Partner Therapeutics has enrolled the first subject in the Phase II SCOPE trial of inhaled Leukine (sargramostim) in non-hospitalised Covid-19 patients who are at higher risk of progression to severe disease.
The FDA-approved Leukine is a yeast-derived recombinant human granulocyte-macrophage colony-stimulating factor.
The randomised, placebo-controlled, double-blind trial will assess the role of Leukine in lowering progression and the need for hospitalisation in Covid-19 patients.
It will enrol approximately 400 subjects in various sites in the US and Latin and South America, with expansion of the trial planned to more countries.
The primary endpoints of the trial will be Covid-19-related emergency room visit, hospitalisation, or death.
University of Utah Division of Pulmonary Medicine and Critical Care Medicine chief and principal investigator of SCOPE trial Dr Robert Paine said: “Prior research in patients with acute respiratory distress syndrome has shown that Leukine is safe and associated with a trend toward a reduction in mortality.
“I believe that administering Leukine by inhalation as early as possible in the course of the illness has important potential to reduce progression, reduce the need for invasive procedures such as mechanical ventilation, and hasten recovery.”
Partner Therapeutics commenced a study in August last year to analyse the efficacy of Leukine in hospitalised Covid-19 patients needing oxygen. The results from the trial, which has concluded enrolment in February, are anticipated in the coming weeks.
In another development, the University of Pittsburgh has granted three multi-centre research contracts to Versiti to coordinate clinical trials in the US to establish optimal treatment plans for preventing blood clots in Covid-19 patients.
The funding is provided by the US National Institutes of Health (NIH).
These NIH-managed research projects are called Accelerating COVID-19 Therapeutic Interventions and Vaccines-4 (ACTIV-4) Antithrombotics.
As the coordinating centre for VENUS, Versiti is conducting ACTIV-4A study in hospitalised Covid-19 patients, ACTIV-4B in patients who are not hospitalised, and ACTIV-4C in patients discharged from the hospital.