A phase two trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has begun to investigate the safety and efficacy of IC14, a lab-created monoclonal antibody meant to treat the respiratory troubles of COVID-19.
The name of the trial, the COVID-19 anti-CD14 Treatment Trial (CaTT), refers to how IC14 operates. It binds to a human protein known as CD14. Found circulating as a stand-alone protein, as well as in the blood and airway fluid, CD14 helps immune cells recognize pathogens and injured cells, acting as an alarm for the immune system. However, SARS-CoV-2 infection can cause it to go into overdrive, spurring a dangerous hyperactive inflammatory response that can lead to dangerous inflammation and tissue damage in the lungs, and even respiratory failure.
“By blocking a protein called CD14 during the early stages of COVID-19 respiratory disease, the monoclonal antibody IC14 could potentially temper the immune system’s harmful inflammatory responses to SARS-CoV-2, thereby limiting associated tissue damage and improving patients’ health outcomes,” Dr. Anthony S. Fauci, NIAID director, said.
The blinded CaTT study will take on between 300 and 350 adult patients from 10-15 sites nationwide. They will either be given IC14 or a placebo for four days, but all participants will also receive intravenous infusions of the antiviral drug remdesivir for five consecutive days. The study will continue for 60 days, with results expected to follow next year. Scientists hope that IC14 could help those afflicted with COVID-19 respiratory disease to recover enough to no longer require hospital care.
If the antibody passes muster and is both safe and effective at reducing the severity of COVID-19 respiratory disease, it could be tested in a larger phase three efficacy trial. An independent data and safety monitoring board will oversee the study’s safety and integrity.