Effect of regular intravenous immunoglobulin therapy on prognosis of severe pneumonia in patients with COVID-19

Xie, Yun; Cao, Song; Dong, Hui; Li, Qingyun; Chen, Erzhen; Zhang, Wenkai; Yang, Lijing; Fu, Shouzhi; Wang, Ruilan

doi:10.1016/j.jinf.2020.03.044

Cited by 225 publications

(239 citation statements)

References 10 publications

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“…IVIg during the rst 48 hours of admission to the ICU versus those who received IVIg treatment 48 hours or more after ICU admission were 23.3% and 57.1%, respectively (P = 0.009) [21]. The mortality rates reported by Xie et al are similar to our ndings, suggesting that IVIg treatment, administered early-on, could signi cantly reduce mortality in critically ill COVID-19 patients.…”

Section: Discussionsupporting

confidence: 86%

The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: A randomised placebo-controlled double-blind clinical trial

Gharebaghi

Nejadrahim

Mousavi

et al. 2020

Preprint

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Background: Coronavirus disease 2019 (COVID-19) has infected people in many countries worldwide. Discovering an effective treatment for this disease, particularly in severe cases, has become the subject of intense scientific investigation. Therefore, the objective of this study was to evaluate the efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 infection.Methods: This study was conducted as a randomised placebo-controlled double-blind clinical trial. Fifty-nine patients with severe COVID-19 infection who did not respond to initial treatments were randomly assigned into two groups. One group received IVIg (human)—four vials daily for three days (in addition to initial treatment), while the other group received a placebo. Patients’ demographic, clinical, and select laboratory test results, as well as the occurrence of in-hospital mortality, were recorded. Results: Among the total subjects, 30 patients received IVIg and 29 patients received a placebo. Demographics, clinical characteristics, and laboratory tests were not statistically different (P > 0.05) between the two groups. The in-hospital mortality rate was significantly lower in the IVIg group compared to the control group (6 [20.0%] vs. 14 [48.3%], respectively; P = 0.022). Multivariate regression analysis demonstrated that administration of IVIg did indeed have a significant impact on mortality rate (aOR = 0.003 [95% CI: 0.001–0.815]; P = 0.042).Conclusions: Our study demonstrated that the administration of IVIg in patients with severe COVID-19 infection who did not respond to initial treatment could improve their clinical outcome and significantly reduce mortality rate. Further multicenter studies with larger sample sizes are nonetheless required to confirm the appropriateness of this medication as a standard treatment.Trial registration: A study protocol was registered at the Iranian Registry of Clinical Trials (www.IRCT.ir), number IRCT20200501047259N1. It was registered retrospectively on May 17th, 2020.

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Section: Discussionsupporting

confidence: 86%

The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: A randomised placebo-controlled double-blind clinical trial

Gharebaghi

Nejadrahim

Mousavi

et al. 2020

Preprint

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“…In this study, 58 patients were included, and 28 patients died during 28 days of admission (total mortality = 48.2%). The mortality rate of patients who received IVIg during 48 hours of admission to ICU and those who received IVIg after 48 hours of admission were 23.3% vs 57.1%, respectively (p = 0.009)(15). The mortality rate of Xie et al study is close to our results, which shows that early IVIg treatment could signi cantly reduce the mortality of critically ill COVID-19 patients.…”

supporting

confidence: 81%

Intravenous Immunoglobulin Gamma for Severe Cases of Coronavirus Disease of 2019: A Randomized Placebo-Controlled Double-Blinded Clinical Trial

