This trial involved an incredible amount of cooperation across hospital staff, from clinical care teams to research operations to nursing, and of course, it would not have been possible without our patients who were willing to participate.Richard A. Zuckerman, MD, MPH
A drug that was studied at Dartmouth-Hitchcock Medical Center (DHMC) for treating severe COVID-19 has shown to be highly effective at preventing COVID-19 patients from needing to be put on a ventilator. Lenzilumab, made by the biopharmaceutical company Humanigen, Inc., works by preventing and treating an immune hyper-response called the “cytokine storm,” a life-threatening, systemic inflammatory response in the body. Trial results showed that patients who received lenzilumab and other treatments, including steroids and/or remdesivir, had a 54 percent greater relative likelihood of survival without the need for a ventilator. DHMC was the only hospital in New England to be part of the lenzilumab trial, and only one of 18 participating sites nationally
“DHMC was part of the lenzilumab trial from the beginning, which means we were able to offer our COVID-19 patients access to some of the most cutting-edge treatments available throughout the pandemic,” said Richard A. Zuckerman, MD, MPH, an infectious disease and international health physician at DHMC who served as co-primary investigator with Clinical Pharmacology Section Chief Lionel D. Lewis, MD, in DHMC’s lenzilumab trial. “This trial involved an incredible amount of cooperation across hospital staff, from clinical care teams to research operations to nursing, and of course, it would not have been possible without our patients who were willing to participate. Because of their efforts, this therapy could prevent a significant number of COVID-19 patients from progressing to needing a ventilator, which complicates recovery immensely.”
The primary objective of the randomized, double-blind, placebo-controlled, multi-center trial was to assess whether lenzilumab, in addition to other treatments, which included dexamethasone or other steroids, and/or remdesivir, could alleviate the cytokine storm and improve ventilator-free survival. The study significantly improved patient outcomes. Lenzilumab appeared to be safe and well-tolerated in patients, and the drug is expected to be reviewed soon by the Food and Drug Administration (FDA) for treatment of COVID-19, Zuckerman said.
“The results from our Phase 3 clinical trial with lenzilumab treatment were associated with better outcomes in hospitalized hypoxic COVID-19 patients who had not yet progressed to the point of requiring a ventilator,” said Cameron Durrant, MD, MBA, Chief Executive Officer of Humanigen. “Additionally, the trial incorporated a diverse population with various comorbidities, most commonly a body mass index above 30, which is representative of a real-world, high-risk population. Our next step is to submit an application for emergency use authorization to the FDA as soon as possible. We are also sharing these results with U.S. governmental agencies and other authorities worldwide.”
“Conducting this trial in the midst of a worldwide pandemic was no easy feat, but such times demonstrate how important medical research is to ensure we can advance medical care in a safe way for all patients,” Zuckerman said.
About Dartmouth-Hitchcock Health
Dartmouth-Hitchcock Health (D-HH), New Hampshire’s only academic health system and the state’s largest private employer, serves a population of 1.9 million across northern New England. D-HH provides access to more than 2,000 providers in almost every area of medicine, delivering care at its flagship hospital, Dartmouth-Hitchcock Medical Center (DHMC) in Lebanon, NH. DHMC was named again in 2020 as the #1 hospital in New Hampshire by U.S. News & World Report, and recognized for high performance in 9 clinical specialties and procedures. Dartmouth-Hitchcock Health includes the Norris Cotton Cancer Center, one of only 51 NCI-designated Comprehensive Cancer Centers in the nation; Children's Hospital at Dartmouth-Hitchcock, the state’s only children’s hospital; member hospitals in Lebanon, Keene, and New London, NH, and Windsor, VT, and Visiting Nurse and Hospice for Vermont and New Hampshire; and 24 Dartmouth-Hitchcock clinics that provide ambulatory services across New Hampshire and Vermont. The D-HH system trains nearly 400 residents and fellows annually, and performs world-class research, in partnership with the Geisel School of Medicine at Dartmouth and the White River Junction VA Medical Center in White River Junction, VT.