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SARS-CoV-2Phase 1/2NCT06684379

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 study testing PRS CK STORM in people with SARS-CoV-2 and Influenza, Human, run by PEACHES BIOTECH at 3 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PRS CK STORM
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
3 sitesSpain
Study dates
2 Oct 2024to 2 Oct 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent by the participant 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.
  • 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.
Show all 10Show fewer
  • Respiratory rate higher than 20 breaths/min or PaCO2 lower than 32 mmHg.
  • Leukocyte count higher than 12000/μL, lower than 4000/μL or over 10% immature forms or bands.
  • Need for oxygen therapy.
  • 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 cannot join

  • Failure to perform screening or baseline examinations.
  • Body Mass Index (BMI) more than or equal to 35.
  • Irreversible critical condition, as assessed by the investigator.
  • Active autoimmune diseases or severe immunosuppression, unless stable and controlled for at least 3 months prior to the inclusion in the study.
  • Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, may bias the clinical assessment, such as:
  • 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.
Show all 19Show fewer
  • 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).
  • Myocardial infarction, unstable angina, heart failure within 3 months before screening.
  • Bradycardia (heartbeat less than 50/min).
  • 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 ).
  • Uncontrolled diabetes mellitus (blood glucose level above 500 mg/dL) at the time of admission.
  • 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.
  • Metastases.
  • 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)].
  • Inability to comply with the study and monitoring procedures.
  • Pregnant and breastfeeding females (pregnancy test positive).
  • Suspected or known active drug or alcohol abuse.
  • Enrollment in another investigational drug study within 1 month before the screening
  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Francesca Sarno, Dr. contact

+34 674 747 199

francesca.sarno@livingcells.org

Juan Carlos de Gregorio contact

+34 607964152

jcg@peaches.es

Spain3 sites, 3 recruiting

  • Hospital Universitario Príncipe de Asturias

    Alcalá de Henares, Madrid, 28805

    José Sanz Moreno, Dr

    Recruiting

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

    Ángela Cano Yuste, Dr

    Recruiting

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, Madrid, 28942

    Juan Victor San Martin Lopez, Dr

    Recruiting

Other trials in Spain

About this study

Official title: 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 in Patients With Acute Respiratory Infection Caused by SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV)

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:

Read more
  • 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.

Being tested
Placebo comparator, PRS CK STORM
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
Medical subject headings
Influenza, Human, Respiratory Syncytial Virus Infections, Respiratory Distress Syndrome, Systemic Inflammatory Response Syndrome, COVID-19, Lung Diseases, Pneumonia, Cytokine Release Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo comparatorDrug

    Also called Saline Solution

    2 vials of saline solution 0.9% for infusion

  • PRS CK STORMDrug

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

  • PRS CK STORMDrug

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

Study groups in NCT06684379
Study groupRoleWhat they receive
Saline Solution 0,9% for injectionActive comparatorParticipants will receive 2 vials, containing each 10 mL of Intravenous (IV) infusion of normal saline (0.9%)
Receives: Drug: Placebo comparator
PRS CK STORM - dose AExperimentalA 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.
Receives: Drug: PRS CK STORM
PRS CK STORM - dose BExperimentalA 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.
Receives: Drug: PRS CK STORM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events (AEs)

    Number and proportion of subjects experiencing AEs.

    Measured: Up to 12 months

  2. Serious adverse events (SAEs)

    Number and proportion of subjects experiencing SAEs

    Measured: Up to 12 months

  3. Treatment-emergent adverse events (TEAEs)

    Number and proportion of subjects experiencing TEAEs

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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)

    Measured: 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) .

    Measured: 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

    Measured: 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

    Measured: : 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

    Measured: 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

    Measured: Day 1, Day 3, Day 6, Day 7, Day 30, Day 90 and Day 365

Secondary outcomes (10)

  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

    Measured: 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

    Measured: Day 7, Day 14 and Day 365

  3. Average hospital stays (in days)

    Average of days that participants stay in the hospital

    Measured: Up to 12 months

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

    Percentage of participants requiring admission to ICU

    Measured: Up to 12 months

  5. Duration of ICU stay

    Average of days that participants stay in ICU

    Measured: Up to 12 months

  6. Thorax radiological findings

    Percentage of participants with the following thorax radiological findings:

    • Pneumonia (unilateral, bilateral).
    • Infiltrates.
    • Stabilization.
    • radiological evolution.

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start2 Oct 2024
  3. Primary completion2 Oct 2026 (estimated)
  4. Study completion2 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Subjects will be randomized in blocks; the study will be conducted in 2 parts in sequential groups of doses A and B of PRS CK STORM and consecutively evaluated in 2 sentinel groups of 4 participants. Participants will be randomized to receive treatment in groups of 2, for 5 consecutive days, until 48 hours after the last drug administration (short-term safety follow-up period).
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06684379
Sponsor's protocol ID
PRSCK-21P01
Other IDs
2023-507700-32-00, 2023
Status last verified
Jun 2026
First submitted
23 Oct 2024
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing PRS CK STORM in people with SARS-CoV-2 and Influenza, Human, run by PEACHES BIOTECH at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Francesca Sarno, Dr. (+34 674 747 199, francesca.sarno@livingcells.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (AEs) (time frame: Up to 12 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06684379, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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