Background The use of rosuvastatin plus colchicine and emtricitabine/tenofovir in hospitalized patients with SARS-CoV-2 disease (COVID-19) has not been assessed. The objective of this study was to assess the effectiveness and safety of rosuvastatin plus colchicine, emtricitabine/tenofovir, and their combined use in these patients. Methods This was a randomized, controlled, open-label, multicentre, parallel, pragmatic study conducted in six referral hospitals in Bogotá, Colombia. The study enrolled hospitalized patients over 18 years of age with a confirmed diagnosis of COVID-19 complicated with pneumonia, not on chronic treatment with the study medications, and with no contraindications for their use. Patients were assigned 1:1:1:1. 1) emtricitabine with tenofovir disoproxil fumarate (FTC/TDF, 200/300 mg given orally for 10 days); 2) colchicine plus rosuvastatin (COLCH+ROSU, 0.5 mg and 40 mg given orally for 14 days); 3) emtricitabine with tenofovir disoproxil plus colchicine and rosuvastatin at the same doses and for the same period of time (FTC/TDF+COLCH+ROSU); or 4) the Colombian consensus standard of care, including a corticosteroid (SOC). The primary endpoint was 28-day all-cause mortality. A modified intention-to-treat analysis was used together with a usefulness analysis to determine which could be the best treatment. The trial was registered at ClinicalTrials.gov: NCT04359095 Findings Out of 994 candidates considered between August 2020 and March 2021, 649 (65.3%) patients agreed to participate and were enrolled in this study; among them, 633 (97.5%) were included in the analysis. The mean age was 55.4 years (SD ± 12.8 years), and 428 (68%) were men; 28-day mortality was significantly lower in the FTC/TDF+COLCH+ROSUV group than in the SOC group, 10.7% (17/159) vs. 17.4% (28/161) (hazard ratio [HR] 0.53; 95% CI 0.29 to 0.96). Mortality in the FTC/TDF group was 13.8% (22/160, HR 0.68, 95% CI 0.39 to 1.20) and 14.4% in the COLCH+ROSU group (22/153) (HR 0.78, 95% CI 0.44 to 1.36). A lower need for invasive mechanical ventilation was observed in the FTC/TDF+COLCH+ROSUV group than in the SOC group (risk difference [RD] - 0.08, 95% CI 0.11 to 0.04). Three patients presented severe adverse events, one severe diarrhoea in the COLCH+ROSU and one in the FTC/TDF+COLCH+ROSU group and one general exanthema in the FTC/TDF group. Interpretation The combined use of FTC/TDF+COLCH+ROSU reduces the risk of 28-day mortality and the need for invasive mechanical ventilation in hospitalized patients with pulmonary compromise from COVID-19. More randomized controlled trials are needed to compare the effectiveness and cost of treatment with this combination versus other drugs that have been shown to reduce mortality from SARS-CoV-2 infection and its usefulness in patients with chronic statin use.

BACKGROUNDThe effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir, and of their combined use in hospitalized patients with coronavirus disease 2019 (Covid-19) pneumonia is unclear.METHODSIn each hospital, hospitalized adults with Covid-19 pneumonia, were randomly assigned, in a 1:1 ratio, to receive: a) standard of care; or b) emtricitabine/tenofovir; or c) colchicine + rosuvastatin; or d) emtricitabine/tenofovir + colchicine + rosuvastatin. The primary outcome was all-cause mortality within the first 28 days after randomization. Severe adverse events (SAE) were those with a high probability of being treatment-related.RESULTS633 patients were randomized in 6 hospitals in Bogota, Colombia. Overall, 98% of the patients received glucocorticoids during hospitalization. The cumulative incidence of death through day 28 was 10.7% in the emtricitabine/tenofovir + colchicine + rosuvastatin arm, 14.4% in the colchicine + rosuvastatin arm, 13.8% in the emtricitabine/tenofovir arm, and 17.4% in the standard of care arm, with adjusted risk differences (aRD) against the standard treatment of -0.07 (95% confidence interval [CI], -0.17 to 0.04), aRD -0.03 (95%CI: -0.11 to 0.05) and aRD: -0.05 (95%CI: -0.15 to 0.05), respectively. Need for invasive mechanical ventilation was lower in the emtricitabine/tenofovir + colchicine + rosuvastatin arm compared to the standard treatment arm, aRD: -0.06 (95%CI: -0.11 to -0,01), but no differences were found between the other comparisons. SAE occurred in 3 patients distributed in the 3 treatment arms.CONCLUSIONSAmong patients hospitalized with moderate and severe SARS Covid-19, the use of the emtricitabine/tenofovir + colchicine + rosuvastatin combination emerges as a treatment alternative.ClinicalTrials.gov number: NCT04359095

The impact of COVID-19 pandemic on mental health of adolescents are emerging and require particular attention in settings where challenges like armed conflict, poverty and internal displacement have previously affected their mental wellbeing. This study aimed to determine the prevalence of mental health problems and symptoms of anxiety and depression, probable post-traumatic stress disorder, and resilience capacity in adolescents in a post-armed conflict area in Colombia during the COVID-19 pandemic. A cross-sectional study was conducted with 657 school attending adolescents aged 12 to 18 years old. Mental health information was obtained through screening scales for anxiety (GAD-7), depression (PHQ-8), probable post-traumatic stress disorder (PCL-5) and resilience capacity (CD-RISC-25). The prevalence observed for moderate to severe depression symptoms was 30.0% (CI95%=26.5–33.7) and for moderate to severe anxiety symptoms was 18.9% (CI95%=16.0-22.1). A prevalence of probable post-traumatic stress disorder (PTSD) of 22.3% (CI95%=18.1–27.2) was found. The CD-RISC-25 results for resilience had a median score of 54 [IQR:30]. Our results are in line with emerging evidence that suggests multiple domains of adolescents’ mental wellbeing were negatively impacted by the pandemic, and agree with other studies of regions affected by the armed conflict that show an increase in the prevalence of mental health disorders in young populations. In contrast, our data show lower resilience than other studies of adolescents. These findings call for multidisciplinary actions necessary to respond effectively to the impact of the pandemic on the mental health of adolescents, as well as to guarantee a successful educational recovery, being schools key places in which prompt intervention might reduce the burden of mental distress in adolescents.

Los objetivos de este trabajo fueron identificar los temas de mayor interés, las principales necesidades deinformación y los aspectos o sugerencias para la construcción de un sistema de información sobre el cuidadode la salud de la población infantil en los municipios. Se realizaron siete talleres en siete municipios, con laparticipación de 71 representantes de 19 entidades relacionadas con el cuidado de la salud de la poblacióninfantil. Se encontró que la falta de articulación, unificación y consolidación de la información ocasiona quela toma de decisiones se realice a partir de resultados desactualizados, incompletos o inexistentes. Por tanto,en los territorios se necesita un espacio donde se presente un panorama completo de la población infantil,articulando las diferentes instituciones y consolidando periódicamente los temas de interés.