COVID-19-associated acute respiratory distress syndrome
Conditions
Interventions
Ten patients with COVID-19 will receive an intravenous infusion of three doses of 500.000 cells/kg of umbilical cord mesechymal cells and five patients will receive a placebo (saline, albumin and ACD
Sponsors
Paulo Roberto Slud Brofman
Pontifícia universidade Católica do Paraná
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: COVID-19 patients, that require intensive care surveillance and ventilatory support, PaO2/FiO2 less than or equal to 200 (Berlin criteria of moderate-to-severe acute respiratory)
Exclusion criteria
Exclusion criteria: Previous or current history of malignancy under treatment; pre-existing thromboembolic disease; concomitant HIV or tuberculosis infection; pre-existing transplant or use immunosuppressive therapy and pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety through the assessment of adverse events. Security will be assessed by recording all adverse events, according to the Common Terminology Criteria for Adverse Events version 5.0, based on duration, intensity and possible association with the treatment under study. In particular, the absolute number of unexpected and suspected severe adverse events and serious adverse events recorded during the follow-up study that should not exceed 10%, will be taken into account. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy after using the advanced therapy product, compared to the placebo group. Evaluation parameters: mortality; improved PaO2/ FiO2 ratio compared to the baseline; days on invasive mechanical ventilation; days on non-invasive mechanical ventilation; radiological score (change from baseline); variation of laboratory parameters compared to baseline; cytokine profile before and after cell infusion. | — |
Countries
Brazil
Contacts
Public ContactPaulo Brofman
Pontifícia Universidade Católica do Paraná
Outcome results
None listed