Coronavirus infection
Conditions
Interventions
Forty patients with COVID-19 will receive an intravenous infusion of one dose of 1.000.000 umbilical cord mesenchymal cells per kilo of the patient. Twenty patients will receive a placebo (saline, alb
Sponsors
Pontifícia Universidade Católica do Paraná
Pontifícia Universidade Católica do Paraná
Eligibility
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: Both sexes; aged 18 - 70 years old; hospitalized patients; radiological diagnosis of viral pneumonia; virological diagnosis of SARS-CoV-2 infection by PCR; with noninvasive ventilatory support; PaO2 / FIO2 ratio between 200 and 300; C-reactive protein and ferritin above the reference value considered normal; use of corticosteroids in the dose recommended by the literature (CoDex or Recovery Protocols)
Exclusion criteria
Exclusion criteria: Contraindications for use of corticosteroids; immunosuppressive and antiviral treatment; morbid obesity (BMI> 35); multiple organ dysfunction syndrome; pre-malignant neoplastic conditions with life expectancy lower than 1 year old; pre-existing chronic illnesses like chronic dialysis kidney disease, chronic liver disease, congestive heart failure Class IV; pre-existing thromboembolic pathology; pre-existing severe allergic reaction; history of HIV and tuberculosis; enrollment in another clinical trial; pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The expected primary outcome is safety in the use of intravenously infused CTM-TCU suspension in patients with pneumonia caused by SARS-CoV-2. | — |
Secondary
| Measure | Time frame |
|---|---|
| The expected secondary outcome include the effectiveness of the CTM-TCU infusion in patients with pneumonia caused by SARS-CoV-2. | — |
Countries
Brazil
Contacts
Public ContactPaulo Brofman
Pontifícia Universidade Católica do Paraná
Outcome results
None listed