Preventive COVID-19 human super immunoglobulin (COVID-HIG) candidate products, upcoming clinical trials

Biopharmaceutical companies Emergent BioSolutions and Mount Sinai Health System today announced the launch of a clinical program to evaluate Emergent's COVID-19 human super immunoglobulin (COVID-HIG) candidates to support their use in protecting health care workers and military personnel who are most at high risk of exposure to SARS-CoV-2, the virus that causes COVID-19.
first study will assess the safety and pharmacodynamics of three dose levels administered in a single or repeated intravenous infusion in healthy adults.
second study will assess the safety, pharmacodynamics, and pharmacodynamics of COVID-HIG in asymptomatic or mild COVID-19 patients.
Laura Saward, Senior Vice President and Head of Therapeutics at Emergent BioSolutions, said, "Emergent is pleased to work with Mount Sinai, a leader in clinical research, to combat COVID-19 and to expand the clinical evaluation of COVID-HIG.
this innovative public-private partnership between government and healthcare providers has the potential to have a significant impact, benefiting our frontline healthcare workers."
, also known as polyclonal antibodies, is a concentrated antibody product derived from antibody-rich plasma in recovering patients.
in order to produce plasma-sourced products, plasma is collected from human supply pools and then manufactured or separated into specialized therapeutic products.
COVID-HIG is derived from plasma in patients with high levels of anti-SARS-CoV-2 antibodies.
note that COVID-HIG has not been approved by the U.S. Food and Drug Administration and has not yet determined its safety and effectiveness.
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