Login Register Cart 0
Generic placeholder image

Coronaviruses

Editor-in-Chief

ISSN (Print): 2666-7967
ISSN (Online): 2666-7975

Back
Journal Home About Journal Editorial Board Current Issue Volumes/Issues
Subscribe
Clinical Trial

Colchicine with Infliximab Compared to Infliximab in Hospitalized Patients with COVID-19 Pneumonia: An Open-label Randomized Trial

Author(s): Mahdi Yadollahzadeh, Somayyeh Nasiripour, Najmeh Moradi Shahrbabak, Nader Rezaie, Mohsen Farrokhpour, Mehdi Azimi, Shirin Izadi, Farhad Zamani, Maryam Farasatinasab* and Hootan Diba

Volume 5, Issue 1, 2024

Published on: 14 November, 2023

Article ID: e141123223567 Pages: 6

DOI: 10.2174/0126667975271636231109051950

Price: $65

conference banner
Abstract

Background: Anti-inflammatory agents have been proposed to improve oxygenation and mortality rates in severe COVID-19 pneumonia. This study has assessed the impact of colchicine as a coadjuvant inflammatory agent to infliximab in adults hospitalized with severe COVID-19 pneumonia.

Method: In this randomized, open-label clinical trial, 63 severe COVID-19 pneumonia patients according to the criteria of the National Institutes of Health, 18 to 85 years old, with an increase in TNF-α and IL-6 levels, were randomized to receive colchicine 1 mg for 7 days and infliximab as a single dose of 300 mg on the first day of treatment or infliximab as a single dose of 300 mg on the first day. The primary outcomes assessed were oxygenation parameters (PaO2/FiO2 ratio and lung infiltrate) after seven days, ICU and hospital length of stay, and in-hospital mortality rates. Secondary outcomes included laboratory data and drug safety after 7 days.

Result: 52 patients with similar baseline characteristics completed the study. There were no significant differences in oxygenation parameters (PaO2/FiO2 ratio and lung infiltrate) after seven days, median ICU and hospital length of stay, and in-hospital mortality rates between the two groups. Laboratory data showed no differences between both the groups seven days after the treatment. Also, no serious side effects were observed during the study among the two groups, except for one patient, who experienced diarrhea.

Conclusion: Our results cannot support the addition of colchicine to promote the improvement of clinical outcomes in severe COVID-19 pneumonia.

