Eli Lilly and Company said Monday it is moving into a Phase 3 clinical trial of its antibody treatment for Covid-19.
The Indianapolis-based pharmaceutical giant said that it plans to recruit 2,400 residents and staff at long-term care facilities for its trial.
Nursing home residents and staff are particularly vulnerable to severe forms of Covid-19. As of July 30, there have been nearly 63,000 deaths in long term care facilities, accounting for at least 44% of total deaths in 43 states, according to the Kaiser Family Foundation. That percentage is very likely an undercount.
In June, Lilly became the first company in the US to start testing an antibody therapy in humans. LY-CoV555, as it’s called, was created by Lilly in cooperation with AbCellera, from an antibody first identified in a blood sample taken from one of the first US patients to recover from Covid-19.
With this trial, the company will work with the National Institute of Allergy and Infectious Diseases and the Covid-19 Prevention Network to administer the therapy to residents and staff at several long-term care facilities that have had a recently diagnosed case of Covid-19.
The hope is that this antibody therapy will provide protection, and possibly ease symptoms for those who do get infected.
What are antibodies? Antibodies are proteins the immune system makes naturally to provide the body protection from a virus or toxin. Unlike with a vaccine -- which stimulates the body to make these protective antibodies over a couple of weeks -- a therapy like this delivers a lab-made antibody that provides protection instantly.
The protection doesn’t last as long as a vaccine would, but if it works, it could be given as a protective treatment every few months.
More about the trial: This trial will determine if a single dose reduces the rate of infection through four weeks. It will also determine if it can reduce complications from Covid-19 for eight weeks.
To help with the trial, Lilly has created custom-made mobile research units to assist long term care facilities conduct these studies. These units will be sent to long-term care facilities throughout the country and will bring a lab, clinical trial supplies and specialized staff on-site, creating an on location infusion clinic.
Lilly has two other ongoing trials in the US with LY-CoV555. The company has finished dosing hospitalized patients in a Phase 1 study, but it continues to follow up with those patients. A Phase 2 study involving people who have been recently diagnosed with Covid-19 is ongoing.
The company says the treatment so far has been “well tolerated” by patients, and there have been no drug-related severe adverse events. How well these therapies work is still to be determined.