Remdesivir for Severe Coronavirus Disease 2019 (COVID-19) Versus a Cohort Receiving Standard of Care

被引：131

作者：

Olender, Susan A. ^{[1
]}

Perez, Katherine K. ^{[2
]}

Go, Alan S. ^{[3
]}

Balani, Bindu ^{[4
]}

Price-Haywood, Eboni G. ^{[5
,6
]}

Shah, Nirav S. ^{[7
]}

Wang, Su ^{[8
]}

Walunas, Theresa L. ^{[9
]}

Swaminathan, Shobha ^{[10
]}

Slim, Jihad ^{[11
]}

Chin, BumSik ^{[12
]}

De Wit, Stephane ^{[13
]}

Ali, Shamim M. ^{[14
,15
]}

Viladomiu, Alex Soriano ^{[16
]}

Robinson, Philip ^{[17
]}

Gottlieb, Robert L. ^{[18
,19
]}

Tsang, Tak Yin Owen ^{[20
]}

Lee, I-Heng ^{[21
]}

Hu, Hao ^{[22
]}

Haubrich, Richard H. ^{[21
]}

Chokkalingam, Anand P. ^{[21
]}

Lin, Lanjia ^{[21
]}

Zhong, Lijie ^{[21
]}

Bekele, B. Nebiyou ^{[21
]}

Mera-Giler, Robertino ^{[21
]}

Phulpin, Chloe ^{[23
]}

Edgar, Holly ^{[23
]}

Gallant, Joel ^{[21
]}

Diaz-Cuervo, Helena ^{[24
]}

Smith, Lindsey E. ^{[21
]}

Osinusi, Anu O. ^{[21
]}

Brainard, Diana M. ^{[21
]}

Bernardino, Jose, I ^{[25
]}

机构：

[1] Columbia Univ, Dept Internal Med, Div Infect Dis, Irving Med Ctr, New York, NY USA

[2] Houston Methodist, Houston, TX USA

[3] Kaiser Permanente Northern Calif, Div Res, Oakland, CA USA

[4] Hackensack Univ, Med Ctr, Hackensack, NJ USA

[5] Ochsner Hlth Syst, New Orleans, LA USA

[6] Ochsner Clin Sch, New Orleans, LA USA

[7] NorthShore Univ Hlth Syst, Evanston, IL USA

[8] RWJBarnabas Med Grp, St Barnabas Med Ctr, Livingston, NJ USA

[9] Northwestern Univ, Feinberg Sch Med, Chicago, IL 60611 USA

[10] Rutgers New Jersey Med Sch, Newark, NJ USA

[11] St Michaels LLC, Prime Healthcare Serv, Newark, NJ USA

[12] Natl Med Ctr, Seoul, South Korea

[13] CHU St Pierre, NEAT ID Fdn, Brussels, Belgium

[14] Chelsea & Westminster Hosp, NEAT ID Fdn, London, England

[15] Moi Univ, Sch Med, Eldoret, Kenya

[16] Univ Barcelona, Hosp Clin Barcelona, IDIBAPS, Barcelona, Spain

[17] Hoag Mem Hosp, Newport Beach, CA USA

[18] Baylor Univ, Med Ctr Dallas, Dallas, TX USA

[19] Baylor Scott & White Hlth, Dallas, TX USA

[20] Princess Margaret Hosp, Kwai Chung, Hong Kong, Peoples R China

[21] Gilead Sci, Foster City, CA USA

[22] Gilead Sci, Causeway Bay, Hong Kong, Peoples R China

[23] Gilead Sci, Stockley Pk, Uxbridge, Middx, England

[24] Gilead Sci, Madrid, Spain

[25] Hosp La Paz, IdiPAZ, Madrid, Spain

来源：

CLINICAL INFECTIOUS DISEASES | 2021年 / 73卷 / 11期

关键词：

SARS-CoV-2; severe COVID-19; remdesivir; antiviral treatment; EFFICACY; RISK;

D O I：

10.1093/cid/ciaa1041

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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 (remdesivir-cohort). GS-US-540-5807 is an ongoing real-world, retrospective cohort study of clinical outcomes in patients receiving standard-of-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 remdesivir- and 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.

引用

页码：E4166 / E4174

页数：9

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