November 24, 2020 -- Capricor Therapeutics has begun a phase II trial of its CAP-1002 cell therapy for patients with severe COVID-19 disease.
Two patients have received the therapy, which consists of allogeneic cardiosphere-derived cells, according to the firm. The phase II double-blind, placebo-controlled study, called Inspire, is now enrolling people diagnosed with COVID-19 who need supplemental oxygen; it will eventually include up to 60 patients.
The primary objectives of the study are to determine the safety and effectiveness of IV infused CAP-1002 for improving clinical outcomes in severe to critical patients with COVID-19. Patients will either receive CAP-1002 or placebo (1:1 ratio) and undergo baseline safety and efficacy assessments prior to administration.
CAP-1002 targets cardiac dysfunction and may be useful for treating cardiac complications of the illness, the company said.