Q. Was the bamlanivimab arm of a clinical trial (ACTIV-3) terminated?
A. Yes. The National Institute of Allergy and Infectious Diseases (NIAID)-sponsored ACTIV-3 clinical trial is a platform trial designed to test the safety and efficacy of various investigational agents, including bamlanivimab, for the treatment of patients hospitalized with COVID-19. The trial was paused on October 13, 2020, by the independent Data Safety Monitoring Board (DSMB). On October 26, 2020, it was announced that no additional patients in ACTIV-3 would receive bamlanivimab. This recommendation was based on trial data suggesting that bamlanivimab is unlikely to help hospitalized COVID-19 patients recover from a more advanced stage of disease.
The population being studied in the ACTIV-3 trial is different than the population authorized to use bamlanivimab under the EUA.
The EUA authorizes emergency use for the treatment of mild to moderate COVID-19 in non-hospitalized adult and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization, while the ACTIV-3 trial studied hospitalized patients with COVID-19. This EUA request was based on the interim results from Lillyâs BLAZE-1 clinical trial that includes non-hospitalized patients. The EUA limits the authorized use of bamlanivimab. Bamlanivimab is not authorized for use in patients who are hospitalized due to COVID-19, or who require oxygen therapy due to COVID-19, or who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.