Evaluating a new treatment to prevent severe COVID-19 complications

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 for the Treatment of Acute Respiratory Distress Syndrome (ARDS) Caused by SARS-Cov-2, Influenza A, Influenza B and Respiratory Syncytial Virus (RSV)

This study is testing a new treatment to see if it can help hospitalized COVID-19 patients avoid severe complications caused by inflammation.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peaches Biotech (Industry-sponsored)
• Locations: 1 site (Fuenlabrada, Madrid)
• Trial ID: NCT06684379 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the safety and efficacy of two doses of PRS CK STORM, a treatment derived from cocultured monocytes and mesenchymal stromal cells, in preventing cytokine storms in hospitalized patients with confirmed SARS-CoV-2 infection. Participants will be randomized to receive either the treatment or a placebo while also receiving standard care for COVID-19. The study aims to determine the safety of the treatment and its effectiveness in reducing inflammatory responses associated with severe COVID-19. It involves a double-blind, randomized design with a focus on monitoring cytokine profiles post-treatment.

Who should consider this trial

Good fit: Ideal candidates are hospitalized adults over 18 years old with a confirmed SARS-CoV-2 infection and symptoms for no more than 10 days.

Not a fit: Patients who are not hospitalized or have had symptoms for more than 10 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of severe inflammatory responses in COVID-19 patients, potentially improving survival rates.

How similar studies have performed: Other studies have explored similar approaches to managing cytokine storms in COVID-19, but the specific use of PRS CK STORM is novel.

Eligibility criteria

Inclusion Criteria:

1. Signed informed consent by the patient 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. Hospitalized patients with a diagnosis of ARDS confirmed by Berlin criteria.
4. 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.
5. 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.
6. Need for oxygen therapy.
7. Participants to be hospitalized or who have been admitted for less than 3 days and who have had symptoms up to a maximum of 10 days prior to screening.
8. 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:

1. Failure to perform screening or baseline examinations.
2. Body Mass Index (BMI) more than or equal to 35.
3. Irreversible critical condition.
4. Active autoimmune diseases or severe immunosuppression.
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: 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 60 (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 except skin malignancies (other than melanoma) or indolent prostate cancer
   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 \[HCV ribonucleic acid (RNA) detectable in any subject with positive anti-HCV antibody (HCV Ab)\].
   10. Other serious active viral infections apart from SARS-CoV-2, influenza A, influenza B or RSV that require specific antimicrobial treatment.
6. Inability to comply with the study and monitoring procedures.
7. Pregnant and breastfeeding females (pregnancy test positive).
8. Suspected or known history of 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.

Where this trial is running

Fuenlabrada, Madrid

• Hospital Universitario de Fuenlabrada — Fuenlabrada, Madrid, Spain (Recruiting)

Study contacts

• Principal investigator: David Bernal, Dr. — Hospital Universitario de Fuenlabrada
• Study coordinator: Francesca Sarno, Dr.

Conditions SARS-CoV-2; Influenza, Human; Respiratory Syncytial Virus Infections; Respiratory Distress Syndrome; SARS-CoV-2 infection; Causing atypical respiratory disease; 2019 Novel Coronavirus; COVID-19 Virus