Remdesivir for the Treatment of Covid-19 - Final Report

John H Beigel; Kay M Tomashek; Lori E Dodd; Aneesh K Mehta; Barry S Zingman; Andre C Kalil; Elizabeth Hohmann; Helen Y Chu; Annie Luetkemeyer; Susan Kline; Diego Lopez de Castilla; Robert W Finberg; Kerry Dierberg; Victor Tapson; Lanny Hsieh; Thomas F Patterson; Roger Paredes; Daniel A Sweeney; William R Short; Giota Touloumi; David Chien Lye; Norio Ohmagari; Myoung-Don Oh; Guillermo M Ruiz-Palacios; Thomas Benfield; Gerd Fätkenheuer; Mark G Kortepeter; Robert L Atmar; C Buddy Creech; Jens Lundgren; Abdel G Babiker; Sarah Pett; James D Neaton; Timothy H Burgess; Tyler Bonnett; Michelle Green; Mat Makowski; Anu Osinusi; Seema Nayak; H Clifford Lane; ACTT-1 Study Group Members; Henrik Nielsen

doi:10.1056/NEJMoa2007764

Remdesivir for the Treatment of Covid-19 - Final Report

John H Beigel, Kay M Tomashek, Lori E Dodd, Aneesh K Mehta, Barry S Zingman, Andre C Kalil, Elizabeth Hohmann, Helen Y Chu, Annie Luetkemeyer, Susan Kline, Diego Lopez de Castilla, Robert W Finberg, Kerry Dierberg, Victor Tapson, Lanny Hsieh, Thomas F Patterson, Roger Paredes, Daniel A Sweeney, William R Short, Giota TouloumiDavid Chien Lye, Norio Ohmagari, Myoung-Don Oh, Guillermo M Ruiz-Palacios, Thomas Benfield, Gerd Fätkenheuer, Mark G Kortepeter, Robert L Atmar, C Buddy Creech, Jens Lundgren, Abdel G Babiker, Sarah Pett, James D Neaton, Timothy H Burgess, Tyler Bonnett, Michelle Green, Mat Makowski, Anu Osinusi, Seema Nayak, H Clifford Lane, ACTT-1 Study Group Members, Henrik Nielsen (Member of study group)

Research output: Contribution to journal › Journal article › Research › peer-review

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Abstract

BACKGROUND: Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious.

METHODS: We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only.

RESULTS: A total of 1062 patients underwent randomization (with 541 assigned to remdesivir and 521 to placebo). Those who received remdesivir had a median recovery time of 10 days (95% confidence interval [CI], 9 to 11), as compared with 15 days (95% CI, 13 to 18) among those who received placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P<0.001, by a log-rank test). In an analysis that used a proportional-odds model with an eight-category ordinal scale, the patients who received remdesivir were found to be more likely than those who received placebo to have clinical improvement at day 15 (odds ratio, 1.5; 95% CI, 1.2 to 1.9, after adjustment for actual disease severity). The Kaplan-Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29 (hazard ratio, 0.73; 95% CI, 0.52 to 1.03). Serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%) and in 163 of the 516 patients who received placebo (31.6%).

CONCLUSIONS: Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.).

Original language	English
Journal	The New England Journal of Medicine
Volume	383
Issue number	19
Pages (from-to)	1813-1826
Number of pages	14
ISSN	0028-4793
DOIs	https://doi.org/10.1056/NEJMoa2007764
Publication status	Published - 5 Nov 2020

Keywords

remdisivir
COVID-19

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10.1056/NEJMoa2007764

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7262788/pdf/NEJMoa2007764.pdf

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Beigel, J. H., Tomashek, K. M., Dodd, L. E., Mehta, A. K., Zingman, B. S., Kalil, A. C., Hohmann, E., Chu, H. Y., Luetkemeyer, A., Kline, S., Lopez de Castilla, D., Finberg, R. W., Dierberg, K., Tapson, V., Hsieh, L., Patterson, T. F., Paredes, R., Sweeney, D. A., Short, W. R., ... Nielsen, H. (2020). Remdesivir for the Treatment of Covid-19 - Final Report. The New England Journal of Medicine, 383(19), 1813-1826. Advance online publication. https://doi.org/10.1056/NEJMoa2007764

