|drug4077||severity of lung involvement with COVID-19. Wiki||1.00|
|D011658||Pulmonary Fibrosis NIH||0.26|
There is one clinical trial.
Currently, there is no approved treatment for COVID-19 in France, either for the acute phase, nor for the late chronic phase. the investigator suggest that nintedanib has the potential to block the development of lung fibrosis when initiated early enough to inhibit the activation of mesenchymal cells and the progression of virus-induced pulmonary fibrosis. Computerized Tomography (CT) manifestations of fibrosis or fibrous stripes are described in COVID-19 (Ye, Eur Radiol 2020). Pan et al observed fibrous stripes in 17% patients in the early phase of the disease (Pan, Eur Radiol 2020). Ye et al observed bronchiectasis in 2 patients (15.4%) and evidence of pulmonary fibrosis in 3 patients (23.7%) at HRCT performed at 4 weeks (Ye, Eur Radiol 2020). Long term data are still lacking in patients with COVID-19 and the investigators do not know how many patients will have fibrotic sequelae from the acute illness.
Description: Change in Forced Vital Capacity over 12 months assessed by Annual Rate of Decline in FVC in Overall PopulationMeasure: The primary objective is to assess whether nintedanib slows the progression of lung fibrosis in COVID-19 survivors as assessed by the decline in the forced vital capacity (FVC) over 12 months compared to placebo. Time: at inclusion and 12 months.
Description: Rate of decline in DLCO estimated by linear regression of DLCO from baseline to 12 months from DLCO measurement at inclusion, 6 and 12 monthsMeasure: compare the rate of decline of DLCO over 12 months Time: at inclusion, 6 and 12 months
Description: Absolute change from baseline in the Six-minute walk test (6MWT) at 12 monthsMeasure: compare exercise capacity at 12 months Time: at 12 months
Description: HRCT fibrosis score and HRCT fibrosis extension (visual and computer-based assessment) at inclusion and 12 monthsMeasure: compare high resolution CT (HRCT) lung opacities extension at 12 months Time: at inclusion and 12 months
Description: Absolute change from baseline in the total score on the St. George's Respiratory Questionnaire questionnaire at 12 monthsMeasure: compare change in health-related quality of life Time: at 12 months
Description: Absolute change from baseline in the Dyspnea score (Multidimensional Dyspnea Profile and mMRC score) at 3, 6, 9 and 12 monthsMeasure: compare the evolution of dyspnea over time Time: at 3, 6, 9 and 12 months
Description: The absolute change from baseline Hospital Anxiety and Depression score at 3, 6, 9 and 12 monthsMeasure: compare change in Depression and anxiety over time Time: at 3, 6, 9 and 12 months
Description: Biomarker assay (KL-6, NT-proBNP, CRP, D-dimers) at inclusion and 12 monthsMeasure: compare change in lung injury, pulmonary hypertension and inflammation biomarkers Time: at inclusion and 12 months
Description: Percentage of patients with a tricuspid regurgitation velocity > 2.5, 2.8 and 3.4 m/sec evaluated at baseline and at 12 months.Measure: pulmonary hypertension prevalence at inclusion and 12 months Time: at inclusion and 12 months
Description: MUC5B at risk allele detection at inclusionMeasure: association between genetic susceptibility (MUC5B polymorphism) and lung fibrosis in COVID-19 survivors Time: at inclusion
Description: Incidence of clinical or biological adverse events with nintedanib versus placebo over 12 monthsMeasure: safety of nintedanib Time: over 12 months
Data processed on January 01, 2021.
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