Gharebaghi

Nejadrahim

Mousavi

et al. 2020

Preprint

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Abstract Background: Coronavirus disease of 2019 (COVID-19) with high-transmission power has infected people in many countries around the world. Discovering an effective medication for the treatment of this disease, especially in severe cases, has become the subject of intense scientific investigations. Therefore, the objective of this study was to evaluate the efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 infection.Methods: The study was conducted as a randomized placebo-controlled double-blinded clinical trial. Fifty-nine patients with severe COVID-19 infection who did not respond to initial treatment were randomly assigned into two groups. One group received IVIg (human) four vials every day for three days in addition to initial treatment, and the other group received placebo. Patients’ demographic, clinical, and selected laboratory test results, as well as the occurrence of in-hospital mortality, were recorded. Result: Among included patients, 30 patients received IVIg and 29 patients received placebo. Demographics, clinical characteristics and evaluated laboratory tests of two groups were not statistically different (P>0.05). The in-hospital mortality rate was significantly lower in the IVIg group as compared to the control group (6 [20.0%] vs 14 [48.3%], respectively, p = 0.022). Multivariate regression analysis demonstrated that administration of IVIg had a significant impact on mortality rate (aOR= 0.003 [95%CI: 0.001 - 0.815], p=0.042).Conclusion: Our study was the first randomized double-blinded study that demonstrated that the administration of IVIg in patients with severe COVID-19 infection who did not respond to initial treatment could improve their clinical outcome and reduce the mortality rate. However, further multicenter studies with larger samples size are required to confirm the applicability of using this medication as the standard treatment.Trial registration: The study protocol is registered at the Iranian Registry of Clinical Trials (www.IRCT.ir) with the registration number of IRCT20200501047259N1. Registered 17 May 2020. Retrospectively registered.

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“…Although IVIG are considered a therapeutic option for hyperinflammation in patients with severe COVID-19 30 , the results of this study may support the use of high dose IVIG as a therapy for COVID-19. Positive results have already been reported for IVIG in case studies 31,32 . IVIG is being tested in an ongoing clinical trial 33 .…”

Section: Discussionmentioning

confidence: 57%

Cross-neutralization activity against SARS-CoV-2 is present in currently available intravenous immunoglobulins

Díez

Romero

Vergara‐Alert

et al. 2020

Preprint

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Background: There is a crucial need for effective therapies that are immediately available to counteract COVID-19 disease. Recently, ELISA binding cross-reactivity against components of human epidemic coronaviruses with currently available intravenous immunoglobulins (IVIG) Gamunex-C and Flebogamma DIF (5% and 10%) have been reported. In this study, the same products were tested for neutralization activity against SARS-CoV-2, SARS-CoV and MERS-CoV and their potential as an antiviral therapy. Methods: The neutralization capacity of six selected lots of IVIG was assessed against SARS-CoV-2 (two different isolates), SARS-CoV and MERS-CoV in cell cultures. Infectivity neutralization was measured by determining the percent reduction in plaque-forming units (PFU) and by cytopathic effects for two IVIG lots in one of the SARS-CoV-2 isolates. Neutralization was quantified using the plaque reduction neutralization test 50 (PRNT50) in the PFU assay and the half maximal inhibitory concentration (IC50) in the cytopathic/cytotoxic method (calculated as the minus log10 dilution which reduced the viral titer by 50%). Results: All IVIG preparations showed neutralization of both SARS-CoV-2 isolates, ranging from 79 to 89.5% with PRNT50 titers from 4.5 to >5 for the PFU method and ranging from 47.0%-64.7% with an IC50 ~1 for the cytopathic method. All IVIG lots produced neutralization of SARS-CoV ranging from 39.5 to 55.1 % and PRNT50 values ranging from 2.0 to 3.3. No IVIG preparation showed significant neutralizing activity against MERS-CoV. Conclusion: In cell culture neutralization assays, the tested IVIG products contain antibodies with significant cross-neutralization capacity against SARS-CoV-2 and SARS-CoV. However, no neutralization capacity was demonstrated against MERS-CoV. These preparations are currently available and may be immediately useful for COVID-19 management.

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Effect of regular intravenous immunoglobulin therapy on prognosis of severe pneumonia in patients with COVID-19

Cited by 225 publications

References 10 publications

The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: A randomised placebo-controlled double-blind clinical trial

The use of intravenous immunoglobulin gamma for the treatment of severe coronavirus disease 2019: A randomised placebo-controlled double-blind clinical trial

Intravenous Immunoglobulin Gamma for Severe Cases of Coronavirus Disease of 2019: A Randomized Placebo-Controlled Double-Blinded Clinical Trial

Cross-neutralization activity against SARS-CoV-2 is present in currently available intravenous immunoglobulins

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