The Efficacy of Colchicine as an Adjunct Therapy in Non-hospitalized COVID-19 Patients: A Randomized Placebo-Controlled Trial


如何引用文章

全文:

详细

Background:The therapeutic potential of oral colchicine administration may help combat COVID-19 infection due to reduced disease severity and mortality risk.

Objective:This randomized trial aimed to assess the effect of colchicine treatment on the inflammatory and hematologic markers as well as clinical features in non-hospitalized patients with mild-to-moderate COVID-19 disease.

Method:In the present placebo-controlled randomized trial, 80 non-hospitalized COVID-19 patients were enrolled and followed for 14 days. Subjects randomly received oral colchicine or placebo tablets once a day for two weeks. The fever and cough clinical signs, as well as Creactive protein (CRP) and lymphopenia, were evaluated through the follow-up.

Results:No significant between-group differences were observed in terms of the duration of clinical symptoms, CRP, and lymphopenia at 0, 7, and 14 days of intervention. Although the proportion of participants with fever, cough, positive CRP, and lymphopenia was higher reduced in the colchicine group than the placebo during treatment, no significant differences were found between groups. Due to no adverse effects detected in this trial, colchicine therapy was well-tolerated and safe.

Conclusion:Our findings revealed that colchicine adjuvant therapy had no beneficial effect on clinical and para-clinical parameters in non-hospitalized COVID-19 patients during 14 days of intervention. The present trial does not support colchicine as a potential treatment against COVID-19 disease.

Clinical trial Registration:The present study protocol was approved by the IRCT (IRCT20200408046990N2, https://en.irct.ir/trial/47468).

