The Eli Lilly pharmaceutical company recently announced that it is starting a late-stage trial, involving 2,400 participants (residents and staff) in nursing homes, to study whether an experimental COVID-19 antibody treatment can prevent the virus’ spread in residents and staff.
The company has been testing the drug in hospitals to determine if it will perform as a treatment for patients with COVID-19. This new phase 3 trial is to test whether the drug (LY-CoV555) will work prophylactically to prevent the disease.
The new trial is being performed in partnership with several long-term care facility networks nationwide and the U.S. National Institute of Allergy and Infectious Diseases (NIAID).
Lilly has created mobile research units that include retrofitted recreational vehicles capable of being used to respond to outbreaks of the Coronavirus in nursing homes across the country.
The drug (LY-CoV555) belongs to a class of treatments known as monoclonal antibodies that are among the most widely used biotechnology medicines. Regeneron Pharmaceuticals Inc. and other pharmaceutical companies are also testing similar treatments against COVID-19.
Compliance Perspective
Facilities participating in trials to test experimental treatments/drugs for COVID-19 should ensure that residents, their families, and representatives are aware and approve of the resident’s participation in any experimental study regarding COVID-19 to ensure compliance with state and federal regulations regarding residents’ rights to be informed about and to make treatment decisions.
Discussion Points:
- Review policies and procedures regarding the appropriate measures to take for ensuring that residents’ rights are protected regarding participation in a trial of experimental drugs.
- Train staff regarding residents’ rights to be informed and make treatment decisions, including F578 – the right to participate in or refuse to participate in experimental research.
- Periodically audit to ensure that residents, their families, and their representatives are advised and approve of their participation in any trials for testing COVID-19 treatments.
