Promising effects of tocilizumab in COVID-19: A non-controlled, prospective clinical trial.
Antibodies, Monoclonal, Humanized
/ administration & dosage
Antiviral Agents
/ administration & dosage
Betacoronavirus
/ drug effects
COVID-19
Coronavirus Infections
/ drug therapy
Female
Humans
Infusions, Intravenous
Interleukin-6
/ blood
Kaplan-Meier Estimate
Lung
/ diagnostic imaging
Male
Middle Aged
Pandemics
Pneumonia, Viral
/ drug therapy
Prospective Studies
Respiration, Artificial
SARS-CoV-2
Severity of Illness Index
Tomography, X-Ray Computed
COVID-19
Coronavirus
Interleukin 6
SARS-CoV-2
Tocilizumab
Journal
International immunopharmacology
ISSN: 1878-1705
Titre abrégé: Int Immunopharmacol
Pays: Netherlands
ID NLM: 100965259
Informations de publication
Date de publication:
Nov 2020
Nov 2020
Historique:
received:
10
06
2020
revised:
31
07
2020
accepted:
31
07
2020
pubmed:
6
9
2020
medline:
24
11
2020
entrez:
5
9
2020
Statut:
ppublish
Résumé
The clinical presentation of SARS-CoV-2 infection ranges from mild symptoms to severe complications, including acute respiratory distress syndrome. In this syndrome, inflammatory cytokines are released after activation of the inflammatory cascade, with the predominant role of interleukin (IL)-6. The aim of this study was to evaluate the effects of tocilizumab, as an IL-6 antagonist, in patients with severe or critical SARS-CoV-2 infection. In this prospective clinical trial, 76 patients with severe or critical SARS-CoV-2 infection were evaluated for eligibility, and ultimately, 42 patients were included. Tocilizumab was administered at a dose of 400 mg as a single dose via intravenous infusion. Primary outcomes included changes in oxygenation support, need for invasive mechanical ventilation, and death. Secondary outcomes included radiological changes in the lungs, IL-6 plasma levels, C-reactive protein levels, and adverse drug reactions. The data were analyzed using SPSS software. Of the 42 included patients, 20 (48%) patients presented the severe infection stage and 22 (52%) were in the critical stage. The median age of patients was 56 years, and the median IL-6 level was 28.55 pg/mL. After tocilizumab administration, only 6 patients (14%) required invasive ventilation. Additionally, 35 patients (83.33%) showed clinical improvement. By day 28, a total of 7 patients died (6 patients in the critical stage and 1 patient in the severe stage). Neurological adverse effects were observed in 3 patients. Based on the current results, tocilizumab may be a promising agent for patients with severe or critical SARS-CoV-2 infection, if promptly initiated during the severe stage.
Sections du résumé
BACKGROUND
BACKGROUND
The clinical presentation of SARS-CoV-2 infection ranges from mild symptoms to severe complications, including acute respiratory distress syndrome. In this syndrome, inflammatory cytokines are released after activation of the inflammatory cascade, with the predominant role of interleukin (IL)-6. The aim of this study was to evaluate the effects of tocilizumab, as an IL-6 antagonist, in patients with severe or critical SARS-CoV-2 infection.
METHODS
METHODS
In this prospective clinical trial, 76 patients with severe or critical SARS-CoV-2 infection were evaluated for eligibility, and ultimately, 42 patients were included. Tocilizumab was administered at a dose of 400 mg as a single dose via intravenous infusion. Primary outcomes included changes in oxygenation support, need for invasive mechanical ventilation, and death. Secondary outcomes included radiological changes in the lungs, IL-6 plasma levels, C-reactive protein levels, and adverse drug reactions. The data were analyzed using SPSS software.
RESULTS
RESULTS
Of the 42 included patients, 20 (48%) patients presented the severe infection stage and 22 (52%) were in the critical stage. The median age of patients was 56 years, and the median IL-6 level was 28.55 pg/mL. After tocilizumab administration, only 6 patients (14%) required invasive ventilation. Additionally, 35 patients (83.33%) showed clinical improvement. By day 28, a total of 7 patients died (6 patients in the critical stage and 1 patient in the severe stage). Neurological adverse effects were observed in 3 patients.
CONCLUSIONS
CONCLUSIONS
Based on the current results, tocilizumab may be a promising agent for patients with severe or critical SARS-CoV-2 infection, if promptly initiated during the severe stage.
Identifiants
pubmed: 32889241
pii: S1567-5769(20)31903-2
doi: 10.1016/j.intimp.2020.106869
pmc: PMC7402206
pii:
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Antiviral Agents
0
IL6 protein, human
0
Interleukin-6
0
tocilizumab
I031V2H011
Types de publication
Clinical Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
106869Informations de copyright
Copyright © 2020 Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
Références
N Engl J Med. 2020 Apr 30;382(18):1708-1720
pubmed: 32109013
Engineering (Beijing). 2020 Oct;6(10):1192-1198
pubmed: 32346491
J Glob Antimicrob Resist. 2020 Jun;21:340-341
pubmed: 32353526
Semin Immunopathol. 2017 Jul;39(5):529-539
pubmed: 28466096
Autoimmun Rev. 2020 Jun;19(6):102537
pubmed: 32251717
CNS Neurosci Ther. 2020 May;26(5):499-501
pubmed: 32266761
JAMA Intern Med. 2020 Jul 1;180(7):934-943
pubmed: 32167524
Lancet. 2020 Mar 28;395(10229):1033-1034
pubmed: 32192578
Eur J Intern Med. 2020 Jun;76:43-49
pubmed: 32482597
N Engl J Med. 2020 May 7;382(19):1787-1799
pubmed: 32187464
Lancet Infect Dis. 2020 Jul;20(7):774-775
pubmed: 32243815
Iran J Pharm Res. 2020 Winter;19(1):31-36
pubmed: 32922466
Crit Care Med. 2017 Feb;45(2):e124-e131
pubmed: 27632680
Autoimmun Rev. 2020 Jul;19(7):102568
pubmed: 32376398
Int J Antimicrob Agents. 2020 May;55(5):105954
pubmed: 32234467
J Med Virol. 2020 Oct;92(10):2042-2049
pubmed: 32369191
J Med Virol. 2020 Jun 3;:
pubmed: 32492210
Osong Public Health Res Perspect. 2020 Apr;11(2):74-80
pubmed: 32257772
J Med Virol. 2020 Jul;92(7):814-818
pubmed: 32253759
J Neurol Sci. 2020 Jun 15;413:116832
pubmed: 32299017
Lancet Rheumatol. 2020 Aug;2(8):e474-e484
pubmed: 32835257
Int J Antimicrob Agents. 2020 Aug;56(2):106043
pubmed: 32502524
Hum Vaccin Immunother. 2017 Sep 2;13(9):1972-1988
pubmed: 28841363
Ther Adv Musculoskelet Dis. 2018 Oct 07;10(10):195-199
pubmed: 30327685
Clin Med Insights Arthritis Musculoskelet Disord. 2010 Dec 19;3:81-9
pubmed: 21234291
Anesthesiology. 2020 Jun;132(6):1317-1332
pubmed: 32195705
Proc Natl Acad Sci U S A. 2020 May 19;117(20):10970-10975
pubmed: 32350134
N Engl J Med. 2020 Jun 11;382(24):2327-2336
pubmed: 32275812
N Engl J Med. 2020 May 21;382(21):2012-2022
pubmed: 32227758