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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2651 | Obesity Wiki | 1.00 |
| drug1838 | Hypertension Wiki | 1.00 |
| drug3775 | Statins (Cardiovascular Agents) Wiki | 1.00 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.08 |
| D055371 | Acute Lung Injury NIH | 0.08 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.07 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
This is an open label, dose escalating safety study of the advanced therapy investigational medicinal product (ATIMP) KI-MSC-PL-205, where patients diagnosed with SARS-CoV-2-induced severe acute respiratory distress syndrome (ARDS), according to the Berlin Definition, and who are on respirator/ventilator (used synonymously in this protocol) support due to respiratory insufficiency with or without concomitant circulatory problems, will be included and treated with a single dose of KI-MSC-PL-205.
Description: The incidence of pre-specified treatment related adverse events of interest (TRAEIs) occurring during the 10 days interval beginning with the start of the ATIMP infusion: New ventricular tachycardia, ventricular fibrillation or asystole within 10 days after infusion New cardiac arrhythmia requiring cardioversion within 10 days after infusion Clinical scenario consistent with transfusion incompatibility or transfusion-related infection within 10 days after infusion Thromboembolic events (e.g. Pulmonary embolism) within 10 days after infusion Cardiac arrest or death within 10 days after infusion
Measure: The incidence of pre-specified treatment related adverse events of interest (TRAEIs). Time: From drug administration to day 10 post-infusionDescription: All-cause mortality at 60 days and then annually
Measure: Safety; All-cause mortality Time: 60 days post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusionDescription: Changes from baseline (Day 1; prior to administration of ATIMP) in the leucocyte Count (number/L)
Measure: Changes in Leucocytes Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusionDescription: Changes from baseline (Day 1; prior to administration of ATIMP) in the trombocyte Count (number/L)
Measure: Changes in Trombocytes Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusionDescription: Changes from baseline (Day 1; prior to administration of ATIMP) in the plasma concentration of CRP (mg/L)
Measure: Changes in plasma concentration of C-reactive protein (CRP) Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusionDescription: Changes from baseline (Day 1; prior to administration of ATIMP) in the plasma concentration of PK (INR)
Measure: Changes in plasma concentration of Prothrombin complex (PK) Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusionDescription: Changes from baseline (Day 1; prior to administration of ATIMP) in the plasma concentration of creatinine (μmol/L)
Measure: Changes in plasma concentration of Creatinine Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusionDescription: Changes from baseline (Day 1; prior to administration of ATIMP) in the plasma concentration of ASAT (μkat/L)
Measure: Changes in plasma concentration of Aspartate amino transferase (ASAT) Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusionDescription: Changes from baseline (Day 1; prior to administration of ATIMP) in the plasma concentration of ALAT (μkat/L)
Measure: Changes in plasma concentration of Alanine amino transferase (ALAT) Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusionDescription: Changes from baseline (Day 1; prior to administration of ATIMP) in the plasma concentration of NT-proBNP (ng/L)
Measure: Changes in plasma concentration of N-terminal pro-brain natriuretic peptide (NT-proBNP) Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusionDescription: Changes from baseline (Day 1; prior to administration of ATIMP) in blood pressure (mmHg)
Measure: Changes in Blood pressure Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusionDescription: Changes from baseline (Day 1; prior to administration of ATIMP) in body temperature (°C)
Measure: Changes in Body temperature Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusionDescription: Changes from baseline (Day 1; prior to administration of ATIMP) in pulmonary compliance (dynamic and static) until day 10 post-infusion
Measure: Efficacy; Changes in pulmonary compliance Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusionDescription: Changes from baseline (Day 1; prior to administration of ATIMP) in driving pressure (Plateau pressure- PEEP) until day 10 post-infusion
Measure: Efficacy; Changes in driving pressure (Plateau pressure- PEEP) Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusionDescription: Changes from baseline (Day 1; prior to administration of ATIMP) in oxygenation (PaO2/FiO2) until day 10 post-infusion
Measure: Efficacy; Changes in oxygenation (PaO2/FiO2) Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusionDescription: Number of days with ventilator support
Measure: Efficacy; Duration of ventilator support Time: Baseline (pre-infusion),day 1, 2, 3, 4, 7, 10 and 60 post-infusionDescription: Changes in amount of pulmonary bilateral infiltrates assessed by pulmonary X-ray from baseline (Day 1; prior to administration of ATIMP) until day 60
Measure: Efficacy; Pulmonary bilateral infiltrates Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusionDescription: Changes in Sequential Organ Failure Assessment (SOFA) score from baseline (Day 1; prior to administration of ATIMP) and during the ICU-period
Measure: Efficacy; Sequential Organ Failure Assessment (SOFA) score Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, end of ICUDescription: Duration of ICU stay and hospital stay (number of days; whole hospital period + calculated from Day 1)
Measure: Efficacy; Hospital stay Time: Day 60 post-infusionDescription: Recovery of lung function assessed by Spirometry (FEV1, Vital Capacity) at day 60 and then annually
Measure: Lung function Time: Day 60 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusionDescription: To assess development of lung fibrosis using the HRCT Fibrosis Score using Computed tomography (CT) at baseline and on day 1, 3, 7, 10, end of ICU-residence, end of hospital stay, day 60, 6 month and 12 month and end of study (if possible during the infectious stage depending on hospital safety regimen during the pandemic).
Measure: Lung fibrosis Time: Baseline (pre-infusion), day 1, 3, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusionDescription: Assessment of the patient's physical capacity by 6-Minute-Walk-Test (6MWT), starting at 6 months post Day 1 and then annually
Measure: Six minutes walk test Time: 6 months, 1, 2, 3, 4 and 5 years post-infusionDescription: Changes in Quality of Life by assessing the Short Form Health Survey (SF-36) score (starting at 6 months post Day 1 and then annually; patient reported outcome)
Measure: Changes in Quality of life Time: 6 months, 1, 2, 3, 4 and 5 years post-infusionDescription: Change in blood biomarkers related to the proposed mechanisms of action of KI-MSC-PL-205 in ARDS
Measure: Blood biomarkers Time: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusionDescription: Sensitisation tests (test for donor-specific antibodies) against KI-MSC-PL-205 donor
Measure: Sensitisation test Time: Baseline (pre-infusion), day 60 post-infusionAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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