CClinicalTrials.gg
Sign In
RecruitingNCT06684379Updated Jun 10, 2026

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)

A Phase 1/2 interventional study of Placebo comparator and PRS CK STORM in SARS-CoV-2, Influenza, Human and Respiratory Syncytial Virus Infections, sponsored by PEACHES BIOTECH. Recruiting at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by PEACHES BIOTECH · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This is a double-blind, randomized, phase I/II pilot clinical trial of two doses of PRS CK STORM in adult participants with SIRS caused by SARS-Cov-2, influenza A, influenza B and RSV All participants will receive the standard of care for SIRS, according to its viral origin:

  • Clinical management of COVID-19: hospital care (Centro de Coordinación de Alertas y Emergencias Sanitarias, 2020).
  • Clinical practice guidelines for influenza (WHO, 2024). Participants who meet the eligibility criteria will be randomized in blocks to reach the 2:2:1 ratio (dose A: dose B: placebo).

This study consists of two parts:

Part 1: Doses A and B of PRS CK STORM will be evaluated in 2 groups of 4 participants (3:1; PRS CK STORM: placebo). It starts with a first sentinel group of 4 participants who will be assigned to placebo or study drug dose A. First, only 2 participants will randomly be assigned to receive the active treatment of dose A or placebo for 5 consecutive days. These 2 first participants will be followed up to 48h after the last drug administration (short-term safety follow-up period) when a safety assessment will be completed before treating the other 2 participants in this group.

If the study drug is considered safe during the short-term safety assessment planned 48h after the last drug administration, then 2 additional participants will be treated with dose A for 5 consecutive days to complete the first sentinel group of 4 participants. These 2 participants will be followed up to 48h after the last study drug administration before moving to dose B.

After the assessment of data collected follow-up for this first group, a second small sentinel group of other 4 participants will be treated with a higher dosage (dose B) following the same process, as long as dose A has been considered safe. First, only 2 participants will randomly receive the active treatment of dose B or placebo for 5 consecutive days and then these 2 first participants will be followed up to 48h after the last drug administration when a safety assessment will be completed before treating the other 2 participants in this group.

If the study drug is considered safe during the safety assessment planned 48h after last drug administration, then two additional participants will be treated with dose B for 5 consecutive days to complete the sentinel second group of 4 participants evaluating dose B. These 2 participants will be also followed up to 48h after the last study drug administration when a safety assessment will be completed before treating the other 2 participants in this group.

All these 8 participants included in Part 1 will continue in a long-term safety follow-up period until 1 year post treatment.

Part 2: 42 additional participants will be treated for 5 consecutive days. These 42 participants will be randomized to three treatment arms: 17 in the active arm with dose A, 17 participants in the active arm with dose B and 8 participants in the placebo arm. All participants in Part 2 will be followed up to 48h after the last study drug (short-term safety follow-up period). Once all participants treated in Part 2 finished the short-term safety follow-up period (48h after last study drug administration), all data will be verified and statistically analyzed in an interim analysis. All participants will be followed up to 1 year post treatment (long-term safety follow-up period). Therefore, considering the participants enrolled in Part 1 and Part 2 the total number of participants for safety, tolerability and efficacy analysis will be 50 assigned to three different arms (total randomization ratio 2:2:1), 20 participants will be assigned to dose A, 20 participants will be assigned to dose B and 10 participants will be assigned to placebo.

To sum up, considering the participants enrolled in Part 1 and Part 2 the total number of participants for safety, tolerability and efficacy analysis will be 50 assigned to three different arms (total randomization ratio 2:2:1), 20 participants will be assigned to dose A of PRS CK STORM, 20 participants will be assigned to dose B of PRS CK STORM and 10 participants will be assigned to placebo.

The estimated duration of the study for individual participants will be 12 months (screening: 3 days, treatment period: 5 days, short-term safety follow-up period: 2 days after the last drug intake and long-term safety follow-up period: up to 48 weeks from randomization).

It is hypothesized that both doses of PRS CK STORM for intravenous administration are safe, well tolerated and clinically beneficial versus placebo for participants with SIRS-associated cytokine storm.

