Investigating efficacy of colchicine plus phenolic monoterpenes fraction as a potential treatment for patients diagnosed with COVID-19: A randomized controlled parallel clinical trial
Siavash Vaziri, Alireza Janbakhsh, Mohammad Hossein Zamanian, Yadollah Shakiba, Shayan Mostafaei, Amir Hossein Norooznezhad, Kamran Mansouri, Ph.D Ahmad Bagheri, Farhad Abdali, Kavyan Fatahpour, Ali Mostafaie
Heliyon, doi:10.1016/j.heliyon.2024.e27373
Background: COVID-19 now is a serious concern for the world healthcare system. This study aimed to investigate possible therapeutic effect of colchicine and phenolic monoterpenes accompanied by standard care of treatment (SCT) in patients diagnosed with COVID-19.
Methods: In this randomized controlled parallel clinical trial, a total number of 179 (of 200) patients with confirmed COVID-19 were enrolled according to the inclusion and exclusion criteria. The patients were allocated by simple randomization method into two groups control (receiving SCT with 71 patients) and intervention (receiving SCT plus colchicine and phenolic monoterpenes with 107 patients). The mortality ratio during hospitalization as well as a 2-week follow-up, ICU admission rate, and hospitalization duration were assessed as main outcomes. Results: The mortality ratio was 0.9% (1/108) and 8.45% (6/71) in the intervention and the control groups (p-value= 0.035) respectively, these ratios after a 14-day follow-up were 1.85% (2/108), and 9.85 (7/71) respectively (p-value= 0.031). Also, the ICU admission was significantly lower (p-value= 0.006) in the intervention group 2/108 (1.85%) compared with controls 10/71 (14.08%). Moreover, the duration of hospitalization followed a similar pattern to ICU admission with 4.17 ± 1.34 vs. 6.39 ± 2.59 days in the intervention and control groups respectively (p-value< 0.001). Furthermore, no significant side effect was found between the groups. Conclusion: According to the results, the combination of colchicine plus phenolic monoterpenes could be an additive treatment for the SCT. The authors strongly recommend further trials on this combination with other SCTs.
Conflict of interest Prof. Ali Mostafaie and Mr. Kavyan Fattahipour are employees of Zist Tolid Razi Co. Other authors declare no actual or potential conflict of interest.
J o u r n a l P r e -p r o o f
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