for the ConPlas-19 Study Group* *Complete list of the ConPlas-19 study group provided in the Supplement.

Spain is one of the European countries most largely affected by COVID-19, being Madrid the epicenter. A good knowledge of the main features of hospitalized patients during the complete lockdown should improve the management of new COVID-19 surges. All patients hospitalized at one large tertiary hospital in Madrid for suspected COVID-19 pneumonia from March 1 to May 31 were retrospectively identified. A total of 1752 patients were admitted with suspected pneumonia due to SARS-CoV-2 infection during the 3-month study period. The peak of daily admissions (n = 84) was reached on March 24, whereas the maximal cumulative number of hospitalized patients (n = 626) occurred on March 30. Overall, 85.3% had a positive PCR test for SARS-CoV-2 at least once during admission. Their median age was 65 (54–77) and 59.9% were male. The median length of hospitalization was of 7 (4–13) days. Roughly 6.5% were admitted at the intensive care unit. Death occurred in 242 (13.8%). Overall, 75% of deaths occurred in patients older than 75 years-old. It was 38.2% in patients hospitalized older than 80 years-old versus 2.2% in patients younger than 60 years-old (p < 0.001). Up to 94 (38.8%) of deceased patients had been transferred from nursing homes. The median Charlson co-morbidity score was 6 in deceased patients. The in-hospital mortality rate during the first wave of COVID-19 in Madrid was 14%. It was largely driven by older age, the presence of underlying chronic conditions (≥2) and living at nursing homes.

Bacterial infections may complicate the course of COVID-19 patients. The rate and predictors of bacterial infections were examined in patients consecutively admitted with COVID-19 at one tertiary hospital in Madrid between March 1st and April 30th, 2020. Among 1594 hospitalized patients with COVID-19, 135 (8.5%) experienced bacterial infectious events, distributed as follows: urinary tract infections (32.6%), bacteremia (31.9%), pneumonia (31.8%), intra-abdominal infections (6.7%) and skin and soft tissue infections (6.7%). Independent predictors of bacterial infections were older age, neurological disease, prior immunosuppression and ICU admission (p < 0.05). Patients with bacterial infections who more frequently received steroids and tocilizumab, progressed to lower Sap02/FiO2 ratios, and experienced more severe ARDS (p < 0.001). The mortality rate was significantly higher in patients with bacterial infections as compared to the rest (25% vs 6.7%, respectively; p < 0.001). In multivariate analyses, older age, prior neurological or kidney disease, immunosuppression and ARDS severity were associated with an increased mortality (p < 0.05) while bacterial infections were not. Conversely, the use of steroids or steroids plus tocilizumab did not confer a higher risk of bacterial infections and improved survival rates. Bacterial infections occurred in 8.5% of patients hospitalized with COVID-19 during the first wave of the pandemic. They were not independently associated with increased mortality rates. Baseline COVID-19 severity rather than the incidence of bacterial infections seems to contribute to mortality. When indicated, the use of steroids or steroids plus tocilizumab might improve survival in this population.

Introduction SARS-CoV-2 pneumonia is often associated with hyper-inflammation. The cytokine-storm-like is one of the targets of current therapies for coronavirus disease 2019 (COVID-19). High Interleukin-6 (IL6) blood levels have been identified in severe COVID-19 disease, but there are still uncertainties regarding the actual role of anti-IL6 antagonists in COVID-19 management. Our hypothesis was that the use of sarilumab plus corticosteroids at an early stage of the hyper-inflammatory syndrome would be beneficial and prevent progression to acute respiratory distress syndrome (ARDS). Methods We randomly assigned (in a 1:1 ratio) COVID-19 pneumonia hospitalized patients under standard oxygen therapy and laboratory evidence of hyper-inflammation to receive sarilumab plus usual care (experimental group) or usual care alone (control group). Corticosteroids were given to all patients at a 1 mg/kg/day of methylprednisolone for at least 3 days. The primary outcome was the proportion of patients progressing to severe respiratory failure (defined as a score in the Brescia-COVID19 scale ≥ 3) up to day 15. Results A total of 201 patients underwent randomization: 99 patients in the sarilumab group and 102 patients in the control group. The rate of patients progressing to severe respiratory failure (Brescia-COVID scale score ≥ 3) up to day 15 was 16.16% in the Sarilumab group versus 15.69% in the control group (RR 1.03; 95% CI 0.48–2.20). No relevant safety issues were identified. Conclusions In hospitalized patients with Covid-19 pneumonia, who were under standard oxygen therapy and who presented analytical inflammatory parameters, an early therapeutic intervention with sarilumab plus standard of care (including corticosteroids) was not shown to be more effective than current standard of care alone. The study was registered at EudraCT with number: 2020-002037-15. Supplementary Information The online version contains supplementary material available at 10.1007/s40121-021-00543-2.