High-Dose Intravenous Immunoglobulin in Severe Coronavirus Disease 2019: A Multicenter Retrospective Study in China (preprint)

ABSTRACT

Background: The effective treatment of COVID-19 remains unclear. We reported successful use of high-dose intravenous immunoglobulin (IVIg) in cases of severe COVID-19, but evidence for such treatment is still lacking.Methods: A multi-center retrospective study was conducted to evaluate the effectiveness of IVIg administered within two weeks of disease onset at a total dose of 2 g/kg body weight, in addition to standard care. The primary endpoint was 28-day mortality. Efficacy of high-dose IVIg was assessed by using the Cox proportional hazards regression model and the Kaplan-Meier curve adjusted by propensity score-matched (PSM) and inverse probability of treatment weighting (IPTW) analysis.Results: Overall, 26 patients who received high-dose IVIg with standard therapy and 79 patients who received standard therapy only were enrolled in this study. The IVIg group was associated with a lower 28-day mortality rate and less time to normalization of inflammatory markers including IL-6, IL-10 and ferritin compared with the control. The adjusted HR of 28-day mortality in high-dose IVIg group was 0.28 (95%CI 0.06-1.10, p=0.061) in propensity score-matched (PSM) analysis, and 0.24 (95%CI 0.06-0.99, p<0.001) in inverse probability of treatment weighting (IPTW) adjustment. In subgroup analysis, patients with no comorbidities or treated in the first week of disease were associated with more benefit from high-dose IVIg.Conclusions: High-dose IVIg administered in severe COVID-19 patients within 14 days of onset was linked to reduced 28-day mortality, more prominent with those having no comorbidities or treated at earlier stage.Funding Statement None.Declaration of Interests All authors declared no competing financial interests.Ethics Approval Statement The study protocol was approved by the institutional ethics board of Peking Union Medical College Hospital (PUMCH, No. ZS-2299, Feb 6, 2020), and all participants provided written consent for participating this study.