Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokin
The purpose of this clinical trial is to evaluate the safety, tolerability and efficacy of two doses (dose A and dose B) of Standardized Conditioned Medium Obtained by Coculture of M2-macrophages and fat-derived Mesenchymal Stromal Cells (PRS CK STORM) in the modulation of the cytokine storm in participants with acute
| Condition(s) | SARS-CoV-2, Influenza, Human, Respiratory Syncytial Virus Infections, Respiratory Distress Syndrome, Systemic Inflammatory Response Syndrome |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | The purpose of this clinical trial is to evaluate the safety, tolerability and efficacy of two doses (dose A and dose B) of Standardized Conditioned Medium Obtained by Coculture of M2-macrophages and fat-derived Mesenchymal Stromal Cells (PRS CK STORM) in the modulation of the cytokine storm in participants with acute respiratory infection caused by SARS-Cov-2, influenza A, influenza B and respiratory syncytial virus (RSV) in need for oxygen therapy. 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 modulate inflammatory processes, such as the cytokine storm in participants with SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV? * Are both doses of PRS CK STORM (dose A and dose B) effective as an intraven |
| Who can participate | Inclusion Criteria: 1. Signed informed consent by the participant or legal representative prior to the initiation of any study-specific procedure. 2. Males and females aged ≥ 18 years old at the time of the consent. 3. Confirmed diagnosis of SARS-CoV-2, influenza virus A, influenza virus B or RSV pneumonia by positive RT-PCR (results of a PCR prior to screening will be valid only if the PCR has been done for all 4 viruses and in 3 days prior to the screening visit). PCR will include the analysis of SARS-Cov-2, influenza A, influenza B and RSV. 4. Diagnosis of systemic inflammatory response syndrome (SIRS), defined by the satisfaction of any two of the criteria below: 1. Body temperature over 38 ºC or under 36 ºC. 2. Heart rate greater than 90 beats/minute. 3. Respiratory rate higher than 2 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | PEACHES BIOTECH |
| Locations | Alcalá de Henares, Madrid, Spain; Fuenlabrada, Madrid, Spain; Córdoba, Spain |
| Start date | 2024-10-02 |
| NCT ID | NCT06684379 |
| Official listing | https://clinicaltrials.gov/study/NCT06684379 |