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dc.contributor.authorBeigel, John H.
dc.contributor.authorFinberg, Robert W.
dc.contributor.authorACTT-1 Study Group Members
dc.date2022-08-11T08:08:11.000
dc.date.accessioned2022-08-23T15:45:42Z
dc.date.available2022-08-23T15:45:42Z
dc.date.issued2020-05-22
dc.date.submitted2020-05-26
dc.identifier.citation<p>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 MD, 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. Remdesivir for the Treatment of Covid-19 - Preliminary Report. N Engl J Med. 2020 May 22. doi: 10.1056/NEJMoa2007764. Epub ahead of print. PMID: 32445440. <a href="https://doi.org/10.1056/NEJMoa2007764">Link to article on publisher's site</a></p>
dc.identifier.issn0028-4793 (Linking)
dc.identifier.doi10.1056/NEJMoa2007764
dc.identifier.pmid32445440
dc.identifier.urihttp://hdl.handle.net/20.500.14038/27589
dc.description<p>Full author list omitted for brevity. For the full list of authors, see article. </p>
dc.description.abstractBACKGROUND: Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), none have yet been shown to be efficacious. METHODS: We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement. 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 1063 patients underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed shortened time to recovery in the remdesivir group. Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P < 0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04). Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%). CONCLUSIONS: Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACCT-1 ClinicalTrials.gov number, NCT04280705.).
dc.language.isoen_US
dc.relation<p><a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=32445440&dopt=Abstract">Link to Article in PubMed</a></p>
dc.rightsCopyright © 2020 Massachusetts Medical Society. Publisher PDF posted after 6 months as allowed by the publisher's author rights policy at https://www.nejm.org/page/author-center/permissions.
dc.subjectCOVID-19
dc.subjectcoronavirus disease 2019
dc.subjecttreatment
dc.subjectremdesivir
dc.subjectclinical trial
dc.subjectAdaptive COVID-19 Treatment Trial (ACTT)
dc.subjectClinical Trials
dc.subjectImmunology and Infectious Disease
dc.subjectInfectious Disease
dc.subjectRespiratory Tract Diseases
dc.subjectTherapeutics
dc.subjectVirus Diseases
dc.titleRemdesivir for the Treatment of Covid-19 - Preliminary Report
dc.typeJournal Article
dc.source.journaltitleThe New England journal of medicine
dc.identifier.legacyfulltexthttps://escholarship.umassmed.edu/cgi/viewcontent.cgi?article=1042&amp;context=covid19&amp;unstamped=1
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/covid19/40
dc.legacy.embargo2020-11-22T00:00:00-08:00
dc.identifier.contextkey17863506
refterms.dateFOA2022-08-23T15:45:42Z
html.description.abstract<p>BACKGROUND: Although several therapeutic agents have been evaluated for the treatment of coronavirus disease 2019 (Covid-19), none have yet been shown to be efficacious.</p> <p>METHODS: We conducted a double-blind, randomized, placebo-controlled trial of intravenous remdesivir in adults hospitalized with Covid-19 with evidence of lower respiratory tract involvement. 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.</p> <p>RESULTS: A total of 1063 patients underwent randomization. The data and safety monitoring board recommended early unblinding of the results on the basis of findings from an analysis that showed shortened time to recovery in the remdesivir group. Preliminary results from the 1059 patients (538 assigned to remdesivir and 521 to placebo) with data available after randomization indicated that those who received remdesivir had a median recovery time of 11 days (95% confidence interval [CI], 9 to 12), as compared with 15 days (95% CI, 13 to 19) in those who received placebo (rate ratio for recovery, 1.32; 95% CI, 1.12 to 1.55; P < 0.001). The Kaplan-Meier estimates of mortality by 14 days were 7.1% with remdesivir and 11.9% with placebo (hazard ratio for death, 0.70; 95% CI, 0.47 to 1.04). Serious adverse events were reported for 114 of the 541 patients in the remdesivir group who underwent randomization (21.1%) and 141 of the 522 patients in the placebo group who underwent randomization (27.0%).</p> <p>CONCLUSIONS: Remdesivir was superior to placebo in shortening the time to recovery in adults hospitalized with Covid-19 and evidence of lower respiratory tract infection. (Funded by the National Institute of Allergy and Infectious Diseases and others; ACCT-1 ClinicalTrials.gov number, NCT04280705.).</p>
dc.identifier.submissionpathcovid19/40
dc.contributor.departmentDepartment of Medicine, Division of Infectious Diseases and Immunology


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