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Name (Synonyms) | Correlation | |
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drug15 | 0.9% Sodium-chloride Wiki | 0.50 |
drug3981 | rNAPc2 Wiki | 0.50 |
drug209 | Anakinra Prefilled Syringe Wiki | 0.50 |
Navigate: Correlations HPO
There are 4 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. 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 in the trial is days alive and free of organ support at day 21. This endpoint is defined as the number of days that a patient is alive and free of organ support through the first 21 days after trial entry. Organ support is defined as receipt of invasive or non-invasive mechanical ventilation, high flow nasal oxygen (>30 L/min), vasopressor therapy, or ECMO support. Death at any time (including beyond 21 days) during the index hospital stay is assigned the worst possible score of -1.
Measure: Mortality and days free of organ support Time: 21 daysDescription: A composite endpoint of death, deep vein thrombosis, pulmonary embolism, systemic arterial thromboembolism, myocardial infarction, or ischemic stroke collected during hospitalization or at 28 days and 90 days after enrollment (whichever is earlier).
Measure: Arterial and venous thrombotic conditions Time: 28 days and 90 daysDescription: Ordered categorical endpoint with three possible outcomes based on the worst status of each patient through day 30 following randomization: no 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 28 days following randomization.
Measure: Hospital-free days Time: 28 daysDescription: Days alive not on a ventilator assessed at 28 days following randomization.
Measure: Ventilator-free days Time: 28 daysDescription: Symptomatic proximal venous thromboembolism (DVT or PE).
Measure: Venous thromboembolism Time: 28 days and 90 daysDescription: Days alive not on a vasopressor assessed at 28 days following randomization.
Measure: Vasopressor-free days Time: 28 daysDescription: Days alive not on renal replacement assessed at 28 days following randomization.
Measure: Renal replacement free days Time: 28 daysDescription: Hospital re-admission within 28 days.
Measure: Hospital re-admission Time: 28 daysDescription: As defined by KDIGO criteria.
Measure: Acute kidney injury Time: Duration of studyDescription: Use of extracorporeal membrane oxygenation (ECMO) support.
Measure: ECMO support Time: Duration of studyDescription: Dialysis or ECMO.
Measure: Mechanical circuit thrombosis Time: Duration of studyDescription: Peak scale over 28 days, scale at 14 days, and proportion with improvement by at least 2 categories compared to enrollment, at 28 days.
Measure: WHO ordinal scale Time: 28 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
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 randomizationDescription: 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 randomizationSequential randomized, multicenter, active comparator study to evaluate the hypothesis that rNAPc2 (AB201), a novel, potent and highly selective tissue factor inhibitor with anticoagulant, anti-inflammatory and potential antiviral properties, shortens time to recovery compared to heparin in hospitalized patients with COVID-19 and elevated D-dimer levels.
Description: central lab D-dimer results
Measure: Change in D-dimer level from Baseline to Day 8 (Phase 2b) Time: 8 daysDescription: clinical events as reported by site
Measure: Number of major or non-major clinically relevant bleeding events within thirty (30) days of randomization (Phase 2b) Time: 30 daysDescription: scale as assessed by investigator and clinical adjudication committee
Measure: Time to recovery within thirty (30) days of randomization using the ACTT ordinal scale (Phase 3) Time: 30 daysDescription: central lab D-dimer results
Measure: Change in D-dimer level from baseline to Day 10 (Phase 2b) Time: 10 daysDescription: clinical events as reported by site
Measure: Number of major or non-major clinically relevant bleeding events with rNAPc2 vs. heparin (Phase 2b and 3) Time: 30 daysDescription: clinical events as reported by site
Measure: Number of bleeding events in subjects treated with higher vs. lower dose rNAPc2 at Day 10 (Phase 2b) Time: 10 daysDescription: clinical events as reported by site
Measure: Time to first occurrence of a composite of thrombotic events and all-cause mortality within thirty (30) days of randomization (Phase 3 only) Time: 30 daysDescription: clinical events as reported by site
Measure: Time to first occurrence of thrombotic events within thirty (30) days of randomization (Phase 3 only) Time: 30 daysDescription: clinical events as reported by site
Measure: Time to all-cause mortality within thirty (30) days of randomization (Phase 3 only) Time: 30 daysDescription: central lab samples collected per protocol
Measure: Change in Tissue Factor laboratory values in rNAPc2 treated subjects who had clinical events related to coagulation and inflammation from baseline to Days 8 and 10 (Phase 2b) Time: day 8 and day 10Description: central lab samples collected per protocol
Measure: Change in interleukin-6 laboratory values in rNAPc2 treated subjects who had clinical events related to coagulation and inflammation from baseline to Days 8 and 10 (Phase 2b) Time: day 8 and day 10Description: central lab samples collected per protocol
Measure: Change in high sensitivity C-reactive protein laboratory values in rNAPc2 treated subjects who had clinical events related to coagulation and inflammation from baseline to Days 8 and 10 (Phase 2b) Time: day 8 and day 10Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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