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Research Background
Research BackgroundESC 2021The ECLA PHRI COLCOVID Trial
ESC 2021The ECLA PHRI COLCOVID TrialCoronavirus disease 2019 is a severe acute respiratory syndrome caused by the infection of type 2 coronavirus (SARS-CoV-2).
Research design and results
Research design and resultsESC 2021The ECLA PHRI COLCOVID Trial
Inclusion criteria
● Adults (age ≥18 years old)
● Hospitalized patients suspected of being infected with COVID-19
● With severe acute respiratory syndrome: dyspnea, imaging manifestations of typical or atypical pneumonia, blood oxygen saturation ≤93%
Exclusion criteria
Exclusion criteria● There are clear indications or contraindications for the use of colchicine
● The PCR test of SARS-CoV-2 was negative
● Creatinine clearance rate of chronic kidney disease <15 ml/min/m2
● Pregnant or breastfeeding women
Primary endpoint
Primary endpoint1.
2.
Figure 1 Cohort study design
Figure 1 Cohort study design Figure 1 Cohort study design(Figure 1) The study included 1279 COVID-19 hospitalized patients, of which 640 patients entered the colchicine group and 639 patients entered the control group
Table 1 Baseline characteristics of the two groups of patients
Table 1 Baseline characteristics of the two groups of patients Table 1 Baseline characteristics of the two groups of patients(Figure 2) The incidence of the 28-day composite endpoint was 25.
Figure 2 The 28-day composite endpoint event hazard ratio
Figure 2 The 28-day composite endpoint event risk ratio Figure 2 The 28-day composite endpoint event risk ratio(Table 2) In the colchicine group, the incidence of intubation needs or death caused by respiratory failure within 28 days was 143/640, while that of the control group was 173/639 (HR: 0.
Table 2 Efficacy Endpoints
Table 2 Efficacy Endpoint Table 2 Efficacy Endpoint(Table 3) In terms of serious adverse events, the incidence of severe diarrhea was 11.
Table 3 Serious adverse events
Table 3 Serious Adverse Events Table 3 Serious Adverse Events(Table 4) During the period from November 27, 2020 to March 4, 2021, 5,610 patients received colchicine treatment, and 5,730 patients received conventional treatment
Table 4 Mortality at 28-day follow-up
Table 4 Mortality after 28-day follow-up Table 4 Mortality after 28-day follow-up(Table 5) The clinical trial registration started on March 23, 2020 and was completed on December 22, 2020
Table 5 The main clinical endpoints of the intentional analysis
Table 5 The main clinical endpoints of the intentional analysis Table 5 The main clinical endpoints of the intentional analysisAnalysis conclusion
Analysis conclusionESC 2021The ECLA PHRI COLCOVID Trial
ESC 2021The ECLA PHRI COLCOVID TrialFor hospitalized patients diagnosed with COVID-19, colchicine is beneficial for major respiratory events (respiratory death or ventilation), but colchicine does not significantly reduce the risk of death in hospitalized patients with COVID-19 on a statistical level And mechanical ventilation risks
Research discussion
Research discussionESC 2021The ECLA PHRI COLCOVID Trial
ESC 2021The ECLA PHRI COLCOVID TrialExisting studies have shown that cytokine storm can cause severe clinical symptoms and even death in COVID-19 patients.
Expert Reviews
Expert ReviewsESC 2021The ECLA PHRI COLCOVID Trial
ESC 2021The ECLA PHRI COLCOVID TrialAt present, the COVID-19 disease is still spreading globally
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