Dartmouth-Hitchcock (D-H) in Lebanon is one of the first academic medical centers studying a new FDA-approved drug with the potential to treat COVID-19 patients hospitalized pneumonia. Lenzilumab is a monoclonal antibody that could prevent COVID-19 pneumonia from progressing to respiratory failure or death.
The primary objective is to assess whether the use of lenzilumab, alongside standard 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 those who have biomarkers indicating they are at high risk of disease progression. A total of 238 patients from medical centers nationwide will be chosen at random to receive either lenzilumab or a placebo.
“This Humanigen study is an important complement to the studies we already have here,” said 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 turnaround is a testament to the agility of the clinical research teams involved in this time of crisis. 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 among the most rural locations engaged in this level of scientific research addressing COVID-19. 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,” said Zuckerman.