Dartmouth-Hitchcock Joins Clinical Trial for New COVID-19 Drug
Dartmouth-Hitchcock (D-H) is one of the first academic medical centers selected for a new FDA-approved national Phase 3 study of a drug with the potential to treat patients in the hospital with COVID-19 pneumonia. Lenzilumab is a monoclonal antibody that could prevent the severity of COVID-19-associated pneumonia from progressing to respiratory failure or death.
The primary objective is to assess whether the use of lenzilumab, alongside current standard of care practices, can alleviate the immune-mediated Cytokine Release Syndrome and reduce the need for invasive mechanical ventilation and the number of deaths. The study is aimed toward people with COVID-19 pneumonia upon hospitalization who have biomarkers indicating they are at high risk of disease progression. A total of 238 patients from medical centers nationwide will be randomized to receive lenzilumab or a placebo in a 1:1 ratio.
“This Humanigen study is an important complement to the studies we already have here,” says D-H Principal Investigator Richard Zuckerman, MD, MPH, of D-H’s Section of Infectious Disease and International Health. “First, we have the option of remdesivir as an antiviral, but this will not prevent many cases of progression to more severe disease from COVID-19 that is driven by immune activation, which is the part of this infection that makes people very sick. So, we opted to pursue the Humanigen product because it is attempting to prevent the immune cytokine storm and reduce the need for mechanical ventilation, which has been shown to be associated with more prolonged stays in the hospital and physical weakness.”
D-H completed site preparation to join the study in eight days—an unprecedented period from planning to initiation. The remarkable turnaround is a testament to the agility of the clinical research teams involved. Participation has required focused efforts from all stakeholders, including operational efforts, health system support and efficiencies, key clinician partnerships, as well as national partnerships.
D-H is one of the most rural locations engaged in this level of scientific research addressing the COVID-19 pandemic. Regional clinical partners and patients have expressed gratitude in knowing that D-H has made these clinical trials available to our patients.
If successful, this clinical trial may lead to FDA approval of lenzilumab for COVID-19. “Adding this potential treatment to our portfolio gives us the ability to address the many phases of COVID-19,” says Zuckerman.
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-H provides access to more than 2,400 providers in almost every area of medicine, delivering care at its flagship hospital, Dartmouth-Hitchcock Medical Center (DHMC) in Lebanon, NH. DHMC was named in 2019 as the #1 hospital in New Hampshire by U.S. News & World Report, and recognized for high performance in 13 clinical specialties and procedures. Dartmouth-Hitchcock Health also includes the Norris Cotton Cancer Center, one of only 51 NCI-designated Comprehensive Cancer Centers in the nation; the Children's Hospital at Dartmouth-Hitchcock, the state’s only children’s hospital; affiliated 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-H 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.