The disease caused by the SARS-CoV-2 virus is a viral disease that infects the lungs, producing flu-like symptoms. Elderly infected patients and/or those with co-morbidities may suffer from acute respiratory distress syndrome due to pneumonia (COVID-19 disease). Given the high transmission, this virus has spread in recent months from Wuhan (China) to the whole world, becoming a global emergency pandemic. The lack of curative treatment for this disease justifies the need to carry out clinical trials that provide quality evidence on treatment options. Given the pathophysiology of the disease, which involves an uncontrolled inflammatory response of alveolar cells, a treatment that attenuates the cytokine cascade could be key in rescuing the patient's lung tissue. Mesenchymal cells, due to their immunoregulatory potential and regenerative capacity, can be an effective treatment for patients infected with the SARS-CoV-2 virus. In the present study we propose a therapy with undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue, a treatment whose safety has already been described in other clinical trials and that shows promising results in pilot studies carried out in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
1 infusion of undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue
Best treatment option for COVID-19 according to investigator criteria
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital Universitario de Cruces
Barakaldo, Spain
Hospital Universitario de La Princesa
Madrid, Spain
Hospital Infantil Universitario Niño Jesus
Madrid, Spain
Hospital Ramón Y Cajal
Madrid, Spain
Complejo Universitario La Paz
Madrid, Spain
Mortality due to lung involvement due to SARS-CoV-2 virus infection at 28 days of treatment
Percentage of patients death due to lung involvement due to SARS-CoV-2 virus infection at 28 days of treatment
Time frame: 28 days
Mortality due to lung involvement due to SARS-CoV-2 virus infection at 14 days of treatment
Percentage of patients death due to lung involvement due to SARS-CoV-2 virus infection at 14 days of treatment
Time frame: 14 days
Mortality from any cause at 28 days
Percentage of patients death due to any cause at 28 days of treatment
Time frame: 28 days
Days without mechanical respirator and without vasopressor treatment for 28 days
Number of days without mechanical respirator and without vasopressor treatment for 28 days
Time frame: 28 days
Patients alive without mechanical ventilation and without vasopressors on day 28
Percentage of patients alive without mechanical ventilation and without vasopressors on day 28
Time frame: 28 days
Patients alive and without mechanical ventilation on day 14
Percentage of patients alive and without mechanical ventilation on day 14
Time frame: 14 days
Patients alive and without mechanical ventilation on day 28
Percentage of patients alive and without mechanical ventilation on day 28
Time frame: 28 days
Patients alive and without vasopressors on day 28
Percentage of patients alive and without vasopressors on day 28
Time frame: 28 days
Days without vasopressors for 28 days
Number of days without vasopressors for 28 days
Time frame: 28 days
Patients cured at 15 days
Percentage of patients cured at 15 days
Time frame: 15 days
Incidence of Treatment-Emergent Adverse Events
Percentage of patients with each adverse event
Time frame: 1 year
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