TESTED HERE FIRST
COVID-19 treatment tested by ECU, Vidant receives FDA emergency use authorization
Dr. Paul Cook, chief of the Division of Infectious Diseases at ECU’s Brody School of Medicine, gives a presentation about the novel coronavirus on March 3, 2020. Cook has headed several COVID-19 clinical trials aimed at improving patient care.
(Photo by Cliff Hollis)
An East Carolina University infectious disease specialist at Vidant Medical Center was among the first to trial a new COVID-19 antibody treatment that was granted an emergency use authorization (EUA) by the U.S. Food and Drug Administration on Monday.
Dr. Paul Cook, chief of the Division of Infectious Diseases at ECU’s Brody School of Medicine, began enrolling patients in August in the clinical trial investigating the monoclonal antibody treatment now named bamlanivimab developed by pharmaceutical company Eli Lilly.
Early studies of the treatment showed a statistically significant reduction in the need for patient hospitalization as compared with a placebo.
“What it means is that we’re at the forefront — it doesn’t mean that we’re the only place in town,” Cook said. “I’ve gotten emails about it asking, ‘How are we going to do this?’ and, ‘Where is it going to be done?’ We already know how to do it because we have already been doing it. We’ll probably do it at our infusion center, which we already have in place.”
Cook added that the early supply of the EUA-approved treatment is limited, so providers will have to be judicious in determining a patient’s eligibility.
Bamlanivimab is a monoclonal antibody targeting the spike protein of SARS-CoV-2, designed to prevent the virus from attaching and entering human cells. It is intended for higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19. It is one of six drug and biological products that have received the emergency use authorization from the FDA. Veklury — also known as remdesivir — which has also been tested at ECU, became the first and thus far only fully FDA-approved treatment for COVID-19 on Oct. 22.
“The FDA’s emergency authorization of bamlanivimab provides health care professionals on the frontline of this pandemic with another potential tool in treating COVID-19 patients,” said Dr. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research in a release from the FDA. “We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available.”
BEYOND BAMLANIVIMAB
Clinical trial moves forward, combining this antibody with another
Once the initial clinical trial showed that bamlanivimab, also known as LY-CoV555, to be effective in treating high-risk COVID-19 patients in the early stages of their infection, the trial was expanded. Cook, his colleagues at ECU and other sites around the nation are testing a combination treatment of bamlanivimab and an additional SARS-CoV-2 neutralizing antibody called etesevimab, or LY-CoV016. The treatment is intended for higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19.
Cook said that the combination therapy is similar to the one used to treat President Trump when he was diagnosed with COVID-19.
“We think that these double monoclonal antibodies are probably better than one,” Cook said. “We don’t know that for sure but that’s why we do trials.
“There’s concern with pretty much any infection about development of resistance. If you’ve got two monoclonal antibodies, the chance of overcoming resistance is greater than if you just have one. Basically, it should improve the efficacy of the product.”
Cook noted that because bamlanivimab is in a limited supply compared to the amount of patients nationwide that could benefit from it, patients who do not qualify for bamlanivimab due to supply issues could potentially still be treated with it as part of the BLAZE-1 combination trial.
Because the clinical trial is ongoing and double-blind — meaning that neither providers nor patients know which patients have received the treatment, and which received a placebo — Cook and other ECU health care providers are unable to draw strong conclusions about the efficacy of the treatments based on their own patients who are enrolled in the trial. However, according to Eli Lilly, data from a new interim analysis of this BLAZE-1 clinical trial showed that the combination therapy reduced viral load, symptoms and COVID-related hospitalization and ER visits.
Related stories:
COVID-19 Clinical Trial: ECU, Vidant begin trial of COVID-19 treatment
Funding COVID-19 Research: How ECU’s Brody School of Medicine will use $15M in CARES Act funding
COVID-19 Antibody Treatment: ECU, Vidant conducting COVID-19 antibody clinical procedure