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.
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 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 ITAC trial will determine if single infusion of hIVIG is effective in preventing further progression and mortality related to COVID-19. It will evaluate clinical data to examine severity experienced by participants and assess progression of disease as well as recovery from COVID-19.
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.
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health (NIH)
- Emergent Bio Solutions
- Grifols Therapeutics
- Takeda Pharmaceuticals
- CSL Behring
- Gilead Sciences
- International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
- Kirby Institute, UNSW Sydney, Australia
- 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