RESUMEN
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.
RESUMEN
Se informa sobre el estudio micológico realizado en una población de 1.175 pacientes adultos remitidos por el servicio médico de la ciudad de Manizales. Fue posible establecer diagnóstico positivo en 779 pacientes (66,3 por ciento), con 72 (6,1 por ciento) casos de pitiriasis versicolor, 1(0,1 por ciento) por Tinea nigra palmaris, 291 (24,8 por ciento) micosis cutáneas por dermatofitos y 184 (15,7 por ciento) casos de candidiasis. La distribución de frecuencia agrupó a 15 Microsporum, 101 Epidermophyton y 257 Trichophyton. Fueron 357 (95,7 por ciento) antropofílicos, 10 (2,7 por ciento) geofílicos y 6 (1,6 por ciento) zoofílicos. Las especies aisladas fueron: M canis, M. gypseum, E. floccosum, T. rubrum, T. mentagrophytes, T. tonsurans, T. verrucosum, Cladosporium werneckii, Malassezia furtur y otros. En el estudio de las onicopatías se encontraron: 82 (7,0 por ciento) casos por dermatofitos 103 (8,8 por ciento) casos por Candida albicans; en 46 (3,9 por ciento) casos se aislaron hongos no dermatófitos incriminados como agentes patógenos oportunistas, por algunos autores. No hubo diagnóstico micológico en 10 (0.8 por ciento) casos por obtenerse en los cultivos Mycelia sterilla, y fueron negativos 386 (32,8 por ciento). Se indican los procedimientos para análisis micológico y se mencionan consideraciones generales sobre la patología de la dermatofitos