Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care
Olender et al.
, Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care
, Clinical Infectious Diseases, doi:10.1093/cid/ciaa1041
Comparative analysis between remdesivir trial GS-US-540–5773 and a retrospective SOC cohort with similar inclusion criteria, showing lower mortality and higher recovery at day 14 with remdesivir.[Gérard, Wu, Zhou]
show significantly increased risk of acute kidney injury with remdesivir.
risk of death, 58.8% lower, RR 0.41, p = 0.001, treatment 24 of 312 (7.7%), control 102 of 818 (12.5%), odds ratio converted to relative risk, day 14, weighted multivariable logistic regression.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Olender et al., 24 Jul 2020, retrospective, USA, peer-reviewed, 33 authors.
Abstract: Clinical Infectious Diseases
Remdesivir for Severe Coronavirus Disease 2019 (COVID19) Versus a Cohort Receiving Standard of Care
Susan A. Olender,1 Katherine K. Perez,2 Alan S. Go,3 Bindu Balani,4 Eboni G. Price-Haywood,5 Nirav S. Shah,6 Su Wang,7 Theresa L. Walunas,8
Shobha Swaminathan,9 Jihad Slim,10 BumSik Chin,11 Stéphane De Wit,12 Shamim M. Ali,13 Alex Soriano Viladomiu,14 Philip Robinson,15 Robert L. Gottlieb,16
Tak Yin Owen Tsang,17 I-Heng Lee,18 Hao Hu,19 Richard H. Haubrich,18 Anand P. Chokkalingam,18 Lanjia Lin,18 Lijie Zhong,18 B. Nebiyou Bekele,18
Robertino Mera-Giler,18 Chloé Phulpin,20 Holly Edgar,20 Joel Gallant,18 Helena Diaz-Cuervo,21 Lindsey E. Smith,18 Anu O. Osinusi,18 Diana M. Brainard,18 and
Jose I Bernardino22; For the GS-US-540–5773 and GS-US-540–5807 Investigators
(See the Editorial Commentary by Gandhi on pages e4175–8.)
Background. We compared the efficacy of the antiviral agent, remdesivir, versus standard-of-care treatment in adults with severe coronavirus disease 2019 (COVID-19) using data from a phase 3 remdesivir trial and a retrospective cohort of patients with
severe COVID-19 treated with standard of care.
Methods. GS-US-540–5773 is an ongoing phase 3, randomized, open-label trial comparing two courses of remdesivir (remdesivircohort). GS-US-540–5807 is an ongoing real-world, retrospective cohort study of clinical outcomes in patients receiving standardof-care treatment (non-remdesivir-cohort). Inclusion criteria were similar between studies: patients had confirmed severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, were hospitalized, had oxygen saturation ≤94% on room air or required
supplemental oxygen, and had pulmonary infiltrates. Stabilized inverse probability of treatment weighted multivariable logistic regression was used to estimate the treatment effect of remdesivir versus standard of care. The primary endpoint was the proportion of
patients with recovery on day 14, dichotomized from a 7-point clinical status ordinal scale. A key secondary endpoint was mortality.
Results. After the inverse probability of treatment weighting procedure, 312 and 818 patients were counted in the remdesivirand non-remdesivir-cohorts, respectively. At day 14, 74.4% of patients in the remdesivir-cohort had recovered versus 59.0% in the
non-remdesivir-cohort (adjusted odds ratio [aOR] 2.03: 95% confidence interval [CI]: 1.34–3.08, P < .001). At day 14, 7.6% of patients in the remdesivir-cohort had died versus 12.5% in the non-remdesivir-cohort (aOR 0.38, 95% CI: .22–.68, P = .001).
Conclusions. In this comparative analysis, by day 14, remdesivir was associated with significantly greater recovery and 62% reduced odds of death versus standard-of-care treatment in patients with severe COVID-19.
Clinical Trials Registration. NCT04292899 and EUPAS34303.
Keywords. SARS-CoV-2; severe COVID-19; remdesivir; antiviral treatment.
Coronavirus disease 2019 (COVID-19) is a major global public
health and socioeconomic crisis, with over 18 million cases
identified worldwide and more than 700 000 deaths (as of
Received 29 May 2020; editorial decision 16 July 2020; accepted 20 July 2020; published online
July 24, 2020.
Correspondence: R. H. Haubrich, Gilead Sciences, Inc, 333 Lakeside Dr, Foster City, CA USA
Clinical Infectious Diseases® 2021;73(11):e4166–74
© The Author(s) 2020. Published by Oxford University Press for the Infectious Diseases
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