作者简介

Sepideh Hejazi

Lung Diseases Research Center, Mashhad University of Medical Science

Email: info@benthamscience.net

Zohreh Jahani

Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences

Email: info@benthamscience.net

Sepideh Elyasi

Department of Clinical Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences

Email: info@benthamscience.net

Davoud Salarbashi

Infectious Diseases Research Centre, Gonabad University of Medical Sciences

Email: info@benthamscience.net

Mona Kabiri

Nanotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences

编辑信件的主要联系方式.
Email: info@benthamscience.net

参考

  1. Hariyanto TI, Halim DA, Jodhinata C, Yanto TA, Kurniawan A. Colchicine treatment can improve outcomes of coronavirus disease 2019 (COVID‐19): A systematic review and meta‐analysis. Clin Exp Pharmacol Physiol 2021; 48(6): 823-30. doi: 10.1111/1440-1681.13488 PMID: 33719081
  2. Mehta KG, Patel T, Chavda PD, Patel P. Efficacy and safety of colchicine in COVID-19: A meta-analysis of randomised controlled trials. RMD Open 2021; 7(3): e001746. doi: 10.1136/rmdopen-2021-001746 PMID: 34810227
  3. Pascual-Figal DA, Roura-Piloto AE, Moral-Escudero E, et al. Colchicine in recently hospitalized patients with COVID-19: A randomized controlled trial (COL-COVID). Int J Gen Med 2021; 14: 5517-26. doi: 10.2147/IJGM.S329810 PMID: 34539185
  4. Pourdowlat G, Saghafi F, Mozafari A, et al. Efficacy and safety of colchicine treatment in patients with COVID ‐19: A prospective, multicenter, randomized clinical trial. Phytother Res 2022; 36(2): 891-8. doi: 10.1002/ptr.7319 PMID: 35107188
  5. Deftereos SG, Giannopoulos G, Vrachatis DA, Siasos GD, Giotaki SG, Gargalianos P. 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 network open 2020; 3(6): e2013136.
  6. Karatza E, Ismailos G, Karalis V. Colchicine for the treatment of COVID-19 patients: Efficacy, safety, and model informed dosage regimens. Xenobiotica 2021; 51(6): 643-56. doi: 10.1080/00498254.2021.1909782 PMID: 33845715
  7. Absalón-Aguilar A, Rull-Gabayet M, Pérez-Fragoso A, et al. Colchicine is safe though ineffective in the treatment of severe COVID-19: A randomized clinical trial (COLCHIVID). J Gen Intern Med 2022; 37(1): 4-14. doi: 10.1007/s11606-021-07203-8 PMID: 34755269
  8. Vitiello A, Ferrara F, Pelliccia C, Granata G, La Porta R. Cytokine storm and colchicine potential role fighting SARS-CoV-2 pneumonia. Ital J Med 2020; 14(2): 88-94. doi: 10.4081/itjm.2020.1284
  9. Reyes AZ, Hu KA, Teperman J, et al. Anti-inflammatory therapy for COVID-19 infection: The case for colchicine. Ann Rheum Dis 2021; 80(5): 550-7. doi: 10.1136/annrheumdis-2020-219174 PMID: 33293273
  10. Sarwar M, Ali Z, Fatima M, Sarfraz Z, Sarfraz A, Cherrez-Ojeda I. Colchicine, COVID‐19 and hematological parameters: A meta‐analysis. J Clin Lab Anal 2021; 35(12): e24057. doi: 10.1002/jcla.24057 PMID: 34708886
  11. Schlesinger N, Firestein BL, Brunetti L. Colchicine in COVID-19: An old drug, new use. Curr Pharmacol Rep 2020; 6(4): 137-45. doi: 10.1007/s40495-020-00225-6 PMID: 32837853
  12. 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. doi: 10.1136/rmdopen-2020-001455 PMID: 33542047
  13. Vitiello A, Ferrara F. Colchicine and SARS-CoV-2: Management of the hyperinflammatory state. Respir Med 2021; 178: 106322. doi: 10.1016/j.rmed.2021.106322 PMID: 33550151
  14. 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. Immun Inflamm Dis 2022; 10(2): 255-64. doi: 10.1002/iid3.562 PMID: 34970856
  15. Salehzadeh F, Pourfarzi F, Ataei S. The impact of colchicine on COVID-19 patients: A clinical trial study. Mediterr J Rheumatol 2022; 33(2): 232-6. doi: 10.31138/mjr.33.2.232 PMID: 36128202
  16. Bonaventura A, Vecchié A, Dagna L, Tangianu F, Abbate A, Dentali F. Colchicine for COVID-19: Targeting NLRP3 inflammasome to blunt hyperinflammation. Inflamm Res 2022; 71(3): 293-307. doi: 10.1007/s00011-022-01540-y PMID: 35113170
  17. Demidowich AP, Levine JA, Apps R, et al. Colchicine’s effects on metabolic and inflammatory molecules in adults with obesity and metabolic syndrome: Results from a pilot randomized controlled trial. Int J Obes 2020; 44(8): 1793-9. doi: 10.1038/s41366-020-0598-3 PMID: 32461554
  18. Misra DP, Gasparyan AY, Zimba O. Benefits and adverse effects of hydroxychloroquine, methotrexate and colchicine: searching for repurposable drug candidates. Rheumatol Int 2020; 40(11): 1741-51. doi: 10.1007/s00296-020-04694-2 PMID: 32880032
  19. Sandhu T, Tieng A, Chilimuri S, Franchin G. A case control study to evaluate the impact of colchicine on patients admitted to the hospital with moderate to severe COVID-19 infection. Can J Infect Dis Med Microbiol 2020; 2020
  20. Scarsi M, Piantoni S, Colombo E, et al. Association between treatment with colchicine and improved survival in a single-centre cohort of adult hospitalised patients with COVID-19 pneumonia and acute respiratory distress syndrome. Ann Rheum Dis 2020; 79(10): 1286-9. doi: 10.1136/annrheumdis-2020-217712 PMID: 32732245
  21. Group RC. Colchicine in patients admitted to hospital with COVID-19 (RECOVERY): A randomised, controlled, open-label, platform trial. Lancet Respir Med 2021; 9(12): 1419-26. doi: 10.1016/S2213-2600(21)00435-5 PMID: 34672950
  22. Diaz R, Orlandini A, Castellana N, Caccavo A, Corral P, Corral G. Effect of colchicine vs usual care alone on intubation and 28-day mortality in patients hospitalized with COVID-19: A randomized clinical trial. JAMA network open 2021; 4(12): e2141328.
  23. Dorward J, Yu LM, Hayward G, et al. Colchicine for COVID-19 in the community (PRINCIPLE): A randomised, controlled, adaptive platform trial. Br J Gen Pract 2022; 72(720): e446-55. doi: 10.3399/BJGP.2022.0083 PMID: 35440469
  24. Tardif JC, Bouabdallaoui N, L’Allier PL, et al. Colchicine for community-treated patients with COVID-19 (COLCORONA): A phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial. Lancet Respir Med 2021; 9(8): 924-32. doi: 10.1016/S2213-2600(21)00222-8 PMID: 34051877
  25. Golpour M, Mousavi T, Alimohammadi M, et al. The effectiveness of Colchicine as an anti-inflammatory drug in the treatment of coronavirus disease 2019: Meta-analysis. Int J Immunopathol Pharmacol 2021; 35. doi: 10.1177/20587384211031763 PMID: 34250834
  26. Lan SH, Hsu CK, Lai CC, et al. Effect of colchicine on the outcomes of patients with COVID-19: A systematic review and meta-analysis of randomised controlled trials. Ann Med 2022; 54(1): 1956-65. doi: 10.1080/07853890.2022.2096919 PMID: 35833737

补充文件

附件文件
动作
1. JATS XML
下载

版权所有 © Bentham Science Publishers, 2024