Capricor’s Phase 2 INSPIRE study will enroll patients who have a confirmed diagnosis of SARS-CoV-2 and require supplemental oxygen.
The INSPIRE trial is a randomized, double-blind, placebo-controlled study that will enroll up to 60 patients from multiple, geographically diverse trial sites across the United States. Patient participation will be a maximum of 13 weeks from screening.
The promise of CAP-1002 in COVID-19 is its immunomodulatory properties, which have been demonstrated in multiple clinical trials as well as in critically ill COVID-19 patients. Multiple published peer-reviewed studies of CDCs have demonstrated favorable modulation of various inflammatory cytokines and regulation of the immune response. The current understanding of COVID-19’s later stages are thought to be due to overstimulation of the immune system, which triggers a cytokine storm in which the body is overwhelmed with pro-inflammatory molecules. This immune response may become excessive and pathologic, inducing ARDS, multi-system organ failure and death.
Please visit ClinicalTrials.gov for more information regarding the INSPIRE clinical trial.