Dartmouth-Hitchcock is one of the first academic medical centers 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 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 Principal Investigator Richard Zuckerman, MD, 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.
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.