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
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:
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.
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:
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.
2,356 studies on the registry are indexed under Influenza, Human; 184 are open to participants now.
This study's planned enrollment of 50 is below the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →This is the only study on the registry with PEACHES BIOTECH as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of systemic inflammatory response syndrome (SIRS), defined by the satisfaction of any two of the criteria below:
Exclusion Criteria:
, advanced or unstable disease that may interfere with primary or secondary variable evaluations, may bias the clinical assessment, such as:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 2 vials, containing each 10 mL of Intravenous (IV) infusion of normal saline (0.9%)
Drug: Placebo comparator
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
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
2 vials of saline solution 0.9% for infusion
Also known as: Saline Solution
1 vial of PRS CK STORM (dose A) and 1 vial of placebo for infusion
2 vials of PRS CK STORM (dose B) for infusion.
Adverse Events (AEs)
Number and proportion of subjects experiencing AEs.
Time frame: Up to 12 months
Serious adverse events (SAEs)
Number and proportion of subjects experiencing SAEs
Time frame: Up to 12 months
Treatment-emergent adverse events (TEAEs)
Number and proportion of subjects experiencing TEAEs
Time frame: Up to 12 months
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
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
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
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
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
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
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
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
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
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
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
Average hospital stays (in days)
Average of days that participants stay in the hospital
Time frame: Up to 12 months
Participants requiring admission to Intensive Care Unit (ICU)
Percentage of participants requiring admission to ICU
Time frame: Up to 12 months
Duration of ICU stay
Average of days that participants stay in ICU
Time frame: Up to 12 months
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
Overall survival (in weeks)
Proportion of participants who survive the disease during the follow-up period
Time frame: Up to 12 months
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
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
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
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
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
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
Plan to share: No
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