|drug1148||Edoxaban Tablets Wiki||0.50|
|drug952||Current care per UCLA treating physicians Wiki||0.50|
|drug3214||Standard therapy for COVID-19 according to the stablished hospital protocols. Wiki||0.50|
|D010148||Pain, Intractable NIH||0.50|
|D002925||Ciliary Motility Disorders NIH||0.50|
There are 4 clinical trials
COVID-19 is associated with a cytokine storm that leads to respiratory distress, multiorgan failure and elevated mortality. Oral colchicine exhibits high anti-inflammatory capacity attributed to the inhibition of microtubules polymerization, inflammasome and production of IL-1β and IL-6, which could prevent the inflammatory storm in COVID-19 patients at risk. We present a randomized clinical trial, controlled, open-label and pragmatic, including COVID-19 patients requiring hospitalization but no intensive care yet. Colchicine will be started within the first 48 hours and then administered for four weeks using a descending dose. The benefit will be study in terms of clinical evolution (WHO 7-point scale) and IL-6 levels, as well as other clinical and biochemical secondary end-points. In the case of positive results, the clinical impact would be relevant given that this oral medication is widely accessible which would help to prevent the inflammatory complications associated with COVID-19.
Description: improve in the clinical evolution of patients hospitalizedMeasure: Changes in the patients' clinical status through the 7 points ordinal scale WHO R&D Blueprint expert group Time: 7,14,28 Days
Description: improve in the clinical evolution of patients hospitalizedMeasure: Changes in IL-6 concentrations Time: up to day 28.
Description: time needed to reduce at least 2 points in the 7-point Ordinal Scale for Clinical Improvement by WHO R&D Blueprint expert group (0-7)Measure: Improvement in the clinical status Time: up to day 28.
Description: Sequential Organ Failure Assessment (SOFA score) (0-14)Measure: Changes in the score for the Sequential Organ Failure Assessment (SOFA score) Time: up to day 28.
Description: National Early Warning Score (NEWS scaleMeasure: Changes in the punctuation in the National Early Warning Score Time: up to day 28.
Description: C-reactive protein,Measure: Changes in other inflammatory markers Time: up to day 28
Description: TNF-alfa,Measure: Changes in other inflammatory markers Time: up to day 28
Description: GDF-15,Measure: Changes in other inflammatory markers Time: up to day 28
Description: IL-1βMeasure: Changes in other inflammatory markers Time: up to day 28
Description: D-dimerMeasure: Changes in severity markers Time: up to day 28
Description: leucocytesMeasure: Changes in severity markers Time: up to day 28
Description: lymphocytesMeasure: Changes in severity markers Time: up to day 28
Description: plateletsMeasure: Changes in severity markers Time: up to day 28
Description: LDHMeasure: Changes in severity markers Time: up to day 28
Description: ferritinMeasure: Changes in severity markers Time: up to day 28
Description: myocardial stress markers hsTnTMeasure: Changes in myocardial damage Time: up to day 28
Description: myocardial stress markers NT-proBNPMeasure: Changes in myocardial damage Time: up to day 28
Description: RT-PCR assayMeasure: Time until reaching a virus negative status Time: up to day 28
Description: Length of hospital stayMeasure: Length of hospital stay Time: up to day 28
Description: Number of days in the intensive care unit.Measure: Number of days in the intensive care unit. Time: up to day 28
Description: MortalityMeasure: Mortality Time: up to day 28
Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care per UCLA treating physicians versus current care per UCLA treating physicians alone (control arm). Importantly, this adaptive trial design allows for patients in either study arm to receive other investigational drugs for COVID-19 as new science emerges.
Description: Number of participants experiencing any of the following: All-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS)Measure: Composite of all-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS) Time: 90 Days
Description: Change from initial troponin level to maximum level of troponin among measures taken during hospitalization and at 30 daysMeasure: Delta (peak minus baseline) troponin level Time: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Description: Change from baseline BNP level (Day 1) to maximum level of BNP among measures taken during hospitalization and at 30 daysMeasure: Delta (baseline to peak) brain natriuretic peptide (BNP) level Time: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Description: Number of participants experiencing LVEF of < 50% on echocardiogram with failure to show an improvement of ≥ 5% at 30 daysMeasure: Change in left ventricular ejection fraction (LVEF) on echocardiography Time: Baseline, Day 30
Description: D-Dimer is a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis, so named because it contains two D fragments of the fibrin protein joined by a cross-linkMeasure: Delta (peak minus baseline) D-Dimer inflammatory biomarker level Time: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Description: Number of participants released and re-admitted to the hospital within 90 days of enrollmentMeasure: Re-hospitalization at 90 days Time: 90 days
Based on data regarding the effect of colchicine on the modulation of immune system and decreasing cytokine release and inflammation the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect on COVID-19 Polymerase chain reaction(PCR) positive patients .
