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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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)

Double-blind, Randomized, Placebo-controlled, Pilot Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Two Doses of a Conditioned Medium From a Co-culture of M2-macrophages and Fat-derived Mesenchymal Cells (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)

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) (NCT06684379) is a Phase 1 / Phase 2 interventional studying SARS-CoV-2 and Influenza, Human, sponsored by PEACHES BIOTECH. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For SARS-CoV-2, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 50 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused SARS-CoV-2 subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Signed willing to sign a consent form by the patient 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. Hospitalized patients with a diagnosis of ARDS confirmed by Berlin criteria. 4. 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. 5. 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 20 breaths/min or PaCO2 lower than 32 mmHg. 4. Leukocyte count higher than 12000/μL, lower than 4000/μL or over 10% immature forms or bands. 6. Need for oxygen therapy. 7. Participants to be hospitalized or who have been admitted for less than 3 days and who have had symptoms up to a maximum of 10 days prior to screening. 8. Female participants must be, either surgically sterilized or at least 1 year postmenopausal (confirmed by follicle-stimulating hormone \[FSH\] more than 20 international units \[Ius\] only for women under 54) or using adequate birth control (hormonal contraception, intrauterine contraceptive device, double barrier methods \[condom with spermicide, diaphragm with spermicide, or condom and diaphragm\]) or sexual abstinence for up to 90 days after the last treatment administration. Male participants must be willing to use barrier contraception (condom) for up to 90 days after the last treatment administration. Who Should NOT Join This Trial: 1. Failure to perform screening or baseline examinations. 2. Body Mass Index (BMI) more than or equal to 35. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Signed informed consent by the patient 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. Hospitalized patients with a diagnosis of ARDS confirmed by Berlin criteria. 4. 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. 5. 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 20 breaths/min or PaCO2 lower than 32 mmHg. 4. Leukocyte count higher than 12000/μL, lower than 4000/μL or over 10% immature forms or bands. 6. Need for oxygen therapy. 7. Participants to be hospitalized or who have been admitted for less than 3 days and who have had symptoms up to a maximum of 10 days prior to screening. 8. Female participants must be, either surgically sterilized or at least 1 year postmenopausal (confirmed by follicle-stimulating hormone \[FSH\] more than 20 international units \[Ius\] only for women under 54) or using adequate birth control (hormonal contraception, intrauterine contraceptive device, double barrier methods \[condom with spermicide, diaphragm with spermicide, or condom and diaphragm\]) or sexual abstinence for up to 90 days after the last treatment administration. Male participants must be willing to use barrier contraception (condom) for up to 90 days after the last treatment administration. Exclusion Criteria: 1. Failure to perform screening or baseline examinations. 2. Body Mass Index (BMI) more than or equal to 35. 3. Irreversible critical condition. 4. Active autoimmune diseases or severe immunosuppression. 5. Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, may bias the clinical assessment, such as: 1. Liver function test abnormalities or other signs of hepatic insufficiency: Aspartate transaminase (AST), alanine transaminase (ALT) more than 3 per upper limit of the reference range, total bilirubin more than or equal to 2 mg/dL; except for subjects with isolated elevation of indirect bilirubin relating to Gilbert syndrome. 2. Renal insufficiency (serum creatinine more than 2 mg/dL (more than 150 μmol/L) and creatinine clearance less than 60 (according to Cockcroft-Gault formula). 3. Myocardial infarction, unstable angina, heart failure within 3 months before screening. 4. Bradycardia (heartbeat less than 50/min). 5. Atrioventricular block (type II / Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcF interval (males more than 450 msec and females more than 470 msec using Fridericia's formula: QTc = QT/ RR\^2 ). 6. Uncontrolled diabetes mellitus (blood glucose level above 500 mg/dL) at the time of admission. 7. Malignant tumors within the last 5 years except skin malignancies (other than melanoma) or indolent prostate cancer 8. Metastases. 9. Human Immunodeficiency Virus (HIV), HBV \[hepatitis B surface antigen (HBs Ag) positive (+), or detected sensitivity on the HBV deoxyribonucleic acid (DNA), polymerase chain reaction (PCR) qualitative test for hepatitis B core antibody (HBc Ab) positive subjects\] or HCV \[HCV ribonucleic acid (RNA) detectable in any subject with positive anti-HCV antibody (HCV Ab)\]. 10. Other serious active viral infections apart from SARS-CoV-2, influenza A, influenza B or RSV that require specific antimicrobial treatment. 6. Inability to comply with the study and monitoring procedures. 7. Pregnant and breastfeeding females (pregnancy test positive). 8. Suspected or known history of drug or alcohol abuse. 9. Enrollment in another investigational drug study within 1 month before the screening 10. Subject who has any condition, including any psychological or psychiatric condition, in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study.

Treatments Being Tested

DRUG

Placebo comparator

A single dose of saline solution 0.9% for infusion

DRUG

PRS CK STORM

A single dose of PRS CK STORM (dose A) for infusion

DRUG

PRS CK STORM

A single dose of PRS CK STORM (dose B) for infusion.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06684379), the sponsor (PEACHES BIOTECH), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06684379 clinical trial studying?

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 STO… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06684379?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06684379?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06684379. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06684379. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.