Colchicine Is Safe Though Ineffective in the Treatment of Severe COVID-19: a Randomized Clinical Trial (COLCHIVID).

BACKGROUND: Colchicine is an available, safe, and effective anti-inflammatory drug and has been suggested as a COVID-19 treatment, but its usefulness in hospitalized severe COVID-19 patients has not been thoroughly demonstrated. OBJECTIVE: To address the safety and efficacy of colchicine in hospitalized patients with severe COVID-19. DESIGN: We conducted a triple-blind parallel non-stratified placebo-controlled clinical trial. PARTICIPANTS: We recruited 116 hospitalized patients with severe COVID-19 in Mexico. INTERVENTIONS: Patients were randomized to receive 1.5 mg of colchicine or placebo at the time of the recruitment in the study (baseline) and 0.5 mg BID PO to complete 10 days of treatment. MAIN MEASURES: The primary composite outcome was the progression to critical disease or death. Besides, we evaluated immunological features at baseline and after recovery or disease progression in 20 patients. KEY RESULTS: Fifty-six patients were allocated to colchicine and 60 patients received placebo. The study was suspended after the second interim analysis demonstrated colchicine had no effect on the primary outcome (OR 0.83, 95%CI 0.35-1.93, P = 0.67), nor in the days of ICU and hospital stays. Adverse events were similar between groups (OR 1.63, 95% CI 0.66-3.88, P = 0.37). After colchicine treatment, patients had higher BUN and lower serum levels of IL-8, IL-12p70, and IL-17A. CONCLUSIONS: Colchicine is safe but not effective in the treatment of severe COVID-19. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04367168.

Women with Acute Myocardial Infarction: Clinical Characteristics, Treatment, and In-Hospital Outcomes from a Latin American Country.

Background: Women are underrepresented in acute myocardial infarction (AMI) studies. Furthermore, there is scarce information regarding women with AMI in Latin America. Aims: To describe the presentation, clinical characteristics, risk factor burden, evidence-based care, and in-hospital outcome in a population of women with AMI admitted to a coronary care unit (CCU) in Mexico. Methods: Retrospective cohort study including patients with AMI admitted from January 2006 to December 2021 in a CCU. We identified patients with ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI). We described demographic characteristics, clinical variables, treatment, and in-hospital outcomes according to gender. Cox regression analysis was used to identify predictors of mortality. Results: Our study included 12,069 patients with AMI, of whom 7,599 had STEMI and 4,470 had NSTEMI. Women represented 19.6% of the population. Women had higher rates of hypertension, diabetes, stroke, and atrial fibrillation than men. For STEMI, women were less likely to receive reperfusion therapy (fibrinolysis; 23.7 vs. 28.5%, p < 0.001 and primary percutaneous coronary intervention (PCI); 31.2 vs. 35.1%, p = 0.001) and had more major adverse events than men: heart failure (4.2 vs. 2.5%, p = 0.002), pulmonary edema (3.4% vs. 1.7%, p < 0.001), major bleeding (2.1% vs. 1%, p = 0.002), stroke (1.3% vs. 0.6%, p = 0.008), and mortality (15.1% vs. 8.1%, p < 0.001). For NSTEMI, women were less likely to undergo coronary angiography or PCI and had more major bleeding and mortality. Multivariate Cox regression analysis revealed that females had an increase in mortality in STEMI and NSTEMI (HR 1.21, CI 1.01-1.47, p = 0.05 and HR 1.39, CI 1.06-1.81, p = 0.01). Conclusion: Real-world evidence from a hospital in a Latin American low- to middle-income country (LMIC) showed that women with AMI had more comorbidities, received less reperfusion treatment or invasive strategies, and had worse outcomes. In STEMI and NSTEMI, female gender represented an independent predictor of in-hospital mortality.