Description: increasing inflammatory statusMeasure: CRPxN/R ratio change Time: 2 weeks
Description: including change in fever or O2 SaturationMeasure: Clinical deterioration by the WHO definition Time: 2 weeks
Description: change in RT-PCRMeasure: PCR Viral Load Time: 2 weeks
Description: change in CT involvementMeasure: CT severity involvement index Time: 2weeks
Description: change in LDHMeasure: LDH change Time: 2 weeks
There is emerging evidence that patients with SARS-CoV-2 are affected by increased coagulopathy, including in the most advanced forms, a fully blown disseminated intravascular coagulation, leading to multi organ failure (MOF). Post-Morten observations from patients who died because of SARS-CoV-2 infection in Bergamo, Italy and other places have revealed the presence of diffuse venous, arterial and microcirculatorythrombosis, not only restricted to the lung but also involving the kidneys, heart and gut. Thrombin plays a central role in mediating clot forming as well as in mediating inflammation. A direct factor X inhibitor, namely edoxaban can act as prophylactic measure to mitigate the risk of venous and arterial thrombotic complications. Colchicine is an inexpensive (generic drug), orally administered, and a potent anti-inflammatory medication. It might accelerate SARS-CoV-2 clearance. The aim of the CONVINCE study is therefore to assess the safety and efficacy of edoxaban and/or colchicine administration in SARS-CoV-2 infected patients who are managed outside the hospital with respect to the occurrence of fatalities, hospitalisation, major vascular thrombotic events or the SARS-CoV-2 clearance rate under RT PCR.
Description: To assess the effect of edoxaban versus no active treatment on the composite endpoint of asymptomatic proximal deep-vein thrombosis, symptomatic proximal or distal deep-vein thrombosis, symptomatic pulmonary embolism or thrombosis, myocardial infarction, ischemic stroke, non-CNS systemic embolism or death at day 25 (+/-3) after randomization.Measure: Edoxaban vs. no active treatment Time: Baseline to day 25
Description: To assess the effect of colchicine versus no active treatment on the SARS-CoV-2 clearance rates under RT PCR or freedom from death or hospitalisation at day 14 (+/-3) after randomization.Measure: Colchicine vs no active treatment Time: Baseline to day 14
Description: An intraluminal filling defect on CT scan or MR venography in the IVC or iliac veins.Measure: Number of patients with asymptomatic proximal deep-vein thrombosis Time: Baseline to day 25
Description: Typical symptoms of DVT associated with non-compressible vein segment on ultrasonography or an intra-luminal filling defect on venography, CT venography or MRI venography,located in the inferior vena cava (IVC), the iliac vein, the common femoral vein, the femoral or the popliteal vein.Measure: Number of patients with symptomatic proximal or distal deep-vein thrombosis Time: Baseline to day 25
Description: Typical symptoms of PE associated with an intra-luminal filling defect in (sub) segmental or more proximal branches on spiral computed tomography scan (CT) or computerized tomographic pulmonary angiography (CTPA). a considerable perfusion defect (~ 75% of a segment) with a local normal ventilation result (high probability) during perfusion-ventilation lung scan (PLS, VLS or V/Q scan). an intraluminal filling defect or a sudden cut-off of vessels (~more than 2.5 mm in diameter) on a catheter guided pulmonary angiogram. In case of an inconclusive CTPA, inconclusive V/Q scan or inconclusive angiography demonstration of DVT in the lower extremities e.g. by compression ultrasound or venography will be requiredMeasure: Number of patient with symptomatic pulmonary embolism or thrombosis Time: Baseline to day 25
Description: For the primary analysis, MI endpoint will be defined based on the third universal definition of myocardial infarction with the exception of periprocedural MI after PCI, which will be defined according to the SCAI definition.Measure: Number of patients with myocardial infarction Time: Baseline to day 25
Description: Ischemic stroke is defined as an acute episode of focal cerebral, spinal, or retinal dysfunction caused by CNS infarctionMeasure: Number of patients with non-CNS systemic embolism Time: Baseline to day 25
Description: Death will be classified in 5 categories with respect to cause. Thromboembolism, cardiovascular, bleeding, Pulmonary other known cause. In general, all deaths will be assumed to be due to thromboembolism or pulmonary in nature unless another cause is obviousMeasure: Number of deaths Time: Baseline to day 25
Description: Need for non-invasive or invasive ventilationMeasure: Ventilation need Time: Baseline to day 25
Data processed on January 01, 2021.
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