02

Conditions studied

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

Keywords

  • SARS-CoV-2 infection
  • Causing atypical respiratory disease (COVID-19)
  • 2019 Novel Coronavirus
  • COVID-19 Virus
  • SARS Coronavirus 2
  • COVID-19-associated cytokine storm
  • Lung Diseases
  • Pneumonia
  • M2-macrophages
  • Mesenchymal cells
  • Influenza A Virus
  • Influenza B Virus
  • RSV Infection
  • Acute Respiratory Distress Syndrome
  • ARDS, Human
  • Respiratory Distress Syndrome, Acute
  • Cytokine storm
  • Systemic Inflammatory Response Syndrome
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 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.
  5. Need for oxygen therapy.
  6. 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

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, as assessed by the investigator.
  4. Active autoimmune diseases or severe immunosuppression, unless stable and controlled for at least 3 months prior to the inclusion in the study.

  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 not justified by a pulmonary acute inflammation process: 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 30 (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, unless stable during that time. Skin malignancies (other than melanoma) and indolent prostate cancer are excluded from this criterion.
    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)].
  6. Inability to comply with the study and monitoring procedures.
  7. Pregnant and breastfeeding females (pregnancy test positive).
  8. Suspected or known active 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.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Saline Solution 0,9% for injection

    Participants will receive 2 vials, containing each 10 mL of Intravenous (IV) infusion of normal saline (0.9%)

    Drug: Placebo comparator

  • Experimental
    PRS CK STORM - dose A

    A sterile secretome derived from the co-culture of M2-type macrophages and ASC (adipose stromal cells) containing 116,059 pg/mL Tissue Inhibitor of Matrix Metalloproteinase- 1 (TIMP-1). Participants will receive a total dose of 1,160,585.366 pg of TIMP-1 via IV infusion and 1 vial of saline solution (0.9%) via IV infusion.

    Drug: PRS CK STORM

  • Experimental
    PRS CK STORM - dose B

    A sterile secretome derived from the co-culture of M2-type macrophages and ASC (adipose stromal cells) containing 116,059 pg/mL TIMP-1. Participants will receive a total dose of 2,321,170.732 pg of TIMP-1 via IV infusion.

    Drug: PRS CK STORM

Interventions

  • DrugPlacebo comparator

    2 vials of saline solution 0.9% for infusion

    Also known as: Saline Solution

  • DrugPRS CK STORM

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

  • DrugPRS CK STORM

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

05

What researchers measure

Primary outcomes

  1. Adverse Events (AEs)

    Number and proportion of subjects experiencing AEs.

    Time frame: Up to 12 months

  2. Serious adverse events (SAEs)

    Number and proportion of subjects experiencing SAEs

    Time frame: Up to 12 months

  3. Treatment-emergent adverse events (TEAEs)

    Number and proportion of subjects experiencing TEAEs

    Time frame: Up to 12 months

  4. Safety measures: Clinical evaluation through physical examination

    Number and proportion of subjects with abnormal findings of physical examination parameters (head, ears, Nervous system,Gastrointestinal system, Respiratory system, Lymph nodes Musculoskeletal system, Neck, Throat, Cardiovascular system, Skin, Nose) will be evaluated

    Time frame: Day 7, Day 30, Day 90 and Day 365

  5. Changes from Baseline in vital signs: body temperature

    Body Temperature of participants will be measure d in Celsius (ºC)

    Time frame: From Day 1 to Day 7, Day 30, Day 90 and Day 365

  6. Changes from Baseline in vital signs: oximetry

    Levels of blood oxygen saturation (SpO2) using a pulse oximeter will be measured in percentage

    Time frame: From Day 1 to Day 7, Day 30, Day 90 and Day 365

  7. Changes from Baseline in vital signs: Heart rate

    Heart rate will be measured as number of beats per minute (bpm)

    Time frame: From Day 1 to Day 7, Day 30, Day 90 and Day 365

  8. Changes from Baseline in vital signs: Respiratory rate

    Respiratory rate will be measured as number of breaths taken per minute (Breaths/min) .

