and temperature. The study will have limited follow-up for 24 weeks (about six months). Participants will be reimbursed $500 if all procedures are completed.
Monoclonal antibodies are intended to provide immediate antiviral activity that will last several weeks. Additionally, monoclonal antibodies don't carry the transfusion risk of convalescent plasma.The drug LY3819253 was selected based on data demonstrating activity against SARS-CoV-2 in laboratory studies, and phase 1 pharmacokinetics and safety data, and has been given to about 400 people so far.
ACTIV-2 is part of NIH's Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private partnership program to create a coordinated research strategy that prioritizes and speeds development of the most promising treatments and vaccines. ACTIV-1 originally focused on the drug remdesivir.
