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February 5, 2021

NIH’s hIVIG trial in hospitalised Covid-19 patients close to meeting recruitment target; outpatient study planned for next few months, sources say

The National Institutes of Health’s (NIH’s) Phase III Covid-19 trial testing hyperimmune intravenous immunoglobulin (hIVIG) will close its 500-patient accrual next week, said a source familiar with the study

By Manasi Vaidya

The National Institutes of Health’s (NIH’s) Phase III Covid-19 trial testing hyperimmune intravenous immunoglobulin (hIVIG) will close its 500-patient accrual next week, said a source familiar with the study. In addition, a separate Phase III studying hIVIG in the outpatient setting is expected to start in the next few months, the source noted.

While the trial registry page for the ongoing Phase III ITAC notes trial completion in July, a trial investigator said results should be available soon, likely in 1Q. ITAC has a data and safety monitoring board (DSMB), and there have been no unexpected safety signals thus far, added the source.

For the Phase III Inpatient Treatment With Anti-Coronavirus Immunoglobulin (ITAC) study, hIVIG is provided by Takeda Pharmaceuticals, Emergent BioSolutions, Grifols and CSL Behring, as per an 8 October Emergent press release. For the outpatient study, this news service reported in October 2020 that Emergent was planning with the NIH to initiate such a trial in early, nonhospitalised patients. Apart from Emergent, Grifols will also supply hIVIG for the trial, said the source.

While protocols for the outpatient study are not yet finalised, it will likely be a larger trial than ITAC, with a little more than 1,000 patients, said the source. The goal is to focus on Covid-19 patients who are early in their infection, with symptoms for a certain number of days, the source noted. The trial will likely involve a follow-up of over 90 days, said the source, adding the protocol should be finalised in the next month.

Even though this study was supposed to begin sooner, the decision was made to first observe efficacy signals from ITAC, where results would be achieved faster, said the source. ITAC’s primary endpoint is an ordinal scale involving parameters ranging from death to limiting symptoms due to Covid-19 at day 7. Secondary objectives including mortality will be recorded over a 28-day time period.

hIVIG carries the potential to improve upon convalescent plasma, since it is a standardised high titer polyclonal antibody product, this news service reported 27 October. The hIVIG approach’s polyclonal nature is also an advantage compared to monoclonal antibodies, but it is complicated to manufacture and scale-up, noted the investigator.

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ITAC and the upcoming outpatient study are funded by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and run by the INSIGHT network, which is funded by the NIAID to run HIV treatment trials.

The NIH did not respond to a request for comment before press time.

Manasi Vaidya is a Senior Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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