Oct. 27, 2020, update:
Following a review of ACTIV-3 study data, no more hospitalized COVID-19 patients will receive the study’s current monoclonal antibody treatment candidate, bamlanivimab. More information is available in an Oct. 26 announcement from bamlanivimab’s manufacturer, Eli Lilly. The trial paused recruitment on Oct. 14 at the recommendation of an independent data safety monitoring board.
OHSU had not enrolled any trial participants before the trial paused recruitment. However, the ACTIV-3 trial may evaluate other monoclonal antibody treatment candidates once they become available. OHSU is waiting for information from the trial’s sponsor, the National Institute of Allergies and Infectious Diseases, about the study’s next steps.
Trials are commonly paused to ensure trial participant safety, and the fact that some COVID trials have been paused is a sign that the appropriate checks and balances are in place. OHSU works carefully and diligently to ensure the safety and well-being of any person who enrolls in a clinical trial at OHSU.
Oregon Health & Science University is the only Oregon institution and one of 51 sites involved in an international clinical trial involving synthetic antibodies as a potential coronavirus treatment.
Patients who are hospitalized at OHSU with mild to moderate COVID-19 can volunteer for the Phase 3 trial, which is evaluating the safety and effectiveness of various investigational monoclonal antibody treatments.
“The human immune system uses antibodies to defend against disease-causing pathogens such as the virus that causes COVID-19,” said Akram Khan, M.D., an associate professor of medicine (pulmonology and critical care medicine) in the OHSU School of Medicine and who is a lead OHSU researcher for the study.
“Monoclonal antibodies are synthetic antibodies that are made in the lab and designed to act like natural antibodies,” he said. “Administered to patients with coronavirus, monoclonal antibodies could help naturally produced immune molecules fend off the virus before it can cause severe harm.”
Using natural antibodies found in people infected with COVID-19 as their inspiration, many pharmaceutical companies have developed monoclonal antibodies to help fight off the novel coronavirus. This trial is designed to evaluate different antibodies as they become available.
To begin with, the trial is studying the investigational antibody known as LY-CoV555. The trial’s initial stage aims to enroll approximately 300 volunteers worldwide who have been hospitalized with mild to moderate COVID-19 and have had symptoms for fewer than 13 days.
Enrolled participants will be randomly assigned to receive either an intravenous infusion of an investigational antibody or a placebo infusion of saline. Participants also will receive standard care for COVID-19, including the antiviral drug remdesivir. Volunteers will be followed for 90 days.
This study is part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines, or ACTIV, program, a public-private partnership to prioritize and speed development of the most promising treatments and vaccines. ACTIV is supported by Operation Warp Speed, the U.S. government’s multi-agency effort to develop, manufacture and distribute COVID-19 vaccines, therapeutics and diagnostics.
The trial is sponsored by the National Institute of Allergy and Infectious Disease, which is part of the National Institutes of Health. OHSU’s involvement is funded through the Prevention and Early Treatment of Acute Lung Injury, or PETAL, network, which is supported by the NIH’s National Heart, Lung and Blood Institute (grant 1OT2HL156812-01). C. Terri Hough, M.D., M.Sc., a professor of medicine and chief of the pulmonology and critical care medicine division in the OHSU School of Medicine, is the principal investigator of the PETAL Network’s Pacific Northwest Clinical Center, which is centered at OHSU.