U.S. announces clinical trial of antibody treatment for COVID-19
Aug 06 2020
The studies will also receive support through Operation Warp Speed, the White House initiative aimed at accelerating access to vaccines and treatments to fight COVID-19. Antibody treatments are more expensive and challenging to manufacture in bulk than traditional vaccines."The rapid spread of SARS-CoV-2 among residents of long-term care facilities combined with the higher mortality rate for the elderly creates the urgent need for therapies to prevent COVID-19 in this vulnerable population", said the company's statement, which noted that over 40% of Covid-19 deaths in the USA have been linked to long-term care homes.
The National Institutes of Health (NIH) said on Tuesday it would launch two trials to evaluate antibody COVID-19 drugs and follow these up with trials for other experimental therapies in patients with the disease.
On June 4, 2020, the US Centers for Medicare & Medicaid Services posted its first set of federal COVID-19 nursing home data on a new website.
It is launching the phase 3 trial in partnership with several long-term care facility networks across the country as well as the U.S. National Institute of Allergy and Infectious Diseases (NIAID). The study will enroll up to 2,400 participants across nursing homes who are either diagnosed with Covid-19 or at the risk of exposure. "We're excited to partner with Lilly to determine whether LY-CoV555 can prevent or mitigate progression of COVID-19 infection in this vulnerable population that has been greatly impacted by this virus".
To address the challenging aspects of running a clinical trial in a long-term care facility during a pandemic, Lilly created customized mobile research units to support the on-site study.
Lilly's drug, developed in collaboration with Canadian biotechnology company AbCellera Biologics Inc., was derived from the blood sample of one of the first Americans to recover from Covid-19 earlier this year. We are working on a drug very fast to stop the spread of corona virus.
To run the study, Lilly is using customized recreational vehicles to take the antibody and personnel to US nursing homes where a resident or staff member has been infected. The study will enroll patient volunteers now infected with SARS-CoV-2 who have mild to moderate disease but who are not hospitalized.
Daniel said that clinical trials are not easy in the current environment. The company hopes to have over 100,000 doses available by year-end, he said.