Abstract: Articles Effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trial
H.G. Gait
an-Duarte, MD MSc.,a* C. Alvarez-Moreno, MD PhD.,b C.J. Rinc
on-Rodríguez, MSc.,c N. Yomayusa-Gonz
alez, MD.,d e f g h ~a, MD MSc., W. Adarme-Jaimes, PhD.,i J.A. Cort
es, MD., J.C. Villar, MD PhD., J.S. Bravo-Ojeda, MD., A. García-Pen j k
n-Sarmiento, MD.,m V.A. Rodríguez-Romero, PhD., S.L. Villate-Soto, MSc., G. Buitrago, MD PhD.,l J. Chaco n o p M. Macias-Quintero, MSc., C.P. Vaca, MSc., C. G
omez-Restrepo, MD PhD., and N. Rodríguez-Malag
on, MPH.q a Clinical Research Institute, Universidad Nacional de Colombia, Hospital Universitario Nacional de Colombia, Bogot
a, Colombia b Internal Medicine Department, Universidad Nacional de Colombia, Clínica Universitaria Colombia, Clínica Colsanitas, Bogot
a, Colombia c Department of Clinical Epidemiology and Biostatistics, Pontificia Universidad Javeriana, Bogot
a, Colombia d
n Universitaria Sanitas, Clínica Reina Sofía, Global Institute of Clinical Excellence-Translational Research Group, Fundacio Clínica Colsanitas, Bogot
a, Colombia e Internal Medicine Department, Universidad Nacional de Colombia, Infectious Diseases Service, Hospital Universitario Nacional de Colombia, Bogot
a, Colombia f
n Cardioinfantil - Instituto de Cardiología, Bogot
a, Colombia Research Department, Fundacio g Clínica Santa María del Lago, Clínica Colsanitas, Bogot
a, Colombia h Internal Medicine Department, Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Bogot
a, Colombia i SEPRO Group, School of Engineering, Universidad Nacional de Colombia, Bogot
a, Colombia j Department of Clinical Epidemiology and Biostatistics, Pontificia Universidad Javeriana, Bogot
a, Colombia k Clinical Research Institute, Universidad Nacional de Colombia, Bogot
a, Colombia l Clinical Research Institute, Universidad Nacional de Colombia, Hospital Universitario Nacional de Colombia, Bogot
a, Colombia m
n Universitaria Sanitas, Bogot
a, Colombia Clínica Reina Sofía, Clínica Colsanitas, Fundacio n Universidad Nacional de Colombia, Bogot
a, Colombia o Pharmacy Department, Universidad Nacional de Colombia, Bogot
a, Colombia p Department of Clinical Epidemiology and Biostatistics, Pontificia Universidad Javeriana, Bogot
a, Colombia q Department of Clinical Epidemiology and Biostatistics, Pontificia Universidad Javeriana, Bogot
a, Colombia Summary Background The use of rosuvastatin plus colchicine and emtricitabine/tenofovir in hospitalized patients with SARSCoV-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 Bogot
a, 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..