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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1399 | Enoxaparin 40Mg/0.4Ml Inj Syringe 0.4Ml Wiki | 0.25 |
| drug289 | Angiography scanner Wiki | 0.25 |
| drug3890 | TNKase Wiki | 0.25 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug872 | Centrum Adult (under 50) multivitamin Wiki | 0.25 |
| drug2715 | Optical Coherence Tomography (OCT) Wiki | 0.25 |
| drug1285 | Duplex ultrasound and Computed Tomography Angiography Wiki | 0.25 |
| drug4533 | intensive care unit admission ratio Wiki | 0.25 |
| drug33 | 18F-GP1 PET CT Wiki | 0.25 |
| drug31 | 18F-DX600 PET/CT Wiki | 0.25 |
| drug2737 | Oxidative Stress ELISA Kit Wiki | 0.25 |
| drug1206 | Diagnostic examination for venous thromboembolism Wiki | 0.25 |
| drug3079 | PreserVision AREDS formulation gel tabs Wiki | 0.25 |
| drug3596 | Serology test for COVID-19 Wiki | 0.18 |
| drug1396 | Enoxaparin Wiki | 0.13 |
| drug2575 | No intervention Wiki | 0.05 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D004617 | Embolism NIH | 0.88 |
| D020246 | Venous Thrombosis NIH | 0.36 |
| D054556 | Venous Thromboembolism NIH | 0.35 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D013927 | Thrombosis NIH | 0.35 |
| D013923 | Thromboembolism NIH | 0.29 |
| D016769 | Embolism and Thrombosis NIH | 0.25 |
| D002546 | Ischemic Attack, Transient NIH | 0.18 |
| D009203 | Myocardial Ischemia NIH | 0.17 |
| D007238 | Infarction NIH | 0.15 |
| D054058 | Acute Coronary Syndrome NIH | 0.10 |
| D009205 | Myocarditis NIH | 0.08 |
| D020141 | Hemostatic Disorders NIH | 0.06 |
| D001778 | Blood Coagulation Disorders NIH | 0.06 |
| D008171 | Lung Diseases, NIH | 0.05 |
| D016638 | Critical Illness NIH | 0.03 |
| D011024 | Pneumonia, Viral NIH | 0.03 |
| D011014 | Pneumonia NIH | 0.03 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.01 |
| D018352 | Coronavirus Infections NIH | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002204 | Pulmonary embolism HPO | 1.00 |
| HP:0002625 | Deep venous thrombosis HPO | 0.36 |
| HP:0001907 | Thromboembolism HPO | 0.32 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002326 | Transient ischemic attack HPO | 0.18 |
| HP:0001658 | Myocardial infarction HPO | 0.17 |
| HP:0012819 | Myocarditis HPO | 0.08 |
| HP:0001928 | Abnormality of coagulation HPO | 0.06 |
| HP:0002088 | Abnormal lung morphology HPO | 0.05 |
| HP:0002090 | Pneumonia HPO | 0.03 |
Navigate: Correlations HPO
There are 16 clinical trials
To date, the investigators have successfully employed a radiotracer (18F-sodium fluoride) as a marker of necrotic inflammation in human atherosclerosis. The investigators aim to further the mechanistic understanding of atherothrombosis by studying the activation of glycoprotein IIb/IIIa receptors in cardiovascular thrombus using the novel platelet radiotracer (18F-GP1). Binding of 18F-GP1 to activated platelets in venous and arterial thrombi has already been demonstrated in pre-clinical studies and a phase 1 trial in man. If successful, this study would define the role of the glycoprotein IIb/IIIa receptor within in vivo thrombosis across a range of cardiovascular diseases.
Description: Expression of the glycoprotein IIb/IIIa receptor (assessed by SUV) within thrombus in the arterial and venous circulation.
Measure: Ratio of 18F-GP1 standardised uptake values (SUV's) in thrombus compared with the SUVs recorded in the blood pool. Time: 6 months from end of recruitmentDescription: Expression of the glycoprotein IIb/IIIa receptor (assessed by SUV) within thrombus in the arterial and venous circulation in all 5 disease states
Measure: Ratio of 18F-GP1 standardised uptake values (SUV's) in thrombus formed in each of the 5 disease states. Time: 6 months from end of recruitmentPatients with COVID-19 in the Intensive Care Unit (ICU) or hospitalized with severe form have a poor prognosis (almost 30% rate of death). They present often a high cardiovascular risk profile (almost 30% of hypertension and 19% of diabetes). Troponin has been described to be elevated in a high proportion of patients (one fifth of all patients and 50% of non-survivors) suggesting the possibility of cardiomyopathies. High levels of DDimers (81% of non survivors) and fibrin degradation products are also associated with increased risk of mortality suggesting also the possibility of venous thromboembolism. Therefore, screening for cardiomyopathies and venous thromboembolism could represent an important challenge for patients with COVID-19 management.
