Study: COVID-19 Patients on Intravenous Immunoglobin Have Reduced Hospital Stays, Test Negative Earlier
Intravenous immunoglobin (IVIG), which has demonstrated therapeutic benefits in a wide range of diseases, has been shown to reduce the duration of hospital stay for patients with COVID-19, as well as achieving RT-PCR negativity earlier, according to a study published in The Journal of Infectious Diseases. Additionally, the duration for body temperature normalization, oxygen saturation, and mechanical ventilation were significantly shorter for patients who received IVIG in addition to standard of care (SOC) when compared to those only receiving SOC.
IVIG has been reported to have a wide range of therapeutic benefits in the treatment of a variety of inflammatory, infectious, autoimmune, and viral diseases, and has been shown to be particularly beneficial in the treatment of severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS) and influenza, according to the study authors. Immunoglobin has shown antiviral and anti-inflammatory effects through increasing certain cytokine secretions and has been recommended by the World Health Organization COVID-19 therapeutic guidelines in the list of selective methods.
The phase 2 study followed 100 patients in 4 Indian cities with the objective of evaluating the safety and efficacy of IVIG in the treatment of COVID-19 patients with moderate pneumonia. Participants were randomized into 2 treatment arms: 1 receiving IVIG alongside SOC, and the other receiving only SOC, which consisted of azithromycin, lopinavir/ritonavir, piperacillin and tazobactam, acetaminophen, and pantocid. The primary endpoint was the number of days from the initiation of treatment to hospital discharge, with follow-up examinations on days 14 and 28.
According to the results of the study, duration of hospital stay was significantly shorter (P = .0001) for the IVIG group, with patients being released after 7.7 days on average compared to 17.5 days for the control group. Further, the median time to RT-PCR negativity was significantly lower in the IVIG treatment arm, achieved after 7 days compared to 18 days for the SOC group. Ninety-two percent of the test group was RT-PCR negative at day 14, compared to 24% of the control arm.
The researchers also tracked a number of secondary efficacy outcomes, monitoring mean duration required to reduce the body temperature to <37°C, normalization of oxygen, normalization of respiratory rate, mean duration for cessation of cough, mean duration of mechanical ventilation, and length of stay in ICU. All these secondary efficacy variables showed significant clinical improvement in the test group, with the exception of respiratory rate and number of days of stay in ICU, according to the study. The researchers also note that treatment with IVIG within 48 hours of admission reduced ventilator usage and the duration of stay in the intensive coronary care unit, ultimately lowering 28-day mortality.
In both groups, there were only mild to moderate adverse events (AEs) experienced, save for one patient death in the SOC group. A total of 17 AEs were reported by 15 patients in the test group, whereas a total of 20 AEs were reported by 12 patients in the control group, according to the study. Mild reactions to IVIG were found to occur within the first 30 minutes of infusion, which were relieved by reducing the infusion rate or temporarily stopping the infusion. Based on these safety results and the outcomes associated with IVIG in the study, the researchers concluded that IVIG was safe and efficacious as an adjuvant with other antiviral drugs in the treatment of COVID-19.
Raman R S, Vijaykumar Bhagwan Barge, Anil Kumar Darivenula, et al. A Phase II Safety and Efficacy Study on Prognosis of Moderate Pneumonia in COVID-19 patients with Regular Intravenous Immunoglobulin Therapy. J Infect Dis. Feb 15 2021; jiab098. doi: 10.1093/infdis/jiab098.