RecruitingPhase 1/2

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)

Spain50 participantsStarted 2024-10-02

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed informed consent by the patient or legal representative prior to the initiation of any study-specific procedure.
✓. Males and females aged ≥ 18 years old at the time of the consent.
✓. Hospitalized patients with a diagnosis of ARDS confirmed by Berlin criteria.
✓. 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.
✓. Diagnosis of systemic inflammatory response syndrome (SIRS), defined by the satisfaction of any two of the criteria below:
✓. Body temperature over 38 ºC or under 36 ºC.
✓. Heart rate greater than 90 beats/minute.
✓. Respiratory rate higher than 20 breaths/min or PaCO2 lower than 32 mmHg.

Exclusion criteria

What they're measuring

Adverse Events (AEs)

Timeframe: Up to 12 months

Serious adverse events (SAEs)

Timeframe: Up to 12 months

Treatment-emergent adverse events (TEAEs)

Timeframe: Up to 12 months

Safety measures: Clinical evaluation through physical examination

Timeframe: Day 7, Day 30, Day 90 and Day 365

Changes from Baseline in vital signs: body temperature

Timeframe: From Day 1 to Day 7, Day 30, Day 90 and Day 365

Changes from Baseline in vital signs: oximetry

Timeframe: From Day 1 to Day 7, Day 30, Day 90 and Day 365

Changes from Baseline in vital signs: Heart rate

Timeframe: From Day 1 to Day 7, Day 30, Day 90 and Day 365

Changes from Baseline in vital signs: Respiratory rate

Timeframe: From Day 1 to Day 7, Day 30, Day 90 and Day 365

Trial details

NCT IDNCT06684379

SponsorPEACHES BIOTECH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-02

Contact for this trial

Francesca Sarno, Dr.

+34 674 747 199 francesca.sarno@livingcells.org

View on ClinicalTrials.gov More SARS-CoV-2 trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Signed informed consent by the patient or legal representative prior to the initiation of any study-specific procedure.
✓. Males and females aged ≥ 18 years old at the time of the consent.
✓. Hospitalized patients with a diagnosis of ARDS confirmed by Berlin criteria.
✓. 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.
✓. Diagnosis of systemic inflammatory response syndrome (SIRS), defined by the satisfaction of any two of the criteria below:
✓. Body temperature over 38 ºC or under 36 ºC.
✓. Heart rate greater than 90 beats/minute.
✓. Respiratory rate higher than 20 breaths/min or PaCO2 lower than 32 mmHg.

Exclusion criteria

What they're measuring

Adverse Events (AEs)

Timeframe: Up to 12 months

Serious adverse events (SAEs)

Timeframe: Up to 12 months

Treatment-emergent adverse events (TEAEs)

Timeframe: Up to 12 months

Safety measures: Clinical evaluation through physical examination

Timeframe: Day 7, Day 30, Day 90 and Day 365

Changes from Baseline in vital signs: body temperature

Timeframe: From Day 1 to Day 7, Day 30, Day 90 and Day 365

Changes from Baseline in vital signs: oximetry

Timeframe: From Day 1 to Day 7, Day 30, Day 90 and Day 365

Changes from Baseline in vital signs: Heart rate

Timeframe: From Day 1 to Day 7, Day 30, Day 90 and Day 365

Changes from Baseline in vital signs: Respiratory rate

Timeframe: From Day 1 to Day 7, Day 30, Day 90 and Day 365