News Release
Tuesday 13 April 2021
A clinical trial examining the safety and efficacy of a monoclonal antibody for the treatment of people suffering from respiratory diseases and low oxygen in the blood due to infection with SARS-CoV-2, the virus that causes COVID-19 tested. The Phase 2 trial, 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 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 airway fluid and which also circulates as a stand-alone protein. CD14 helps immune cells to recognize pathogens and injured or dying cells, warns the immune system of danger and causes it to react.
Research suggests that during SARS-CoV-2 infection in the lungs, CD14 greatly facilitates the later stages of the immune response to the virus, which could potentially lead to a hyperactive inflammatory response and a ‘cytokine storm’. Cytokines, proteins secreted by immune cells, affect the immune response. A cytokine storm is a severe immune response in which the body rapidly 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, which can result 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 can potentially temper the immune system’s damaging inflammatory responses to SARS-CoV-2, limiting tissue damage and improving the patient’s health outcomes. “Anthony S. Fauci, managing director of NIAID, said
The CaTT study will include between 300 and 350 COVID-19 patients aged 18 years or older in 10 to 15 nationwide hospitals. Volunteers will be randomly assigned to receive intravenous infusions of IC14 or placebo for four days. Neither the participants nor the study team will know until the end of the trial who will receive the monoclonal antibody or the placebo. All participants will also receive intravenous infusions of the antiviral inhibitor remdesivir for five consecutive days. The study team will follow participants for 60 days. Results are expected in early 2022.
The main aim of the CaTT study is to determine whether treatment with IC14 takes 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 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 diseases. If the results of the CaTT study are promising, 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, emeritus professor of medicine, in the Division of Lung, Critical Care. and sleep medicine at the University of Washington in Seattle. The NIAID-funded immune tolerance network provides operational support for the trial, for which the Coordination Center at Vanderbilt University in Nashville, Tennessee is based. Implicit Bioscience Ltd., Seattle and Brisbane, Australia, provide IC14 for the study, and Gilead Sciences, Inc., Foster City, California, provide brake design.
An independent Data and Safety Monitoring Board (DSMB) will review interim data from the trial to ensure patient well-being and safety as well as study integrity.
Further information on the CaTT study is available at ClinicalTrials.gov under study identifier NCT04391309.
NIAID conducts and supports research – at NIH, across the United States and worldwide – to study the causes of infectious and immune-mediated diseases, and to develop better ways to prevent, diagnose, and treat these diseases. News reports, fact sheets and other NIAID related material are available on the NIAID website.
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