DECLARATIONS
Funding: No specific funding was received from any bodies in the public, commercial or not-for-profit sectors to carry out work described in this article.
Conflicts of Interest: The authors declare no conflicts of interest.
Availability of data and material: The Dataset of the study is available from the corresponding author on reasonable request.
Code availability: Not applicable.
Author contributions: MB and RÇ designed and planned the study, RÇ, SY, MA, MHU, and MİK collected the data, SY and MB carried out the data evaluation and basic analyses, all authors contributed to the follow-up of the patients and interpretation of results. RÇ and MB wrote the first draft, and all authors provided critical feedback for the last version.
Ethics approval : Individual written patient consent and local ethic committee approval was obtained for this study (date/number: 24.02.2022, 2022/04-09).
Word count: 3326 words in main text without references
Abstract word count : 248 words.
Number of tables : 5 tables, 1 supplementary table
Number of figures: 3 figures and 17 supplementary figures
References: 45
Supplementary data: Yes
Introduction: In our study, we aimed to evaluate the effect of high dose intravenous anakinra treatment on development of thrombotic events in severe and critical COVID-19 patients.
Material and methods : This retrospective observational study was conducted at a tertiary referral center in Aksaray, Turkey. The study population consisted of two groups as follows; the patients receiving high dose intravenous anakinra (anakinra group) added to background therapy and the patients treated with standard of care (SoC) as historical control group. Age, gender, mcHIS scores, and comorbidities such as DM, HT, and CHD of the patients were determined as the variables to be matched.
Results: We included 114 patients in SoC and 139 patients in Anakinra group into the study. Development of any thromboembolic event (5% vs 12.3%, p=0.038; OR:4.3) and PTE (2.9% vs 9.6%, p=0.023; OR:5.1) were lower in Anakinra group than SoC. No patient experienced CVA and/or clinically evident DVT both in two arms.
After 1:1 PS matching, 88 patients in SoC and 88 patients in Anakinra group were matched and included into the analysis. In survival analysis, development of any thromboembolic event, PTE, and MI were higher in SoC compared to Anakinra. Survival rate was also lower in patients with SoC arm than Anakinra in patients who had any thromboembolic event as well as MI.
Conclusion : In our study, development of thrombosis were associated with hyperinflammation in patients with severe and critical COVID-19. Intravenous high-dose anakinra treatment decreases both venous and arterial events in patients with COVID-19.
Key words: Anakinra, COVID-19, thrombosis, inflammasome, hyperinflammation