Efficacy of short-course colchicine treatment in hospitalized patients with moderate to severe COVID-19 pneumonia and hyperinflammation: a randomized clinical trial.

Some patients with COVID-19 pneumonia develop an associated cytokine storm syndrome that aggravates the pulmonary disease. These patients may benefit of anti-inflammatory treatment. The role of colchicine in hospitalized patients with COVID-19 pneumonia and established hyperinflammation remains unexplored. In a prospective, randomized controlled, observer-blinded endpoint, investigator-initiated trial, 240 hospitalized patients with COVID-19 pneumonia and established hyperinflammation were randomly allocated to receive oral colchicine or not. The primary efficacy outcome measure was a composite of non-invasive mechanical ventilation (CPAP or BiPAP), admission to the intensive care unit, invasive mechanical ventilation requirement or death. The composite primary outcome occurred in 19.3% of the total study population. The composite primary outcome was similar in the two arms (17% in colchicine group vs. 20.8% in the control group; p = 0.533) and the same applied to each of its individual components. Most patients received steroids (98%) and heparin (99%), with similar doses in both groups. In this trial, including adult patients with COVID-19 pneumonia and associated hyperinflammation, no clinical benefit was observed with short-course colchicine treatment beyond standard care regarding the combined outcome measurement of CPAP/BiPAP use, ICU admission, invasive mechanical ventilation or death (Funded by the Community of Madrid, EudraCT Number: 2020-001841-38; 26/04/2020).

Inadequate use of antibiotics in the covid-19 era: effectiveness of antibiotic therapy.

BACKGROUND: Since December 2019, the COVID-19 pandemic has changed the concept of medicine. This work aims to analyze the use of antibiotics in patients admitted to the hospital due to SARS-CoV-2 infection. METHODS: This work analyzes the use and effectiveness of antibiotics in hospitalized patients with COVID-19 based on data from the SEMI-COVID-19 registry, an initiative to generate knowledge about this disease using data from electronic medical records. Our primary endpoint was all-cause in-hospital mortality according to antibiotic use. The secondary endpoint was the effect of macrolides on mortality. RESULTS: Of 13,932 patients, antibiotics were used in 12,238. The overall death rate was 20.7% and higher among those taking antibiotics (87.8%). Higher mortality was observed with use of all antibiotics (OR 1.40, 95% CI 1.21-1.62; p < .001) except macrolides, which had a higher survival rate (OR 0.70, 95% CI 0.64-0.76; p < .001). The decision to start antibiotics was influenced by presence of increased inflammatory markers and any kind of infiltrate on an x-ray. Patients receiving antibiotics required respiratory support and were transferred to intensive care units more often. CONCLUSIONS: Bacterial co-infection was uncommon among COVID-19 patients, yet use of antibiotics was high. There is insufficient evidence to support widespread use of empiric antibiotics in these patients. Most may not require empiric treatment and if they do, there is promising evidence regarding azithromycin as a potential COVID-19 treatment.

Inappropriate antibiotic use in the COVID-19 era: Factors associated with inappropriate prescribing and secondary complications. Analysis of the registry SEMI-COVID.

BACKGROUND: Most patients with COVID-19 receive antibiotics despite the fact that bacterial co-infections are rare. This can lead to increased complications, including antibacterial resistance. We aim to analyze risk factors for inappropriate antibiotic prescription in these patients and describe possible complications arising from their use. METHODS: The SEMI-COVID-19 Registry is a multicenter, retrospective patient cohort. Patients with antibiotic were divided into two groups according to appropriate or inappropriate prescription, depending on whether the patient fulfill any criteria for its use. Comparison was made by means of multilevel logistic regression analysis. Possible complications of antibiotic use were also identified. RESULTS: Out of 13,932 patients, 3047 (21.6%) were prescribed no antibiotics, 6116 (43.9%) were appropriately prescribed antibiotics, and 4769 (34.2%) were inappropriately prescribed antibiotics. The following were independent factors of inappropriate prescription: February-March 2020 admission (OR 1.54, 95%CI 1.18-2.00), age (OR 0.98, 95%CI 0.97-0.99), absence of comorbidity (OR 1.43, 95%CI 1.05-1.94), dry cough (OR 2.51, 95%CI 1.94-3.26), fever (OR 1.33, 95%CI 1.13-1.56), dyspnea (OR 1.31, 95%CI 1.04-1.69), flu-like symptoms (OR 2.70, 95%CI 1.75-4.17), and elevated C-reactive protein levels (OR 1.01 for each mg/L increase, 95% CI 1.00-1.01). Adverse drug reactions were more frequent in patients who received ANTIBIOTIC (4.9% vs 2.7%, p < .001). CONCLUSION: The inappropriate use of antibiotics was very frequent in COVID-19 patients and entailed an increased risk of adverse reactions. It is crucial to define criteria for their use in these patients. Knowledge of the factors associated with inappropriate prescribing can be helpful.