@article{62b246637dcb4d4e84219af71f7f498f,

title = "Remdesivir for the Treatment of Covid-19 - Final Report",

abstract = "BACKGROUND: Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious.METHODS: We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only.RESULTS: A total of 1062 patients underwent randomization (with 541 assigned to remdesivir and 521 to placebo). Those who received remdesivir had a median recovery time of 10 days (95% confidence interval [CI], 9 to 11), as compared with 15 days (95% CI, 13 to 18) among those who received placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P<0.001, by a log-rank test). In an analysis that used a proportional-odds model with an eight-category ordinal scale, the patients who received remdesivir were found to be more likely than those who received placebo to have clinical improvement at day 15 (odds ratio, 1.5; 95% CI, 1.2 to 1.9, after adjustment for actual disease severity). The Kaplan-Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29 (hazard ratio, 0.73; 95% CI, 0.52 to 1.03). Serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%) and in 163 of the 516 patients who received placebo (31.6%).CONCLUSIONS: Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.).",

keywords = "remdisivir, COVID-19",

author = "Beigel, {John H} and Tomashek, {Kay M} and Dodd, {Lori E} and Mehta, {Aneesh K} and Zingman, {Barry S} and Kalil, {Andre C} and Elizabeth Hohmann and Chu, {Helen Y} and Annie Luetkemeyer and Susan Kline and {Lopez de Castilla}, Diego and Finberg, {Robert W} and Kerry Dierberg and Victor Tapson and Lanny Hsieh and Patterson, {Thomas F} and Roger Paredes and Sweeney, {Daniel A} and Short, {William R} and Giota Touloumi and Lye, {David Chien} and Norio Ohmagari and Myoung-Don Oh and Ruiz-Palacios, {Guillermo M} and Thomas Benfield and Gerd F{\"a}tkenheuer and Kortepeter, {Mark G} and Atmar, {Robert L} and Creech, {C Buddy} and Jens Lundgren and Babiker, {Abdel G} and Sarah Pett and Neaton, {James D} and Burgess, {Timothy H} and Tyler Bonnett and Michelle Green and Mat Makowski and Anu Osinusi and Seema Nayak and Lane, {H Clifford} and {ACTT-1 Study Group Members} and Henrik Nielsen",

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month = nov,

day = "5",

doi = "10.1056/NEJMoa2007764",

language = "English",

volume = "383",

pages = "1813--1826",

journal = "The New England Journal of Medicine",

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publisher = "Massachusetts Medical Society",

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Beigel, JH, Tomashek, KM, Dodd, LE, Mehta, AK, Zingman, BS, Kalil, AC, Hohmann, E, Chu, HY, Luetkemeyer, A, Kline, S, Lopez de Castilla, D, Finberg, RW, Dierberg, K, Tapson, V, Hsieh, L, Patterson, TF, Paredes, R, Sweeney, DA, Short, WR, Touloumi, G, Lye, DC, Ohmagari, N, Oh, M-D, Ruiz-Palacios, GM, Benfield, T, Fätkenheuer, G, Kortepeter, MG, Atmar, RL, Creech, CB, Lundgren, J, Babiker, AG, Pett, S, Neaton, JD, Burgess, TH, Bonnett, T, Green, M, Makowski, M, Osinusi, A, Nayak, S, Lane, HC, ACTT-1 Study Group Members & Nielsen, H 2020, 'Remdesivir for the Treatment of Covid-19 - Final Report', The New England Journal of Medicine, vol. 383, no. 19, pp. 1813-1826. https://doi.org/10.1056/NEJMoa2007764

