Coronavirus infection of unspecified location
Conditions
Interventions
Mesenchymal stem cell from umbilical cord tissue will be administered systemically via intravenous infusion. Treatment consists of a single dose on day 1 of the study. The dosage will be customized ac
E02.095.147.500.500
Sponsors
StemCorp
StemCorp
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 18 years or older; Admission to the ICU by COVID-19, confirmed by positive RT-PCR for SARS-CoV-2 (test registered by ANVISA); Diagnosis of acute respiratory distress syndrome related to COVID-19 and defined by changes in radiological images, gas exchange and the need for invasive mechanical ventilation (WHO classification 7 or higher); Be on invasive mechanical ventilation for a period greater than or equal to seven days; Absence of weaning from mechanical ventilation in the next 24 hours.
Exclusion criteria
Exclusion criteria: Patients who are part of experimental treatments or who have participated in any clinical trial in the last 3 months; Patients who have some type of active cancer, according to the medical record of the ICU, which is generally based on clinical history obtained with the patient's family members; Patients with an autoimmune disease, according to the medical record of the ICU, which is generally based on clinical history obtained with the patient's family members; Pregnant and lactating patients. For female patients in reproductive age, a hCG test will be collected to exclude the possibility of pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety of the clinical protocol will be assessed by monitoring adverse events from the infusion (day 1) until the end of the patient's follow-up (day 21). ;Serious adverse events such as prolonged hospital stay, suspected infection by cell therapy product, embolism, infarction or death will be monitored and recorded in a specific form. | — |
Secondary
| Measure | Time frame |
|---|---|
| CD4+ T cell count and cytokine levels (days 1, 3, 6, 10 14 and 21);Monitoring of type of ventilatory support, use of vasoactive drugs and use of dialysis (days 1-21);Assessment of gas exchange improvement by measuring the PaO2 / FiO2 ratio (days 1 - 10);Levels of C-reactive protein, D-dimer, ferritin, thrombomodulin, as well as leukocyte and lymphocyte count (days 1, 3, 6, 10, 14 and 21);Assessment of improvement in respiratory mechanics, in particular the measurement of dynamic compliance of the respiratory system (days 1 - 10);Time to clinical improvement, defined as the time from the patient's inclusion in the study to the decline of 2 categories on the WHO ordinal progression scale or hospital discharge (whatever comes first);Length of hospital stay (day 21);Survival (day 21) | — |
Countries
Brazil
Contacts
Public ContactEsper Kallas
Outcome results
None listed