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Efficacy and safety of Tocilizumab, plasmapheresis and their combination in severe COVID-19: A randomized clinical trial
BACKGROUND: This study sought to evaluate and compare the effectiveness of plasmapheresis, Tocilizumab, and Tocilizumab with plasmapheresis treatment on the removal of inflammatory cytokines and improvement clinically of patients with severe COVID-19 in Intensive Care Units (ICU) due to the associat...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier B.V.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9767880/ https://www.ncbi.nlm.nih.gov/pubmed/36577157 http://dx.doi.org/10.1016/j.intimp.2022.109623 |
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author | Gholinataj jelodar, Mohsen Rafieian, Shahab Saghafi, Fatemeh Hadad zedegan, Navid Birjandi, Behnaz Rafieian, Shiva Allah dini, Azadeh Dehghanpour, Hanieh Khalaj, Fatemeh Zare, Samira Dehghan Chenari, Hanieh Hajimaghsoudi, Majid Mojtaba Sohrevardi, Seyed Mirzaei, Samaneh Jamialahmadi, Tannaz Atkin, Stephen L. Sahebkar, Amirhossein |
author_facet | Gholinataj jelodar, Mohsen Rafieian, Shahab Saghafi, Fatemeh Hadad zedegan, Navid Birjandi, Behnaz Rafieian, Shiva Allah dini, Azadeh Dehghanpour, Hanieh Khalaj, Fatemeh Zare, Samira Dehghan Chenari, Hanieh Hajimaghsoudi, Majid Mojtaba Sohrevardi, Seyed Mirzaei, Samaneh Jamialahmadi, Tannaz Atkin, Stephen L. Sahebkar, Amirhossein |
author_sort | Gholinataj jelodar, Mohsen |
collection | PubMed |
description | BACKGROUND: This study sought to evaluate and compare the effectiveness of plasmapheresis, Tocilizumab, and Tocilizumab with plasmapheresis treatment on the removal of inflammatory cytokines and improvement clinically of patients with severe COVID-19 in Intensive Care Units (ICU) due to the association between increased cytokine release and the severity of COVID-19. METHODS: This clinical trial study was conducted in three treatment arms in Iran. All patients received standard care and randomization into one of three treatment groups; Tocilizumab (TCZ) alone, plasmapheresis alone, or a combination of Tocilizumab and plasmapheresis. Demographics, clinical evaluation, oxygenation status, laboratory tests and imaging data were evaluated in the three groups and re-checked 48 h after the end of treatment trials. Primary outcomes were oxygenation status, the need for mechanical ventilation and the rate of death. RESULTS: Ninety-four patients were included in the trial after meeting the eligibility requirements. Twenty-eight patients received Tocilizumab alone, 33 had plasmapheresis alone, and 33 received both Tocilizumab and plasmapheresis. Baseline characteristics did not differ between three groups that included demographic, clinical and laboratory parameters. Following therapy, there was no difference between the three groups for CRP, ferritin, d-dimer, IL-6, pro-calcitonin and neutrophil to lymphocyte ratio (NLR) (P > 0.05). While a significant reduction was found in CRP levels within each group (32.04 ± 42.43 to 17.40 ± 38.11, 51.28 ± 40.96 to 26.36 ± 33.07 and 41.20 ± 34.27 to 21.56 ± 24.96 in the tocilizumab, plasmapheresis, and combined group, respectively) (p < 0.05), procalcitonin levels were elevated significantly in the Tocilizumab group (0.28 ± 0.09 to 0.37 ± 0.11) (p < 0.05). Clinically there was no difference between the three groups following treatment for O(2) saturation levels with supplementary oxygen at discharge, endotracheal intubation rate, use of NIVPP, mortality, mean hospital and ICU length of stay (p > 0.05). CONCLUSION: Study results showed that the reduction of serum inflammatory markers, the rate of intubation and therapeutic complications including death were no different between the three groups; however, CRP levels were significantly reduced in all three groups, indicating that the interventions reduced inflammation likely through a reduction in the cytokine storm, though clinical outcomes were unaffected. |
format | Online Article Text |
id | pubmed-9767880 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Elsevier B.V. |
record_format | MEDLINE/PubMed |
