A Randomized, Single-blind, Group sequential, Active-controlled Study to evaluate the clinical efficacy and safety of a-Lipoic acid for critically ill patients with coronavirus disease 2019(COVID-19)

Ming Zhong; Aijun Sun; Ting Xiao; Ge Yao; Ling Sang; Xia Zheng; Jinyan Zhang; Xuejuan Jin; Lei Xu; Wenlong Yang; Peng Wang; Kai Hu; Dingyu Zhang; Junbo Ge

The clinical trials of hydroxychloroquine combined with azithromycin in the treatment of COVID-19 by Molina et al [29] (N = 11) focused on patients with mild COVID-19. In another clinical trial focused on patients with severe COVID-19, there was no significant difference in viral RNA loads or duration of viral RNA detectability between the lopinavir-ritonavir combination treatment group and the control group, but lopinavir-ritonavir treatment group presented with lower all-cause mortality on day 28 (P>0.05) [30] . Thus, in addition to the anti-virus treatment strategy, searching for other treatment strategies are of clinical importance aiming to alleviate the complications of COVID patients and reduce the mortality rate of patients with severe and critically ill COVID-19 was also essential. This trial has several limitations. In particular, the trial did not have sufficient number of cases. Because the epidemic situation in Wuhan was rapidly under control during the trial period, and critically ill COVID patients participating other clinical trials could not be enrolled in this study, only 17 critically ill COVID patients were enrolled in this study. Another limitation is that we use all-cause mortality as our secondary outcome, which could not distinguish death due to primary SARS-COV-2 insult from secondary bacterial infection, which was common in late phrase of critically ill patients with COVID-19. Further clinical studies are needed to verify the promising efficacy of ALA injection in patients with critically ill COVID-19.