COVID-19 MedDRA version: 20.0 Level: LLT Classification code 10051905 Term: Coronavirus infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: Células mesenquimales troncales adultas alogénicas de médula ósea expandidas en suspensión
Product Code: MSV®-allo
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: célu
Sponsors
CITOSPIN S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women or men of equal or more than 18 years of age 2. SARS-CoV-2 infection confirmed by molecular testing. 3. Admitted to the Intensive Care Unit with pneumonia secondary to COVID-19 infection in the last 48 hours, who meet at least one of these criteria: to. Respiratory distress. yes. Respiratory rate (RR) equal or more than 30 rpm. C. Basal oxygen saturation at rest equal or less than 93%. re. Arterial partial pressure of oxygen (PaO2) / inspiratory fraction of oxygen (FiO2) equal or less than 300 mmHg. 4. Compliance of the patient or his legal representative for participation in the study. 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 24 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Active tumor disease. 2. Pregnancy. 3. Participation in another active clinical trial. 4. Any circumstance that in the researcher's opinion justifies the patient's non-participation in the trial. 5. Not consent to participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessing the safety and efficacy of MSV-allo® in obtaining recovery from respiratory failure in patients with pneumonia due to severe / critical COVID-19 infection.;Secondary Objective: 1. Time to recover from the symptoms and clinical signs after the MSV-allo® administration 2. Time to reach the normalization of imaging tests, chest radiography and/or lung CT 3. Modification in the inflammatory response in terms of blood levels of cytokines and chemokines. 4. Modification in the number of leukocytes and lymphocyte populations. 5. Safety, tolerability and immunogenicity profiles of MSV-allo® in patients with severe COVID-19;Primary end point(s): 1. Proportion of patients in whom removal of invasive mechanical ventilation has been achieved in less than 7 days after IMP administration. 2. Proportion of patients surviving on day 28 from diagnosis;Timepoint(s) of evaluation of this end point: 7 days from treatment and 28 days from diagnosis | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of patients who have achieved a complete clinical response, with disappearance of the symptoms of the disease. 2. Proportion of patients who have achieved a complete radiological response 3. Proportion of patients who did not require immunosuppressive treatment after treatment.;Timepoint(s) of evaluation of this end point: Periodically during hospitalization | — |
Countries
Spain
Contacts
Public ContactCRO
Effice spi S.L.
Outcome results
None listed