Study on Safety and Efficacy of Two Doses of PRS CK STORM in the Modulation of the Cytokine Storm… (NCT06684379) | Clinical Trial Compass
RecruitingPhase 1/2
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)
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 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.
Who can participate
Age range
18 Years
Sex
ALL
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 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1/Phase 2 trial, what does that mean for how much is already known about whether PRS CK STORM is safe, and how does that uncertainty compare to standard treatments already available for my respiratory infection?
2The trial is testing two different doses of PRS CK STORM — can you explain what that means for me as a potential participant, and is there a chance I could receive a dose that turns out to be less effective or less safe?
3The study is specifically focused on monitoring safety signals like heart rate, blood pressure, ECG changes, and lab results — are there any pre-existing conditions I have that might make those safety checks a particular concern for me?
4This trial covers four different viruses — SARS-CoV-2, Influenza A, Influenza B, and RSV — does my specific diagnosis affect whether this trial might even be worth discussing as an option, and does the treatment approach differ depending on which virus I have?
5Given that the trial is actively recruiting right now, how would participating affect my current treatment plan, and is there a standard-of-care option I should consider first before deciding whether to explore enrollment with you?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Events (AEs)
Timeframe: Up to 12 months
2
Serious adverse events (SAEs)
Timeframe: Up to 12 months
3
Treatment-emergent adverse events (TEAEs)
Timeframe: Up to 12 months
4
Safety measures: Clinical evaluation through physical examination
Timeframe: Day 7, Day 30, Day 90 and Day 365
5
Changes from Baseline in vital signs: body temperature
Timeframe: From Day 1 to Day 7, Day 30, Day 90 and Day 365
6
Changes from Baseline in vital signs: oximetry
Timeframe: From Day 1 to Day 7, Day 30, Day 90 and Day 365
7
Changes from Baseline in vital signs: Heart rate
Timeframe: From Day 1 to Day 7, Day 30, Day 90 and Day 365
. 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.
Exclusion criteria
. 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.
. 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.
Changes from Baseline in vital signs: Respiratory rate
Timeframe: From Day 1 to Day 7, Day 30, Day 90 and Day 365
9
Changes from Baseline in vital signs: Diastolic Blood Pressure
Timeframe: From Day 1 to Day 7, Day 30, Day 90 and Day 365
10
Changes from Baseline in vital signs: Systolic blood pressure
Timeframe: : From Day 1 to Day 7, Day 30, Day 90 and Day 365
11
Safety measures: electrocardiograms (ECG)
Timeframe: Day 7, Day 30, Day 90 and Day 365
12
Safety measures: Laboratory results
Timeframe: Day 1, Day 3, Day 6, Day 7, Day 30, Day 90 and Day 365