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.

Introducción: La situación de crisis generada por la COVID-19 y las medidas adoptadas han generado cambios sociales en las dinámicas normales de la población general y en especial para los trabajadores de la salud, que se encuentran en atención del paciente con infección sospechada o confirmada. Estudios recientes han detectado en ellos síntomas depresivos y ansiosos y síndrome de burnout, afecciones personales y sociales que alteran su capacidad de respuesta durante la emergencia sanitaria. El objetivo es generar recomendaciones de promoción y protección de la salud mental de los trabajadores y equipos de salud dispuestos como primera línea de atención en la emergencia sanitaria por COVID-19. Métodos: Se realizó una búsqueda rápida de literatura en PubMed y Google Scholar, y un consenso de expertos iterativo y mediante consulta electrónica, con 13 participantes de las áreas de psicología, psiquiatría y medicina; la gradación de su fuerza y direccionalidad se realizó según las normas internacionales del Joanna Briggs Institute. Resultados: Se generaron 31 recomendaciones sobre el autocuidado del trabajador de la salud, el cuidado comunitario entre los equipos de salud, el cribado de signos de alarma en salud mental y para las instituciones sanitarias. Conclusiones: Las actividades de promoción y protección en salud mental para el afrontamiento de la emergencia sanitaria generada por la COVID-19 en todo el mundo pueden abarcar acciones articuladas entre el trabajador, los equipos de salud y las instituciones sanitarias como parte de un cuidado integral, comunitario, corresponsable y sostenidas en el tiempo.

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

Introduction The crisis situation generated by COVID-19 and the measures adopted have generated social changes in the normal dynamics of the general population and especially for health workers, who find themselves caring for patients with suspected or confirmed infection. Recent studies have detected in them depression and anxiety symptoms and burnout syndrome, with personal and social conditions impacting their response capacity during the health emergency. Our aim was to generate recommendations for the promotion and protection of the mental health of health workers and teams in the first line of care in the health emergency due to COVID-19. Methods A rapid literature search was carried out in PubMed and Google Scholar, and an iterative expert consensus and through electronic consultation, with 13 participants from the areas of psychology, psychiatry and medicine; the grading of its strength and directionality was carried out according to the international standards of the Joanna Briggs Institute. Results Thirty-one recommendations were generated on self-care of health workers, community care among health teams, screening for alarm signs in mental health and for health institutions. Conclusions The promotion and protection activities in mental health to face the health emergency generated by COVID-19 worldwide can include coordinated actions between workers, health teams and health institutions as part of a comprehensive, community care, co-responsible and sustained over time.

Introducción. La infección por SARS-COV2, que en principio se pensó solo causaba manifestaciones respiratorias, también puede ocasionar síntomas gastrointestinales, renales, neurológicos, cardiovasculares e incluso cutáneos según algunos reportes. Presentación del caso. Paciente femenina de 36 años quien asistió al servicio de urgencias por cuadró clínico consistente en disnea, astenia, adinamia, odinofagia leve y cefalea. Como antecedentes de relevancia se registró obesidad, tabaquismo y ocupación como trabajadora de la salud. Dados los síntomas, se indicó tratamiento antimalárico y antirretroviral para tratar COVID-19, diagnóstico que fue confirmado a los tres días de ingreso, pero al cuarto día de instaurado este manejo la mujer presentó polidipsia y rash macular, pruriginoso y generalizado. Por sospecha de toxicodermia, el tratamiento fue suspendido y con esto el cuadro cutáneo mejoró. Luego de 8 días de hospitalización, la paciente recibió el alta, junto con recomendaciones de bioseguridad y confinamiento durante 28 días. Conclusiones. El caso descrito corresponde a un evento de toxicodermia en una paciente con COVID-19 en manejo con antirretroviral y antimalárico. A partir de los hallazgos, se establece que la exploración minuciosa de piel y mucosas en los pacientes con sospecha o diagnóstico confirmado de COVID-19 puede ser de gran ayuda para la correcta caracterización de esta nueva enfermedad.