|drug2971||Placebo of FX06 Wiki||1.00|
|D012127||Respiratory Distress Syndrome, Newborn NIH||0.08|
|D055371||Acute Lung Injury NIH||0.08|
|D012128||Respiratory Distress Syndrome, Adult NIH||0.07|
There is one clinical trial.
Vascular leakage following endothelial injury, responsible for interstitial and alveolar edema, is a major feature of pathogen induced acute lung injury. As acute respiratory distress syndrome (ARDS) due to pandemic Covid-19 is associated with more than 60% mortality, controlling vascular leakage may be a major target to decrease the mortality associated with the spreading of the disease in France. FX06, a drug under clinical development containing fibrin-derived peptide beta15-42, is able to stabilize cell-cell interactions, thereby reducing vascular leak and mortality in several animal models, particularly during lipopolysaccharide-induced and dengue hemorrhagic shock . A phase I study was conducted in humans, with no specific adverse event detected with a dose up to 17.5 mg/kg. In a phase II randomized multicentre double-blinded trial in 234 patients suffering from ST+ acute coronary syndrome, FX06 treated patients exhibited a 58% decrease in the early necrotic core zone. Importantly, adverse events were highly comparable between groups, indicating a high safety profile for the drug . Lastly, the drug was used as a salvage therapy in a patient exhibiting a severe ARDS following EBOLA virus infection . Altogether, those data indicate that FX06 is well tolerated in humans and is a potent regulator of vascular leakage. Our hypothesis here is that FX06 may decrease pulmonary vascular hyperpermeability during ARDS following SARS-CoV-2 infection, thereby improving gas exchanges and the outcome of infected patients.
Description: Assessed by transpulmonary thermodilution Transpulmonary thermodilution systems, part of the standard management in ICU, allow a direct evaluation of vascular hyperpermeability in the lungs using thermodilution technique. EVLWi is a reliable parameter, independently associated with mortality during ARDSMeasure: Change in extravascular lung water index (EVLWi) Time: Between Day 1 and Day 7
Description: measured by transpulmonary thermodilution during 7 daysMeasure: Evolution of daily extravascular lung water index (EVLWi) Time: Between Day 1 and Day 7
Description: measured by transpulmonary thermodilution during 7 daysMeasure: Evolution of daily cardiac index Time: Between Day 1 and Day 7
Description: measured by transpulmonary thermodilution during 7 daysMeasure: Evolution of global end-diastolic volume index Time: Between Day 1 and Day 7
Description: measured by transpulmonary thermodilution during 7 daysMeasure: Evolution of pulmonary vascular permeability index Time: Between Day 1 and Day 7
Description: Evolution of blood biological criteria (g/L)Measure: Evolution of albuminemia Time: Between Day 1 and Day 7
Description: Scale from 0 to 12 better with higher score indicating more severe radiological pulmonary severityMeasure: Evolution of radiological Weinberg score Time: Day 1 to Day 30
Description: Scale from 0 to 4 betterwith higher score indicating more severe pulmonary diseaseMeasure: Evolution of pulmonary Sequential Organ Failure Assessment) score. Time: Day 1 to day 15
Description: Scale from 0 to 24, lower is better.Measure: Evolution of SOFA (Sequential Organ Failure Assessment) score Time: Day 15
Description: one or more SOFA sub-score >=3Measure: Organ failure free days Time: Day 15
Description: measured at day 1 at time 0 (before FX06 application) and after 5, 15, 30, 60 minMeasure: Evolution of FX06 concentration Time: Day 1
Description: A test for immunogenicity will be performed on a serum sample at day 7 (2 days after the end of treatment administration) to detect any antibody against FX06. The assay will consist in a three-fold procedure, as recommended by the manufacturer. An initial screening assay will qualitatively measure antibodies to FX06. Samples deemed positive will be subject to a confirmatory assay, which will determine the specificity of the detected antibody against FX06. The third tier of the assay will consist in titre analysis to semi-quantitatively assess the antibody response.Measure: Immunogenicity (antibody against FX06) induced by the drug, performed by ELISA according to manufacturer's procedure Time: Day 7
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