Item request has been placed! ×
Item request cannot be made. ×
loading  Processing Request

Colchicine to reduce coronavirus disease-19-related inflammation and cardiovascular complications in high-risk patients post-acute infection with SARS-COV-2-a study protocol for a randomized controlled trial.

Item request has been placed! ×
Item request cannot be made. ×
loading   Processing Request
اقرأ على الانترنت اقرأ أكثر حفظ في قائمتي
  • معلومة اضافية
    • المصدر:
      Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
    • بيانات النشر:
      Original Publication: [London] : BioMed Central, 2006-
    • الموضوع:
      Colchicine*/therapeutic use ; Colchicine*/adverse effects ; COVID-19*/complications ; COVID-19 Drug Treatment*; Humans ; Double-Blind Method ; SARS-CoV-2 ; Post-Acute COVID-19 Syndrome ; Anti-Inflammatory Agents/therapeutic use ; Anti-Inflammatory Agents/adverse effects ; Inflammation/drug therapy ; Cardiovascular Diseases/prevention & control ; Multicenter Studies as Topic ; Randomized Controlled Trials as Topic ; Treatment Outcome ; Adult
    • نبذة مختصرة :
      Background: There is no known effective pharmacological therapy for long COVID, which is characterized by wide-ranging, multisystemic, fluctuating, or relapsing symptoms in a large proportion of survivors of acute COVID. This randomized controlled trial aims to assess the safety and efficacy of an anti-inflammatory agent colchicine, to reduce symptoms among those at high risk of developing long COVID.
      Methods: This multi-centre, parallel arm, 1:1 individual randomized, placebo-controlled, double-blind superiority trial will enrol 350 individuals with persistent post-COVID symptoms. Participants will be randomized to either colchicine 0.5 mg once daily (< 70 kg) or twice daily (≥ 70 kg) or matched placebo for 26 weeks and will be followed up until 52 weeks after randomization. The primary trial objective is to demonstrate the superiority of colchicine over a placebo in improving distance walked in 6 min at 52 weeks from baseline. The secondary objectives are to assess the efficacy of colchicine compared to placebo with respect to lung function, inflammatory markers, constitutional symptoms, and mental health state. In a sub-sample of 100 participants, cardiac biomarkers of myocardial injury and myocardial oedema using MRI will be compared.
      Discussion: Persistent inflammatory response following SARS-CoV-19 is one of the postulated pathophysiological mechanisms of long COVID. Colchicine, a low-cost anti-inflammatory agent, acts via multiple inflammatory pathways and has an established safety profile. This trial will generate evidence for an important health priority that can rapidly translate into practice.
      Trial Registration: This clinical trial has been registered prospectively on www.
      Clinicaltrials: gov with registration CTRI/2021/11/038234 dated November 24, 2021.
      (© 2024. The Author(s).)
    • References:
      Front Immunol. 2023 Mar 09;14:1129459. (PMID: 36969241)
      Respir Care. 2003 Aug;48(8):783-5. (PMID: 12890299)
      Evid Based Med. 2006 Dec;11(6):184. (PMID: 17213178)
      Eur Respir J. 2020 Jul 2;56(1):. (PMID: 32398306)
      JAMA. 2023 Jun 13;329(22):1934-1946. (PMID: 37278994)
      Open Forum Infect Dis. 2022 May 07;9(7):ofac228. (PMID: 35818362)
      JAMA Intern Med. 2023 Jun 1;183(6):554-564. (PMID: 36951829)
      J Eval Clin Pract. 2017 Apr;23(2):377-381. (PMID: 27592691)
      PLoS One. 2021 Oct 28;16(10):e0258351. (PMID: 34710097)
      J Biomed Inform. 2019 Jul;95:103208. (PMID: 31078660)
      Nat Med. 2022 Mar;28(3):583-590. (PMID: 35132265)
      Clin Microbiol Infect. 2022 Jul;28(7):955-972. (PMID: 35182760)
      Cureus. 2022 Nov 27;14(11):e31933. (PMID: 36582565)
      Semin Arthritis Rheum. 2015 Dec;45(3):341-50. (PMID: 26228647)
      Soc Sci Med. 2021 Jan;268:113426. (PMID: 33199035)
      Int J Biol Sci. 2022 Jul 11;18(12):4768-4780. (PMID: 35874958)
      Med Sci Sports Exerc. 1982;14(5):377-81. (PMID: 7154893)
      Qual Life Res. 2011 Dec;20(10):1727-36. (PMID: 21479777)
      N Engl J Med. 2013 Oct 17;369(16):1522-8. (PMID: 23992557)
      Lancet Respir Med. 2022 Aug;10(8):761-775. (PMID: 35472304)
      J Gen Intern Med. 2001 Sep;16(9):606-13. (PMID: 11556941)
      J Psychosom Res. 1993;37(2):147-53. (PMID: 8463991)
      Nat Rev Microbiol. 2023 Mar;21(3):133-146. (PMID: 36639608)
    • Grant Information:
      ECD/CSTPU/Adhoc/COVID-19/13/2021-22 Indian Council of Medical Research
    • Contributed Indexing:
      Keywords: Colchicine; Inflammation; Long COVID; Lung function; Randomized controlled trial
    • الرقم المعرف:
      SML2Y3J35T (Colchicine)
      0 (Anti-Inflammatory Agents)
    • الموضوع:
      Date Created: 20240611 Date Completed: 20240612 Latest Revision: 20240614
    • الموضوع:
      20240614
    • الرقم المعرف:
      PMC11167886
    • الرقم المعرف:
      10.1186/s13063-024-08205-7
    • الرقم المعرف:
      38863076