BOURBONNAIS – CSL Behring announced on October 8th the company has their first patients enrolled in Phase 3 COVID-19 trials.
CSL Behring’s anti-COVID-19 Hyperimmune Globulin (CoVIg-19) solution is a plasma taken from COVID-19 survivors who recovered that will aid in developing neutralizing antibodies in those participants in the study.
Up to 500 adult patients from 58 locations across the United States, Mexico, and sixteen other countries on five continents will participate in the trials. The study will determine the safety, tolerability and efficacy for patients. Those involved in the trial will receive remdesivir as well as standard care to evaluate the efficacy of the anti-COVID-19 Hyperimmune Globulin.
Trials would aid those at highest risk for serious complications as an early treatment through their anti-COVID-19 Hyperimmune Globulin (CoVIg-19) which is now under evaluation. Participants in the trial will receive a dose of the Hyperimmune immunoglobulin antibodies, or a saline solution (placebo).
Participants will only receive a single infusion.
“The rapid progress we’ve made since we initiated this program just a few months ago to reach this key milestone of enrolling patients in the trial is a powerful testament to the collaboration, determination and innovation taking place across the biomedical community as we work to fight the COVID-19 pandemic,” said Julie Kim, President of Plasma-Derived Therapies Business Unit, Takeda and co-leader of the CoVIg-19 Alliance. “This study will help us understand how CoVIg-19 could potentially become an important therapeutic option. To support our efforts, we encourage all those people who have recovered from COVID-19 to donate their plasma, which contains vital antibodies that have fought off the disease and could help others do the same.”
The Phase 3 clinical trials are sponsored by the University of Minnesota, National Institute of Allergy and Infections Diseases (NIAID) and the National Institutes of Health (NIH). If successful, the company’s drug will become one of the earliest treatment options for patients hospitalized for the novel coronavirus.
“When we created the CoVIg-19 Plasma Alliance in April, the goal was to partner to accelerate our timelines so that we could develop and deliver a reliable and sustainable treatment option for people suffering the impact of COVID-19 and to support countries around the world in their efforts to fight the current pandemic,” said Bill Mezzanotte, MD, MPH, Executive Vice President, Head of Research and Development and Chief Medical Officer, CSL Behring and co-leader of the CoVIg-19 Alliance. “Thanks to the unprecedented collaboration from the CoVIg-19 Plasma Alliance members, commitment from those who have recovered from the virus and generously chosen to donate their plasma, as well as the strong support from the NIH, we are hopeful that data from the clinical trial will be available before the end of the year. If the trial proves successful, this therapy could bring new hope to those suffering serious health consequences from COVID-19.”
The University of Missouri and FirstHealth Moore Regional Hospital in North Carolina have overseen recruiting efforts for the trials. Data will be made public by at the end of the trial, which is expected to be completed by July 2021.