Background: There are no specific generally accepted therapies for the coronavirus disease 2019 (COVID-19). The full spectrum of COVID-19 ranges from asymptomatic disease to mild respiratory tract illness to severe pneumonia, acute respiratory distress syndrome (ARDS), multisystem organ failure, and death. The efficacy of corticosteroids in viral ARDS remains unknown. We postulated that adjunctive treatment of established ARDS caused by COVID-19 with intravenous dexamethasone might change the pulmonary and systemic inflammatory response and thereby reduce morbidity, leading to a decrease in duration of mechanical ventilation and in mortality. Methods/design: This is a multicenter, randomized, controlled, parallel, open-label, superiority trial testing dexamethasone in 200 mechanically ventilated adult patients with established moderate-to-severe ARDS caused by confirmed SARS-CoV-2 infection. Established ARDS is defined as maintaining a PaO 2 /FiO 2 ≤ 200 mmHg on PEEP ≥ 10 cmH 2 O and FiO 2 ≥ 0.5 after 12 ± 3 h of routine intensive care. Eligible patients will be randomly assigned to receive either dexamethasone plus standard intensive care or standard intensive care alone. Patients in the dexamethasone group will receive an intravenous dose of 20 mg once daily from day 1 to day 5, followed by 10 mg once daily from day 6 to day 10. The primary outcome is 60-day mortality. The secondary outcome is the number of ventilator-free days, defined as days alive and free from mechanical ventilation at day 28 after randomization. All analyses will be done according to the intention-to-treat principle.

Despite the increasing evidence of the benefit of corticosteroids for the treatment of moderate-severe coronavirus disease 2019 (COVID-19) patients, no data are available about the potential role of high doses of steroids for these patients. We evaluated the mortality, the risk of need for mechanical ventilation (MV), or death and the risk of developing a severe acute respiratory distress syndrome (ARDS) between high (HD) and standard doses (SD) among patients with a severe COVID-19. All consecutive confirmed COVID-19 patients admitted to a single center were selected, including those treated with steroids and an ARDS. Patients were allocated to the HD (≥ 250 mg/day of methylprednisolone) of corticosteroids or the SD (≤ 1.5 mg/kg/day of methylprednisolone) at discretion of treating physician. Five hundred seventy-three patients were included: 428 (74.7%) men, with a median (IQR) age of 64 (54-73) years. In the HD group, a worse baseline respiratory situation was observed and male gender, older age, and comorbidities were significantly more common. After adjusting by baseline characteristics, HDs were associated with a higher mortality than SD (adjusted OR 2.46, 95% CI 1.59-3.81, p < 0.001) and with an increased risk of needing MV or death (adjusted OR 2.35, p = 0.001). Conversely, the risk of developing a severe ARDS was similar between groups. Interaction analysis showed that HD increased mortality exclusively in elderly patients. Our real-world experience advises against exceeding 1-1.5 mg/kg/day of corticosteroids for severe COVID-19 with an ARDS, especially in older subjects. This reinforces the rationale of modulating rather than suppressing immune responses in these patients.

BackgroundIn regard to obstetrical analgesia management there are different results related to the use of epidural analgesia versus mechanical adverse outcomes at delivery.MethodsCohort study of 23,183 consecutive, term, singleton vaginal deliveries, including spontaneous and induced labours, at a single institution from January 2004 to June 2016 to determine the association between epidural analgesia and different mechanical complications affecting maternal health such as severe perineal tears (SPT), abnormal foetal head position at delivery, instrumental delivery and caesarean section (CS).Multivariate logistic regression models were constructed to evaluate the risk factors of these mechanical complications with respect to possible cofounders.ResultsEpidural analgesia was used in 15,821 (68.24%) women. The logistic regression model showed a non-significant association between the use of epidural analgesia and SPT (odds ratio [OR], 078; 95% confidence interval [CI], 0.48–1.26; p = 0.310). Instrumental delivery and CSs were more frequently performed in cases than controls (p = < 0.001), with OR of 1.19 (95% CI: 1.10–1.29) for CS and with OR of 3.27 (95% CI: 2.93–4.61) for instrumental delivery. The abnormal foetal position head at delivery were significantly lower in the neonates delivered without epidural analgesia compared with those in which epidural analgesia was used (p < 0.001) with OR of 1.43 (95% CI:1.27–1.72).ConclusionsEpidural analgesia is not associated with an increase of SPT, but it was an independent risk factor for instrumental delivery, CS and abnormal foetal head position at delivery.