Sarasota Memorial Hospital Joins Coronavirus Antibody Drug Study

SARASOTA, FL — Sarasota Memorial Hospital has a new experimental treatment in its arsenal to try to reduce the inflammatory response in some patients hospitalized with severe coronavirus, according to a news release from the hospital system.

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

IC14 targets an immune system protein called CD14, which helps immune cells detect and fight bacteria, viruses or other pathogens that attack human cells, the hospital said. CD14 also has the unusual ability to amplify the body’s inflammatory responses in a variety of sites, however, and in a viral disease such as COVID-19, it can trigger excessive inflammation — called a “cytokine storm” — that quickly can lead 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 Dr. Kirk Voelker, 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.”

Like what you're reading? Invite a friend to subscribe to free Sarasota newsletters and real-time email alerts.

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 four 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, SMH said. The main goal of the study is to determine whether IC14 decreases the time it takes people with COVID-19 respiratory disease to recover and whether they spend less time receiving medical care in a hospital. Results from the trial are expected in early 2022.

On Monday, SMH became the first U.S. site 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 seven days of screening, require oxygen support and meet other clinical criteria, the hospital said.

Sarasota Memorial’s Clinical Research Center has participated in other COVID-19 clinical trials, including studies testing Regeneron Pharmaceuticals' REGN-CoV-2 antibody cocktail. It was tested as a therapy for patients with COVID-19, as well as a treatment to prevent infection in healthy adults exposed to the virus, SMH said. These monoclonal antibody treatments are now available for use outside of clinical trials.

For more information about any of the hospital’s coronavirus clinical trials, call 941-917-2225 Monday through Friday between 8 a.m. and 3 p.m.