    Time frame: From Day 1 to Day 7, Day 30, Day 90 and Day 365

  9. Changes from Baseline in vital signs: Diastolic Blood Pressure

    Diastolic blood pressure will be measured in mmHg

    Time frame: From Day 1 to Day 7, Day 30, Day 90 and Day 365

  10. Changes from Baseline in vital signs: Systolic blood pressure

    Systolic blood pressure will be measured in mmHg

    Time frame: : From Day 1 to Day 7, Day 30, Day 90 and Day 365

  11. Safety measures: electrocardiograms (ECG)

    Cardiac dysfunction will be monitored by 12-lead ECGs. Abnormal or normal readings will be evaluated

    Time frame: Day 7, Day 30, Day 90 and Day 365

  12. Safety measures: Laboratory results

    Abnormal or normal laboratory test results (biochemistry, hematology, coagulation, and urinalysis) will be evaluated

    Time frame: Day 1, Day 3, Day 6, Day 7, Day 30, Day 90 and Day 365

Secondary outcomes

  1. Severity of hypoxemia

    Severity of hypoxemia measured as changes in SpO2/FiO2 ratio. Severity according to SpO2/FiO2 values is classified as: * Normal: SpO2/FiO2 greater than 299 mmHg * Mild: 219 mmHg greater than SpO2/FiO2 and less than or equal to 299 mmHg * Moderate: 139 mmHg greater than SpO2/FiO2 and less than or equal to 219 mmHg * Severe: SpO2/FiO2 less than or equal to 139 mmHg

    Time frame: Up to 12 months

  2. Death rate

    Percentage of participants who died since the beginning of treatment. Death rate at each timepoint will be studied by means of a difference between independent proportions tests

    Time frame: Day 7, Day 14 and Day 365

  3. Average hospital stays (in days)

    Average of days that participants stay in the hospital

    Time frame: Up to 12 months

  4. Participants requiring admission to Intensive Care Unit (ICU)

    Percentage of participants requiring admission to ICU

    Time frame: Up to 12 months

  5. Duration of ICU stay

    Average of days that participants stay in ICU

    Time frame: Up to 12 months

  6. Thorax radiological findings

    Percentage of participants with the following thorax radiological findings: * Pneumonia (unilateral, bilateral). * Infiltrates. * Stabilization. * radiological evolution.

    Time frame: Day 7 and Day 10 Up to 12 months

  7. Overall survival (in weeks)

    Proportion of participants who survive the disease during the follow-up period

    Time frame: Up to 12 months

  8. Progression-free survival (in weeks)

    Period from the initiation of treatment until the detection of disease progression or worsening symptoms in a participant with COVID-19.

    Time frame: Up to 12 months

  9. Need for invasive mechanical ventilation

    The need of the use of a ventilation machine to fully or partially provide artificial ventilation via an invasive procedure such as intubation (endotracheal tube) or tracheostomy (tracheostomy tube) will be evaluated.

    Time frame: Up to 12 months

  10. Time to invasive mechanical ventilation (in days)

    Period of time (in days) under need of the use of a ventilation machine to fully or partially provide artificial ventilation via an invasive procedure such as intubation (endotracheal tube) or tracheostomy (tracheostomy tube).

    Time frame: Up to 12 months

Other outcomes

  1. Variations in anti-inflamatory cytokine levels

    Changes in the concentrations of anti-inflammatory (TIMP-1 and IL-1Ra) cytokines before and after treatment. Blood samples will be collected from participants to carry out cytokine quantification

    Time frame: Day 1, Day 3 and Day 6

  2. Variation in pro-inflammatory cytokine levels

    Changes in the concentrations of pro-inflammatory (TNF-α, IL-1β, IL-6 and IL-18) cytokines before and after treatment. Blood samples will be collected from participants to carry out cytokine quantification.

