|drug3768||Standard-of-care treatment Wiki||0.58|
|drug4034||Tocilizumab Prefilled Syringe Wiki||0.58|
|drug278||Anakinra Prefilled Syringe Wiki||0.58|
|D055370||Lung Injury NIH||0.11|
|D014947||Wounds and Injuries NIH||0.10|
There are 3 clinical trials
Endothelial injury as a consequence of SARS-CoV-2 infection leads to a dysregulated host inflammatory response and activation of coagulation pathways. Macro- and micro-vascular thrombosis may contribute to morbidity, organ failure, and death. Therapeutic anticoagulation with heparin may improve clinical outcomes in patients with COVID-19 through anti-thrombotic, anti-inflammatory, and anti-viral activities of heparins. This pragmatic, Bayesian adaptive randomized controlled trial will determine whether therapeutic anticoagulation with heparin (subcutaneous low molecular weight heparin or intravenous unfractionated heparin) versus usual care reduces the need for intubation or death in hospitalized patients with COVID-19 not initially requiring invasive mechanical ventilation. The trial uses an adaptive design which was chosen to overcome limitations in available data to inform a priori estimation of event rates and possible effect sizes. The adaptive design also includes response-adaptive randomization based on baseline D-dimer level, probing for differential efficacy across subgroups defined based on initial D-dimer level. This Bayesian adaptive randomized trial will stop at a conclusion 1) when the posterior probability that the proportional odds ratio is greater than 1.0 reaches 99% (definition of benefit); 2) when the posterior probability that the proportional odds ratio is greater than 1.2 is less than 10% (definition of futility) or; 3) when the posterior probability that the proportional odds ratio is less than 1.0 is greater than 90% (definition of harm). The trial will enroll a maximum of 3,000 patients, although in many simulations the trial may require fewer patients. The trial is strategically aligned with the international REMAP-CAP/COVID platform trial to accelerate evidence generation.
Description: The primary endpoint is an ordinal endpoint with three possible outcomes based on the worst status of each patient through day 30: no requirement for invasive mechanical ventilation, invasive mechanical ventilation, or death.Measure: Intubation and mortality Time: 30 days
Description: Invasive mechanical ventilationMeasure: Intubation Time: 30 days
Description: Days alive outside of the hospital through 30 days following randomizationMeasure: Hospital-free days Time: 30 days
Description: Number of days alive outside of the ICU through 30 days following randomizationMeasure: ICU-free days Time: 30 days
Description: Number of days alive without the use of a ventilator through 30 days following randomization.Measure: Ventilator-free days Time: 30 days
Description: The use of non-invasive mechanical ventilation or high flow nasal cannulaMeasure: Non-invasive ventilation Time: 30 days
Description: Number of days alive without the use of vasopressors/inotropes and ventilation (including high flow nasal cannula >30 L/min and FIO2 >40%) through 21 days following randomization, ranked with death at anytime during 21 days as -1Measure: Organ support-free Time: 21 days
Description: As defined by the International Society on Thrombosis and Haemostasis (ISTH)Measure: Major bleeding Time: Intervention period (maximum 14 days)
Description: Laboratory-confirmedMeasure: Heparin-induced thrombocytopenia (HIT) Time: Intervention period (maximum 14 days)
Randomized, placebo controlled study to determine if nebulized heparin may reduce the severity of lung injury caused by the novel coronavirus, also known as COVID-19
The COVID-19 pandemic has been spreading continuously, and in Brazil, until July 19, 2020, there have been more than 2,000,000 cases with more than 79,000 deaths, with daily increases. The present study proposes to evaluate the efficacy of methylprednisolone and heparin in treatment of patients with COVID-19 pneumonia in a randomized, controlled, 2x2 factorial study.
Description: Severity assessment will be performed using the ordinal severity scale during hospitalization.Measure: Severity assessment by ordinal severity scale Time: 3 days, 7 days, 14 days, 28 days after randomization
Description: Severity assessment will be performed using the SOFA score during hospitalization.Measure: Severity assessment by SOFA score Time: 3 days, 7 days, 14 days, 28 days after randomization
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