The first patient has been enrolled in the iLeukPulm clinical trial, a randomized phase 2 study of inhaled Leukine (sargramostim, rhu-GM-CSF) in hospitalized COVID-19 patients with acute hypoxemia.

LEUKINE (sargramostim) is a recombinant human granulocyte-macrophage colony stimulating factor (rhuGM-CSF) that stimulates the differentiation, maturation and mobilization of cells involved in the innate and adaptive immune response. It has been shown to facilitate cellular signaling, epithelial repair and other critical processes that enhance the immune response and help defend the body against infection and cancer. The study is being conducted by Partner Therapeutics, Inc. (Lexington, MA, USA) which has acquired the rights to Leukine and will evaluate the safety and efficacy of sargramostim in combination with institutional standard of care on clinical outcomes in these patients.

The iLeukPulm study is supported by the US Department of Defense’s (DoD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), as part of a USD 35 million contract for the advanced development and emergency use of Leukine for COVID-19 treatment. The study is currently enrolling patients in the US and additional sites are expected to join the study in the coming weeks. In addition to the US study, Leukine is also being evaluated in clinical trials in Belgium and Singapore. The SARPAC study (Sargramostim in Patients with Acute Hypoxic Respiratory Failure and Acute COVID-19) in Belgium is a prospective, randomized, open-label controlled study designed to assess whether inhaled Leukine (sargramostim) can restore lung function and other clinical outcomes in COVID-19 patients experiencing acute hypoxemia. The Singapore trial is open to hospitalized patients with acute hypoxic respiratory failure due to COVID-19 who are randomized to receive Leukine intravenously.

“Prior research in patients with acute respiratory distress syndrome has shown that sargramostim administered intravenously is safe and associated with a trend toward a reduction in mortality. These findings provide strong support for clinical research to assess the safety and efficacy of sargramostim in the treatment of COVID-19 infection,” said Dr. Robert Paine, chief of the division of pulmonary medicine at the University of Utah and one of the principal investigators of the study. “I believe that administering sargramostim by inhalation as soon as patients are hospitalized and require oxygen due to COVID-19 could improve time to recovery, facilitate long-term healing of the lung, and reduce the need for invasive procedures such as mechanical ventilation.”

“Prior research in patients with acute respiratory distress syndrome has shown that sargramostim administered intravenously is safe and associated with a trend toward a reduction in mortality.1 These findings provide strong support for clinical research to assess the safety and efficacy of sargramostim in the treatment of COVID-19 infection,” added Dr. Paine. “I believe that administering sargramostim by inhalation as soon as patients are hospitalized and require oxygen due to COVID-19 could improve time to recovery, facilitate long-term healing of the lung, and reduce the need for invasive procedures such as mechanical ventilation.”

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