spelling | pubmed-97678802022-12-21 Efficacy and safety of Tocilizumab, plasmapheresis and their combination in severe COVID-19: A randomized clinical trial Gholinataj jelodar, Mohsen Rafieian, Shahab Saghafi, Fatemeh Hadad zedegan, Navid Birjandi, Behnaz Rafieian, Shiva Allah dini, Azadeh Dehghanpour, Hanieh Khalaj, Fatemeh Zare, Samira Dehghan Chenari, Hanieh Hajimaghsoudi, Majid Mojtaba Sohrevardi, Seyed Mirzaei, Samaneh Jamialahmadi, Tannaz Atkin, Stephen L. Sahebkar, Amirhossein Int Immunopharmacol Review BACKGROUND: This study sought to evaluate and compare the effectiveness of plasmapheresis, Tocilizumab, and Tocilizumab with plasmapheresis treatment on the removal of inflammatory cytokines and improvement clinically of patients with severe COVID-19 in Intensive Care Units (ICU) due to the association between increased cytokine release and the severity of COVID-19. METHODS: This clinical trial study was conducted in three treatment arms in Iran. All patients received standard care and randomization into one of three treatment groups; Tocilizumab (TCZ) alone, plasmapheresis alone, or a combination of Tocilizumab and plasmapheresis. Demographics, clinical evaluation, oxygenation status, laboratory tests and imaging data were evaluated in the three groups and re-checked 48 h after the end of treatment trials. Primary outcomes were oxygenation status, the need for mechanical ventilation and the rate of death. RESULTS: Ninety-four patients were included in the trial after meeting the eligibility requirements. Twenty-eight patients received Tocilizumab alone, 33 had plasmapheresis alone, and 33 received both Tocilizumab and plasmapheresis. Baseline characteristics did not differ between three groups that included demographic, clinical and laboratory parameters. Following therapy, there was no difference between the three groups for CRP, ferritin, d-dimer, IL-6, pro-calcitonin and neutrophil to lymphocyte ratio (NLR) (P > 0.05). While a significant reduction was found in CRP levels within each group (32.04 ± 42.43 to 17.40 ± 38.11, 51.28 ± 40.96 to 26.36 ± 33.07 and 41.20 ± 34.27 to 21.56 ± 24.96 in the tocilizumab, plasmapheresis, and combined group, respectively) (p < 0.05), procalcitonin levels were elevated significantly in the Tocilizumab group (0.28 ± 0.09 to 0.37 ± 0.11) (p < 0.05). Clinically there was no difference between the three groups following treatment for O(2) saturation levels with supplementary oxygen at discharge, endotracheal intubation rate, use of NIVPP, mortality, mean hospital and ICU length of stay (p > 0.05). CONCLUSION: Study results showed that the reduction of serum inflammatory markers, the rate of intubation and therapeutic complications including death were no different between the three groups; however, CRP levels were significantly reduced in all three groups, indicating that the interventions reduced inflammation likely through a reduction in the cytokine storm, though clinical outcomes were unaffected. Elsevier B.V. 2023-02 2022-12-21 /pmc/articles/PMC9767880/ /pubmed/36577157 http://dx.doi.org/10.1016/j.intimp.2022.109623 Text en © 2022 Elsevier B.V. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Review Gholinataj jelodar, Mohsen Rafieian, Shahab Saghafi, Fatemeh Hadad zedegan, Navid Birjandi, Behnaz Rafieian, Shiva Allah dini, Azadeh Dehghanpour, Hanieh Khalaj, Fatemeh Zare, Samira Dehghan Chenari, Hanieh Hajimaghsoudi, Majid Mojtaba Sohrevardi, Seyed Mirzaei, Samaneh Jamialahmadi, Tannaz Atkin, Stephen L. Sahebkar, Amirhossein Efficacy and safety of Tocilizumab, plasmapheresis and their combination in severe COVID-19: A randomized clinical trial |
title | Efficacy and safety of Tocilizumab, plasmapheresis and their combination in severe COVID-19: A randomized clinical trial |
title_full | Efficacy and safety of Tocilizumab, plasmapheresis and their combination in severe COVID-19: A randomized clinical trial |
title_fullStr | Efficacy and safety of Tocilizumab, plasmapheresis and their combination in severe COVID-19: A randomized clinical trial |
title_full_unstemmed | Efficacy and safety of Tocilizumab, plasmapheresis and their combination in severe COVID-19: A randomized clinical trial |
title_short | Efficacy and safety of Tocilizumab, plasmapheresis and their combination in severe COVID-19: A randomized clinical trial |
title_sort | efficacy and safety of tocilizumab, plasmapheresis and their combination in severe covid-19: a randomized clinical trial |
topic | Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9767880/ https://www.ncbi.nlm.nih.gov/pubmed/36577157 http://dx.doi.org/10.1016/j.intimp.2022.109623 |
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