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Adding colchicine to tocilizumab in hospitalized patients with severe COVID-19 pneumonia: An open-label randomized controlled trial

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submitted on 2024-02-12, 05:59 and posted on 2024-02-12, 06:00 authored by Alaa Rahhal, Mostafa Najim, Amer Hussein Aljundi, Ahmed Mahfouz, Sumaya Mehdar Alyafei, Ahmed Awaisu, Mhd, Baraa Habib, Ibrahim Obeidat, Mohanad Mohammed Faisal, Meshaal Ali Alanzi, Arun Prabhakaran Nair, Areeg Elhassan, Abdullah Al-Dushain, Alaaeldin Abdelmajid Abdelmajid, Ahmed Elfadil Abdelgader, Ahmed Mahmoud Ahmed Moursi, Ahmad Eid Nazzal Alharafsheh, Mohd Ragheb Abou Kamar, Wael Goravey, Amr Salah Omar, Mohammed Abukhattab, Mohamad Yahya Khatib, Mohamed Gaafar Mohamedali, Muna A. Rahman AlMaslamani, Samar Alemadi

Introduction:

Colchicine acts upstream in the cytokines cascade by inhibiting the nod-like receptor protein 3 (NLRP3) inflammasome while interleukin 6 (IL-6) receptor antagonists, such as tocilizumab, block the end result of the cytokines cascade. Hence, adding colchicine to tocilizumab with the aim of blocking the early and end products of the cytokines cascade, might reduce the risk of developing cytokine storm.

Methods and analysis:

We aim to conduct an open-label randomized controlled trial to evaluate the efficacy and safety of adding colchicine to tocilizumab among patients with severe COVID-19 pneumonia to reduce the rate of invasive mechanical ventilation and mortality. We will include patients with severe COVID-19 pneumonia who received tocilizumab according to our local guidelines. Enrolled patients will be then randomized in 1:1 to colchicine versus no colchicine. Patients will be followed up for 30 days. The primary outcome is the rate of invasive mechanical ventilation and will be determined using Cox proportional hazard model.

Discussion:

Given colchicine’s ease of use, low cost, good safety profile, and having different anti-inflammatory mechanism of action than other IL-6 blockade, colchicine might serve as a potential anti-inflammatory agent among patients with severe COVID-19 pneumonia. This study will provide valuable insights on the use of colchicine in severe COVID-19 when added to IL-6 antagonists.

Ethics and dissemination:

The Medical Research Center and Institutional Review Board at Hamad Medical Corporation in Qatar approved the study protocol (MRC-01-21-299). Results of the analysis will be submitted for publication in a peer-reviewed journal.

Other Information

Published in: Medicine
License: http://creativecommons.org/licenses/by/4.0/
See article on publisher's website: https://dx.doi.org/10.1097/md.0000000000030843

Funding

Open Access funding provided by the Qatar National Library.

History

Language

  • English

Publisher

Wolters Kluwer

Publication Year

  • 2022

License statement

This Item is licensed under the Creative Commons Attribution 4.0 International License.

Institution affiliated with

  • Hamad Medical Corporation
  • Heart Hospital - HMC
  • Qatar University
  • Qatar University Health - QU
  • College of Pharmacy - QU HEALTH

Methodology

We aim to conduct an open-label randomized controlled trial to evaluate the efficacy and safety of adding colchicine to tocilizumab among patients with severe COVID-19 pneumonia to reduce the rate of invasive mechanical ventilation and mortality. We will include patients with severe COVID-19 pneumonia who received tocilizumab according to our local guidelines. Enrolled patients will be then randomized in 1:1 to colchicine versus no colchicine. Patients will be followed up for 30 days. The primary outcome is the rate of invasive mechanical ventilation and will be determined using Cox proportional hazard model.

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