Description: Incidence of cardiomyopathies and/or venous thromboembolism at day 28
Measure: Determine the incidence of cardiomyopathies and venous thromboembolism Time: 28 daysDescription: Incidence of mortality at day 28
Measure: Mortality Time: 28 daysDescription: Number of day of using mechanical ventilation for each patients
Measure: Duration of mechanical ventilation Time: 28 daysDescription: Incidence of shock at day 28
Measure: shock at day 28 Time: 28 daysDescription: Number of day in intensive care unit
Measure: length of stay in the intensive care unit Time: 28 daysReports of acute pulmonary embolism (APE) associated with COVID-19 have emerged in the literature. For example, Chen et al. described 25 pulmonary CT angiograms examinations from 1008 COVID-19 patients; 10 were positive for pulmonary embolism mostly as segmental or sub-segmental APE. Case reports of APE in Covid-19 patients have been published. Cui et al. found an incidence of deep venous thrombosis in intensive care unit (ICU) patients with severe Covid-19 pneumonia near to 25% (20/81), however without any correlation with potential APE. Despite these initial reports, it is not clear whether APE is more frequent in Covid-19 patients or if the association is just random. In favor of the former, D-dimer levels have been reported as elevated in patients with Covid-19 by two studies, and it has been suggested an independent association between the severity of the disease and the level of D-dimer. Finally, Tang et al. showed that anticoagulant therapy is associated with a decreased mortality at Day-28 in severe Covid-19 patients, in favor of a possible associated coagulopathy. The purpose of this study is to describe the rate of pulmonary embolus in patients classified as COVID-19 infection and who underwent chest CT angiography. The purpose of this study is to describe the rate of pulmonary embolus in patients classified as COVID-19 infection and who underwent chest CT angiography.
Worldwide observational studies indicate a significant prothrombogenic effect associated with SARS-CoV-2 infection with a high incidence of venous thromboembolism (VTE), notably life-threatening pulmonary embolism. According to recommendations for acute medical illnesses, all COVID-19 hospitalized patients should be given VTE prophylaxis such as a low molecular weight heparin (LMWH). A standard prophylactic dose (eg. Enoxaparin 4000IU once daily) could be insufficient in obese patients and VTE has been reported in patients treated with a standard prophylactic dose. In COVID-19 patients, guidelines from several international societies confirm the existence of an hypercoagulability and the importance of thromboprophylaxis but the "optimal dose is unknown" and comparative studies are needed. In view of these elements, carrying out a trial comparing various therapeutic strategies for the prevention of VTE in hospitalized patients with COVID-19 constitutes a health emergency. Thus, we hypothesize that an increased prophylactic dose of weight-adjusted LMWH would be greater than a lower prophylactic dose of LMWH to reduce the risk of life-threatening VTE in hospitalized patients. The benefit-risk balance of this increase dose will be carefully evaluated because of bleeding complications favored by possible renal / hepatic dysfunctions, drug interactions or invasive procedures in COVID-19 patients. This multicenter randomized (1:1) open-label controlled trial will randomize hospitalized adults with COVID-19 infection to weight-adjusted prophylactic dose vs. lower prophylactic dose of LMWH.
