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There are 11 clinical trials
Patients 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 28Measure: Determine the incidence of cardiomyopathies and venous thromboembolism Time: 28 days
Description: Incidence of mortality at day 28Measure: Mortality Time: 28 days
Description: Number of day of using mechanical ventilation for each patientsMeasure: Duration of mechanical ventilation Time: hospitalisation duration
Description: Incidence of shock during hospitalisationMeasure: Shock Time: hospitalisation duration
Description: Number of day at hospitalMeasure: length of stay Time: hospitalisation duration
Description: Setting up or not of mechanical ventilationMeasure: Mechanical ventilation Time: hospitalisation duration
Description: Administration or not of renal replacement therapyMeasure: Renal replacement therapy Time: hospitalisation duration
The aim of this study is to investigate the prevalence and possible risk factors of the occurrence of a DVT in 12 intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020).
Description: to investigate the prevalence of a DVT in patients at the ICU.Measure: the prevalence of a DVT in patients at the ICU. Time: 1 day at ICU
Description: evaluate pO2 and pCO2 (mmHg) in patients with and without a DVTMeasure: Oxygen partial pressure and Carbon dioxide partial pressure levels in the blood Time: 1 day at ICU
Description: evaluate Potassium, Sodium, Calcium, Bicarbonate, Base excess, Lactate levels (mmol/l) in patients with and without a DVTMeasure: Potassium, Sodium, Calcium, Bicarbonate, Base excess, Lactate levels in the blood Time: 1 day at ICU
Description: evaluate glucose, haemoglobin, ureum, creatinine, total bilirubin levels (mg/dl) in patients with and without a DVTMeasure: glucose, haemoglobin, ureum, creatinine, total bilirubin levels in the blood Time: 1 day at ICU
Description: evaluate oxygen saturation, basophils, eosinophils, monocytes, neutrophils, haematocrit and prothrombine levels in the blood (%) in patients with and without a DVTMeasure: oxygen saturation, basophils, eosinophils, monocytes, neutrophils, haematocrit and prothrombine levels in the blood Time: 1 day at ICU
Description: evaluate white blood cells (x 10*9/L), red blood cells (x 10*12/L) and platelets levels (x 109/L) in the blood in patients with and without a DVTMeasure: white blood cells, red blood cells and platelets in the blood Time: 1 day at ICU
Description: evaluate PT (%)aPTT (sec)Fibrinogen (g/L)D-dimers (mg/L) PT (INR) (ratio) AST (U/L)ALT (U/L)Lactate dehydrogenase (U/L)Troponin T (ng/L)CRP (mg/L)Ferritin (mg/L) in the blood in patients with and without a DVTMeasure: PT (%)aPTT (sec)Fibrinogen (g/L)D-dimers (mg/L) PT (INR) (ratio) AST (U/L)ALT (U/L)Lactate dehydrogenase (U/L)Troponin T (ng/L)CRP (mg/L)Ferritin (mg/L)in the blood Time: 1 day at ICU
Description: revalence of co morbidities such as Cardiovascular disease, n (%) Hypertension, n (%) Diabetes, n (%) Respiratory disease, n (%) Malignancy, n (%) Chronic renal disease, n (%) Chronic liver disease, n (%) Chronic bowel disease, n (%) Chronic nerve disease, n (%) Cerebrovascular disease, n (%) HIV/AIDS, n (%) Haematological disease, n (%) Obesity, n (%) Rheumatological disease, n (%) Dementia, n (%) in patients with and without a DVT admitted at the ICU in 1 dayMeasure: prevalence of co-morbidities Time: 1 day at ICU
Description: prevalence of vital signs such Temperature (°C) Breathing rate (#/min) Systolic blood pressure (mmHg) Mean arterial blood pressure (mmHg) Heart rate (#/min) Glasgow Coma Scale in patients with and without a DVTMeasure: prevalence of vital signs at icu admission Time: at ICU admission
Description: prevalance of complications such as ARDS Acute kidney failure Acute heart failure Septic shock Secondary infection Seizure Stroke Hyperglaecemia Hypoglaecemia during ICU stay in patients with and without DVTMeasure: prevalence of complications during icu stay Time: from ICU admission to cross sectional moment (29/3/2020)
Description: evaluation of treatment such as Antiviral treatment Antibiotic treatment Antifungal treatment Corticosteroid treatment CRRT IVIg treatment Plaquenil treatment during ICU stay in patients with and without DVTMeasure: evaluation of treatment Time: from ICU admission to cross sectional moment (29/3/2020)
Description: evaluation of the oxygen therapy such as Invasive mechanical ventilation FiO2 (mmHg) PEEP Length of ventilationA ECMO Invasive mechanical ventilation + ECMO Vasopressor/inotropic support Neuromuscular blocking agents Prone ventilation in patients with and without DVTMeasure: evaluation of the oxygen therapy Time: from ICU admission to cross sectional moment (29/3/2020)
The purpose of this study is to evaluate the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection (i.e., COVID-19).
