ABSTRACT
BACKGROUND: The efficacy and safety of high versus medium doses of glucocorticoids for the treatment of patients with COVID-19 has shown mixed outcomes in controlled trials and observational studies. We aimed to evaluate the effectiveness of methylprednisolone 250 mg bolus versus dexamethasone 6 mg in patients with severe COVID-19. METHODS: A randomised, open-label, controlled trial was conducted between February and August 2021 at four hospitals in Spain. The trial was suspended after the first interim analysis since the investigators considered that continuing the trial would be futile. Patients were randomly assigned in a 1:1 ratio to receive dexamethasone 6 mg once daily for up to 10 days or methylprednisolone 250 mg once daily for 3 days. RESULTS: Of the 128 randomised patients, 125 were analysed (mean age 60 ± 17 years; 82 males [66%]). Mortality at 28 days was 4.8% in the 250 mg methylprednisolone group versus 4.8% in the 6 mg dexamethasone group (absolute risk difference, 0.1% [95% CI, -8.8 to 9.1%]; p = 0.98). None of the secondary outcomes (admission to the intensive care unit, non-invasive respiratory or high-flow oxygen support, additional immunosuppressive drugs, or length of stay), or prespecified sensitivity analyses were statistically significant. Hyperglycaemia was more frequent in the methylprednisolone group at 27.0 versus 8.1% (absolute risk difference, -18.9% [95% CI, -31.8 to - 5.6%]; p = 0.007). CONCLUSIONS: Among severe but not critical patients with COVID-19, 250 mg/d for 3 days of methylprednisolone compared with 6 mg/d for 10 days of dexamethasone did not result in a decrease in mortality or intubation.
ABSTRACT
Background: Infection with SARS-CoV-2 is becoming the leading cause of death in most countries during the 2020 pandemic.Objective: to assess the association between COVID-19 and cause-specific death.Design: Retrospective cohort study.Setting and Participants: We included data from inpatients diagnosed with COVID-19 between March 18 and April 21, 2020, who died during their hospital stay. Demographic, clinical and management data were collected. Causes of death were ascertained by review of medical records.Results: The sample included 100 individuals. The median age was 85 (IQR 15), 59% were men. Fifteen patients (15%) died from complications unrelated to COVID-19. In univariate analysis, these patients compared to those who died from COVID-19 complications had a greater likelihood of dementia (47% vs 20%) and dependency in activities of daily living (93% vs 48%), higher Charlson comorbidity index scores (6 vs 5), a lower likelihood of fever at diagnosis (47% vs 77%), and higher lymphocyte counts (1,000 vs 660). In multivariate analysis, patients were older (OR 1.10, 95% CI 1.00–1.23) and more often had heart failure (OR 5.58, 95% CI 1.09–28.66). The presence of X-ray infiltrates was uncommon (OR 0.03, 95% CI 0.01–0.17). A higher percentage of patient deaths from causes unrelated to COVID-19 complications occurred during the two first weeks of the pandemic.Conclusions: Fifteen percent of patients with COVID-19 died from causes unrelated to COVID-19 complications. Most of these patients had more comorbidities and were frail and elderly. These findings can partially explain the excess mortality in older people.