Name (Synonyms) | Correlation | |
---|---|---|
drug1754 | Pacing + mindfulness Wiki | 0.58 |
drug690 | Current care per UCLA treating physicians Wiki | 0.58 |
drug2341 | Standard therapy for COVID-19 according to the stablished hospital protocols. Wiki | 0.58 |
drug1006 | Graded exposure therapy Wiki | 0.58 |
drug960 | Follow up Wiki | 0.41 |
There are 3 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 hospitalized
Measure: Changes in the patients' clinical status through the 7 points ordinal scale WHO R&D Blueprint expert group Time: 7,14,28 DaysDescription: improve in the clinical evolution of patients hospitalized
Measure: 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 scale
Measure: 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 28Description: TNF-alfa,
Measure: Changes in other inflammatory markers Time: up to day 28Description: GDF-15,
Measure: Changes in other inflammatory markers Time: up to day 28Description: IL-1β
Measure: Changes in other inflammatory markers Time: up to day 28Description: D-dimer
Measure: Changes in severity markers Time: up to day 28Description: leucocytes
Measure: Changes in severity markers Time: up to day 28Description: lymphocytes
Measure: Changes in severity markers Time: up to day 28Description: platelets
Measure: Changes in severity markers Time: up to day 28Description: LDH
Measure: Changes in severity markers Time: up to day 28Description: ferritin
Measure: Changes in severity markers Time: up to day 28Description: myocardial stress markers hsTnT
Measure: Changes in myocardial damage Time: up to day 28Description: myocardial stress markers NT-proBNP
Measure: Changes in myocardial damage Time: up to day 28Description: RT-PCR assay
Measure: Time until reaching a virus negative status Time: up to day 28Description: Length of hospital stay
Measure: Length of hospital stay Time: up to day 28Description: Number of days in the intensive care unit.
Measure: Number of days in the intensive care unit. Time: up to day 28Description: Mortality
Measure: Mortality Time: up to day 28Participants 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 DaysDescription: Change from initial troponin level to maximum level of troponin among measures taken during hospitalization and at 30 days
Measure: Delta (peak minus baseline) troponin level Time: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalizedDescription: Change from baseline BNP level (Day 1) to maximum level of BNP among measures taken during hospitalization and at 30 days
Measure: Delta (baseline to peak) brain natriuretic peptide (BNP) level Time: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalizedDescription: Number of participants experiencing LVEF of < 50% on echocardiogram with failure to show an improvement of ≥ 5% at 30 days
Measure: Change in left ventricular ejection fraction (LVEF) on echocardiography Time: Baseline, Day 30Description: 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-link
Measure: Delta (peak minus baseline) D-Dimer inflammatory biomarker level Time: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalizedDescription: Number of participants released and re-admitted to the hospital within 90 days of enrollment
Measure: Re-hospitalization at 90 days Time: 90 daysBased 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 status
Measure: CRPxN/R ratio change Time: 2 weeksDescription: including change in fever or O2 Saturation
Measure: Clinical deterioration by the WHO definition Time: 2 weeksDescription: change in RT-PCR
Measure: PCR Viral Load Time: 2 weeksDescription: change in CT involvement
Measure: CT severity involvement index Time: 2weeksDescription: change in LDH
Measure: LDH change Time: 2 weeks