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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
Jul 2021  
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Mortality 22% Improvement Relative Risk Colchicine  Gaitán-Duarte et al.  LATE TREATMENT  RCT Is late treatment with colchicine + rosuvastatin beneficial for COVID-19? RCT 314 patients in Colombia (August 2020 - March 2021) Lower mortality with colchicine + rosuvastatin (not stat. sig., p=0.38) c19early.org Gaitán-Duarte et al., eClinicalMedicine, Jul 2021 Favorscolchicine Favorscontrol 0 0.5 1 1.5 2+
Colchicine for COVID-19
5th treatment shown to reduce risk in September 2020, now with p = 0.00000031 from 56 studies.
Lower risk for mortality, ICU, hospitalization, and recovery.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 112 treatments. c19early.org
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).
Although the 22% lower mortality is not statistically significant, it is consistent with the significant 28% lower mortality [17‑37%] from meta analysis of the 43 mortality results to date.
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, study period 24 August, 2020 - 20 March, 2021, 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).
This PaperColchicineAll
Effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trial
H G Gaitán-Duarte, C Álvarez-Moreno, C J Rincón-Rodríguez, N Yomayusa-González, J A Cortés, MD PhD J C Villar, MD J S Bravo-Ojeda, MD MSc A García-Peña, PhD W Adarme-Jaimes, PhD V A Rodríguez-Romero, MSc S L Villate-Soto, MD PhD G Buitrago, J Chacón-Sarmiento, MSc M Macias-Quintero, MSc C P Vaca, C Gómez-Restrepo, N Rodríguez-Malagón
eClinicalMedicine, doi:10.1016/j.eclinm.2021.101242
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 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 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
Author's contributions Hernando G. Gait an-Duarte: leader researcher, design, contact with external entities, data collection, analysis and interpretation, funding, writing; Carlos Alvarez-Moreno: design, data collection, analysis and interpretation; Carlos Javier Rincon: design, analysis and interpretation, writing; Nancy Yomayusa-Gonz alez: data collection, analysis and interpretation, writing; Jorge Alberto Cort es: data collection, analysis and interpretation, writing; Juan Carlos Villar: design, data collection; Juan Sebasti an Bravo-Ojeda: data collection; Angel Garc ıa-Peña: design, data collection; Wilson Adarme-Jaimes: design, data collection; Viviana Rodr ıguez-Romero: design, analysis and interpretation; Steffany L Villate-Soto: supervisory role; Giancarlo Buitrago: design, data analysis and interpretation, writing; Julio Chac on-Sarmiento: data collection; Mart ın Mac ıas-Quintero: data analysis; Claudia Patricia Vaca: analysis and interpretation; Carlos G omez-Restrepo: analysis and interpretation; Nelcy Rodr ıguez-Malag on: design, data collection, analysis and interpretation. Supplementary materials Supplementary material associated with this article can be found, in the online version, at doi:10.1016/j. eclinm.2021.101242.
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Late treatment
is less effective
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