Name (Synonyms) | Correlation | |
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drug1839 | Placebo capsules Wiki | 0.71 |
drug1837 | Placebo Tablet Wiki | 0.71 |
drug8 | 0.9% Sodium-chloride Wiki | 0.71 |
drug262 | Azithromycin Wiki | 0.12 |
drug1086 | Hydroxychloroquine Wiki | 0.07 |
There are 2 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 daysDescription: Invasive mechanical ventilation
Measure: Intubation Time: 30 daysDescription: Days alive outside of the hospital through 30 days following randomization
Measure: Hospital-free days Time: 30 daysDescription: Number of days alive outside of the ICU through 30 days following randomization
Measure: ICU-free days Time: 30 daysDescription: Number of days alive without the use of a ventilator through 30 days following randomization.
Measure: Ventilator-free days Time: 30 daysDescription: The use of non-invasive mechanical ventilation or high flow nasal cannula
Measure: Non-invasive ventilation Time: 30 daysDescription: 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 -1
Measure: Organ support-free Time: 21 daysDescription: As defined by the International Society on Thrombosis and Haemostasis (ISTH)
Measure: Major bleeding Time: Intervention period (maximum 14 days)Description: Laboratory-confirmed
Measure: 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