Pilot Study Evaluating Two Intravenous Doses of PRS CK STORM to Modulate Cytokine Storm in Adults With Severe Respiratory Infections Caused by SARS-CoV-2, Influenza AB, or RSV

What this Trial Is About

Researchers are evaluating two doses of a drug called PRS CK STORM to see if it is safe and effective in treating the cytokine storm that can occur in adults with severe respiratory infections caused by viruses like SARS-CoV-2, influenza A, influenza B, and RSV. This study is a phase III randomized, double-blind clinical trial aiming to compare two doses of PRS CK STORM with a placebo to understand their impact on inflammation and cytokine levels in participants needing oxygen therapy. Participants will receive either dose A or dose B of PRS CK STORM or a placebo through intravenous infusion for 5 consecutive days. The study is divided into two parts an initial small sentinel group where doses are tested sequentially with safety checks after initial dosing, followed by a larger group randomized to one of the three arms. All participants receive standard care for their viral infection. After treatment, participants undergo short-term safety follow-up for 48 hours and long-term follow-up for up to one year. During the study, participants will have regular assessments including physical exams, vital sign monitoring, lab tests, ECGs, and chest imaging at multiple time points up to one year. Researchers will track adverse events, severity of hypoxemia, hospital and ICU stays, survival, and need for mechanical ventilation. The total duration of participation is about 12 months, including screening, treatment, and follow-up periods to evaluate safety, tolerability, and efficacy of the study drug doses compared to placebo.

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