Colchicine and high-intensity rosuvastatin in the treatment of non-critically ill patients hospitalised with COVID-19: a randomised clinical trial
RCT 250 late stage (80% on oxygen) hospitalized patients in the USA, showing no significant differences with combined colchicine/rosuvastatin treatment.
There was a trend towards increased risk, which authors note may be due to chance because the patients enrolled in the treatment arm were in more serious condition, for example, patients in the treatment arm were more frequently on oxygen, more frequently on HFNC/NIV, and had higher mean SOFA scores.
Colchicine 0.6mg two times daily for 3 days followed by 0.6mg daily, and high-intensity rosuvastatin 40mg daily.
This study is excluded in the after exclusion results of meta
analysis:
very late stage, >50% on oxygen/ventilation at baseline.
risk of death, 75.0% higher, RR 1.75, p = 0.54, treatment 7 of 125 (5.6%), control 4 of 125 (3.2%), day 60.
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risk of death, 100% higher, RR 2.00, p = 0.50, treatment 6 of 125 (4.8%), control 3 of 125 (2.4%), day 30.
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risk of mechanical ventilation, 200.0% higher, RR 3.00, p = 0.28, treatment 6 of 125 (4.8%), control 2 of 125 (1.6%).
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risk of severe case, 46.2% higher, RR 1.46, p = 0.34, treatment 19 of 125 (15.2%), control 13 of 125 (10.4%), day 60, primary outcome.
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risk of severe case, 72.7% higher, RR 1.73, p = 0.17, treatment 19 of 125 (15.2%), control 11 of 125 (8.8%), day 30, primary outcome.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Shah et al., 24 Feb 2023, Randomized Controlled Trial, USA, peer-reviewed, median age 61.0, 23 authors, study period October 2020 - September 2021, this trial uses multiple treatments in the treatment arm (combined with rosuvastatin) - results of individual treatments may vary, trial
NCT04472611 (history) (COLSTAT).
Abstract: Original research
Colchicine and high-intensity
rosuvastatin in the treatment of non-
critically ill patients hospitalised with
COVID-19: a randomised clinical trial
Tayyab Shah,1,2 Marianne McCarthy,1,2 Irem Nasir,2,3 Herb Archer,2,3 Elio Ragheb,1
Jonathan Kluger,1 Nitu Kashyap,1,2 Carlos Paredes,1,2 Prashant Patel,2,4 Jing Lu,1
Prakash Kandel,2,4 Christopher Song,2,4 Mustafa Khan,2,3 Haocheng Huang,1
Faheem Ul Haq,2,5 Rami Ahmad,1,2 Christopher Howes,2,3 Brian Cambi,2,4
Gilead Lancaster,2,5 Michael Cleman,2,3 Charles Dela Cruz,1,2 Helen Parise,1
Alexandra Lansky 1,2
To cite: Shah T, McCarthy M,
Nasir I, et al. Colchicine and
high-intensity rosuvastatin in
the treatment of non-critically
ill patients hospitalised with
COVID-19: a randomised
clinical trial. BMJ Open
2023;13:e067910. doi:10.1136/
bmjopen-2022-067910
► Prepublication history and
additional supplemental material
for this paper are available
online. To view these files,
please visit the journal online
(http://dx.doi.org/10.1136/
bmjopen-2022-067910).
Received 31 August 2022
Accepted 16 January 2023
© Author(s) (or their
employer(s)) 2023. Re-use
permitted under CC BY-NC. No
commercial re-use. See rights
and permissions. Published by
BMJ.
1
Yale School of Medicine, New
Haven, Connecticut, USA
2
Yale New Haven Health System,
New Haven, Connecticut, USA
3
Greenwich Hospital, Greenwich,
CT, USA
4
Lawrence & Memorial Hospital,
New London, CT, USA
5
Bridgeport Hospital, Bridgeport,
CT, USA
Correspondence to
Dr Alexandra Lansky;
a lexandra.lansky@y ale.edu
ABSTRACT
Objective To evaluate the effect of colchicine and high-
intensity rosuvastatin in addition to standard of care on the
progression of COVID-19 disease in hospitalised patients.
Design A pragmatic, open-label, multicentre, randomised
controlled trial conducted from October 2020 to September
2021. Follow-up was conducted at 30 and 60 days. The
electronic medical record was used at all stages of the
trial including screening, enrolment, randomisation, event
ascertainment and follow-up.
Setting Four centres in the Yale New Haven Health
System.
Participants Non-critically ill hospitalised patients with
COVID-19.
Interventions Patients were randomised 1:1 to either
colchicine plus high-intensity rosuvastatin in addition to
standard of care versus standard of care alone. Assigned
treatment was continued for the duration of index
hospitalisation or 30 days, whichever was shorter.
Primary and secondary outcome measures The
prespecified primary endpoint was progression to severe
COVID-19 disease (new high-flow or non-invasive
ventilation, mechanical ventilation, need for vasopressors,
renal replacement therapy or extracorporeal membrane
oxygenation, or death) or arterial/venous thromboembolic
events (ischaemic stroke, myocardial infarction, deep
venous thrombosis or pulmonary embolism) evaluated at
30 days.
Results Among the 250 patients randomised in this trial
(125 to each arm), the median age was 61 years, 44%
were women, 15% were Black and 26% were Hispanic/
Latino. As part of the standard of care, patients received
remdesivir (87%), dexamethasone (92%), tocilizumab
(18%), baricitinib (2%), prophylactic/therapeutic
anticoagulation (98%) and aspirin (91%). The trial was
terminated early by the data and safety monitoring
board for futility. No patients were lost to follow-up due
to electronic medical record follow-up. There was no
significant difference in the primary endpoint at 30..
Late treatment
is less effective
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