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0 0.5 1 1.5 2+ Mortality 22% Improvement Relative Risk c19early.org/o Gaitán-Duarte et al. NCT04359095 Colchicine RCT LATE Is late treatment with colchicine+rosuvastatin beneficial for COVID-19? RCT 314 patients in Colombia Lower mortality with colchicine+rosuvastatin (not stat. sig., p=0.38) Gaitán-Duarte et al., eClinicalMedicine, doi:10.1016/j.eclinm.2021.101242 Favors colchicine Favors control
Effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trial
Gaitán-Duarte et al., eClinicalMedicine, doi:10.1016/j.eclinm.2021.101242, NCT04359095 (history)
Gaitán-Duarte et al., Effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in.., eClinicalMedicine, doi:10.1016/j.eclinm.2021.101242, NCT04359095
Jul 2021   Source   PDF  
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RCT 633 hospitalized patients in Colombia, 153 treated with colchicine + rosuvastatin, not showing statistically significant differences in outcomes. Improved results were seen with the combination of emtricitabine/tenofovir disoproxil + rosuvastatin + colchicine. NCT04359095 (history).
risk of death, 22.0% lower, HR 0.78, p = 0.38, treatment 22 of 153 (14.4%), control 28 of 161 (17.4%), NNT 33, adjusted per study, Cox proportional hazards.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Gaitán-Duarte et al., 10 Jul 2021, Randomized Controlled Trial, Colombia, peer-reviewed, 17 authors, average treatment delay 10.0 days, dosage 0.5mg days 1-14, this trial uses multiple treatments in the treatment arm (combined with rosuvastatin) - results of individual treatments may vary, trial NCT04359095 (history).
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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. Cortes, 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, Bogota, Colombia b Internal Medicine Department, Universidad Nacional de Colombia, Clínica Universitaria Colombia, Clínica Colsanitas, Bogota, Colombia c Department of Clinical Epidemiology and Biostatistics, Pontificia Universidad Javeriana, Bogota, Colombia d n Universitaria Sanitas, Clínica Reina Sofía, Global Institute of Clinical Excellence-Translational Research Group, Fundacio Clínica Colsanitas, Bogota, Colombia e Internal Medicine Department, Universidad Nacional de Colombia, Infectious Diseases Service, Hospital Universitario Nacional de Colombia, Bogota, Colombia f n Cardioinfantil - Instituto de Cardiología, Bogota, Colombia Research Department, Fundacio g Clínica Santa María del Lago, Clínica Colsanitas, Bogota, Colombia h Internal Medicine Department, Hospital Universitario San Ignacio, Pontificia Universidad Javeriana, Bogota, Colombia i SEPRO Group, School of Engineering, Universidad Nacional de Colombia, Bogota, Colombia j Department of Clinical Epidemiology and Biostatistics, Pontificia Universidad Javeriana, Bogota, Colombia k Clinical Research Institute, Universidad Nacional de Colombia, Bogota, Colombia l Clinical Research Institute, Universidad Nacional de Colombia, Hospital Universitario Nacional de Colombia, Bogota, Colombia m n Universitaria Sanitas, Bogota, Colombia Clínica Reina Sofía, Clínica Colsanitas, Fundacio n Universidad Nacional de Colombia, Bogota, Colombia o Pharmacy Department, Universidad Nacional de Colombia, Bogota, Colombia p Department of Clinical Epidemiology and Biostatistics, Pontificia Universidad Javeriana, Bogota, Colombia q Department of Clinical Epidemiology and Biostatistics, Pontificia Universidad Javeriana, Bogota, 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 Bogota, 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..
Late treatment
is less effective
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