6/28/23, 11:39 PM ITAC Pathway Feedback Search Clinical Topics Home Studies ITAC ITAC Disease COVID 19 infection Trial question What is the role of hyperimmune IVIG in patients hospitalized with COVID-19? Study design Multi-center Double blinded RCT Population Characteristics of study participants 43.0% female N = 579 57.0% male 579 patients (250 female, 329 male) Inclusion criteria: hospitalized patients with symptomatic COVID-19 Key exclusion criteria: previous passive immunotherapies; end-organ failure; known IgA deficiency with anti-IgA antibodies; certain thrombotic conditions and prothrombotic disorders Interventions N=295 hyperimmune IVIG (single infusion of 400 mg/kg of hyperimmune immunoglobulin to COVID-19 plus remdesivir) N=284 placebo (a single infusion of saline plus remdesivir) Primary outcome Percentage of patients with favorable clinical categories 1 and 2 60.0 % 60 56 45.0 % https://web.pathway.md/studies/recv9VEC9QoqE1pMe 1/2 6/28/23, 11:39 PM ITAC Pathway 30.0 % 15.0 % No significant difference 0.0 % Hyperimmune intravenous immunoglobulin Placebo No significant difference in the percentage of patients with favorable clinical categories 1 and 2 (60% vs. 56%; RRR 1.11, 95% CI 0.91 to 1.35) Secondary outcomes No significant difference in the percentage of patients who were discharged or with favorable clinical category 1 (91% vs. 89%; RRR 1.07, 95% CI 0.92 to 1.26) No significant difference in death at day 28 (6% vs. 8%; HR 0.8, 95% CI 0.42 to 1.51) Safety outcomes No significant differences in the percentage of patients with composite safety outcome of death, serious adverse effects and infections at day 28. Significant difference in infusion reactions (18.6% vs. 9.5%). Conclusion In hospitalized patients with symptomatic COVID-19, hyperimmune IVIG was not superior to placebo with respect to the percentage of patients with favorable clinical categories 1 and 2. Reference ITAC (INSIGHT ) Study Group. Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial. Lancet. 2022 Feb 5;399(10324):530-540. Open reference URL https://web.pathway.md/studies/recv9VEC9QoqE1pMe 2/2