Efficacy and safety of chloroquine and hydroxychloroquine in the treatment of patients with COVID-19 combined with diabetes mellitus A protocol for systematic review and meta-analysis

Background: Diabetes is a common chronic metabolic disease. COVID-19 is a large-scale infectious disease that broke out in 2019, and 212 countries have now been infected with this infectious disease. Some studies have shown that COVID-19 combined with diabetes is an independent risk factor for death or other adverse outcomes. There is currently no specific and effective drug treatment. More and more people have realized that the low-cost CQ and its derivative HCQ have antiviral and anti-inflammatory capabilities and may play a huge role in the fight against COVID-19. At the same time, HCQ can be used as an oral hypoglycemic agent and has the effect of lowering blood glucose. However, there is no evidence-based medicine to confirm the effectiveness and safety of CQ and HCQ in the treatment of COVID-19 patients with diabetes. Therefore, we will conduct a systematic review and meta-analysis to synthesize the existing clinical evidences. Methods and analysis: Chinese literature comes from CNKI, Wanfang, VIP, CBM databases. English literature mainly searches Cochrane Library, PubMed, Web of Science, EMBASE. We will retrieve each database from December 2019 to August 2020. At the same time, we will look for clinical trial registration and gray literature. This study only included clinical randomized controlled trials. The reviewers independently conduct literature selection, data analysis, quality analysis, and evaluation. The primary outcomes include Sputum virus nucleic acid negative time, lung imaging improvement time, mortality rate, mechanical ventilation rate, ICU hospitalization time, hospitalization time, clinical improvement, symptoms Improvement, fasting blood glucose, 2-hour postprandial blood glucose, glycosylated hemoglobin, fasting insulin, adverse reactions, etc. Finally, we will conducted a meta-analysis through Review Manager Software version 5.3. Results: The results will be published in peer-reviewed journals and presented at a relevant conference. Conclusion: This study will explore the effectiveness and safety of CQ and HCQ in the treatment of COVID-19 patients with diabetes. It will provide evidence-based medical evidence for CQ and HCQ in the treatment of diabetes with COVID-19. Registration number: INPLASY202070109.