Abstract
ObjectTo evaluate the clinical efficacy and safety of α-Lipoic acid (ALA) for critically ill patients with coronavirus disease 2019 (COVID-19).MethodsA randomized, single-blind, group sequential, active-controlled trial was performed at JinYinTan Hospital, Wuhan, China. Between February 2020 and March 2020, 17 patients with critically ill COVID-19 were enrolled in our study. Eligible patients were randomly assigned in a 1:1 ratio to receive either ALA (1200 mg/d, intravenous infusion) once daily plus standard care or standard care plus equal volume saline infusion (placebo) for 7 days. All patients were monitored within the 7 days therapy and followed up to day 30 after therapy. The primary outcome of this study was the Sequential Organ Failure Estimate (SOFA) score, and the secondary outcome was the all-cause mortality within 30 days.ResultNine patients were randomized to placebo group and 8 patients were randomized to ALA group. SOFA score was similar at baseline, increased from 4.3 to 6.0 in the placebo group and increased from 3.8 to 4.0 in the ALA group (P = 0.36) after 7 days. The 30-day all-cause mortality tended to be lower in the ALA group (3/8, 37.5%) compared to that in the placebo group (7/9, 77.8%, P = 0.09).ConclusionIn our study, ALA use is associated with lower SOFA score increase and lower 30-day all-cause mortality as compared with the placebo group. Although the mortality rate was two-folds higher in placebo group than in ALA group, only borderline statistical difference was evidenced due to the limited patient number. Future studies with larger patient cohort are warranted to validate the role of ALA in critically ill patients with COVID-19.Clinical Trial Registrationhttp://www.chictr.org.cn/showproj.aspx?proj=49534.
Highlights
Since December 2019, the novel coronavirus pneumonia 2019 (COVID-19) induced by severe acute respiratory coronavirus 2 (SARS-CoV-2) has become a worldwide pandemic and is overwhelming health care systems globally
These findings suggested that the cytokine release syndrome (CRS) may be associated with COVID-19
There were no significant differences between groups in demographic characteristics, baseline laboratory test results and Sequential Organ Failure Estimate (SOFA) Score at enrollment
Summary
Since December 2019, the novel coronavirus pneumonia 2019 (COVID-19) induced by severe acute respiratory coronavirus 2 (SARS-CoV-2) has become a worldwide pandemic and is overwhelming health care systems globally. Several studies have shown that C reactive protein (CRP), D-dimer and serum proinflammatory cytokines (IL-6, IL-1β, etc.) was increased in patients with severe COVID-19 [6,7,8,9]. These findings suggested that the cytokine release syndrome (CRS) may be associated with COVID-19. Viral infection can cause the production of reactive oxygen species (ROS), and ROS plays an important role in virus replication and invasion [12], organ damage [13, 14], and systemic inflammatory response [15,16,17,18,19,20]
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