Hopefully, if things happen as a threesome, this will be the final bump on the road to COVID treatment and a vaccine.
Eli Lilly and Company had to discontinue the government-sponsored Phase 3 study of antibody treatment against COVID-19 for safety reasons. The treatment had piqued great interest after President Donald J. Trump talked about how similar treatment helped him recover from the infection.
The October 13 announcement follows AstraZeneca’s decision last month to cancel the vaccination trial because of the illness of a UK participant. Since then, the test has been restarted at all locations except the USA.
And on October 12, Johnson & Johnson paused their COVID vaccine study because of an unexplained illness of a participant.
Lilly researchers looked at how antibodies can help hospital patients recover faster. Study participants also received remdesivir, an antiviral drug that has been shown to be beneficial in treating COVID-19.
The New York Times reported: “[The trial] was halted when the independent safety agency found that the group of patients who received the antibodies had a different “clinical status” than the group who received placebo with saline after five days of treatment. “
The National Institute of Allergies and Infectious Diseases did not disclose what the results were or how the patients were affected. Media speculates that this could be due to several issues, including a significant difference in how one group performed versus the other.
Lilly made the following statement:
“As of last evening, Lilly remained in contact with the sponsor of the study to discuss the recommendation of the Independent Data Security Monitoring Board (DSMB) of the ACTIV-3 clinical trial to suspend the study. ACTIV-3, which evaluates Lilly’s neutralizing antibody bamlanivimab (LY-CoV555) for the treatment of COVID-19 in hospitalized patients, is sponsored by the National Institute for Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
“Currently only the DSMB has reviewed the data from the study, and the NIH leadership and Lilly remain blind to the ongoing study 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.
“It is important that the DSMB also considered the effects of the ACTIV-3 study break on ACTIV-2 and did not recommend any changes to the design or registration of this study.”