|drug3809||Support treatment Wiki||1.00|
|drug1918||Inactivated convalescent plasma Wiki||1.00|
There is one clinical trial.
Coronavirus disease 2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has been shown to predispose patients to thrombotic diseases (venous and arterial) with reported rates in hospitalized patients between 17-40%. The influence of SARS-CoV-2 infection on the coagulation is hypothesized to be regulated by platelet activation, proinflammatory cytokines, endothelial cell injury and stasis. The elevated levels of d-dimer and fibrinogen and clinical signs of organ damage point to a significant hypercoagulable state. The latter induces a high risk for micro-thrombi and multi-organ ischemia. Therefore, early detection and a comprehensive understanding of the influence of the virus on the coagulation and platelet pathways are essential to address this epidemic. It is critical at this time to make all efforts possible to optimize our available technology to care for COVID-19 patients who are at risk for thrombotic disease through appropriate choice, dosing, and laboratory monitoring of antithrombotic therapy. The investigators hypothesize that COVID-19 is a heightened prothrombotic/hypercoagulability state that can be characterized using platelet function testing and thrombelastography. More information is required to study the effect of COVID-19 on coagulation and platelet pathways to develop effective antithrombotic treatment strategies. This is a multi-center center, non-interventional study enrolling patients who are COVID-19 positive or who have tested negative showing indication of the disease (high D-dimer and positive lung imaging). The study specific laboratory assessments will be obtained at baseline (closest to time of hospitalization), Day 3, and Day 8 from baseline and at hospital discharge. Laboratory measurements for TEG 6S , platelet aggregation, T-TAS, urinary thromboxane, genotyping, serum and plasma biomarkers will be analyzed . In-hospital and clinical follow-up data will be entered into a COVID registry Patients will be followed for clinical events during hospitalization, and up to 6 months after discharge. Patients (n=100) hospitalized with at least one of the following will be enrolled. 1. With a confirmed diagnosis of COVID-19 infection using a positive RT- PCR or a positive IgG antibody test prior to or during hospitalization or 2. With a negative COVID-19 RT-PCR test but with symptoms of possible COVID-19 infection and: 1. an elevated D-dimer and/or 2. positive imaging results showing unilateral or bilateral pneumonia or ground-glass opacity in lungs.
Description: Frequency of Hypercoagulability as measured by point-of-care thromboelastography (TEG6s)Measure: Frequency of Hypercoagulability as measured by thromboelastography measured by TEG and platelet aggregation. Time: up to day 8
Description: Incidence of High Platelet Reactivity as measured by platelet aggregation and TEG6sMeasure: Frequency of High Platelet Reactivity (HPR) Time: up to day 8
Description: Frequency of thrombo -inflammatory syndrome as determined by D-Dimer and TEG6sMeasure: Frequency of thrombo-inflammatory syndrome Time: up to day 8
Description: Correlation between TEG6s parameters and clinical outcomes (thrombotic and bleeding events, need for ventilation, death)Measure: Correlation between TEG6s parameters and clinical outcomes Time: through study completion, an average of 6 months
Description: Correlation between HPR and clinical outcomes (thrombotic and bleeding events, need for ventilation, death)Measure: Correlation between HPR and clinical outcomes Time: through study completion, an average of 6 months
Description: Determine response to anticoagulation therapy by calculating change in R-value (CK -CKH)Measure: Determine response to anticoagulation therapy Time: up to day 8
Description: Determine level of platelet aggregation by impedance aggregometryMeasure: Determine level of platelet aggregation Time: up to day 8
Description: Determine percent platelet aggregation by TEG-6S platelet Mapping assayMeasure: Determine level of platelet aggregation Time: up to day 8
Description: Determine platelet thrombi and fibrin rich platelet thrombus Area Under the Curve using TTAS analyzerMeasure: Determine platelet thrombi and fibrin rich platelet thrombus Area Under the Curve Time: up to day 8
Description: Determine short and long IgG, IgM and IgG antibody levels against using multiple specimen types (saliva, whole blood, serum, plasma, urine)Measure: Determine short and long IgG, IgM and IgG antibody levels Time: up to day 6 months
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