Evaluation of the effectiveness of remdesivir in treating severe COVID-19 using data from the ISARIC WHO Clinical Characterisation Protocol UK: a prospective, national cohort study
Arch et al.,
Evaluation of the effectiveness of remdesivir in treating severe COVID-19 using data from the ISARIC WHO..,
medRxiv, doi:10.1101/2021.06.18.21259072 (Preprint)
Prospective PSM analysis of remdesivir use in the UK showing statistically significantly lower mortality at 28 days. For unspecified reasons, the study prioritized short-term outcomes. Mortality at 14 days was also lower but not statistically significant.
Confounding by indication is likely and may only be partially addressed by the variables included in the PSM.
[Gérard, Wu, Zhou] show significantly increased risk of acute kidney injury with remdesivir.
risk of death, 19.9% lower, RR 0.80, p = 0.03, treatment 203 of 1,491 (13.6%), control 777 of 4,676 (16.6%), NNT 33, odds ratio converted to relative risk, PSM, day 28.
|
risk of death, 18.0% lower, RR 0.82, p = 0.12, treatment 140 of 1,502 (9.3%), control 565 of 4,728 (12.0%), NNT 38, odds ratio converted to relative risk, PSM, day 14.
|
risk of mechanical ventilation, 68.0% higher, RR 1.68, p = 0.003, treatment 106 of 1,498 (7.1%), control 153 of 4,602 (3.3%), odds ratio converted to relative risk, PSM, day 28.
|
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
|
Arch et al., 21 Jun 2021, prospective, propensity score matching, United Kingdom, preprint, 10 authors, average treatment delay 6.0 days.
Abstract: medRxiv preprint doi: https://doi.org/10.1101/2021.06.18.21259072; this version posted June 21, 2021. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY-NC-ND 4.0 International license .
Evaluation of the effectiveness of remdesivir in treating severe COVID-19
using data from the ISARIC WHO Clinical Characterisation Protocol UK:
a prospective, national cohort study.
Short Running title: ISARIC4C Remdesivir effectiveness study
Authors
Arch BN1, Kovacs D2*, Scott JT3*, Jones AP1, Harrison EM4, Rosala-Hallas A1, Gamble CG1, Openshaw
PJM 5, Baillie JK6, Semple MG7,8 on behalf of ISARIC4C Investigators
*Joint 2nd authors
Affiliations
1. Liverpool Clinical Trials Centre, Clinical Directorate, Faculty of Health and Life Sciences,
University of Liverpool, UK.
2. Institute of Biodiversity, Animal health and Comparative Medicine, University of Glasgow,
Glasgow, UK
3. MRC-University of Glasgow Centre for Virus Research, Glasgow, UK
4. Centre for Medical Informatics, The Usher Institute, University of Edinburgh, Edinburgh, UK
5. National Heart and Lung Institute, Imperial College London, London, UK
6. Roslin Institute, University of Edinburgh, Edinburgh, UK
7. Health Protection Research Unit in Emerging and Zoonotic Infections, Institute of Infection,
Veterinary and Ecological Sciences, Faculty of Health and Life Sciences, University of
Liverpool, Liverpool, UK.
8. Department of Respiratory Medicine, Alder Hey Children’s Hospital, Liverpool, UK.
Corresponding author
Barbara Arch. Liverpool Clinical Trials Centre, University of Liverpool, Institute in the Park, Alder
Hey Childrens Hospital, Eaton Road, Liverpool, L12 2AP.
Email: barbara.arch@liverpool.ac.uk, Tel: +44(0)151 795 8751
Word Count
Abstract 267/300
Manuscript (excluding Research in Context Panel) 3,579/3,500
NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice.
Page 1 of 22
medRxiv preprint doi: https://doi.org/10.1101/2021.06.18.21259072; this version posted June 21, 2021. The copyright holder for this preprint
(which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.
It is made available under a CC-BY-NC-ND 4.0 International license .
Abstract
Background
Remdesivir was given UK early-access approval for use in COVID-19 in people aged 12 years and
older on 26th May 2020 on the basis of unmet clinical need. Evidence on the side effects, complications
of therapy and effectiveness of this therapy is lacking or conflicting.
Methods
Adults with severe COVID-19 treated with remdesivir were compared with propensity-score matched
controls, identified from the ISARIC WHO Clinical Characterisation Protocol study of UK hospitalised
patients with COVID-19. Remdesivir patients were matched to controls according to baseline
underlying 14-day mortality risk. The effect of remdesivir on short-term outcomes was investigated
(primary outcome: 14-day mortality). Effect sizes were estimated and adjusted for potential
confounders using multivariable modelling.
Results
1,549 patients given remdesivir and 4,964 matched controls were identified satisfying inclusion and
exclusion criteria. The balance diagnostic threshold was achieved. Patients had symptoms for a median
of 6 days prior to..
Late treatment
is less effective
Please send us corrections, updates, or comments. Vaccines and
treatments are complementary. All practical, effective, and safe means should
be used based on risk/benefit analysis. No treatment, vaccine, or intervention
is 100% available and effective for all current and future variants. We do not
provide medical advice. Before taking any medication, consult a qualified
physician who can provide personalized advice and details of risks and
benefits based on your medical history and situation.
FLCCC and
WCH
provide treatment protocols.
Submit