Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06684379

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)

Led by PEACHES BIOTECH · Updated on 2025-08-07

50

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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 Monocytes and fat-derived Mesenchymal Stromal Cells (PRS CK STORM) in the modulation of the cytokine storm for the treatment of the acute respiratory distress syndrome (ARDS) caused by SARS-Cov-2, influenza A, influenza B and respiratory syncytial virus (RSV) in recently hospitalized participants (less than 3 days) 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 for the treatment of ARDS 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 ARDS-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 hospitalized for ARDS 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 ARDS 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

Official Title

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)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent by the patient or legal representative prior to any study procedures
  • Male or female aged 18 years or older at consent
  • Hospitalized with ARDS diagnosed by Berlin criteria
  • Confirmed SARS-CoV-2, influenza A, influenza B, or RSV pneumonia by positive RT-PCR within 3 days before screening
  • Diagnosis of systemic inflammatory response syndrome (SIRS) with at least two of the following: body temperature over 38°C or under 36°C, heart rate over 90 beats/min, respiratory rate over 20 breaths/min or PaCO2 under 32 mmHg, leukocyte count over 12000/μL, under 4000/μL, or over 10% immature forms
  • Requires oxygen therapy
  • Hospitalized or admitted less than 3 days and symptoms present for up to 10 days before screening
  • Female participants must be surgically sterilized, at least 1 year postmenopausal (with FSH confirmation if under 54), or using adequate birth control or sexual abstinence; male participants must agree to use barrier contraception for 90 days after last treatment
Not Eligible

You will not qualify if you...

  • Unable to perform screening or baseline examinations
  • Body mass index (BMI) of 35 or higher
  • Irreversible critical condition
  • Active autoimmune diseases or severe immunosuppression
  • Clinically significant advanced or unstable disease affecting study assessments, including liver function abnormalities (AST, ALT more than 3 times upper limit, bilirubin ≥2 mg/dL except Gilbert syndrome), renal insufficiency (creatinine >2 mg/dL and clearance <60), recent myocardial infarction, unstable angina, heart failure within 3 months, bradycardia (<50 bpm), atrioventricular block (type II or III), congenital long QT syndrome, sinus node dysfunction, prolonged QTcF interval
  • Uncontrolled diabetes mellitus (blood glucose >500 mg/dL) at admission
  • Malignant tumors within last 5 years except certain skin cancers or indolent prostate cancer
  • Metastases
  • HIV, hepatitis B or C infection detected by specific tests
  • Other serious active viral infections requiring specific antimicrobial treatment
  • Unable to comply with study procedures
  • Pregnant or breastfeeding females
  • Known or suspected drug or alcohol abuse
  • Participation in another investigational drug study within 1 month prior to screening
  • Any psychological or psychiatric condition compromising safety or data quality as judged by investigator

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, Spain, 28942

Actively Recruiting

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Research Team

F

Francesca Sarno, Dr.

CONTACT

J

Juan Carlos de Gregorio

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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