Abstract
BackgroundCoronavirus 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.MethodsThis study was conducted as a randomized 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 3 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.ResultsAmong total study 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 = 0.025). 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).ConclusionsOur 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 registrationA study protocol was registered at the Iranian Registry of Clinical Trials (www.IRCT.ir), number IRCT20200501047259N1. It was registered retrospectively on May 17th, 2020.
Highlights
Coronavirus disease 2019 (COVID-19) has infected people in many countries worldwide
Some studies support the use of Lopinavir-Ritonavir, Cao et al demonstrated no obvious efficacy of Lopinavir-Ritonavir in COVID-19 treatment compared to standard treatment [8]
Demographics, clinical characteristics, and evaluated laboratory tests between the treatment and control group did not exhibit significant differences except for between: (1) serum creatinine, which was higher in the control group (1.0 [0.8–1.1] in the treatment group vs. 1.2 [1.0–1.4] in the control group; P = 0.001), (2) white blood cell (WBC) count (1000/mm3), which was higher in the control group (5.05 [4.20–7.00] in the treatment group vs. 6.60 [5.00–10.90] in the control group; P = 0.026), and (3) the overall duration of hospitalization was longer in the treatment group (9 [7,8,9,10,11,12,13] in the treatment group vs. 7 [6,7,8,9] in the control group; P = 0.014)
Summary
Coronavirus disease 2019 (COVID-19) has infected people in many countries worldwide. The objective of this study was to evaluate the efficacy of intravenous immunoglobulin (IVIg) in patients with severe COVID-19 infection. Jalili et al by studying 28,981 hospitalized COVID-19 patients in Iran showed that cumulative risk for death in 30 days was 24.4 (23.8–25.0 95% CI), ranging from 14.8 (14.2–15.4) in < 65 years old patients to 41.6(40.5–42.8) in those with ≥65 years old [4]. The data about chloroquine is controversial, but completed studies are relatively in favor of its efficacy in the treatment of COVID19 [7]. Some studies support the use of Lopinavir-Ritonavir, Cao et al demonstrated no obvious efficacy of Lopinavir-Ritonavir in COVID-19 treatment compared to standard treatment [8]. Beigel et al showed that Remdesivir was superior to placebo in shortening the duration of disease [9]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
