Extracellular Vesicles From Mesenchymal Cells in the Treatment of Acute Respiratory Failure
Severe Acute Respiratory Syndrome (SARS), Acute Respiratory Distress Syndrome (ARDS), Pneumonia
About this trial
This is an interventional treatment trial for Severe Acute Respiratory Syndrome (SARS) focused on measuring SARS-CoV-2, intravenous therapy, extracellular vesicles, ARDS, mesenchymal cells
Eligibility Criteria
Inclusion Criteria: Age >= 18 years old; Chest CT radiological image with ground-glass opacities or chest X-ray with - bilateral infiltrates characteristic of pulmonary edema; In invasive mechanical ventilation with PEEP 5 cm H2O and PaO2/FiO2<250mmHg; Respiratory failure not explained by cardiac causes or fluid overload. Exclusion Criteria: Unable to provide informed consent; Pregnancy or breastfeeding; Patients with active malignancy who have received chemotherapy in the last 2 years; Life expectancy of less than 6 months or in exclusive palliative care; Severe liver failure, with a Child-Pugh score > 12; Previous renal failure: patients already undergoing dialysis or patients with GFR < 30ml/min/1.73 m2 Clinical or radiological suspicion of tuberculosis; Chronic respiratory failure; Use of ECMO; Moribund (high probability of death within the next 48 hours).
Sites / Locations
- Hospital São Rafael
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
EV group
Placebo group
will consist of 10 participants who will receive two infusions of 25 mL of the investigational product (Plasma-Lyte A solution containing EVs obtained from MSCs), intravenously, at intervals of 48 h.
will consist of 5 participants who will receive an equal volume of Plasma-Lyte A, intravenously, following the same schedule as the IV group: two infusions with an interval of 48 hours.