Considering the potential of mesenchymal stromal cells (MSCs) in the treatment of lung injuries by COVID-19, this pilot clinical trial evaluates the safety and potential efficacy of the cell therapy, administered intravenously, in patients with pneumonia associated with COVID-19-associated acute respiratory distress syndrome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Intravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose)
Hospital São Rafael
Salvador, Estado de Bahia, Brazil
RECRUITINGIntrahospital mortality
Time frame: 28 days
Length of stay in the ICU and Hospital
Time frame: 28 days
Days without mechanical ventilation in 28 days
Time frame: 28 days
PaO2 / FiO2 ratio
Time frame: Day 1, Day 2 and Day 7 after cell infusion
Incidence of secondary infections
Time frame: 28 days
Incidence of adverse events
Time frame: 28 days
Quantification of inflammatory response markers
Exploratory evaluation of changes from baseline (percentage) in serum levels of CRP, LDH, Ferritin levels, a panel of cytokines, chemokines immune cell populations by flow cytometry
Time frame: Day 1, Day 3 and Day 7 after cell infusion
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