Beigel, John H., Tomashek, Kay M., Dodd, Lori E., Mehta, Aneesh K., Zingman, Barry S., Kalil, Andre C., Hohmann, Elizabeth, Chu, Helen Y., Luetkemeyer, Annie, Kline, Susan, de Castilla, Diego Lopez, Finberg, Robert W., Dierberg, Kerry ORCID: 0000-0001-8528-7159, Tapson, Victor, Hsieh, Lanny, Patterson, Thomas F., Paredes, Roger, Sweeney, Daniel A., Short, William R., Touloumi, Giota, Lye, David Chien, Ohmagari, Norio, Oh, Myoung-don, Ruiz-Palacios, Guillermo M., Benfield, Thomas, Faetkenheuer, Gerd, Kortepeter, Mark G., Atmar, Robert L., Creech, C. Buddy, Lundgren, Jens, Babiker, Abdel G., Pett, Sarah, Neaton, James D., Burgess, Timothy H., Bonnett, Tyler ORCID: 0000-0001-5545-6433, Green, Michelle, Makowski, Mat, Osinusi, Anu, Nayak, Seema and Lane, H. Clifford (2020). Remdesivir for the Treatment of Covid-19-Final Report. N. Engl. J. Med., 383 (19). S. 1813 - 1827. WALTHAM: MASSACHUSETTS MEDICAL SOC. ISSN 1533-4406

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Abstract

BackgroundAlthough 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. MethodsWe 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. ResultsA 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%). ConclusionsOur 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.) In this randomized, double-blind trial in 1062 adults hospitalized with Covid-19, remdesivir was superior to placebo in shortening the time to recovery (10 days, vs. 15 days with placebo). The estimates of mortality by day 29 were 11.4% with remdesivir and 15.2% with placebo. The benefit of remdesivir was most apparent in patients who were receiving low-flow oxygen at baseline.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Beigel, John H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tomashek, Kay M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dodd, Lori E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mehta, Aneesh K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zingman, Barry S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kalil, Andre C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hohmann, ElizabethUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chu, Helen Y.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Luetkemeyer, AnnieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kline, SusanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
de Castilla, Diego LopezUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Finberg, Robert W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dierberg, KerryUNSPECIFIEDorcid.org/0000-0001-8528-7159UNSPECIFIED
Tapson, VictorUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hsieh, LannyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Patterson, Thomas F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Paredes, RogerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sweeney, Daniel A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Short, William R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Touloumi, GiotaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lye, David ChienUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ohmagari, NorioUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Oh, Myoung-donUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ruiz-Palacios, Guillermo M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Benfield, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Faetkenheuer, GerdUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kortepeter, Mark G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Atmar, Robert L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Creech, C. BuddyUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lundgren, JensUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Babiker, Abdel G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pett, SarahUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Neaton, James D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Burgess, Timothy H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bonnett, TylerUNSPECIFIEDorcid.org/0000-0001-5545-6433UNSPECIFIED
Green, MichelleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Makowski, MatUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Osinusi, AnuUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Nayak, SeemaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lane, H. CliffordUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-312014
DOI: 10.1056/NEJMoa2007764
Journal or Publication Title: N. Engl. J. Med.
Volume: 383
Number: 19
Page Range: S. 1813 - 1827
Date: 2020
Publisher: MASSACHUSETTS MEDICAL SOC
Place of Publication: WALTHAM
ISSN: 1533-4406
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
Medicine, General & InternalMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/31201

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