A knockout blow for Eli Lilly's neutralizing monoclonal antibody

Beyond the known benefits of dexamethasone—a commonly used steroid—and Gilead Pharmaceutical's widely anticipated but mostly disappointing antiviral medication remdesivir, the scientific community has been looking for other covid-19 treatments, including the use of monoclonal antibodies that target specific part of SARS-CoV-2. Regeneron provided the monoclonal antibody cocktail received by President Trump (the jury on their effectiveness is largely still out). Another monoclonal antibody, Eli Lilly's LY-CoV555, is currently under investigation. Yesterday represented a significant setback. In a paper published yesterday in The New England Journal of Medicine, researchers reported that enrollment for a trial of this treatment was stopped in October because it was deemed by statisticians to have been futile; there was no longer any statistical chance that a favorable outcome might have been achieved by continuing the trial.  

The trial, conducted by the National Institutes of Health, enrolled over 300 hospitalized patients who were randomized to receive the antibody cocktail or a placebo in addition to the standard of care for all enrolled patients—95 percent also received remdesivir, while oxygen and dexamethasone were administered on a case-by-case basis. 

The primary outcome measured was sustained recovery over a 90-day period. However, futility was determined after comparing outcomes on day 5, which showed no sign of improvement after receiving the antibody cocktail compared to the placebo. In fact, while the data did not reach statistical significance, it seems that the antibody group fared just slightly worse. Even at the day 28 follow-up for the initially enrolled patients, the treatment group had a slightly increased rate of "primary safety events," a cause for concern. 

While data for this particular neutralizing antibody is less than promising for the treatment of covid-19, it is important to remember that these types of treatments have been shown to vary widely in efficacy for other viruses (including Ebola). Thus, the scientific community shouldn't close the door on other potential antibody therapies. 



New round of provider relief fund payments

The Department of Health and Human Services (HHS) has announced $24.5 billion in disbursements under the Health Resource and Service Administration (HSRA) Phase 3 of the Provider Relief Fund (PRF) program. By the numbers, HHS reports over 70,000 recipients in this latest round. Initially intended to cap at $20 billion, an additional $4.5 billion was added due to the scale of healthcare entities expressing dependence on external support.

Under the original provisions of the program, applicants had to have received funding from initial phases, and demonstrated anticipated percentage revenue loss from coronavirus care, to be considered for additional rounds. Given the scope of affected providers, however, HHS expanded the eligibility to include first-time applicants, and shifted the targeted reimbursement to cap at 88 percent of reported losses.

Pulling out specific examples, HHS reports nursing homes will collectively receive an additional $1.1 billion and transportation services will receive $1.48 billion, and a state-by-state breakdown of funds may be found hereThe Department of Health and Human Services

—Brief19 Policy Team

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