Following the news of Eli Lilly and Company initiating a Phase III trial for their monoclonal antibody, LY-CoV555, for the prevention of COVID-19 in nursing home residents;

Arafa Salam, PhD, Infectious Diseases Analyst at GlobalData, a leading data and analytics company offers her view:

“Although the use of mobile research facilities for clinical trials may seem like an innovative strategy, especially for targeting residents and staff in nursing homes, there may be a delay in trial recruitment. This may be due to recruitment only taking place when the mobile research facility is outside a particular site, rather than at the same time at multiple sites. In addition, there may be delays due to some residents not feeling comfortable with participating in a long and tedious trial. Therefore, there may be a disproportionate recruitment of more nursing home staff rather than residents being recruited.

“The BLAZE-2 is a Phase III trial being conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID). The trial is studying LY-CoV555 for the prevention of SARS-CoV-2 infection and COVID-19 infection in residents and staff in nursing homes in the US. LY-CoV555 is a potent neutralizing IgG1 monoclonal antibody administered intravenously for up to a potential of twelve weeks, the length used in the Phase II trial. Administering LY-CoV555 intravenously (IV) could also pose as a potential setback to recruitment as some residents may not feel comfortable with having IV infusions. Having an IV infusion may not be that much different from the resident having a vaccine for COVID-19 as both requires an injection administration, therefore if some residents may not be inclined to have a vaccine, they may not also want to have an IV infusion.

“Even though, upon the successful efficacy data for this trial, many lives could be saved, as more than 40% of all US COVID-19 related deaths involved nursing home residents and staff, the strategy of using mobile research facilities may prove difficult and may slow down recruitment as recruitment will only occur when the facility is on site. Moreover, some residents may not want to have an IV infusion.

“Other companies such as Regeneron Pharmaceuticals also have a candidate antibody cocktail for prophylactic treatment for COVID-19 known as REGN-COV2, which excludes recruiting nursing home residents. Therefore, although both candidate antibodies from Lilly and Regeneron are for preventative purposes against COVID-19, recruitment for Regeneron may be completed before Lilly’s Phase III trial due to having multiple study sites.”