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In 2 prior clinical studies, gimsilumab demonstrated favorable results in treating the novel coronavirus.
Temple University Hospital has treated its first patient with the novel coronavirus disease 2019 (COVID-19) in their clinical study evaluating gimsilumab for treatment of severe symptoms, according to a press release.1
The BREATHE clinical trial will analyze the effect of administering intravenous gimsilumab on mortality for individuals with COVID-19 and acute respiratory distress syndrome (ARDS).1
COVID-19 is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Confirmed case numbers have surpassed 2 million globally, and 639,000 in the United States.2 Individuals with severe COVID-19 symptoms experience an overactive immune response, which causes lung injury, ARDS, and death. ARDS is a life-threatening inflammatory lung injury requiring hospitalization and ventilation and characterized by a lack of oxygen to the tissue and stiff lungs; ARDS mortality rate is 41%.1
Gimsilumab is a fully monoclonal antibody targeting granulocyte macrophage-colony stimulating factor (GM-CSF); research has shown that GM-CSF is a key driver of lung hyperinflammation. In SARS-CoV-1 animal testing and recently emerging COVID-19 trials from China, data showed that GM-CSF contributes to the immunopathology caused by SARS-CoV-2 infection in patients with or at risk of contracting ARDS. Studies in China also found that GM-CSF was up-regulated in the serum of patients with COVID-19.1
The randomized, double-blind, placebo-controlled, multicenter trial will enroll up to 270 individuals with confirmed COVID-19 cases and clinical evidence of severe lung injury or ARDS. Patients will be randomized 1:1, receiving either gimsilumab or placebo.1
The primary endpoint of the clinical trials is to evaluate the incidence of mortality by day 43; significant secondary endpoints include usage and duration of mechanical ventilation, the number of days in intensive care, as well as the number of days of inpatient hospitalization.1
“Emerging evidence suggests that GM-CSF may contribute to clinical worsening in COVID-19,” principal investigator Gerard J. Criner, MD, FACP, FACCP, chair and professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University and director of the Temple Lung Cancer Center, said in the press release.1 “We are proud to participate in this clinical trial testing gimsilumab in this vulnerable patient population.”
1. Temple Treats First Patient in the U.S. in Clinical Trial of Gimsilumab for Patients with COVID-19 and Acute Respiratory Distress Syndrome. News Release. Temple Health; April 15, 2020. Accessed April 16, 2020. https://www.templehealth.org/about/news/temple-university-hospital-treats-first-patient-in-the-us-in-clinical-trial-of-gimsilumab-for-patients-with-covid-19-and-acute-respiratory-distress-syndrome
2. Coronavirus Resource Center. Johns Hopkins University & Medicine Accessed April 16, 2020..https://coronavirus.jhu.edu/map.html.