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drug209 | Colchicine Tablets Wiki | 1.00 |
drug991 | non Wiki | 1.00 |
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There is one clinical trial.
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 28