Objectives Since the outbreak of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the pressure to minimise its impact on public health has led to the implementation of different therapeutic strategies, the efficacy of which for the treatment of coronavirus disease 2019 (COVID-19) was unknown at the time. Remdesivir (REM) was granted its first conditional marketing authorisation in the EU in June 2020. The European Medicines Agency (EMA) and local health authorities all across the EU have since strongly recommended the implementation of pharmacovigilance activities aimed at further evaluating the safety of this new drug. The objective of this study was to evaluate adverse drug reactions (ADRs) attributed to either REM or hydroxychloroquine (HCQ) in patients hospitalised for COVID-19 in Centro Hospitalar de Lisboa Ocidental, a Portuguese hospital centre based in Lisbon. We present the preliminary results reporting plausible adverse effects of either HCQ or REM. Methods An observational cohort study was carried out between 16 March and 15 August 2020. Participants were divided into two cohorts: those prescribed an HCQ regimen, and those prescribed REM. Suspected ADRs were identified using an active monitoring model and reported to the Portuguese Pharmacovigilance System through its online notification tool. The ADR cumulative incidence was compared between the two cohorts. Results The study included 149 patients, of whom 101 were treated with HCQ and the remaining 48 with REM. The baseline characteristics were similar between the two cohorts. A total of 102 ADRs were identified during the study period, with a greater incidence in the HCQ cohort compared with the REM cohort (47.5% vs 12.5%; p<0.001). Causality was assessed in 81 ADRs, all of which were considered possible. Conclusions Real-world data are crucial to further establish the safety profile for REM. HCQ is no longer recommended for the treatment of COVID-19.

SUMMARY OBJECTIVE Treatment limitation, as well as do-not-resuscitate (DNR) directives, are difficult but important to improve patients’ quality of life and minimize dysthanasia. We aimed to study the approach to withholding, withdrawal, and DNR decisions, patients’ characteristics, and process documentation in a general Intensive Care Unit (ICU) in Portugal. METHODS A retrospective analysis of data regarding the limitation of treatment decisions collected from previously-designed forms and complemented by medical record consultation. RESULTS A total of 1602 patients were admitted to the ICU between 2011 and 2016. DNR decisions were documented in 127 cases (7.9%). Patients with treatment limitations were older and had higher Simplified Acute Physiology Score II. The most frequent diagnosis preceding these decisions was sepsis (52.0%, n = 66); the most common main reason for limiting treatment was a poor prognosis of acute illness. Of the patients to whom a DNR was implemented, 117 (92.1%) died in the ICU (40.1% of the total number of ICU deaths), and hospital mortality was 100%. Participants in these decisions, as well as types of treatment withdrawn and their respective timings, were not registered in medical records. CONCLUSION Treatment limitation and DNR decisions were relatively common, in line with other Southern European studies, but behind Northern European and North American centers. Patients with these limitations were older and more severely ill than patients without such decisions. Documentation of these processes should be clear and detailed, either in specific forms or computerized clinical records; there is room for improvement in this area.

Patients with lymphoproliferative diseases are at an increased risk of an incomplete immune response following vaccination or SARS‐CoV‐2 infection and might develop persistent viral infection and severe COVID‐19 disease. We present a case of successful treatment of persistent and mechanical‐ventilation‐requiring SARS‐CoV‐2 infection in a del17 + CLL patient using exogenous antibodies.

Background Care for the critically ill patient with Cardiovascular Disease (CVD) requires a unique management approach, as the theoretical critical threshold for decompensation is lower and inherent adaptive mechanisms may be compromised. We aimed to characterize the prognostic impact of CVD in patients admitted to an Intensive Care Unit (ICU). Methods We performed a cohort study of consecutive patients admitted to an ICU from January to December 2019. Patients were stratified as follows: (1) established CVD – presence of either atrial fibrillation, heart failure, coronary artery disease and/or peripheral artery disease; (2) at higher risk of CVD – known arterial hypertension, dyslipidemia, diabetes mellitus and/or current smoking, in the absence of established CVD; and (3) at lower risk of CVD – i.e. none of the above. The co-primary endpoints were all-cause death in ICU and death during index hospitalization. Results During 2019, there were 334 admissions in ICU, comprising a total of 296 patients (mean age 67±15 years, 58.1% male). Overall, 69 (23.3%) and 108 (36.5%) died in ICU and during index hospitalization, respectively. Compared to patients at lower risk of CVD, those at higher CVD risk or with established CVD had markers of more severe disease, as noted by higher risk scores (e.g., SAPS-II 35.0±20.0 vs. 43.5±22.3 vs. 52.6±20.0; p&lt;0.001), higher rates of mechanical ventilation (41.5 vs. 57.3 vs. 63.9%; p=0.020), shock during ICU stay (34.0 vs. 52.7 vs. 66.9%; p&lt;0.001) and acute kidney injury (26.4 vs. 35.5 vs. 57.9%; p&lt;0.001), respectively, as well as higher death rates in ICU (5.7 vs. 21.8 vs. 31.6%; p=0.001) and index hospitalization (9.4 vs. 37.3 vs. 46.6%; p&lt;0.001). In multivariate analysis, adjusted for age and cause of admission, established CVD independently predicted the risk of all-cause death in ICU (HR: 2.084; 95% CI: 1.136–3.823; p=0.018) and during index hospitalization (HR 1.712; CI: 1.009–2.889; p=0.046). The analysis for the group of patients at higher risk of CVD yielded similar results to the abovementioned. Conclusion Roughly 4 in every 5 patients admitted in ICU were at risk of or had established CVD. The presence of either of the above independently predicted a two- to three-fold higher risk of death during hospitalization. Our findings emphasize the considerable burden of CVD in ICU and underscore the importance of comprehensive management of the complex critically ill patient. FUNDunding Acknowledgement Type of funding sources: None.

Coronavirus disease 2019 (COVID-19) is a pandemic infection caused by the newly discovered severe acute respiratory syndrome coronavirus 2. Remdesivir (RDV) and corticosteroids are used mainly in COVID-19 patients with acute respiratory failure. The main objective of the study was to assess the effectiveness of remdesivir with and without corticosteroids in the treatment of COVID-19 patients. We conducted a prospective observational study, including adult patients consecutively hospitalized with confirmed COVID-19 and acute respiratory failure. Patients were divided according to treatment strategy: RDV alone versus RDV with corticosteroids. The primary outcome was the time to recovery in both treatment groups. We included 374 COVID-19 adult patients, 184 were treated with RDV, and 190 were treated with RDV and corticosteroid. Patients in the RDV group had a shorter time to recovery in comparison with patients in the RDV plus corticosteroids group at 28 days after admission [11 vs. 16 days (95% confidence Interval 9.7–12.8; 14.9–17.1; p = .016)]. Patients treated with RDV alone had a shorter length of hospital stay. The use of corticosteroids as adjunctive therapy of RDV was not associated with improvement in mortality of COVID-19 patients.