US, WASHINGTON (ORDO NEWS) — Temple University Hospital treated the first patient in the United States as part of the BREATHE clinical trial. In it, scientists evaluate the effect of intravenous treatment with gimsilumab on mortality in patients with Covid-19 and acute respiratory distress syndrome (ARDS). The clinic reported this on its website.
Many Covid-19 patients experience an overactive immune response that leads to lung damage, ARDS, and ultimately death. ARDS is a life-threatening inflammatory damage to the lungs characterized by a lack of oxygen in the tissues and diffuse infiltration. It requires hospitalization and mechanical ventilation, and even with medical care provided by all standards, including mechanical ventilation, the overall mortality rate is 41%.
Gimsilumab is a fully human monoclonal antibody targeted at granulocyte macrophage colony stimulating factor (GM-CSF), which is believed to be a key factor in pulmonary hyperinflammation. Scientists have suggested that GM-CSF makes a significant contribution to the immunopathology caused by coronavirus in patients with ARDS or the risk of its development.
Such conclusions were made on the basis of previous data obtained at the preclinical stage of testing (conducted on model animals) and when monitoring the course of the disease in patients with Covid-19. In particular, it was found that GM-CSF is activated in the serum of Chinese patients with coronavirus.
The researchers conducted an adaptive, randomized, double-blind, placebo-controlled study including a planned interim analysis. “Emerging evidence suggests that GM-CSF may contribute to the clinical deterioration of Covid-19 patients,” explains Dr. Gerard J. Criner, professor of thoracic medicine and Surgery at the Medical School. Lewis Katz at Temple University and director of the Temple Light Center. “We are proud to be participating in a clinical trial of gimsilumab in this vulnerable patient population.”
Gimsilumab has been tested in numerous non-clinical studies and two previous clinical studies, including a four-week phase 1 study in healthy volunteers. He demonstrated a favorable safety and portability profile based on the data collected to date.
A multidisciplinary clinical study will include up to 270 patients with a confirmed diagnosis of Covid-19 and clinical signs of acute lung damage or ARDS. Subjects will be randomized 1: 1 to receive either gimsilumab or placebo. The primary endpoint of the study is mortality by day 43. Key secondary endpoints include the frequency and duration of mechanical ventilation during the study, the number of days in the intensive care unit, and the length of hospital stay.
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