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OBJECTIVE: This study aimed to describe the clinical presentation of COVID-19 in hospitalized patients aged 80 or above and to identify predictors for death and complications throughout the epidemic waves of the disease. METHODS: This was an observational, multicenter, ambispective study conducted between March 2020 and August 2021 using data collected in five centers from southern metropolitan area of Barcelona (COVID-MetroSud cohort). Patients were grouped based on the pandemic waves of inclusion in the registry. We conducted a descriptive analysis, followed by bivariate and multivariate analyses (binary logistic regression) to identify predictors of risk for death or complications. RESULTS: A total of 1192 patients (mean [SD] age 85.7 [4.22] years and 46.8% female) were included. The most frequently reported symptoms in all waves were fever (63.1%), cough (56.5%), dyspnea (48.2%), and asthenia (27.5%). Laboratory and radiological findings consistently showed abnormal bilateral chest X-ray results (72.5% of patients) and elevated inflammatory markers such as lactate dehydrogenase (mean [SD] 335 [188] U/L), C-reactive protein (CRP) (mean [SD] 110 [88.4] U/L), and ferritin (mean [SD] 842 [1561] U/L). Acute respiratory distress syndrome (43.7%), renal failure (19.2%), and delirium (17.5%) were the most frequent complications. The overall mortality rate was 41.4% and declined across the epidemic waves. Age, diabetes mellitus, heart failure, dyspnea, and higher baseline levels of creatinine were identified as risk factors for complications, while a higher Barthel index and presence of cough were found to be protective. Age, dyspnea, abnormal bilateral chest X-ray, CRP, and sodium were identified as risk factors for death. CONCLUSIONS: This study demonstrates the clinical presentation of COVID-19 (fever, cough, dyspnea, and asthenia) and the different risk factors for mortality and complications in octogenarian hospitalized patients throughout the pandemic. These findings could be highly valuable for managing future virus pandemics.
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OBJECTIVES: To assess the effect of hydroxychloroquine (HCQ) and Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) as pre-exposure prophylaxis on COVID-19 risk. METHODS: EPICOS is a double-blind, placebo-controlled randomized trial conducted in Spain, Bolivia, and Venezuela. Healthcare workers with negative SARS-CoV-2 IgM/IgG test were randomly assigned to the following: daily TDF/FTC plus HCQ for 12 weeks, TDF/FTC plus HCQ placebo, HCQ plus TDF/FTC placebo, and TDF/FTC placebo plus HCQ placebo. Randomization was performed in groups of four. Primary outcome was laboratory-confirmed, symptomatic COVID-19. We also studied any (symptomatic or asymptomatic) COVID-19. We compared group-specific 14-week risks via differences and ratios with 95% CIs. RESULTS: Of 1002 individuals screened, 926 (92.4%) were eligible and there were 14 cases of symptomatic COVID-19: 220 were assigned to the TDF/FTC plus HCQ group (3 cases), 231 to the TDF/FTC placebo plus HCQ group (3 cases), 233 to the TDF/FTC plus HCQ placebo group (3 cases), and 223 to the double placebo group (5 cases). Compared with the double placebo group, 14-week risk ratios (95% CI) of symptomatic COVID-19 were 0.39 (0.00-1.98) for TDF + HCQ, 0.34 (0.00-2.06) for TDF, and 0.49 (0.00-2.29) for HCQ. Corresponding risk ratios of any COVID-19 were 0.51 (0.21-1.00) for TDF + HCQ, 0.81 (0.44-1.49) for TDF, and 0.73 (0.41-1.38) for HCQ. Adverse events were generally mild. DISCUSSION: The target sample size was not met. Our findings are compatible with both benefit and harm of pre-exposure prophylaxis with TDF/FTC and HCQ, alone or in combination, compared with placebo.