There is one clinical trial.
This study is an open-label, single-arm study to evaluate the safety and efficacy of Astrostem-V, allogenic adipose tissue derived mesenchymal stem cells (AdMSC), in patients with COVID-19 pneumonia. After each subject completes 12-Weeks visit (Visit 12) and the data management team confirms all individual data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.
Description: Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms.Measure: Treatment related adverse events Time: From baseline to Week 12
Description: Number of subjects with treatment related adverse events as assessed by analysis of adverse events including abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination.Measure: Number of subjects with treatment related abnormal variation of vital signs, physical examination and laboratory test values Time: From baseline to Week 12
Description: Change from baseline in Oxygenation index (PaO2 / FiO2 ratio) at every weekMeasure: Oxygenation index (PaO2 / FiO2 ratio) Time: From baseline to Week 12
Description: Check survival status of the subject at Visit 6, 10(Week 4, 8 and Week 12 if follow-up is possible) and record the status on eCRF.Measure: Mortality rate Time: Week 4, Week 8, and Week 12
Description: Check the duration of the ventilator retention, check when the ventilator treatment has been completed after the baseline.Measure: Ventilator treatment status Time: From Week 1 to Week 12
Description: Perform chest X-ray or CT every week (W1 - W4) after screening, baseline, and W4 followed by 2 - week intervals (W6, W8). The investigator of each clinical trial organ shall check chest X-ray or CT for bilateral shading and evaluate them.Measure: Improvement of pneumonia Time: From baseline to Week 12
Description: Check the SOFA score every week from the baseline to the W4 (W1 - W4) and 2 weeks after the W4 (W6, W8). The Sequential Organ Failure Assessment (SOFA) is a simple and clinically useful indicator that can be used to assess, predict, and monitor long-term failure in patients with multiple organ failure, and therefore increase in SOFA score can be expected to result in multiple organ failure and worse prognosis.Measure: SOFA score (Sequential Organ Failure Assessment) Time: From baseline to Week 12
Description: The Real-time PCR (RT-PCR) test for COVID-19 is measured at weekly intervals (W1 - W4) from baseline to baseline to W4 and 2 weeks after W4.Measure: 2019 nCOV nucleic acid test Time: From baseline to Week 12
Description: Check hospitalization date, date of admission at intensive care unit, or discharge date and record them in eCRF.Measure: Duration of total hospitalization and intensive care unit stay (days) Time: From baseline to Week 12
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports