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

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About: A Randomized, Single-blind, Group sequential, Active-controlled Study to evaluate the clinical efficacy and safety of Î±-Lipoic acid for critically ill patients with coronavirus disease 2019(COVID-19) Goto Sponge NotDistinct Permalink

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Attributes	Values
type	Academic Article research paper schema:ScholarlyArticle
isDefinedBy	Covid-on-the-Web dataset
has title	A Randomized, Single-blind, Group sequential, Active-controlled Study to evaluate the clinical efficacy and safety of Î±-Lipoic acid for critically ill patients with coronavirus disease 2019(COVID-19)
Creator	Wang, Peng Xu, Lei Hu, Kai Ge, Junbo Zhong, Ming Zhang, Dingyu Sang, Ling Zheng, Xia Zhang, Jinyan Xiao, Ting Jin, Xuejuan Sun, Aijun Yang, Wenlong Yao, Ge
Source	MedRxiv
abstract	Object: To evaluate the clinical efficacy and safety of -Lipoic acid (ALA) for critically ill patients with coronavirus disease 2019 (COVID-19). Methods: A 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. Result: Nine 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). Conclusion: In 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. Keywords: Pneumonia; COVID-19; SARS-CoV-2 ; -Lipoic acid
has issue date	2020-04-21(xsd:dateTime)
bibo:doi	10.1101/2020.04.15.20066266
has license	medrxiv
sha1sum (hex)	f15bd14f6272bbffc53872fa649a4b4098546c52
schema:url	https://doi.org/10.1101/2020.04.15.20066266
resource representing a document's title	A Randomized, Single-blind, Group sequential, Active-controlled Study to evaluate the clinical efficacy and safety of Î±-Lipoic acid for critically ill patients with coronavirus disease 2019(COVID-19)
resource representing a document's body	covid:f15bd14f6272bbffc53872fa649a4b4098546c52#body_text
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