News release
Tuesday, April 13, 2021
A clinical trial has begun to test the safety and efficacy of an investigational monoclonal antibody for the treatment of people hospitalized with respiratory disease and low blood oxygen levels due to infection with SARS-CoV-2, the virus that causes COVID-19 has started. The phase 2 study, called the COVID-19 Anti-CD14 Treatment Trial (CaTT), is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The lab-made monoclonal antibody, called IC14, binds to a human protein, CD14, found on the surface of immune cells circulating in the blood and respiratory fluid and also circulating as a protein on its own. CD14 helps immune cells recognize pathogens and damaged or dying cells, alert the immune system to danger, and prompt it to respond.
Research suggests that during SARS-CoV-2 infection in the lungs, CD14 over-amplifies the later stages of the immune response to the virus, potentially leading to a hyperactive inflammatory response and a “cytokine rush.” Cytokines, proteins secreted by immune cells, affect the immune response. A cytokine rush is a severe immune response in which the body quickly releases numerous cytokines into the blood and tissues. In COVID-19 patients, a cytokine storm can cause dangerous levels of inflammation and tissue damage in the lungs, resulting in 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 may be able to dampen the immune system’s damaging inflammatory responses to SARS-CoV-2, limiting associated tissue damage and improving the health outcomes of the immune system. patient. ”said NIAID director Anthony S. Fauci, MD
In the CaTT trial, between 300 and 350 COVID-19 patients 18 years of age or older will be hospitalized at 10 to 15 locations across the country. Volunteer participants will be randomly assigned to receive intravenous infusions of either IC14 or placebo for four days. Neither the participants nor the study team will know who is receiving the monoclonal antibody or the 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 main goal of the CaTT study is to determine whether treatment with IC14 shortens the time it takes for people with COVID-19 respiratory disease to recover, so that they no longer need ongoing medical care in the hospital. Secondary goals are to determine the safety of IC14 in the study population and the efficacy of the drug in reducing the severity of COVID-19 respiratory disease. If the results of the CaTT trial are promising, IC14 can be tested in a larger phase 3 efficacy trial.
The CaTT study is led by protocol co-chairs Mark M. Wurfel, MD, Ph.D., professor of medicine, and Thomas R. Martin, MD, professor emeritus of medicine, in the department of pulmonary, critical care and sleep medicine at University of Washington in Seattle . The NIAID-funded Immune Tolerance Network provides operational support for the trial, for which the coordination center is located at Vanderbilt University in Nashville, Tennessee. Implicit Bioscience Ltd. from Seattle and Brisbane, Australia will provide IC14 for the study, and Gilead Sciences, Inc. from Foster City, California will supply remdesivir.
An independent Data and Safety Monitoring Board (DSMB) will review interim data from the study to ensure patient well-being and safety and the integrity of the study.
More information about the CaTT study is available at ClinicalTrials.gov under Study ID NCT04391309.
NIAID conducts and supports research – at NIH, in the United States and worldwide – to study the causes of infectious and immune-mediated diseases and to develop better means to prevent, diagnose and treat these diseases. News releases, fact sheets and other NIAID-related material are available on the NIAID website.
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