WASHINGTON (Pakistan Point News / Sputnik - 14th April, 2021) The US began a phase 2 trial of a new COVID-19 treatment for hospitalized patients using monoclonal antibodies that prevent inflammation and tissue damage during advanced stages of the disease, the National Institutes of Health (NIH) said on Tuesday.
"The laboratory-created monoclonal antibody, called IC14, binds to a human protein, CD14, that is found on the surface of immune cells circulating in the blood and airway fluid," NIH said in a press release. "CD14 helps immune cells recognize pathogens and injured or dying cells, alerting the immune system to danger and prompting it to respond."
The study will involve between 300 and 350 hospitalized COVID-19 patients aged 18 years or older at 10 to 15 sites nationwide. Volunteer participants will be assigned at random to receive intravenous infusions of either IC14 or a placebo for four days, the release said.
The antibody treatment blocks the CD14 protein, which in the late stages of the disease can cause the immune system to overreact in what is known as a cytokine storm - a development that can generate dangerous levels of inflammation and tissue damage in the lungs, leading to respiratory failure and death.
The study will attempt to gauge the safety of the treatment and determine whether the therapy decreases the time needed for patients to recover. If successful, IC14 will be subjected to a larger phase 3 efficacy trial. Success in phase 3 trials would lead to emergency use authorization by the food and Drug Administration.