Enlivex Therapeutics announced the first patient has been dosed in an investigator-initiated multi-center clinical trial of AllocetraTM in COVID-19 patients with severe illness and respiratory failures.
The clinical trial has been designed to assess Allocetra in combination with standard of care therapy in patients with COVID-19 associated lung dysfunction. Safety, tolerability, cytokine profile and efficacy parameters will be evaluated, with change in PaO2/FiO2 ratio number and severity of adverse events and serious adverse events serving as the co-primary study endpoints.
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The COVID-19 trial is scheduled to run independently of Enlivex’s currently planned Phase IIb clinical trial of Allocetra for the treatment of organ failures associated with sepsis. The planned Phase IIb trial will be a controlled, randomized study that is expected to commence in the fourth quarter of 2020.