Press release
Tuesday, April 13, 2021
A clinical trial begins to test the safety and efficacy of a monoclonal antibody in research for the treatment of hospitalized people with respiratory diseases and low blood oxygen due to infection with SARS-CoV-2, the virus that causes COVID-19. The phase 2 trial, called the COVID-19 Anti-CD14 Treatment Test (CaTT), is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health. .
The laboratory-created monoclonal antibody, called IC14, binds to a human protein, CD14, which is found on the surface of immune cells circulating in the blood and airways and also circulating as to autonomic protein. CD14 helps immune cells recognize pathogens and injured or dying cells, alerting the immune system to danger and asking them to respond.
Research suggests that during SARS-CoV-2 infection in the lungs, CD14 expands the later stages of the immune response to the virus, which can lead to an overactive inflammatory response and a “cytokine storm.” Cytokines, proteins secreted by immune cells, influence the immune response. A cytokine storm is a serious immune reaction in which the body rapidly releases numerous cytokines into the blood and tissues. In patients with COVID-19, a storm of cytokines can lead to dangerous levels of inflammation and tissue damage to the lungs, which can lead to acute respiratory distress syndrome and respiratory failure.
“By blocking a protein called CD14 during the early stages of COVID-19 respiratory disease, the monoclonal antibody IC14 could temper the immune system’s harmful inflammatory responses to SARS-CoV-2, thus limiting the associated tissue damage and improving outcomes. patient health, ”said NIAID Director Anthony S. Fauci, MD
The CaTT study will enroll between 300 and 350 hospitalized COVID-19 patients aged 18 years or older in 10 to 15 locations nationwide. Volunteer participants will be randomly assigned to receive intravenous infusions of IC14 or a placebo for four days. Neither participants nor the study team will know who receives the monoclonal antibody or placebo until the end of the trial. All participants will also receive intravenous infusions of the antiviral drug remdesivir for five consecutive days. The study team will follow the participants for 60 days. Results are expected in early 2022.
The primary goal of the CaTT study is to determine whether treatment with IC14 decreases the time it takes for people with COVID-19 respiratory disease to recover so that they no longer need continued hospital care. Secondary objectives are to determine the safety of IC14 in the study population and the efficacy of the drug to reduce the severity of COVID-19 respiratory disease. If the results of the CaTT study are promising, then IC14 can be tested in a larger phase 3 efficacy trial.
Leading the CaTT study are protocol co-chairs Mark M. Wurfel, MD, Ph.D., professor of medicine, and Thomas R. Martin, MD, professor emeritus of medicine, in the Division of Lung Medicine, Critique and the University of Washington Dream in Seattle. The NIAID-funded immune tolerance network provides operational support for the test, for which the coordination center is headquartered at Vanderbilt University in Nashville, Tennessee. Default Bioscience Ltd. of Seattle and Brisbane (Australia) will provide IC14 for the study and Gilead Sciences, Inc. of Foster City, California, will provide remdesivir.
An independent data control and safety board (DSMB) will review the provisional trial data to ensure patient well-being and safety, as well as the integrity of the study.
You can learn more about the CaTT study at ClinicalTrials.gov with study identifier NCT04391309.
NIAID conducts and supports research — at NIH, throughout the United States, and around the world — to study the causes of infectious and mediated diseases by immunity and to develop better means to prevent, diagnose, and treat these diseases. Press releases, fact sheets and other NIAID related materials are available on the NIAID website.
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