TY - JOUR
T1 - Remdesivir for the treatment of COVID-19 — Final report
AU - ACTT-1 Study Group Members
AU - Essential Regulatory Documents Group Team (ERDG Team)
AU - DMID CROMS Study Information Office Team (SIO Team)
AU - Safety Oversight Committee Support Team (SOCS Team)
AU - DMID CROMS Teleconferencing Team
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 - De Castilla, Diego Lopez
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 - Hewlett, Angela
AU - Johnson, Daniel W.
AU - Brett-Major, David
AU - Cawcutt, Kelly
AU - Lawler, James
AU - Lowe, John
AU - Kratochvil, Cristopher
AU - Fey, Paul
AU - Sullivan, James
AU - Lisco, Steven
AU - Bailey, Kristina
AU - Piquette, Craig
N1 - Publisher Copyright:
Copyright © 2020 Massachusetts Medical Society.
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.
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.
UR - http://www.scopus.com/inward/record.url?scp=85095830695&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85095830695&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa2007764
DO - 10.1056/NEJMoa2007764
M3 - Article
C2 - 32445440
AN - SCOPUS:85095830695
SN - 0028-4793
VL - 383
SP - 1813
EP - 1826
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 19
ER -