The National Institute of Allergy and Infectious Diseases (NIAID) announced in a statement that they have stopped clinical trials of Eli Lilly’s CCP virus antibody treatment on hospitalized patients.
This came after the Data and Safety Monitoring Board (DSMB) conducted an independent investigation and recommended that the trials be halted after discovering that Eli Lilly’s neutralizing antibody treatment isn’t likely to improve a hospitalized patient’s condition. The study was conducted on patients who were already in the later stages of COVID-19, the disease the CCP (Chinese Communist Party) virus causes.
A neutralizing antibody is an antibody that defends the body’s cells from viral molecules or particles by neutralizing them as well as the harm they may bring to the host body.
“The DSMB reviewed data from the ACTIV-3 trial on Oct. 26, 2020 and recommended no further participants be randomized to receive LY-CoV555 and that the investigators be unblinded to the data,” the statement read.
Initially, the plan was to have the first 300 participants enroll in a double-blind study where patients are either given the antibody treatment or the placebo, in addition to Remdesivir, which would continue for five days. If the trial showed improvement to the patient that is also safe and effective, 700 more would also enroll and be followed for 90 days to learn whether the patients have recovered.
As recommended by the DSMB, the trial will stop enrolling patients into the study, but researchers will follow the 326 patients who have already been enrolled in the trial previously until the 90th day, as planned in the original trial.
“NIAID and trial coordinating investigators are in the process of analyzing the data and will provide more information in a forthcoming report,” the statement read.
Eli Lilly stated in a statement that the company “trusts the judgment of the independent DSMB and supports its decisions to exercise caution in ensuring the safety of the patients participating in this study.”
The company’s other studies, which involve patients who are in earlier stages of COVID-19, will continue as planned. Eli Lilly said the study that was halted involved patients who had already been hospitalized—meaning they were already in the “most advanced stage of the disease,” and therefore the treatment didn’t appear to help them improve, suggesting that the treatment may be less effective on patients in the later stages of COVID-19.
“For these reasons, hospitalized patients may have less benefit from neutralizing antibodies, which are a supplement to the patients’ own immune system, as they may have developed their own endogenous antibody response and be in a phase of disease characterized by inflammatory responses to virus,” Eli Lilly stated.
In the meantime, Eli Lilly will wait for “additional data to help us understand whether neutralizing antibodies could play a role in helping hospitalized patients,” as the company is still confident that the antibody treatment will have potential benefits in neutralizing viral pathogens from the CCP virus.