Description: To investigate the safety of in-hospital thromboprophylaxis with twice-daily low-dose enoxaparin thromboprophylaxis as measured by cumulative incidence of ISTH-defined clinically-relevant bleeding events during hospitalization. Clinically relevant bleeding episodes may include any of the following: 1) fatal bleeding; 2) clinically overt bleeding associated with a decline in hemoglobin of ≥2g/dL in a 24h period; 3) retroperitoneal, pulmonary, or central nervous system bleeding; 4) bleeding requiring surgical intervention in an operating suite; 5) bleeding for which a blood product is administered (blood product administration not directly attributable to the patient's underlying condition); 6) bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating suite.Measure: Safety of in-hospital thromboprophylaxis Time: Day 30
Description: The median twice-daily enoxaparin dose, as measured in mg/kg, required to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL in children hospitalized with COVID-19, and to compare dose-requirements by age group (birth to <1 year old, 1-<6 years old, 6-<13 years old, and 13-<18 years old).Measure: Median twice-daily enoxaparin dose Time: 4 hours post initial dose
Description: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by the proportion of serial D-dimer levels obtained at standardized time points that are <2 times the upper limit of normal (<2x ULN) values for age.Measure: Efficacy of in-hospital thromboprophylaxis as measured by the proportion of serial D-dimer levels Time: Enrollment, Day 1, Day 2, and Day 3, 7, and 14 if still hospitalized
Description: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by confirmed HA-VTE.Measure: Efficacy of in-hospital thromboprophylaxis as measured by confirmed HA-VTE Time: Day 30
Description: To investigate, on a preliminary basis, the efficacy of in-hospital thromboprophylaxis with twice-daily enoxaparin in children hospitalized with COVID-19, as measured by median duration of in-hospital increased respiratory support (new requirement for high-flow nasal cannula, non-invasive ventilation, and/or mechanical ventilation, relative to any at-home baseline requirement).Measure: Efficacy of in-hospital thromboprophylaxis as measured by median duration of increased respiratory support Time: Day 30
The main objective of the study is to determine the incidence of deep vein thromboses at Doppler echo in patients with SARS-Cov-2 pneumopathy upon their entry into ICU and after 7 days of hospitalization in ICU. This is a monocentric interventional study (RIPH 2).
Description: Deep vein thrombosis at Doppler echoMeasure: Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU Time: Day 0
Description: Deep vein thrombosis at Doppler echoMeasure: Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU Time: Day 7
This study is being conducted to assess the effectiveness of intermediate versus prophylactic doses of anticoagulation (blood thinners) in patients critically ill with COVID-19 in the intensive care units (ICUs) throughout the hospital. Anticoagulation is part of the patient's usual standard of care but determining the dose of anticoagulation is based on physician preference. The investigators are conducting this study (a randomized trial with adaptive design employing cluster randomization) with the support of all of the ICUs to collect data in order to determine what should be the standard of care in terms of anticoagulation in these critically ill patients. The patients care will not be altered other than the choice of anticoagulation (both approved and used throughout the hospital as standard of care) based on the ICU bed they are assigned. Patient data will be collected until discharge.
