Stem Cells for Severe COVID-19 patients

Phase 1

• Conditions: Coronavirus infection of unspecified location; B34.2

• Registration Number: RBR-4jh63b
• Lead Sponsor: StemCorp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-19
• Study Completion: 2021-12-31
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)