Safety and Efficacy Study of Two Doses of PRS CK STORM to Modulate the Cytokine Storm in ARDS Caused by SARS-Cov-2, Influenza A, Influenza B, and RSV

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of two doses (dose A and dose B) of PRS CK STORM, a conditioned medium from a co-culture of monocytes and fat-derived mesenchymal stromal cells, in treating acute respiratory distress syndrome (ARDS) caused by SARS-Cov-2, influenza A, influenza B, and respiratory syncytial virus (RSV). The trial aims to understand if these doses can modulate the cytokine storm associated with ARDS and compares their effects to a placebo. The study is a double-blind, randomized, phase I/II pilot trial involving hospitalized adults recently admitted (less than 3 days) who need oxygen therapy. Participants will be randomly assigned to receive either dose A, dose B of PRS CK STORM, or a placebo saline infusion. The dosing involves intravenous infusions given for 5 consecutive days. The trial consists of two parts: an initial sentinel group to assess short-term safety followed by a larger group for efficacy and long-term safety evaluation lasting up to 12 months. Participants will undergo multiple assessments including physical exams, vital signs monitoring, electrocardiograms, laboratory tests, and radiological imaging at specified intervals up to one year after treatment. Researchers will track adverse events, severity of ARDS, hospital and ICU stays, survival, and need for mechanical ventilation. The study includes both short-term safety follow-up (48 hours after last dose) and a long-term safety period lasting up to 48 weeks post-randomization.

Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm for the Treatment of Acute Respiratory Distress Syndrome (ARDS) Caused by SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV)