|drug843||Continuation of ARB/ACEI Wiki||1.00|
|drug1040||Discontinuation of ARB/ACEI Wiki||1.00|
|drug2208||Normal Saline Wiki||0.50|
There is one clinical trial.
Up to 1/3 of all patients infected with COVID-19 can develop complications that require hospitalization. Severe pneumonia associated with acute respiratory distress syndrome (ARDS) is the most threatening and feared complication of COVID-19 infection, with mortality rates close to 50% in some groups. Autopsies between these severe cases reveal severe capillary involvement, with signs of intense inflammatory changes, microvascular thrombosis, endothelial injury and abnormal tissue repair. The available evidence suggests that abnormal activation or imbalance in the counter-regulation of the kallikrein-kinin system may play a central role in a positive feedback cycle, leading to consequent diffuse microangiopathy. Blockade of the kallikrein-kinin system can therefore prevent deterioration of lung function by reducing inflammation, edema and microthrombosis. The objective of this phase IIb study is to assess the preliminary effects on the oxygenation parameters of an antisense oligonucleotide that inhibits pre-kallikrein synthesis in patients with moderate to severe COVID-19.
Description: Number of days the patient is alive and not receiving any supplementary respiratory support (oxygen, non-invasive ventilation, high flow nasal catheter or mechanical ventilation) during 15 daysMeasure: Days alive without respiratory support (any supplemental oxygen) after 15 days (DAFOR15) Time: 15 days
Description: Sequential Organic Failure Assessment [SOFA]. This will be a primary secondary outcome. Analysis will check for trends in SOFA up to 15 days in a single model.Measure: SOFA - Sequential Organ Failure Assessment Score up to 15 days after randomization Time: 15 days
Description: Intubation and initiation of mechanical ventilation for any given reasonMeasure: Need for mechanical ventilation Time: 30 days (or until hospital discharge)
Description: Number of days the patient remains in mechanical ventilationMeasure: Duration of mechanical ventilation Time: 30 days (or until hospital discharge)
Description: Daily oxygenation levels assessed using the ROX index [(Oxygen Saturation/Inspired Fraction)/Respiratory Rate] from randomization to discharge or day 14, whichever comes first.Measure: Oxygenation index Time: 14 days
Description: C-reactive protein levels over time up to 15 days or hospital discharge.Measure: C-reactive protein levels during first 15 days after randomization Time: 15 days
Description: Lymphocyte/neutrophil ratio over time up to 15 or until discharge discharge day.Measure: Lymphocyte/neutrophil ratio during first 15 days after randomization Time: 15 days
Description: D-dimer serum levels over time or until hospital discharge.Measure: D-dimer serum level during first 15 days after randomization Time: 15 days
Description: Fibrinogen serum levels over time up to 15 days or until hospital dischargeMeasure: Fibrinogen serum levels during first 15 days after randomization Time: 15 days
Description: Prothrombin Time over time up to 15 days or until hospital discharge.Measure: Prothrombin Time levels during first 15 days after randomization Time: 15 days
Description: Activated Partial Thromboplastin Time over time up to 15 days or until hospital discharge.Measure: Activated Partial Thromboplastin Time during first 15 days after randomization Time: 15 days
Description: One-year all cause mortalityMeasure: Mortality Time: 1 year after randomization
Description: Quality of Life measured by EQ-5D from 11111-33333, lower values being betterMeasure: Euroquol questionnaire for quality of life with 5 dimensions (EQ-5D) Time: 1 year after randomization
Data processed on December 13, 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