C-reactive protein level predicts 30-day mortality and bleeding in patients with venous thromboembolism: A prospective single-center study / Proteína C reactiva como predictor de mortalidad y hemorragia a 30 días en pacientes con enfermedad tromboembólica venosa: estudio prospectivo, monocéntrico

AIMS: The association of on-admission CRP and early adverse outcomes in acute venous thromboembolism (VTE) has not been investigated. We hypothesized that increased on-admission CRP levels would correlate with adverse outcomes in patients with acute VTE. METHOD: In this prospective observational study, consecutive patients with acute VTE were enrolled and CRP levels were measured within the first 24h after diagnosis. Mortality, bleeding and recurrence were recorded during a 30-day follow-up. RESULTS: 586 patients were included. Higher CRP levels were found in patients with mortality (7.5 vs 4.0mg/dL; p = 0.01) and bleeding (7.8 vs 3.9mg/dL; p = 0.03). Multivariable logistic regression showed that CRP levels >5mg/dL were associated with higher mortality (OR 6.25; 95% CI, 2.1-18.6) and bleeding (OR 2.7; CI 95% 1.3-5.7). These results were independent to ESC risk score and simplified PESI score for mortality prediction. The predictive capacity of CRP showed an area under the ROC curve - AUC - of .7 (CI 95% .56-.85) for mortality and .65 (CI 95% .54-.75) for bleeding. The prognostic capacity of the ESC risk score and simplified PESI score was improved after adding the CRP cutoff of 5mg/dL (AUC of .87 CI 95% .79-.95). CONCLUSION: Our findings suggest that on-admission CRP level may be a simple, widely available and valuable biomarker to identify high-risk VTE patients for early mortality and bleeding. CRP ≥5mg/dL was independently associated with 30-day VTE related death and bleeding

OBJETIVOS: La asociación de la medición de PCR al ingreso y las complicaciones precoces en la enfermedad tromboembólica venosa (ETV) aguda no ha sido evaluado. Nuestra hipótesis es que los niveles elevados de PCR al ingreso podrían estar correlacionados con complicaciones precoces en pacientes con ETV aguda. MÉTODOS: Estudio observacional prospectivo, en el que se incluyeron pacientes consecutivos con ETV aguda en los que se midió la PCR en las primeras 24h del diagnóstico. La mortalidad, el sangrado y la recurrencia fueron registrados durante el seguimiento a 30 días. RESULTADOS: Se incluyeron 586 pacientes. Se encontraron niveles más elevados de PCR en pacientes que fallecieron (7,5 vs. 4mg/dl; p = 0,01) y que sangraron (7,8 vs. 3,9mg/dl; p = 0,03). Una regresión logística multivariante mostró que niveles de PCR>5mg/dl se asociaron significativamente con mayor mortalidad (OR: 6,25; IC 95%: 2,1-18,6) y sangrado (OR: 2,7; IC 95%: 1,3-5,7). Estos resultados fueron independientes de las escalas pronósticas de mortalidad ESC y PESI simplificada. La capacidad predictiva de la PCR mostró un área bajo la curva (ABC) ROC de 0,7 (IC 95%: 0,56-0,85) para mortalidad y 0,65 (IC 95%: 0,54-0,75) para sangrado. La capacidad pronóstica de las escalas pronósticas ESC y PESI simplificada mejoró de forma significativa al añadir el punto de corte de PCR>5mg/dl (ABC de 0,87; IC 95%: 0,79-0,95). CONCLUSIÓN: La medición de PCR al ingreso puede ser un marcador sencillo y ampliamente disponible para identificar a pacientes con ETV aguda y alto riesgo de mortalidad y sangrado precoces. Niveles de PCR≥5mg/dl se asociaron de forma independiente con mayor mortalidad y sangrado a 30 días en pacientes con ETV aguda

C-reactive protein level predicts 30-day mortality and bleeding in patients with venous thromboembolism: A prospective single-center study.

AIMS: The association of on-admission CRP and early adverse outcomes in acute venous thromboembolism (VTE) has not been investigated. We hypothesized that increased on-admission CRP levels would correlate with adverse outcomes in patients with acute VTE. METHOD: In this prospective observational study, consecutive patients with acute VTE were enrolled and CRP levels were measured within the first 24h after diagnosis. Mortality, bleeding and recurrence were recorded during a 30-day follow-up. RESULTS: 586 patients were included. Higher CRP levels were found in patients with mortality (7.5 vs 4.0mg/dL; p=0.01) and bleeding (7.8 vs 3.9mg/dL; p=0.03). Multivariable logistic regression showed that CRP levels >5mg/dL were associated with higher mortality (OR 6.25; 95% CI, 2.1-18.6) and bleeding (OR 2.7; CI 95% 1.3-5.7). These results were independent to ESC risk score and simplified PESI score for mortality prediction. The predictive capacity of CRP showed an area under the ROC curve - AUC - of .7 (CI 95% .56-.85) for mortality and .65 (CI 95% .54-.75) for bleeding. The prognostic capacity of the ESC risk score and simplified PESI score was improved after adding the CRP cutoff of 5mg/dL (AUC of .87 CI 95% .79-.95). CONCLUSION: Our findings suggest that on-admission CRP level may be a simple, widely available and valuable biomarker to identify high-risk VTE patients for early mortality and bleeding. CRP ≥5mg/dL was independently associated with 30-day VTE related death and bleeding.