(ITAC) study is an international multi-center trial of the safety, tolerability and efficacy of anti-coronavirus hyper-immune intravenous immunoglobulin (hIVIG) for the treatment of adult hospitalized patients at the onset of clinical progression of COVID-19.
In-patient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) study is an international multi-center trial of the safety, tolerability and efficacy of anti-coronavirus hyper-immune intravenous immunoglobulin (hIVIG) for the treatment of adult hospitalized patients at the onset of clinical progression of COVID-19.
This trial will compare (hIVIG) with matched placebo while Remdesivir will be given to both arms of the study as part of routine care. The aim of the study is to evaluate the potential efficacy of the hIVIG (antibodies) as a potential treatment approach for preventing further disease progression and mortality related to COVID-19.
In future versions of the protocol one or more drugs from a different class and with different mechanisms of action may be studied and compared with other ongoing clinical trials. Such treatments could be studied along with hIVIG if it is found effective and safe in the initial phase of the study.
IHVN will be implementing this trial in 2 of our long term collaborating sites namely National Hospital Abuja and University of Abuja Teaching Hospital (UATH) with support from the Nigeria COVID-19 Research Consortium (NCRC). Patients will be recruited and consented from the hospital isolation centers. Hopefully, this study will provide a platform for research into new areas of infectious disease study and establish collaboration with more global partners.
The Principal Investigator of the Nigerian Study Site is Dr Eriobu Nnakelu. The ITAC Nigerian team will be supervised by the International Coordinating Center (ICC) overseeing other countries such as Japan, Israel, Argentina and Thailand. ITAC is funded by the US National Institute of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID) and is planned to last for 1 year or less depending on the rate of participant recruitment.