Description: Composite of being alive and without clinically-relevant venous or arterial thrombotic events at discharge from ICU (without transfer to another ICU or palliative care unit/hospice) or at 30 days (if ICU duration lasted 30 days or longer).Measure: Total Number of Patients with Clinically Relevant Venous or Arterial Thrombotic Events in ICU Time: Discharge from ICU or 30 days
Description: Composite of being alive and without clinically-relevant venous or arterial thrombotic events at discharge from ICU (without transfer to another ICU or palliative care unit/hospice) or at 30 days (if ICU duration lasted 30 days or longer).Measure: Total Number of Patients with In hospital Clinically Relevant Venous or Arterial Thrombotic Events Time: Discharge from hospital or 30 days
Description: Length of stay measured in days.Measure: ICU Length of Stay Time: Discharge from ICU or 30 days
Description: The impact of intermediate-dose anti-coagulation compared with prophylactic anti-coagulation on rates of acute kidney injury and renal recovery in the ICU will be measured with the total number of patients who need of renal replacement therapy in the ICU.Measure: Total Number of Patients with the Need for Renal Replacement Therapy in the ICU Time: Discharge from hospital or 30 days
Description: Major bleeding will be assessed by BARC criteria, also explored by International Society on Thrombosis and Haemostasis (ISTH) and Thrombolysis in Myocardial Infarction (TIMI) criteria.Measure: Total Number of Patients with Major bleeding in the ICU Time: Discharge from hospital or 30 days
Description: Length of stay measured in days.Measure: Hospital Length of Stay Time: Discharge from hospital or 30 days
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 deathMeasure: Venous thromboembolism Time: 28 days
Description: Risk of major bleeding defined by the ISTHMeasure: Major bleeding Time: 28 days
Description: Risk of Major Bleeding and Clinically Relevant Non-Major Bleeding Defined by the ISTHMeasure: Major Bleeding and Clinically Relevant Non-Major Bleeding Time: 28 days
Description: Risk of Venous Thromboembolism and Major BleedingMeasure: Net Clinical Benefit Time: 28 days and 2 months
Description: Risk of venous thrombosis at other sites: e.g. superficial vein, catheters, hemodialysis access, ECMO, splanchnic, encephalic, upper limbMeasure: Venous Thromboembolism at other sites Time: 28 days
Description: Risk of arterial thrombosis at any sitesMeasure: Arterial Thrombosis Time: 28 days
Description: Risk of all-cause mortalityMeasure: All-Cause Mortality Time: 28 days and 2 months
Description: 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 eCRFMeasure: Factors associated with the risk of venous thromboembolism Time: 28 days
Severe 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 days
Description: Deaths from all causes during the follow-upMeasure: Deaths Time: 7 days
The 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 strokeMeasure: Number of cardiovascular events Time: within 14 days, 30 days, and 90 days of randomization
Description: measured by number of cardiovascular events, and major bleedingMeasure: Net clinical benefit Time: within 14 days, 30 days, and 90 days of enrolment.
Description: ISTH criteria, in-hospital diagnosisMeasure: Disseminated intravascular coagulation Time: within 14 days, 30 days, and 90 days of enrolment
The 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.
Severe SARS-CoV-2 infection, responsible of COVID-19, is accompanied by many venous thromboembolic events. Antithrombotic treatment is the cornerstone of management of many neurovascular diseases (NVDs) and the benefit-risk ratio is crucial to avoid hemorrhagic complications. Therefore, in non-severe COVID-19 patients affected by NVDs, the diagnostic of deep venous thrombosis (DVT) is challenging. Using bedside Doppler ultrasonography (DUS) of lower limbs, this study investigated the rates of DVT in these patients in stroke unit.
An estimated 22% of the global population is at an increased risk of a severe form of COVID-19, while one in four coronavirus patients admitted to intensive care unit will develop a pulmonary embolism. A major public health question remains to be investigated: why COVID-19 is mild for some, critically severe for others and why only a percentage of COVID-19 patients develop thrombosis, despite the disease's proven hypercoagulable state? Patients' intrinsic characteristics might be responsible for the deep variety of disease forms. Our study aims to assess the validity of the hypothesis according to which underlining genetic variations might be responsible for different degrees of severity and thrombotic events risks in the novel coronavirus disease. Moreover, we suspect that prothrombotic genotypes occuring in the genes that encode angiotensin-converting enzyme (ACE-DEL/INS) and angiotensinogen (AGT M235T) are involved in the unpredictable evolution of COVID-19, both in terms of severity and thrombotic events, due to the strong interactions of SARS-CoV-2 with the renin-angiotensin-aldosterone system (RAAS). Therefore, we also aim to assess the validity of the theory according to which there is a pre-existing atypical modulation of RAAS in COVID-19 patients that develop severe forms and/or thrombosis. Our hypothesis is based on various observations. Firstly, there is a substantial similarity with a reasonably related condition such as sepsis, for which there is a validated theory stating that thrombophilic mutations affect patients' clinical response. Secondly, racial and ethnic genetic differences are responsible for significant dissimilar thrombotic risks among various nations. Thirdly, an increase in stroke incidence has been reported in young patients with COVID-19, without essential thrombosis risk factors, favoring the idea that a genetic predisposition could contribute to increase the thrombotic and thromboembolic risk. Fourthly, the plasminogen activator inhibitor (PAI)-1 4G/5G inherited mutation was found to be responsible for a thrombotic state causing post-SARS osteonecrosis.
Description: The difference of prothrombotic genotypes frequency between the three groupsMeasure: Number of patients with thrombophilic profile alterations Time: One year
Description: The differences of RAAS components levels between the three groupsMeasure: Number of patients with RAAS components alterations Time: One year
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