COVID-related Acute Respiratory Distress Syndrome MedDRA version: 21.1 Level: PT Classification code 10001052 Term: Acute respiratory distress syndrome System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Cultured Mesenchymal Stem Cells from Bone Marrow Isolation
Product Code: MSC
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: HUMAN MESENCHYMAL STEM CELLS
Current Spons
Sponsors
Cristina Avendano-Sola
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent prior to performing study procedures (witnessed oral consent with written consent by representatives will be accepted to avoid paper handling). Written consent by patient or representatives will be obtained whenever possible. 2. Adult patients =18 years of age at the time of enrolment. 3. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in oropharyngeal swabs or any other relevant specimen obtained during the course of the disease. 4. Moderate to severe ARDS (PaO2/FiO2 ratio equal or less than 200 mmHg) for less than 72 hours at the time of randomization. 5. Patients requiring invasive ventilation are eligible within 48 hours from intubation. 6. Eligible for ICU admission, according to the clinical team. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Imminent and unavoidable progression to death within 24 hours, irrespective of the provision of treatments (in the opinion of the clinical team). 2. “Do Not Attempt Resuscitation” order in place. 3. Any end-stage organ disease or condition, which in the investigator’s opinion, makes the patient an unsuitable candidate for treatment. 4. History of a moderate/severe lung disorder requiring home-based oxygen therapy. 5. Patient requiring ECMO, hemodialysis or hemofiltration at the time of treatment administration. 6. Current diagnosis of pulmonary embolism. 7. Active neoplasm, except carcinoma in situ or basalioma. 8. Known allergy to the products involved in the allogenic MSC production process. 9. Current pregnancy or lactation (women with childbearing potential should have a negative pregnancy test result at the time of study enrollment). 10. Current participation in a clinical trial with an experimental treatment for COVID-19 (the use of any off-label medicine according to local treatment protocols is not an exclusion criteria). 11. Any circumstances that in the investigator’s opinion compromises the patient’s ability to participate in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of MSC versus a control arm as described in the primary endpoint.;Secondary Objective: - To evaluate the effects of MSC on the secondary efficacy endpoints. - To evaluate the safety and tolerability profiles of MSC.;Primary end point(s): Change in the PaO2/FiO2* ratio from baseline to day 7 of treatment administration, or to the last available PaO2/FiO2 ratio if death occurs before day 7.;Timepoint(s) of evaluation of this end point: At day 7, after treatment administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? All-cause mortality on days 7, 14, and 28 after treatment. ? PaO2/FiO2 ratio at baseline and days 2, 4, 7, 14 and 28 after treatment. ? Oxygen saturation (by standardized measurement) at baseline, daily until day 14, and on day 28 after treatment. ? Time to PaO2/FiO2 ratio greater than 200 mmHg. ? Subjects’ clinical status on the WHO 7-point ordinal scale at baseline, daily until day 14, and on day 28 after treatment. ? Time to an improvement of one category from admission on the WHO 7-point ordinal scale. ? Percentage of patients that worsen at least one category on the WHO 7-point ordinal scale. ? Percentage of patients that improve at least one category (maintained 48h) on the WHO 7-point ordinal scale. ? SOFA scale at baseline and days 2, 4, 7, 14 and 28 after treatment. ? Duration of hospitalization (days). ? Duration of ICU stay (days). ? Oxygen therapy-free days in the first 28 days after treatment. ? Duration of supplemental oxygen. ? Incidence of and duration of non-invasive and invasive mechanical ventilation in the first 28 days after treatment. ? Mechanical ventilation-free days in the first 28 days after treatment. ? Ventilation parameters. ? Incidence of new onset pulmonary fibrosis at 3 and 12 months after treatment, based on CT scan and pulmonary function tests. ? Survival at 3 and 12 months. ? Cumulative incidence of serious adverse events (SAEs) and Grade 3 and 4 adverse events (AEs). ? Cumulative incidence of adverse drug reactions (ADR) in the experimental treatment arm. ? Cumulative incidence of AEs of special interest. ? Levels of analytical markers (CRP, lymphocyte and neutrophil counts, lymphocyte subpopulations, LDH, ferritin, D-dimer, coagulation tests and cytokines...) at baseline and days 2, 4, 7, 14 and 28 after treatment. ? Other soluble and cellular biomarkers that might be involved in the course of the disease and the response to MSC.;Timepoint(s) of evaluation of this end point: At days 2, 4, 7, 1 | — |
Countries
Spain
Contacts
Public ContactConcepcion Payares-Herrera
Hospital Universitario Puerta de Hierro
Outcome results
None listed