Description: Risk of deep vein thrombosis or pulmonary embolism or venous thromboembolism-related death
Measure: Venous thromboembolism Time: 28 daysDescription: Risk of major bleeding defined by the ISTH
Measure: Major bleeding Time: 28 daysDescription: Risk of Major Bleeding and Clinically Relevant Non-Major Bleeding Defined by the ISTH
Measure: Major Bleeding and Clinically Relevant Non-Major Bleeding Time: 28 daysDescription: Risk of Venous Thromboembolism and Major Bleeding
Measure: Net Clinical Benefit Time: 28 days and 2 monthsDescription: Risk of venous thrombosis at other sites: e.g. superficial vein, catheters, hemodialysis access, ECMO, splanchnic, encephalic, upper limb
Measure: Venous Thromboembolism at other sites Time: 28 daysDescription: Risk of arterial thrombosis at any sites
Measure: Arterial Thrombosis Time: 28 daysDescription: Risk of all-cause mortality
Measure: All-Cause Mortality Time: 28 days and 2 monthsDescription: Identification of associations between the risk of venous thromboembolism and clinical (eg. past medical history of thrombosis, cardiovascular risk factors, treatments, severity of COVID-19) and laboratory variables (e.g. D-dimers, fibrinogen, CRP) collected in the eCRF
Measure: Factors associated with the risk of venous thromboembolism Time: 28 daysSevere COVID-19 patients at a high risk of venous thromboembolism. We studied patients in 2 intensive care units of university hospitals in Barcelona and Badalona, Spain. We performed a cut-off screening of deep venous thrombosis (DVT) with bilateral duplex ultrasound to 230 patients.
Description: Patients with symptomatic pulmonary embolism confirmed on the CT-angiography and those with a swollen limb and confirmed deep venous thrombosis on compression ultrasound were considered to have "symptomatic venous thromboembolisms". The remaining patients with positive limb ultrasound or CT-angiography were considered to have "asymptomatic venous thrombembolism"
Measure: Venous thromboembolisms Time: 7 daysDescription: Deaths from all causes during the follow-up
Measure: Deaths Time: 7 daysThe OVID study will show whether prophylactic-dose enoxaparin improves survival and reduces unplanned hospitalizations in ambulatory patients aged 50 or older diagnosed with COVID-19, a novel viral disease characterized by severe systemic, pulmonary, and vessel inflammation and coagulation activation.
Description: including deep vein thrombosis (including catheter-associated), pulmonary embolism, myocardial infarction/myocarditis, arterial ischemia including mesenteric and extremities, acute splanchnic vein thrombosis, or ischemic stroke
Measure: Number of cardiovascular events Time: within 14 days, 30 days, and 90 days of randomizationDescription: measured by number of cardiovascular events, and major bleeding
Measure: Net clinical benefit Time: within 14 days, 30 days, and 90 days of enrolment.Description: ISTH criteria, in-hospital diagnosis
Measure: Disseminated intravascular coagulation Time: within 14 days, 30 days, and 90 days of enrolmentThe purpose of this study is to investigate the prevalence of venous thromboembolism in a regional health care system (Region Östergötland, Sweden) before and during the SARS-COV-2 pandemic. In a retrospective observational study, we will review patient data, diagnostic data and treatment data over a three-month period since the onset of the SARS-COV-2 pandemic. This data will be compared with data from the corresponding time frame during the years 2015 to 2019.
The main objective of this study is to describe the incidence of thromboembolic events in a population of patients hospitalized in intensive care units in France for severe COVID-19. The secondary objective of this study is to describe the evolution of hemostasis parameters during the first two weeks of intensive care hospitalization and to evaluate the influence of different anticoagulation regimens on these parameters and on the incidence of thromboembolic events
To evaluate by intravascular OCT study the presence of microvascular pulmonary thrombosis in patients with COVID-19, high D-dimer levels and contrast CT scan negative for pulmonary thrombosis. We'll also evaluate the extension of microvascular pulmonary thrombosis in patients with contrast CT scan positive for pulmonary embolism in areas where contrast CT scan was negative.
Description: Study primary endpoints will be evaluation of OCT procedure overall safety in COVID-19 pneumonia patients and assessment of the presence of microvascular pulmonary thrombosis in COVID-19 patients, both in "ground glass" and "healthy" ventilated areas.
