Tocilizumab in patients hospitalised with COVID-19 pneumonia: Efficacy, safety, viral clearance, and antibody response from a randomised controlled trial (COVACTA)
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Authors
Rosas, Ivan O.Brau, Norbert
Waters, Michael
Go, Ronaldo C.
Malhotra, Atul
Hunter, Bradley D.
Bhagani, Sanjay
Skiest, Daniel
Savic, Sinisa
Douglas, Ivor S.
Garcia-Diaz, Julia
Aziz, Mariam S.
Cooper, Nichola
Youngstein, Taryn
Sorbo, Lorenzo Del.
Zerda, David J De La
Ustianowski, Andrew
Gracian, Antonio Cubillo.
Blyth, Kevin G.
Carratala, Jordi
Francois, Bruno
Benfield, Thomas
Haslem, Derrick
Bonfanti, Paolo
van der Leest, Cor H.
Rohatgi, Nidhi
Wiese, Lothar
Luyt, Charles Edouard.
Bauer, Rebecca N.
Cai, Fang
Lee, Ivan T.
Matharu, Balpreet
Metcalf, Louis
Wildum, Steffen
Graham, Emily
Tsai, Larry
Bao, Min
UMass Chan Affiliations
PulmonaryDocument Type
Journal ArticlePublication Date
2022-04-28
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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.Source
2022 Apr 21. Link to article on publisher's siteDOI
10.1016/j.eclinm.2022.101409Permanent Link to this Item
http://hdl.handle.net/20.500.14038/27655PubMed ID
35475258Related Resources
Link to Article in PubMedae974a485f413a2113503eed53cd6c53
10.1016/j.eclinm.2022.101409