TY - JOUR

T1 - Remdesivir for the Treatment of Covid-19 - Final Report

AU - Beigel, John H

AU - Tomashek, Kay M

AU - Dodd, Lori E

AU - Mehta, Aneesh K

AU - Zingman, Barry S

AU - Kalil, Andre C

AU - Hohmann, Elizabeth

AU - Chu, Helen Y

AU - Luetkemeyer, Annie

AU - Kline, Susan

AU - Lopez de Castilla, Diego

AU - Finberg, Robert W

AU - Dierberg, Kerry

AU - Tapson, Victor

AU - Hsieh, Lanny

AU - Patterson, Thomas F

AU - Paredes, Roger

AU - Sweeney, Daniel A

AU - Short, William R

AU - Touloumi, Giota

AU - Lye, David Chien

AU - Ohmagari, Norio

AU - Oh, Myoung-Don

AU - Ruiz-Palacios, Guillermo M

AU - Benfield, Thomas

AU - Fätkenheuer, Gerd

AU - Kortepeter, Mark G

AU - Atmar, Robert L

AU - Creech, C Buddy

AU - Lundgren, Jens

AU - Babiker, Abdel G

AU - Pett, Sarah

AU - Neaton, James D

AU - Burgess, Timothy H

AU - Bonnett, Tyler

AU - Green, Michelle

AU - Makowski, Mat

AU - Osinusi, Anu

AU - Nayak, Seema

AU - Lane, H Clifford

AU - ACTT-1 Study Group Members

A2 - Nielsen, Henrik

PY - 2020/11/5

Y1 - 2020/11/5

N2 - BACKGROUND: Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious.METHODS: We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only.RESULTS: A total of 1062 patients underwent randomization (with 541 assigned to remdesivir and 521 to placebo). Those who received remdesivir had a median recovery time of 10 days (95% confidence interval [CI], 9 to 11), as compared with 15 days (95% CI, 13 to 18) among those who received placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P<0.001, by a log-rank test). In an analysis that used a proportional-odds model with an eight-category ordinal scale, the patients who received remdesivir were found to be more likely than those who received placebo to have clinical improvement at day 15 (odds ratio, 1.5; 95% CI, 1.2 to 1.9, after adjustment for actual disease severity). The Kaplan-Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29 (hazard ratio, 0.73; 95% CI, 0.52 to 1.03). Serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%) and in 163 of the 516 patients who received placebo (31.6%).CONCLUSIONS: Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.).

AB - BACKGROUND: Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), no antiviral agents have yet been shown to be efficacious.METHODS: We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. Patients were randomly assigned to receive either remdesivir (200 mg loading dose on day 1, followed by 100 mg daily for up to 9 additional days) or placebo for up to 10 days. The primary outcome was the time to recovery, defined by either discharge from the hospital or hospitalization for infection-control purposes only.RESULTS: A total of 1062 patients underwent randomization (with 541 assigned to remdesivir and 521 to placebo). Those who received remdesivir had a median recovery time of 10 days (95% confidence interval [CI], 9 to 11), as compared with 15 days (95% CI, 13 to 18) among those who received placebo (rate ratio for recovery, 1.29; 95% CI, 1.12 to 1.49; P<0.001, by a log-rank test). In an analysis that used a proportional-odds model with an eight-category ordinal scale, the patients who received remdesivir were found to be more likely than those who received placebo to have clinical improvement at day 15 (odds ratio, 1.5; 95% CI, 1.2 to 1.9, after adjustment for actual disease severity). The Kaplan-Meier estimates of mortality were 6.7% with remdesivir and 11.9% with placebo by day 15 and 11.4% with remdesivir and 15.2% with placebo by day 29 (hazard ratio, 0.73; 95% CI, 0.52 to 1.03). Serious adverse events were reported in 131 of the 532 patients who received remdesivir (24.6%) and in 163 of the 516 patients who received placebo (31.6%).CONCLUSIONS: Our data show that remdesivir was superior to placebo in shortening the time to recovery in adults who were hospitalized with Covid-19 and had evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACTT-1 ClinicalTrials.gov number, NCT04280705.).

KW - remdisivir

KW - COVID-19

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U2 - 10.1056/NEJMoa2007764

DO - 10.1056/NEJMoa2007764

M3 - Journal article

C2 - 32445440

SN - 0028-4793

VL - 383

SP - 1813

EP - 1826

JO - The New England Journal of Medicine

JF - The New England Journal of Medicine

IS - 19

ER -

Remdesivir for the Treatment of Covid-19 - Final Report

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Remdesivir for the Treatment of Covid-19 - Final Report

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