ITAC (Inpatient Treatment with Anti-Coronavirus Immunoglobulin) is an international multicenter, adaptive, randomized double-blind, placebo-controlled trial of the safety, tolerability and efficacy of hyperimmune intravenous immunoglobulin for the treatment of adult hospitalized patients at onset of clinical progression of COVID-19.
This treatment study is intended to evaluate the safety and efficacy of hyperimmune intravenous immunoglobulin (hIVIG) administered to patients hospitalized for medical management of COVID-19 without related serious end-organ failure.
Treatment with hIVIG, derived from the plasma of individuals who recover and develop neutralizing antibodies, is a potentially useful therapeutic approach to COVID-19. Emerging data suggest that humoral immunity to SARS-CoV-2 may develop relatively late in the course of infection and is variable between individuals with some showing limited antibody development. Augmenting host antibody response with hIVIG to SARS-CoV-2 at the onset of clinical progression, before end-organ failure has developed, may reduce the subsequent risk of further disease progression and death.
The planned study sample size is 500 participants. The study population will include consenting hospitalized patients with COVID-19 who have had COVID-19 symptoms ≤ 12 days, and who do not have life-threatening organ dysfunction or organ failure.
For further details about the ITAC study, please visit the INSIGHT website.
For more information about the ITAC Study at Copenhagen ICC, please contact firstname.lastname@example.org