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dc.contributor.authorRosas, Ivan O.
dc.contributor.authorBrau, Norbert
dc.contributor.authorWaters, Michael
dc.contributor.authorGo, Ronaldo C.
dc.contributor.authorMalhotra, Atul
dc.contributor.authorHunter, Bradley D.
dc.contributor.authorBhagani, Sanjay
dc.contributor.authorSkiest, Daniel
dc.contributor.authorSavic, Sinisa
dc.contributor.authorDouglas, Ivor S.
dc.contributor.authorGarcia-Diaz, Julia
dc.contributor.authorAziz, Mariam S.
dc.contributor.authorCooper, Nichola
dc.contributor.authorYoungstein, Taryn
dc.contributor.authorSorbo, Lorenzo Del.
dc.contributor.authorZerda, David J De La
dc.contributor.authorUstianowski, Andrew
dc.contributor.authorGracian, Antonio Cubillo.
dc.contributor.authorBlyth, Kevin G.
dc.contributor.authorCarratala, Jordi
dc.contributor.authorFrancois, Bruno
dc.contributor.authorBenfield, Thomas
dc.contributor.authorHaslem, Derrick
dc.contributor.authorBonfanti, Paolo
dc.contributor.authorvan der Leest, Cor H.
dc.contributor.authorRohatgi, Nidhi
dc.contributor.authorWiese, Lothar
dc.contributor.authorLuyt, Charles Edouard.
dc.contributor.authorBauer, Rebecca N.
dc.contributor.authorCai, Fang
dc.contributor.authorLee, Ivan T.
dc.contributor.authorMatharu, Balpreet
dc.contributor.authorMetcalf, Louis
dc.contributor.authorWildum, Steffen
dc.contributor.authorGraham, Emily
dc.contributor.authorTsai, Larry
dc.contributor.authorBao, Min
dc.date2022-08-11T08:08:12.000
dc.date.accessioned2022-08-23T15:45:59Z
dc.date.available2022-08-23T15:45:59Z
dc.date.issued2022-04-28
dc.date.submitted2022-05-23
dc.identifier.citation2022 Apr 21. <a href="https://doi.org/10.1016/j.eclinm.2022.101409">Link to article on publisher's site</a>
dc.identifier.issn2589-5370 (Linking)
dc.identifier.doi10.1016/j.eclinm.2022.101409
dc.identifier.pmid35475258
dc.identifier.urihttp://hdl.handle.net/20.500.14038/27655
dc.description.abstractBackground: In COVACTA, a randomised, placebo-controlled trial in patients hospitalised with coronavirus disease-19 (COVID-19), tocilizumab did not improve 28-day mortality, but shortened hospital and intensive care unit stay. Longer-term effects of tocilizumab in patients with COVID-19 are unknown. Therefore, the efficacy and safety of tocilizumab in COVID-19 beyond day 28 and its impact on Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) clearance and antibody response in COVACTA were investigated. Methods: Adults in Europe and North America hospitalised with COVID-19 (N = 452) between April 3, 2020 and May 28, 2020 were randomly assigned (2:1) to double-blind intravenous tocilizumab or placebo and assessed for efficacy and safety through day 60. Assessments included mortality, time to hospital discharge, SARS-CoV-2 viral load in nasopharyngeal swab and serum samples, and neutralising anti-SARS-CoV-2 antibodies in serum. ClinicalTrials.gov registration: NCT04320615. Findings: By day 60, 24.5% (72/294) of patients in the tocilizumab arm and 25.0% (36/144) in the placebo arm died (weighted difference -0.5% [95% CI -9.1 to 8.0]), and 67.0% (197/294) in the tocilizumab arm and 63.9% (92/144) in the placebo arm were discharged from the hospital. Serious infections occurred in 24.1% (71/295) of patients in the tocilizumab arm and 29.4% (42/143) in the placebo arm. Median time to negative reverse transcriptase-quantitative polymerase chain reaction result in nasopharyngeal/oropharyngeal samples was 15.0 days (95% CI 14.0 to 21.0) in the tocilizumab arm and 21.0 days (95% CI 14.0 to 28.0) in the placebo arm. All tested patients had positive test results for neutralising anti-SARS-CoV-2 antibodies at day 60. Interpretation: There was no mortality benefit with tocilizumab through day 60. Tocilizumab did not impair viral clearance or host immune response, and no new safety signals were observed. Future investigations may explore potential biomarkers to optimize patient selection for tocilizumab treatment and combination therapy with other treatments.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=35475258&dopt=Abstract">Link to Article in PubMed</a>
dc.titleTocilizumab in patients hospitalised with COVID-19 pneumonia: Efficacy, safety, viral clearance, and antibody response from a randomised controlled trial (COVACTA)
dc.typeArticle
dc.source.journaltitleEClinicalMedicine
dc.source.volume47
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/covid19/392
dc.identifier.contextkey29327231
html.description.abstract<p>Background: In COVACTA, a randomised, placebo-controlled trial in patients hospitalised with coronavirus disease-19 (COVID-19), tocilizumab did not improve 28-day mortality, but shortened hospital and intensive care unit stay. Longer-term effects of tocilizumab in patients with COVID-19 are unknown. Therefore, the efficacy and safety of tocilizumab in COVID-19 beyond day 28 and its impact on Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) clearance and antibody response in COVACTA were investigated. Methods: Adults in Europe and North America hospitalised with COVID-19 (N = 452) between April 3, 2020 and May 28, 2020 were randomly assigned (2:1) to double-blind intravenous tocilizumab or placebo and assessed for efficacy and safety through day 60. Assessments included mortality, time to hospital discharge, SARS-CoV-2 viral load in nasopharyngeal swab and serum samples, and neutralising anti-SARS-CoV-2 antibodies in serum. ClinicalTrials.gov registration: NCT04320615. Findings: By day 60, 24.5% (72/294) of patients in the tocilizumab arm and 25.0% (36/144) in the placebo arm died (weighted difference -0.5% [95% CI -9.1 to 8.0]), and 67.0% (197/294) in the tocilizumab arm and 63.9% (92/144) in the placebo arm were discharged from the hospital. Serious infections occurred in 24.1% (71/295) of patients in the tocilizumab arm and 29.4% (42/143) in the placebo arm. Median time to negative reverse transcriptase-quantitative polymerase chain reaction result in nasopharyngeal/oropharyngeal samples was 15.0 days (95% CI 14.0 to 21.0) in the tocilizumab arm and 21.0 days (95% CI 14.0 to 28.0) in the placebo arm. All tested patients had positive test results for neutralising anti-SARS-CoV-2 antibodies at day 60. Interpretation: There was no mortality benefit with tocilizumab through day 60. Tocilizumab did not impair viral clearance or host immune response, and no new safety signals were observed. Future investigations may explore potential biomarkers to optimize patient selection for tocilizumab treatment and combination therapy with other treatments.</p>
dc.identifier.submissionpathcovid19/392
dc.contributor.departmentPulmonary
dc.source.pages101409


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