|drug1040||Discontinuation of ARB/ACEI Wiki||1.00|
|drug1561||ISIS 721744 Wiki||1.00|
|drug2208||Normal Saline Wiki||0.50|
There is one clinical trial.
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for coronavirus disease 2019 (COVID-19), is associated with a high incidence of acute respiratory distress syndrome (ARDS) and death. Hypertension and cardiovascular disease are risk factors for death in COVID-19. Angiotensin converting enzyme 2 (ACE2), an important component of the renin-angiotensin system, serves as the binding site of SARS-CoV-2 and facilitates host cell entry in the lungs. In experimental models, angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) have been shown to increase ACE2 expression in several organs, potentially promoting viral cell invasion, although these findings are not consistent across studies. Alternatively, ACEIs and ARBs may actually improve mechanisms of host defense or hyperinflammation, ultimately reducing organ injury. Finally, ACEIs and ARBs may have direct renal, pulmonary and cardiac protective benefits in the setting of COVID-19. Therefore, it is unclear if ACEIs and ARBs may be beneficial or harmful in patients with COVID-19. Given the high prevalence of hypertension, cardiovascular and renal disease in the world, the high prevalence of ACEIs or ARBs in these conditions, and the clinical equipoise regarding the continuation vs. discontinuation of ACEIs/ARBs in the setting of COVID, a randomized trial is urgently needed. The aim of this trial is to assess the clinical impact of continuation vs. discontinuation of ACE inhibitors and angiotensin receptor blockers on outcomes in patients hospitalized with COVID-19.
Description: The primary endpoint of the trial will be a global rank score that ranks patient outcomes according to four factors: (1) time to death, (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO), (3) the number of days supported by renal replacement therapy or pressor/inotropic therapy, and (4) a modified sequential Organ Failure Assessment (SOFA) score. The modified SOFA score will include the cardiac, respiratory, renal and coagulation domains of the SOFA score.Measure: Hierarchical composite endpoint Time: Up to 28 days
Description: The Area Under the Curve of the modified SOFA (AUC SOFA) from daily measurements, weighted to account for the shorter observation period among patients who die in-hospital.Measure: AUC SOFA Time: Up to 28 days
Description: CompositeMeasure: Intensive care unit admission or respiratory Failure Requiring Mechanical Ventilation. Time: Up to 28 days
Description: Hypotension Requiring Vasopressors, inotropes or mechanical hemodynamic support (ventricular assist device or intra-aortic balloon pump).Measure: Hypotension Requiring Vasopressors, inotropes or mechanical hemodynamic support Time: Up to 28 days
Description: Number of days in 28-day period feee of invasive or non-invasive mechanical ventilation.Measure: Number of 28-Day Ventilator-Free Days. Time: Up to 28 days
Description: Difference between NT-proBNP at the time of randomization and the maximum valueMeasure: Maximal change in NT-proBNP from baseline Time: 28 days from enrollment
Description: as aboveMeasure: Change in serum creatinine between randomization and discharge (or time of death) Time: Up to 28 days
Description: defined as Kidney Disease Improving Global Outcomes Stage 2 or higher or initiation of renal replacement therapyMeasure: Acute kidney injury during hospitalization Time: Up to 28 days
Description: Proteinuria or Hematuria detected on urinalysisMeasure: Proteinuria or Hematuria Time: Up to 28 days
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