Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Prevention of COVID-19-Associated Cytokine Storm

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2024
The purpose of this clinical trial is to evaluate the safety and tolerability of two doses (dose A and dose B) of Standardized Conditioned Medium Obtained by Coculture of Monocytes and Mesenchymal Stromal Cells (PRS CK STORM) in the prevention of COVID-19-associated cytokine storm in participants with a confirmed diagnosis of SARS-CoV-2 infection, recently hospitalized (less than 3 days) and who have had symptoms for up to a maximum of 10 days prior to screening. The main questions it aims to answer are: * Are both doses of PRS CK STORM (dose A and dose B) safe as an intravenous drug to prevent and treat inflammatory processes, such as the cytokine storm associated with severe infectious processes, including COVID-19? * Are both doses of PRS CK STORM (dose A and dose B) effective as an intravenous drug to prevent COVID-19 associated cytokine storm compared to the control group? * What are the anti-inflammatory and pro-inflammatory cytokine profiles after treatment with two different doses of PRS CK STORM in participants hospitalized for COVID-19 classified with mild disease severity according to the World Health Organization (WHO) Clinical Progression Scale? Researchers will compare both doses of PRS CK STORM with the control group to test whether the anti-inflammatory action of PRS CK STORM is safe and effective in treating inflammatory processes, such as the cytokine storm associated with severe infectious processes, including COVID-19. In addition, the anti-inflammatory and pro-inflammatory cytokine profiles after treatment PRS CK STORM compared to placebo group in COVID-19 participants will be also studied.
Epistemonikos ID: f1affebd83fa51268262b5b50d6f1936afe86bd6
First added on: Apr 17, 2025