SMH Joins Drug Study to Reduce Dangerous Inflammation in COVID-19 Patients

April 16, 2021 – Sarasota

Sarasota Memorial Hospital has a new experimental treatment in its arsenal to try to dampen the deadly inflammatory response in some patients hospitalized with severe COVID-19.

SMH is one of more than a dozen research sites across the nation participating in the multi-center trial of IC14, an anti-CD14 monoclonal antibody drug researchers hope will reduce dangerous levels of inflammation in COVID-19 patients.

IC14 targets an immune system protein called CD14, which helps immune cells detect and fight bacteria, viruses or other pathogens that attack human cells. CD14, however, has the unusual ability to amplify the body’s inflammatory responses in a variety of sites, and in a viral disease such as COVID-19, trigger excessive inflammation – called a “cytokine storm” – that quickly can cascade to multiple organ failure and death.

“We have good experimental treatments that help reduce the viral load in the early phase of COVID, but once the inflammatory response kicks in, it can intensify like wildfire, with devastating results,” said critical care pulmonologist Kirk Voelker, MD, who serves as medical director of Sarasota Memorial’s Clinical Research Center and is the principal investigator at the SMH site. “This anti-CD14 monoclonal antibody works at the beginning of the inflammatory cascade, and we hope will stop the cytokine storm from gaining momentum.”

Sponsored and funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, the randomized, double-blind, placebo-controlled study will enroll between 300 and 350 hospitalized adults over the next several months – over the course of 4 days, half of the patients will receive the IC14 monoclonal antibody and half a placebo. All participants also will receive standard medical care, including antiviral therapy with remdesivir. The main goal of the study is to determine whether treatment with IC14 decreases the time it takes people with COVID-19 respiratory disease to recover such that they no longer need ongoing medical care in the hospital. Results are expected in early 2022.

On Monday, SMH was the first site nationally to enroll a patient in the phase 2 trial, called the COVID-19 anti-CD14 Treatment Trial (CaTT). To be eligible, study participants must be hospitalized with COVID-19, have had a positive PCR test result for the novel coronavirus within 7 days of screening, require oxygen support and meet other clinical criteria. For information about this and other COVID-19 clinical trials available through Sarasota Memorial’s Clinical Research Center, call 941-917-2225 Monday-Friday (8am-3pm).