The preventive effect of Xuebijing injection against cytokine storm for severe patients with COVID-19: A prospective randomized controlled trial.

Introduction: COVID-19 is severely affecting countries globally and mortality is high. Xuebijing (XBJ) injection is widely used in the treatment of severe pneumonia and sepsis in China due to its anti-inflammatory effect and immunoregulation. This study investigated whether Xuebijing injection can prevent the cytokine storm and reduce the mortality from severe COVID-19.

Methods: This was a randomized, double-blinded trial in which 60 eligible patients were recruited from the First people's Hospital of Jingzhou from February 16 to March 25 in 2020. A total of 57 completed the trial, 3 dropped out. The treatment group received routine medication plus Xuebijing injection while the control group received routine medication plus saline.

Results: The secretion of interleukin-6(IL-6), interleukin-8(IL-8) and tumor necrosis factor-α(TNF-α) was suppressed significantly (P < 0.05) by Xuebijing. After 14 days treatment, lymphocyte levels in Xuebijing group was substantially higher than control, C-reactive protein (CRP) level in Xuebijing group was remarkably lower. The 28-day mortality was not significantly different between the two group. After 14 days of treatment, there were significant differences in the rate of mechanical ventilation, rate of septic shock, the proportion of patients severely affected who became critically ill, the duration of improvement of main clinical symptoms (P < 0.05) and the length of ICU hospitalization stay (P < 0.01) for the Xuebijing group compared with controls. No serious adverse reactions were identified in either group.

Conclusions: This study demonstrates that Xuebijing injection may suppress the cytokine storm in severe COVID-19 patients by regulating the secretion of pro- inflammatory cytokine IL-6, IL-8 and TNF -α. However, Xuebijing did not significantly reduce the 28-day mortality.