|drug3447||The usual treatment Wiki||1.00|
|D045169||Severe Acute Respiratory Syndrome NIH||0.04|
|D018352||Coronavirus Infections NIH||0.04|
There is one clinical trial.
Background: A novel Coronavirus (SARS-CoV-2) described in late 2019 in Wuhan, China, has led to a pandemic and to a specific coronavirus-related disease (COVID-19), which is mainly characterized by a respiratory involvement. While researching for a vaccine has been started, effective therapeutic solutions are urgently needed to face this threaten. The renin-angiotensin system (RAS) has a relevant role in COVID-19, as the virus will enter host 's cells via the angiotensin-converting enzyme 2 (ACE2); RAS disequilibrium might also play a key role in the modulation of the inflammatory response that characterizes the lung involvement. Angiotensin-(1-7) is a peptide that is downregulated in COVID-19 patient and it may potentially improve respiratory function in this setting. Methods/Design: The Investigators describe herein the methodology of a randomized, controlled, adaptive Phase II/Phase III trial to test the safety, efficacy and clinical impact of the infusion of angiotensin-(1-7) in COVID-19 patients with respiratory failure requiring mechanical ventilation. A first phase of the study, including a limited number of patients (n=20), will serve to confirm the safety of the study drug, by observing the number of the severe adverse events. In a second phase, the enrollment will continue to investigate the primary endpoint of the study (i.e. number of days where the patient is alive and not on mechanical ventilation up to day 28) to evaluate the efficacy and the clinical impact of this drug. Secondary outcomes will include the hospital length of stay, ICU length of stay, ICU and hospital mortality, time to weaning from mechanical ventilation, reintubation rate, secondary infections, needs for vasopressors, PaO2/FiO2 changes, incidence of deep vein thrombosis, changes in inflammatory markers, angiotensins plasmatic levels and changes in radiological findings. The estimated sample size to demonstrate a reduction in the primary outcome from a median of 14 to 11 days is 56 patients, 60 including a dropout rate of 3% (i.e. 30 per group), but a preplanned recalculation of the study sample size is previewed after the enrollment of 30 patients. Expected outcomes/Discussion: This controlled trial will assess the efficacy, safety and clinical impact of the Angiotensin-(1-7) infusion in a cohort of COVID-19 patients requiring mechanical ventilation. The results of this trial may provide useful information for the management of this disease.
Description: composite outcome of mortality and necessity of mechanical ventilationMeasure: ventilator free days Time: 28 days
Description: number of days free from intensive care unitMeasure: ICU free days Time: trough study completion, on average 40 days
Description: Hospital length of stayMeasure: Hospital length of stay Time: through study completion, on average 60 days
Description: Time to wean from mechanical ventilationMeasure: Time to wean from mechanical ventilation Time: through study completion, on average 14 days
Description: PaO2/FiO2 changes during drug administrationMeasure: PaO2/FiO2 changes during drug administration Time: 48 hours
Description: US confirmed deep vein thrombosisMeasure: Deep vein thrombosis incidence Time: through study completion, on average 30 days
Description: including IL-1, IL-2, IL-6, IL-7, IL-8, IL-10, TNF-alpha, interferon gammaMeasure: Changes in inflammatory markers Time: at randomization, 48 hours after randomization and 72 hours after randomization
Description: Ang II and Ang-(1-7) plasmatic levelsMeasure: RAS effectors levels Time: at randomization, 48 hours after randomization and 72 hours after randomization
Description: Chest x-ray or CT scan changesMeasure: Radiological findings Time: through study completion, on average 30 days
Description: phase 2b = principal safety outcome; phase 3 = secondary outcomeMeasure: Rate of serious adverse events Time: study drug administration/day 28 or ICU discharge or death
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