Measure: optical coherence tomography pulmonary microthrombosis assessment in COVID-19 pneumonia patients Time: through study completion, an average of 1 monthDescription: Pulmonary artery vessel anatomy characterization in COVID-19 pneumonia patients through OCT diagnostic technique Correlations with single trans-thoracic echocardiography (TTE) pulmonary hypertension (PH, estimated systolic pulmonary artery pressure > 35 mmHg) and right ventricular disfunction (RVD: tricuspid annular plane systolic excursion < 17 mm or Doppler tissue imaging S wave < 9.5 cm/sec). Dynamic correlations with standard inflammatory, coagulation and tissue damage biomarkers: CRP, ferritin, D-dimer, NT-proBNPO, troponins, LDH)
Measure: Pulmonary artery vessel anatomy characterization Time: through study completion, an average of 1 monthDescription: Correlations with single trans-thoracic echocardiography (TTE) pulmonary hypertension (PH, estimated systolic pulmonary artery pressure > 35 mmHg) and right ventricular disfunction (RVD: tricuspid annular plane systolic excursion < 17 mm or Doppler tissue imaging S wave < 9.5 cm/sec)
Measure: Correlation between TTE pulmonary hypertension and right ventricular disfunction Time: through study completion, an average of 1 monthDescription: Pneumonia COVID-19 dynamic correlation with inflammation and coagulation markers
Measure: Correlations with standard inflammatory, coagulation and tissue damage Time: through study completion, an average of 1 monthMulticentric case-control study that is aims at: - evaluating the prevalence of pulmonary embolism among a large population of consecutive patients admitted for COVID-19 pneumonia into two large university hospitals in Paris, France: Groupe Hospitalier Paris Saint-Joseph (GHPSJ) and Hôpital Européen Georges Pompidou (HEGP) - and identifying the characteristics associated with pulmonary embolism by using a nested case control study design within the patients who underwent either unenhanced computed tomograpghy (CT) or CT pulmonary angiogram (CTPA) evaluation.
Description: Evaluate the prevalence of Pulmonary embolism among a large population of consecutive COVID-19 patients presenting respiratory symptoms
Measure: Impact of PE on COVID-19 patients Time: March 1st, 2020Description: Identify the clinical, radiological or biological characteristics associated with pulmonary embolism.
Measure: Clinical and radiological characteristics Time: April 20th,2020The purpose of the study COVID-EP is to classify all the complications occurring after the diagnosis of pulmonary embolism in patients tested initially COVID-19 positive and negative by RT-PCR (on nasopharyngeal sample) during the peak of the pandemic in France (April 2020). The patients will be followed for 1 year in order to provide clinical and paraclinical data not yet published in the literature. In order to secondarily confirm the COVID-19 status of initially negative COVID-19 patients (by RT-PCR), a serology test will be performed. The collected complications will then be compared between each of the 3 following groups: [PCR-COVID 19-Neg & Sero-COVID 19-Neg] versus [PCR-COVID 19-Neg & Sero-COVID 19-Pos] versus [PCR-COVID 19-Pos].
Description: PE complications : Chronic interstitial pathology, or Recurrence of PE, or Pulmonary hypertension, or Death.
Measure: % of patients for each group presenting the occurrence of PE complications defined by the occurrence of at least ONE of the following events up to 6 months after PE diagnosis. Time: 6 months after PE diagnosisDescription: PE complications : Chronic interstitial pathology, or Recurrence of PE, or Pulmonary hypertension, or Death.
Measure: % of patients for each group and subgroup presenting the occurrence of PE complications defined by the occurrence of at least ONE of the following events up to 12 months after PE diagnosis. Time: 12 months after PE diagnosisDescription: PE complications : Chronic interstitial pathology, or Recurrence of PE, or Pulmonary hypertension, or Death.
Measure: % of patients in each group presenting the occurrence of each of the following events at each follow-up (3 months, 6 months and 12 months after PE diagnosis). Time: 3, 6 and 12 months after PE diagnosisDescription: Category of treatments: Heparin + AVK Heparin + DOAC PE complication : Chronic interstitial pathology, or Recurrence of PE, or Pulmonary hypertension, or Death.
Measure: Effectiveness of the different category of treatments used in all patients and in the groups: % of occurrence of PE complications for each categories of treatments Time: 12 months after PE diagnosisDescription: Category of treatments: Heparin + AVK Heparin + DOAC Bleeding complications: classification 1-2-3-5 according to BARC
Measure: Effectiveness of the different category of treatments used in all patients and in the groups: % of patients with occurrence of bleeding complications for each categories of treatments Time: 12 months after PE diagnosisDescription: Category of treatments: Heparin + AVK Heparin + DOAC
Measure: Effectiveness of the different category of treatments used in all patients and in the groups: % of patients with no occurrence of complications for each categories of treatments Time: 12 months after PE diagnosisDescription: Category of treatments: Heparin + AVK Heparin + DOAC
Measure: Effectiveness of the different category of treatments used in all patients and in the groups: duration of Heparin treatment (number of day) Time: 12 months after PE diagnosisThe current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is complicated by pneumonia (15 to 20% of cases) requiring hospitalization with oxygen therapy. Almost 20 to 25% of hospitalized patients require intensive care and resuscitation; half die. The main cause of death is acute respiratory distress syndrome (ARDS). However, some deaths have been linked to pulmonary embolism (PE). Recognition of PE is important because there is specific treatment to limit its own mortality. The identification of biological parameters of hemostasis predictive of thromboembolic disease is crucial in these patients. To evaluate the frequency of PE in the patients having to be hospitalized is to practice of a systematic thoracic angiography scanner in the patients having no contra-indication for its realization, as well as during hospitalization in patients deteriorating without any other obvious cause. The thromboembolic events and disturbances of the coagulation system described in patients with SARS-CoV-2 pneumonitis suggest that this viral infection is associated with an increase in the activation of coagulation contributing to the occurrence of thrombosis and especially from PE.
