Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
Recovery Collaborative Group,
Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label,..,
, The Lancet Respiratory Medicine, doi:10.1016/S2213-2600(21)00435-5 (date from earlier preprint), RECOVERY, NCT04381936
RCT with 5,610 colchicine and 5,730 control patients showing mortality RR 1.01 [0.93-1.10]. Very late stage treatment, median 9 days after symptom onset. Baseline oxygen requirements unknown (data is provided but combined with "none"). ISRCTN 50189673.
risk of death, 1.0% higher, RR 1.01, p = 0.77, treatment 1,173 of 5,610 (20.9%), control 1,190 of 5,730 (20.8%).
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risk of mechanical ventilation, 18.0% higher, RR 1.18, p = 0.06, treatment 259 of 3,815 (6.8%), control 228 of 3,962 (5.8%).
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risk of death/intubation, 2.0% higher, RR 1.02, p = 0.47, treatment 1,344 of 5,342 (25.2%), control 1,343 of 5,469 (24.6%).
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risk of no hospital discharge, 2.0% higher, RR 1.02, p = 0.44, treatment 1,709 of 5,610 (30.5%), control 1,698 of 5,730 (29.6%), inverted to make RR<1 favor treatment.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Recovery Collaborative Group et al., 18 May 2021, Randomized Controlled Trial, United Kingdom, peer-reviewed, 35 authors, average treatment delay 9.0 days, dosage 1.5mg day 1, 1mg days 2-10, dose for days 2-10 halved for certain patients, trial
NCT04381936 (history) (RECOVERY).
Abstract: Articles
Colchicine in patients admitted to hospital with COVID-19
(RECOVERY): a randomised, controlled, open-label, platform
trial
RECOVERY Collaborative Group*
Summary
Background Colchicine has been proposed as a treatment for COVID-19 based on its anti-inflammatory actions. We
aimed to evaluate the efficacy and safety of colchicine in patients admitted to hospital with COVID-19.
Methods In this streamlined, randomised, controlled, open-label trial, underway at 177 hospitals in the UK, two
hospitals in Indonesia, and two hospitals in Nepal, several possible treatments were compared with usual care in
patients hospitalised with COVID-19. Patients were eligible for inclusion in the study if they were admitted to hospital
with clinically suspected or laboratory confirmed SARS-CoV-2 infection and had no medical history that might, in the
opinion of the attending clinician, put the patient at significant risk if they were to participate in the trial. Eligible and
consenting adults were randomly assigned (1:1) to receive either usual standard of care alone (usual care group) or
usual standard of care plus colchicine (colchicine group) using web-based simple (unstratified) randomisation with
allocation concealment. Participants received colchicine 1 mg after randomisation followed by 500 µg 12 h later and
then 500 µg twice a day by mouth or nasogastric tube for 10 days in total or until discharge. Dose frequency was
halved for patients receiving a moderate CYP3A4 inhibitor (eg, diltiazem), patients with an estimated glomerular
filtration rate of less than 30 mL/min per 1·73m², and those with an estimated bodyweight of less than 70 kg. The
primary outcome was 28-day mortality, secondary endpoints included time to discharge, the proportion of patients
discharged from hospital within 28 days, and, in patients not on invasive mechanical ventilation at randomisation, a
composite endpoint of invasive mechanical ventilation or death. All analyses were by intention-to-treat. The trial is
registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936.
Lancet Respir Med 2021
Published Online
October 18, 2021
https://doi.org/10.1016/
S2213-2600(21)00435-5
*The writing committee and trial
steering committee are listed at
the end of this manuscript and a
complete list of collaborators in
the Randomised Evaluation of
COVID-19 Therapy (RECOVERY)
trial is provided in the appendix
(pp 2–25).
Correspondence to:
Prof Peter W Horby and
Prof Martin J Landray,
RECOVERY Central Coordinating
Office, Oxford OX3 7LF,
United Kingdom.
recoverytrial@ndph.ox.ac.uk
See Online for appendix
Findings Between Nov 27, 2020, and March 4, 2021, 11 340 (58%) of 19 423 patients enrolled into the RECOVERY trial
were eligible to receive colchicine; 5610 (49%) patients were randomly assigned to the colchicine group and 5730 (51%)
to the usual care group. Overall, 1173 (21%) patients in the colchicine group and 1190 (21%) patients in the usual care
group died within 28 days (rate ratio 1·01 [95% CI 0·93 to 1·10]; p=0·77). Consistent results were seen in all
prespecified subgroups of patients. Median time to discharge alive (10 days [IQR 5 to >28]) was the same in both
groups, and there was no significant difference in the proportion of patients discharged from hospital alive within
28 days (3901 [70%] patients in the colchicine group and 4032 [70%] usual care group; rate ratio 0·98 [95% CI
0·94 to 1·03]; p=0·44). In those not on invasive mechanical ventilation at baseline,..
Late treatment
is less effective
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