Effectiveness of rosuvastatin plus colchicine, emtricitabine/tenofovir and combinations thereof in hospitalized patients with COVID-19: a pragmatic, open-label randomized trial
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.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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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).
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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