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Tests treatment safety and results for SARS-CoV-2
Official title 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)
ClinicalTrials.gov ID: NCT06684379
What this study is testing
What is PRS CK STORM?
PRS CK STORM is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sars-cov-2.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Liver function test abnormalities or other signs of hepatic insufficiency not justified by a pulmonary acute inflammation process: Aspartate...
See the full eligibility 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Alcalá de Henares, Madrid, Spain
- Fuenlabrada, Madrid, Spain
- Córdoba, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alcalá de Henares, Madrid, Spain; Fuenlabrada, Madrid, Spain; Córdoba, Spain. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.