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)

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 intravenous drug to modulate SIRS-associated cytokine storm caused by SARS-Cov-2, influenza A, influenza B and RSV 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 with SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV?

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 modulating the cytokine storm for the treatment of SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV. In addition, the anti-inflammatory and pro-inflammatory cytokine profiles after treatment PRS CK STORM compared to placebo group in these participants will be also studied.

Conditions

• SARS-CoV-2
• Influenza, Human
• Respiratory Syncytial Virus Infections
• Respiratory Distress Syndrome
• Systemic Inflammatory Response Syndrome

Interventions

DRUG

Placebo comparator

2 vials of saline solution 0.9% for infusion

DRUG

PRS CK STORM

1 vial of PRS CK STORM (dose A) and 1 vial of placebo for infusion

DRUG

PRS CK STORM

2 vials of PRS CK STORM (dose B) for infusion.

Sponsors & Collaborators

• PEACHES BIOTECH

  lead INDUSTRY

Principal Investigators

• David Bernal, Dr. · Hospital Universitario de Fuenlabrada

• Guillermo Soria Fernández-Llamazares, Dr · Hospital Universitario de Fuenlabrada

• José Sanz Moreno, Dr · Hospital Universitario Príncipe de Asturias

• Ángela Cano Yuste, Dr · Hospital Universitario Reina Sofia de Cordoba

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-02

Primary Completion

2026-10-02

Completion

2026-10-02

Countries

• Spain

Study Locations