Description: Rate of patients with pulmonary embolism diagnosed by thoracic angiography scanner
Measure: Rate of patients with pulmonary embolism Time: up to Day 12Description: Measure of prothrombin level to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: Prothrombin level measurement Time: up to Day 12Description: Measure of activated partial thromboplastin time to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: activated partial thromboplastin time measurement Time: up to Day 12Description: Measure of fibrinogen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: Fibrinogen measurement Time: up to Day 12Description: Measure of D-dimers to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: D-dimers measurement Time: up to Day 12Description: Measure of Protein C to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: Protein C measurement Time: up to Day 12Description: Measure of Willebrand antigen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: Willebrand antigen measurement Time: up to Day 12Description: Measure of Soluble tissue factor to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: Soluble tissue factor measurement Time: up to Day 12Description: Measure of soluble thrombomodulin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: Soluble thrombomodulin measurement Time: up to Day 12Description: Measure of E-selectin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: E-selectin measurement Time: up to Day 12Description: Measure of thrombin-antithrombin complex to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
Measure: Thrombin-antithrombin complex measurement Time: up to Day 12Description: Assessment of clot formation curve by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis
Measure: Assessment of clot formation curve Time: Day 1Description: Assessment of thrombin generation by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis
Measure: Assessment of thrombin generation Time: Day 1Description: Assessment of fibrinolysis by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis
Measure: Assessment of fibrinolysis Time: Day 1Description: Determine patient mortality
Measure: Mortality Time: Day 30Viral infections provoke the systemic inflammatory response and cause an imbalance between the procoagulant and anticoagulant homeostatic mechanisms. Multiple pathogenic mechanisms are involved, including endothelial dysfunction, increased von Willebrand factor, Toll receptor activation, and tissue factor pathway activation. D-dimer levels greater than 1000 ng / mL are associated with an 18-fold increased risk of mortality. In this context, many patients may require prophylaxis or antithrombotic treatment with low molecular weight heparins. Currently, there is no validated scheme on the dose and timing of the use of antithrombotic drugs. The study aims to identify the effect of two anticoagulant strategies (prophylactic and therapeutic) on the progression to ventilatory support or death in patients with COVID-19 infection who require hospital care.
Description: Identify the benefit of different doses of low molecular weight heparin (enoxaparin) on ventilatory support time in patients requiring hospital care for COVID-19 infection.
Measure: low molecular weight heparin (enoxaparin) and ventilatory support time Time: 30 daysDescription: To compare oral anticoagulation therapy by administering Rivaroxaban 10mg PO every 24 hours on early thrombotic complications
Measure: thrombotic complications and Rivaroxaban Time: 30 daysDescription: Identify the benefit of different doses of low molecular weight heparin (enoxaparin) on the length of hospital stay in patients requiring hospital care for COVID-19 infection.
Measure: low molecular weight heparin (enoxaparin) and length of hospital stay Time: 30 daysDescription: Identify the benefit of different doses of low molecular weight heparin (enoxaparin) over mortality rate in patients requiring hospital care for COVID-19 infection.
