1. Hyperimmune intravenous immunoglobulin (hIVIG) did not increase odds of better outcomes in patients with COVID-19 compared to placebo.
2. The most common adverse reactions with hIVIG were infusion reactions and there were significantly more grade 3 or higher adverse reactions in the hIVIG group compared to placebo.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Passive immunization generally involves the administration of antibodies to provide temporary, but rapid immune response to an acute infection. Hyperimmune intravenous immunoglobulins (hIVIG) are purified immunoglobulin G derived from patients who have recovered from COVID-19 infection. To date, there is limited evidence regarding their effectiveness in patients hospitalized with COVID-19. The aim of this randomized controlled trial was to evaluate the safety and efficacy of hIVIG in hospitalized patients with COVID-19. When added to the current standard treatment regimen, hIVIG was not seen to improve outcomes compared with placebo in patients with COVID-19. Adverse reactions, mainly infusion reactions, were significantly more common in patients in the hIVIG group. Limitations of this study include the delayed time to treatment, which was a median of 8 days from symptom onset. Nonetheless, there may still be a role for future studies in different patient populations.
Click to read the study in The Lancet.
Relevant Reading: Antibody responses to SARS-CoV-2 in patients with COVID-19
In-Depth [randomized controlled trial]: This study was a double-blind, placebo-controlled, phase 3 clinical trial evaluating the efficacy of anti-SARS-CoV-2 hIVIG. The study enrolled 593 patients hospitalized with COVID-19 aged 18 years and older. The average age of participants was 59 years and 43% were female. Patients were randomized (1:1) to receive hIVIG (400 mg/kg) or placebo. All patients received the standard of care, including remdesivir. The primary outcome was clinical status on day 7 post-infusion and patients were followed up to 28 days from randomization. The median time from symptom onset to randomization was 8 days.
For the primary outcome, the odds ratio for a more favorable clinical outcome on day 7 for the hIVIG group was 1.06 (95% CI 0.77-1.45, p=0.72). Rates of hospitalization and death were not significantly different between groups. The most common adverse reaction was infusion reactions in the hIVIG group. 6% of patients in the hIVIG group compared with 1% of the placebo group reported grade 3 or higher infusion reactions (p=0.012).
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