    Time frame: Day 1, Day 3 and Day 6

  3. Severity of hypoxemia measured as SpO2/FiO2 ratio considering relevant risk factors as covariates

    Severity of hypoxemia measured as changes in SpO2/FiO2 ratio. Severity according to SpO2/FiO2 values is classified as: * Normal: SpO2/FiO2 greater than 299 mmHg * Mild: 219 mmHg greater than SpO2/FiO2 and less than or equal to 299 mmHg * Moderate: 139 mmHg greater than SpO2/FiO2 and less than or equal to 219 mmHg * Severe: SpO2/FiO2 less than or equal to 139 mmHg The association between severity of hypoxemia and the treatment regimen will be assessed, adjusting for the following covariates (as they are considered as risk factors): age, obesity, smoking status, sex, high levels of pro-inflammatory cytokines at baseline, hypertension, SIRS cause (SARS-Cov-2, influenza A, influenza B and RSV); previous SARS-Cov-2, influenza A, influenza B and RSV vaccination; number of previous SARS-Cov-2, influenza A, influenza B and RSV infections; Charlson index at screening period; Chronic Obstructive Pulmonary Disease (COPD); diabetes and heart failure

    Time frame: Up to 12 months

06

Study locations

3 of 3 sites recruiting
  • Hospital Universitario Príncipe de Asturias
    Alcalá de Henares, Madrid 28805, Spain
    • José Sanz Moreno, Dr · Principal investigator
    Recruiting
  • Hospital Universitario de Fuenlabrada
    Fuenlabrada, Madrid 28942, Spain
    • Juan Victor San Martin Lopez, Dr · Contact
    Recruiting
  • Hospital Universitario Reina Sofía
    Córdoba, 14004, Spain
    • Ángela Cano Yuste, Dr · Principal investigator
    Recruiting
07

References and documents

Publications

  • Lapuente JP, Gomez G, Marco-Brualla J, Fernandez P, Desportes P, Sanz J, Garcia-Gil M, Bermejo F, San Martin JV, Algaba A, De Gregorio JC, Lapuente D, De Gregorio A, Lapuente B, Gomez S, Andres MLV, Anel A. Evaluation in a Cytokine Storm Model In Vivo of the Safety and Efficacy of Intravenous Administration of PRS CK STORM (Standardized Conditioned Medium Obtained by Coculture of Monocytes and Mesenchymal Stromal Cells). Biomedicines. 2022 May 8;10(5):1094. doi: 10.3390/biomedicines10051094. PubMed 35625831 ↗
  • Centro de Coordinación y Alertas Sanitarias (coord.). Manejo clínico del COVID-19: atención hospitalaria. Madrid: Ministerio de Sanidad; 2020.
  • Clinical practice guidelines for influenza [Internet]. Geneva: World Health Organization; 2024. Available from http://www.ncbi.nlm.nih.gov/books/NBK607904/ PubMed 39374347 ↗
  • Lapuente JP, Blazquez-Martinez A, Marco-Brualla J, Gomez G, Desportes P, Sanz J, Fernandez P, Garcia-Gil M, Bermejo F, San Martin JV, Algaba A, De Gregorio JC, Lapuente D, De Gregorio A, Lapuente B, Andres MV, Anel A. Cytokine Profile and Anti-Inflammatory Activity of a Standardized Conditioned Medium Obtained by Coculture of Monocytes and Mesenchymal Stromal Cells (PRS CK STORM). Biomolecules. 2022 Mar 31;12(4):534. doi: 10.3390/biom12040534. PubMed 35454123 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06684379
Lead sponsor
PEACHES BIOTECH
Responsible party
Sponsor
First posted
Nov 12, 2024
Start date
Oct 2, 2024
Primary completion
Oct 2, 2026 (estimated)
Completion
Oct 2, 2026 (estimated)
Last update
Jun 10, 2026

Study contacts

Francesca Sarno, Dr.
Contact
francesca.sarno@livingcells.org
+34 674 747 199
Juan Carlos de Gregorio
Contact
jcg@peaches.es
+34 607964152
David Bernal, Dr.
principal investigator · Hospital Universitario de Fuenlabrada
Guillermo Soria Fernández-Llamazares, Dr
study chair · Hospital Universitario de Fuenlabrada
José Sanz Moreno, Dr
principal investigator · Hospital Universitario Príncipe de Asturias
Ángela Cano Yuste, Dr
principal investigator · Hospital Universitario Reina Sofia de Cordoba

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Influenza, Human→

Start the discussion