Measure: low molecular weight heparin (enoxaparin) and mortality rate Time: 30 daysNovel coronavirus 2019 (COVID-19) has emerged as a major international public health concern. While much of the morbidity and mortality associated with COVID-19 has been attributed to acute respiratory distress syndrome (ARDS) or end-organ failure, emerging data suggest that disorders of coagulation, in particular hypercoagulability and venous thromboembolism (VTE), may represent an additional major, and possibly preventable, complication (Wu C, et al. JAMA Intern Med. 2020 Mar 13. [Epub ahead of print] and Tang N, et al. Thromb. Haemost. 2020 Feb 19. [EPub Ahead of Print]). Abnormal coagulation testing results, especially markedly elevated D-dimer and FDP, have been associated with a poor prognosis in COVID-19 infection. We propose the following Electronic Health Record (EHR)-guided 10000-patient, retrospective observational cohort study to assess VTE incidence, risk factors, prevention and management patterns, and thrombotic outcomes in patients with COVID-19 infection. In order to gain the valuable perspective of other regional and national centers providing care for large populations of COVID-19, we have started a collaborative network with 5 additional sites which will provide us with de-identified data from 1000 patients each. These 5000 patients in addition to the 5000-patient cohort we are enrolling within the Mass General Brigham Network will comprise this study population.
Description: Frequency (%) of arterial or venous thromboembolism
Measure: Frequency of arterial or venous thromboembolism over 30 days Time: 30 daysDescription: Frequency (%) of arterial or venous thromboembolism
Measure: Frequency of arterial or venous thromboembolism over 90 days Time: 90 daysDescription: Frequency (%) of all-cause death, bleeding, and thromboembolic outcomes
Measure: Frequency of all-cause death, bleeding, and thromboembolic outcomes at 30 days Time: 30 daysDescription: Frequency (%) of all-cause death, bleeding, and thromboembolic outcomes
Measure: Frequency of all-cause death, bleeding, and thromboembolic outcomes at 90 days Time: 90 days- There is a knowledge gap associated with the management of patients with COVID-19 lung injury and a laboratory picture compatible with disseminated intravascular coagulation (DIC). Clinical data to date support that COVID-19 is associated with a prothrombotic state that is not simply explained by an influx of more critically ill individuals. - These patients suffer from severe respiratory failure; hypoxemia and ventilator dependence are the primary concerns; ARDS with respiratory failure is frequently the cause of death. Macroscopic and probable microvascular thromboembolic events are a major concern in this population. - When DIC is associated with COVID-19, it predicts a very poor prognosis. - This study will evaluate the clinical efficacy and safety of low-dose IV bolus tenecteplase (TNK) together with anticoagulation compared with control patients on therapeutic anticoagulation alone in hospitalized adults diagnosed with COVID-19 and acute intermediate-risk PE. - Prospective, multicenter, randomized two-arm trial enrolling consecutive patients who meet enrollment criteria. - The study will generate evidence that low-dose TNK together with anticoagulation is beneficial in these patients
Description: For example, a patient may start with a heart rate of 100 beats/min and systolic blood pressure of 100 mm Hg (shock index = 1) and after therapy there may be an improvement where the heart rate is 90 beats/min, with systolic blood pressure of 110 mm Hg (shock index of 0.81), an improvement of 19%. A normal shock index is between 0.5 and 0.7 in healthy patients.
Measure: Percent improvement in shock index (defined as heart rate divided by systolic blood pressure) 6 hours after the TNK/placebo bolus. Time: 6 hours post TNK/placebo infusionDescription: Assessment of patient status using an ordinal scale will be recorded at baseline and once daily in the morning while hospitalized. Level 1: Discharged (or "ready for discharge" on ambient air or < 2L suppl O2) Level 2: Non-ICU hospital ward (or "ready for hospital ward") not requiring suppl O2 Level 3: Non-ICU hospital ward (or "ready for hospital ward") requiring suppl O2 Level 4. ICU or non-ICU, requiring non-invasive ventilation or high-flow O2 Level 5. ICU, requiring intubation and mechanical ventilation Level 6: ICU, requiring ECMO or mechanical ventilation and additional organ support (e.g. vasopressors, renal replacement therapy) Level 7: Death
Measure: 1. Clinical status at 24 hours after administration of TNK / placebo based upon 7-point scale. Time: 24 +/- 6 hours post TNK/placebo infusion.The charts of patients who developed pulmonary embolism in the course of COVID-19 will be evaluated, retrospectively. Clinical features and laboratory data will be analyzed.
Description: development of pulmonary embolism
Measure: pulmonary embolism Time: 1 yearDescription: need for admission to intensive care unit
Measure: Intensive care unit Time: 1 yearDescription: mortality rate due to pulmonary embolism
Measure: mortality Time: 1 yearAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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