• 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, and Samar Alemadi.
• Pharmacy Department, Hamad Medical Corporation, Doha, Qatar.
• Medicine (Baltimore). 2022 Sep 30; 101 (39): e30618e30618.

IntroductionColchicine 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 AnalysisWe 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.DiscussionGiven 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 DisseminationThe 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.Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.

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