Findings from a multi-country study published in the Lancet Journal have revealed that concentrated solution of antibodies donated by patients who have recovered from COVID-19 is ineffective in treating hospitalized COVID-19 patients.
The study, Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC), tested anti-coronavirus hyperimmune intravenous immunoglobulin (hIVIG) solution among 593 patients in Nigeria, USA, United Kingdom, Germany, Greece, Israel, Japan, Indonesia, Argentina, Spain and Denmark.
Study participants had COVID-19 symptoms for up to 12 days but had not progressed to life-threatening conditions. They were enrolled from October 2020 to February 2021 and received standard care as well as Remdesivir along with hyperimmune intravenous immunoglobulin or with a placebo.
“To our knowledge, this study is the first well-powered placebo-controlled clinical trial to report results of hIVIG for the treatment of hospitalized patients with COVID-19,” the article in the Lancet Journal states.
The International Research Center of Excellence (IRCE) at Institute of Human Virology Nigeria (IHVN) conducted the clinical trial in Nigeria. Principal Investigator of the Nigerian Study Center, Dr. Nnakelu Eriobu states that the research gives important scientific knowledge in a search for a cure for COVID-19.
“Nigeria’s participation in this study shows that we have the capacity to conduct this level of clinical trials. There have been concerns that Africa has limitations in terms of infrastructure to participate in certain kinds of trials. This breaks that ice and gives opportunities for future studies. The research also has African population involved, which is important in reflecting the performance of any intervention in our population before being recommended for wider use” he says.
IRCE Executive Director, Prof. Alash’le Abimiku adds that “it is important for research and academic Institutions in Nigeria to support and encourage Nigerian researchers to collaborate with each other and participate in global multisite clinical trials such as the one described here. This study clearly demonstrates that Nigerian investigators can do excellent high quality research in their home country as long as they are supported with the right enabling environment. IHVN’s goal is to put an end to brain drain by providing high quality research infrastructure at IRCE where young Nigerian researchers can flourish, contributing to global scientific discoveries and knowledge. We are very proud of this important finding by Dr. Eriobu and colleagues.”
The research was funded by the US National Institutes of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health, and carried out by the International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) which has IHVN as a member. Head of the Clinical Hub for Interventional Research at the College of Health & Medicine of The Australian National University in Canberra, Prof. Mark Polizzotto, led the trial.
ITAC (INSIGHT 013) Study Group. Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial. Lancet. 2022 Jan 27:S0140-6736(22)00101-5. doi: 10.1016/S0140-6736(22)00101-5. Epub ahead of print. PMID: 35093205; PMCID: PMC8797010.
Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial – The Lancet