If things do happen in threes, hopefully this will be the last bump in the road to a COVID treatment and a vaccine.
Eli Lilly and Company has had to halt its government-sponsored phase 3 trial of an antibody treatment for COVID-19 for safety reasons. The treatment had garnered a lot of interest after President Donald J. Trump spoke of how a similar treatment helped him recover from the infection.
The Oct. 13 announcement comes on the heels of AstraZeneca’s decision last month to pause their vaccine trial, due to the illness of one of the UK participants. It has since restarted the trial at all sites, except for the United States.
And on Oct. 12, Johnson & Johnson paused their COVID vaccine trial, due to the unexplained illness of a participant.
Researchers at Lilly were studying how antibodies may help hospitalized patients recover more quickly. The study participants also received remdesivir, an antiviral medication that has proved beneficial in treating COVID-19.
The New York Times reported: “[The trial] was paused when the independent safety board found that, after five days of treatment, the group of patients who had received the antibodies showed a different “clinical status” than the group who had received a saline placebo.”
The National Institute of Allergy and Infectious Diseases did not disclose what the findings were or how patients were affected. Media outlets are speculating that it could be due to several issues, including a significant difference in how one group was faring over the other.
Lilly issued the following statement:
“As of last evening, Lilly continued to be in communication with the trial sponsor regarding the recommendation from the independent data safety monitoring board (DSMB) of the ACTIV-3 clinical trial to pause enrollment of the study. ACTIV-3, which is evaluating Lilly’s investigational neutralizing antibody bamlanivimab (LY-CoV555) as a treatment for COVID-19 in hospitalized patients, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
“At this time, only the DSMB has reviewed the data from the trial, and NIH leadership and Lilly remain blinded to the ongoing trial results. Lilly 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.
“Importantly, the DSMB also considered the impact of the ACTIV-3 study pause on ACTIV-2 and did not recommend any changes to that study’s design or enrollment.”