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August 26, 2021

NIH-funded Phase III trial to study Emergent’s COVID-HIG in outpatients

Set to enrol 800 subjects, the trial will analyse the safety and efficacy of hyperimmune globulin products versus placebo.

A Phase III clinical trial, INSIGHT-012, has launched to assess hyperimmune globulin products, including Emergent BioSolutions’s COVID-19 Human Immune Globulin (COVID-HIG), to potentially treat adult patients at risk of disease progression.

COVID-HIG is a plasma-derived therapy intended for outpatients who are at increased risk of developing severe disease, including people aged 55 years and above and immunocompromised patients aged 18 years and above.

Also called OTAC, INSIGHT-012 is a randomised controlled trial funded by the National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID).

It will test the safety and efficacy of hyperimmune globulin products obtained from plasma of Covid-19 patients who have recovered and developed neutralising antibodies to the SARS-CoV-2 virus.

A total of nearly 800 participants will be enrolled at sites in the US and other countries globally.

Subjects across all trial arms will be given infusions of placebo or one of two hyperimmune globulin products, including Emergent’s COVID-HIG, plus standard of care.

The aim is to determine if anti-SARS-CoV-2 hyperimmune globulin administered at the onset of symptoms can offer a fast increase in the natural, and probably delayed, antibody response to the virus.

This mechanism is expected to mitigate the risk of more serious disease and death.

Emergent BioSolutions senior vice-president and therapeutics business unit head Dr Laura Saward said: “Treatment with COVID-HIG earlier in the Covid-19 disease course offers a window of intervention when viral replication is extensive but natural antibody response hasn’t been generated yet.

“This earlier intervention has the potential to improve patient outcomes and keep people out of the hospital.”

Being a polyclonal product containing a variety of antibodies, COVID-HIG could offer other benefits against SARS-CoV-2 variants of concern as shown by in vitro testing, Saward added.

In October 2020, Emergent announced the start of another NIAID-funded Phase III trial, INSIGHT-013, to analyse COVID-HIG to potentially treat hospitalised patients with Covid-19.

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