US-based Emergent BioSolutions has announced the start of the Phase III INSIGHT-013 trial to analyse its plasma-derived therapy, COVID-19 Human Immune Globulin (COVID-HIG), to potentially treat hospitalised patients with Covid-19.
INSIGHT-013, also known as Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC), is funded by the National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID).
The trial will test the safety, tolerability and efficacy of hyperimmune intravenous immunoglobulin products obtained from plasma of Covid-19-recovered individuals who developed neutralising antibodies to SARS-CoV-2, the virus that causes the disease.
In the randomised, controlled trial, patients will receive infusions of a placebo or one of four hyperimmune globulin products, including Emergent’s COVID-HIG, with remdesivir as a background therapy in all arms.
The study plans to enrol around 500 patients across the US and other global sites.
Apart from COVID-HIG, the Phase III trial will assess hyperimmune globulin products by Takeda Pharmaceuticals, Grifols and CSL Behring.
During the ITAC study, investigators will evaluate whether administrating hyperimmune globulin at the onset of symptoms could enhance the natural and possibly delayed antibody response against SARS-CoV-2, in turn mitigating the risk of severe illness and death.
The major objective of the trial is to assess the health status of participants treated with HIG in combination with remdesivir compared to those on placebo plus remdesivir.
Developed by Gilead Sciences, remdesivir is a broad-spectrum antiviral in its investigational stage.
Emergent BioSolutions senior vice-president and therapeutics business unit head Dr Laura Saward said: “Emergent is proud to continue our partnership with NIAID/NIH and the Biomedical Advanced Research and Development Authority (BARDA) to advance potential therapeutic solutions for Covid-19 in hospitalised patients.
“We are drawing from decades of experience developing treatments on our well-established hyperimmune platform to address this serious public health threat.”
Emergent’s COVID-HIG is being developed with a $14.5m funding from BARDA. In August this year, the US Food and Drug Administration (FDA) cleared the investigational new drug (IND) application of COVID-HIG.
With funding from the US Department of Defense, COVID-HIG will also be assessed for its potential as a post-exposure prophylaxis (PEP) therapeutic in people at high risk of exposure to SARS-CoV-2.