Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC)

The challenge

The global pandemic of COVID-19 has posed an unprecedented challenge to find efficient drugs for prevention and treatment. Currently there is no vaccine and no licensed therapeutic agent to treat COVID-19.

The project

ITAC is an international multicentre, adaptive, randomised double-blind, placebo-controlled trial, aimed at assessing the safety, tolerability, and efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin (hIVIG) for the treatment of adults hospitalised at the onset of clinical progression of COVID-19. The ITAC trial will serve as a platform for assessing COVID-19 treatments for adult patients hospitalised for medical management of COVID-19 who do not have serious end-organ failure.

The method

The ITAC trial is conducted by the International Network of Strategic Initiatives in Global HIV Trials (INSIGHT). The study will aim to rapidly enrol 500 patients hospitalised for medical management of COVID-19 across sites in North and South America, Europe, Africa, and Asia. ITAC will enrol eligible patients with confirmed SARS-CoV-2 infection and provide them with hIVIG or placebo to compare their clinical status over a 28-day period. Hyperimmune intravenous immunoglobulin (hIVIG) to SARS-CoV-2, derived from the plasma of individuals who recover and develop neutralising antibodies, is a potentially useful therapeutic approach to COVID-19.

The results

The ITAC study found that the combination of remdesivir plus a highly concentrated solution of antibodies that neutralize SARS-CoV-2, the virus that causes COVID-19, is not more effective than remdesivir alone for treating adults hospitalized with the disease. The trial also found that the safety of this experimental treatment may vary depending on whether a person naturally generates SARS-CoV-2-neutralizing antibodies before receiving it. The results of the multinational Phase 3 trial are published in the journal The Lancet.

The impact

There is a serious and vital need to establish efficient therapeutic agents to combat COVID-19 given its impermanence and pace. Establishing whether hIVIG is safe and effective as rapidly as possible could change the course of this global pandemic. 

Project collaborators
  • International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
  • Copenhagen HIV Program (CHIP) – Copenhagen, Denmark
  • Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL) – London, United Kingdom
  • The Institute for Clinical Research at the Veterans Affairs Medical Center – Washington, D.C, USA.
  • University of Minnesota- Clinical and Translational Science Institute – Minnesota, USA
Project funding
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institutes of Health (NIH)
  • Emergent Bio Solutions
  • Grifols Therapeutics
  • Takeda Pharmaceuticals
  • CSL Behring
  • Gilead Sciences