Graphical Abstract

[1]
Huang R. C-reactive protein, procalcitonin, D-dimer, and ferritin in severe coronavirus disease-2019: A meta-analysis. Ther Adv Respir Dis 2020; 14.
[2]
Yonas E, Alwi I, Pranata R, et al. Elevated interleukin levels are associated with higher severity and mortality in COVID 19 – A systematic review, meta-analysis, and meta-regression. Diabetes Metab Syndr 2020; 14(6): 2219-30.
[http://dx.doi.org/10.1016/j.dsx.2020.11.011] [PMID: 33395783]
[3]
Lim MA, Pranata R, Huang I, Yonas E, Soeroto AY, Supriyadi R. Multiorgan failure with emphasis on acute kidney injury and severity of COVID-19: Systematic review and meta-analysis Can J Kidney Heal Dis 2020; 7.
[4]
Nasiripour S, Zamani F, Farasatinasab M. Can colchicine as an old anti-inflammatory agent be effective in COVID-19? J Clin Pharmacol 2020; 60(7): 828-9.
[http://dx.doi.org/10.1002/jcph.1645] [PMID: 32445400]
[5]
Nawangsih EN, Kusmala YY, Rakhmat II, et al. Colchicine and mortality in patients with coronavirus disease 2019 (COVID-19) pneumonia: A systematic review, meta-analysis, and meta-regression. Int Immunopharmacol 2021; 96: 107723.
[http://dx.doi.org/10.1016/j.intimp.2021.107723] [PMID: 34162130]
[6]
Vrachatis DA, Giannopoulos GV, Giotaki SG, et al. Impact of colchicine on mortality in patients with COVID-19: A meta-analysis. Hellenic J Cardiol 2021; 62(5): 374-7.
[http://dx.doi.org/10.1016/j.hjc.2020.11.012] [PMID: 33421583]
[7]
Salah HM, Mehta JL. Meta-analysis of the effect of colchicine on mortality and mechanical ventilation in COVID-19. Am J Cardiol 2021; 145: 170-2.
[http://dx.doi.org/10.1016/j.amjcard.2021.02.005] [PMID: 33617817]
[8]
Kow CS, Lee LH, Ramachandram DS, Hasan SS, Ming LC, Goh HP. The effect of colchicine on mortality outcome and duration of hospital stay in patients with COVID-19: A meta-analysis of randomized trials 2022 2022; 562..
[http://dx.doi.org/10.1002/iid3.562]
[9]
Peter WH, Mark C, Enti S, et al. Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): A randomised, controlled, open-label, platform trial. MedRxiv 2021.2021.
[10]
Ghaith HS, Gabra MD, Nafady MH, Elshawah HE, Negida A, Kamal MA. A review of the rational and current evidence on colchicine for COVID-19. Curr Pharm Des 2021; 2022: 1381612827666211210142352.
[http://dx.doi.org/10.2174/1381612827666211210142352] [PMID: 34895117]
[11]
Stallmach A, Kortgen A, Gonnert F, Coldewey SM, Reuken P, Bauer M. Infliximab against severe COVID-19-induced cytokine storm syndrome with organ failure—a cautionary case series. Crit Care 2020; 24(1): 444.
[http://dx.doi.org/10.1186/s13054-020-03158-0] [PMID: 32680535]
[12]
Patel S, Wadhwa M. Therapeutic use of specific tumour necrosis factor inhibitors in inflammatory diseases including COVID-19. Biomed Pharmacother 2021; 140: 111785.
[http://dx.doi.org/10.1016/j.biopha.2021.111785] [PMID: 34126316]
[13]
Farrokhpour M, Rezaie N, Moradi N, et al. Infliximab and intravenous gammaglobulin in hospitalized severe covid-19 patients in intensive care unit. Arch Iran Med 2021; 24(2): 139-43.
[http://dx.doi.org/10.34172/aim.2021.22] [PMID: 33636983]
[14]
National Institutes of Health NIH covid-19 treatment guidelines 2020. Available from: https://www.covid19treatmentguidelines.nih.gov/overview/clinical-spectrum
[15]
Parra-Medina R, Sarmiento-Monroy JC, Rojas-Villarraga A, Garavito E, Montealegre-Gómez G, Gómez-López A. Colchicine as a possible therapeutic option in COVID-19 infection. Clin Rheumatol 2020; 39(8): 2485-6.
[http://dx.doi.org/10.1007/s10067-020-05247-5] [PMID: 32556936]
[16]
Manenti L, Maggiore U, Fiaccadori E, et al. Reduced mortality in COVID-19 patients treated with colchicine: Results from a retrospective, observational study. PLoS One 2021; 16(3): e0248276.
[http://dx.doi.org/10.1371/journal.pone.0248276] [PMID: 33760858]
[17]
Brunetti L, Diawara O, Tsai A, et al. Colchicine to weather the cytokine storm in hospitalized patients with COVID-19. J Clin Med 2020; 9(9): 2961.
[http://dx.doi.org/10.3390/jcm9092961] [PMID: 32937800]
[18]
Salehzadeh F, Pourfarzi F, Ataei S. The impact of colchicine on the COVID-19 patients; a clinical trial study. Res Square 2020; 2020: 69374.
[http://dx.doi.org/10.21203/rs.3.rs-69374/v1]
[19]
Lopes MI, Bonjorno LP, Giannini MC, et al. Beneficial effects of colchicine for moderate to severe COVID-19: A randomised, double-blinded, placebo-controlled clinical trial. RMD Open 2021; 7(1): e001455.
[http://dx.doi.org/10.1136/rmdopen-2020-001455] [PMID: 33542047]
[20]
Deftereos SG, Giannopoulos G, Vrachatis DA, et al. Effect of colchicine vs standard care on cardiac and inflammatory biomarkers and clinical outcomes in patients hospitalized with coronavirus disease 2019: The GRECCO-19 randomized clinical trial. JAMA Netw Open 2020; 3(6): e2013136.
[http://dx.doi.org/10.1001/jamanetworkopen.2020.13136] [PMID: 32579195]
[21]
Robinson PC, Liew DFL, Liew JW, et al. The potential for repurposing anti-TNF as a therapy for the treatment of COVID-19. Med 2020; 1(1): 90-102.
[http://dx.doi.org/10.1016/j.medj.2020.11.005] [PMID: 33294881]
[22]
Fisher BA, Veenith T, Slade D, et al. Namilumab or infliximab compared with standard of care in hospitalised patients with COVID-19 (CATALYST): A randomised, multicentre, multi-arm, multistage, open-label, adaptive, phase 2, proof-of-concept trial. Lancet Respir Med 2022; 10(3): 255-66.
[http://dx.doi.org/10.1016/S2213-2600(21)00460-4] [PMID: 34922649]

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy