Download This Paper
Preprints with The Lancet is part of SSRN´s First Look, a place where journals identify content of interest prior to publication. Authors have opted in at submission to The Lancet family of journals to post their preprints on Preprints with The Lancet. The usual SSRN checks and a Lancet-specific check for appropriateness and transparency have been applied. Preprints available here are not Lancet publications or necessarily under review with a Lancet journal. These preprints are early stage research papers that have not been peer-reviewed. The findings should not be used for clinical or public health decision making and should not be presented to a lay audience without highlighting that they are preliminary and have not been peer-reviewed. For more information on this collaboration, see the comments published in The Lancet about the trial period, and our decision to make this a permanent offering, or visit The Lancet´s FAQ page, and for any feedback please contact preprints@lancet.com.
High-Dose Intravenous Immunoglobulin in Severe Coronavirus Disease 2019: A Multicenter Retrospective Study in China
25 Pages Posted: 26 Oct 2020
More...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.
Keywords: COVID-19, high-dose intravenous immunoglobulin, immunomodulation, 28-day mortality, inflammatory markers
Suggested Citation: Suggested Citation