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The CoVIg-19 Plasma Alliance today announced that the National Institute of Allergy and Infectious Diseases (NIAID) sponsored and funded National Institute of Allergy and Infectious Diseases (NIAID) Phase 3 clinical trial with Anti-Coronavirus Immunoglobulin (ITAC) Institutes of Health (NIH), has not reached its limits. No serious safety signal was raised during the test.
The study aimed to determine whether an investigational anti-coronavirus drug intravenous hyperimmunoglobulin (H-Ig) (referred to by the Alliance as CoVIg-19) could reduce the risk of disease progression when added to treatment. standard of care including remdesivir in adult hospitalized patients at risk of serious complications. Analyzes are still ongoing and NIAID and the INSIGHT network intend to publish the full trial results soon.
While the results of this particular clinical trial are disappointing, we are proud that as an industry we have continued this work in a proactive and collaborative manner and that the program can contribute to a growing understanding of this challenging virus and strategies. patient care. Since we embarked on this development program and throughout the pandemic, we have learned a lot from our scientific research. Above all, we have learned that as an industry we have the courage and the ability to work together quickly for the greater good of human health.
Bill Mezzanotte, MD, MPH, Executive Vice President, Head of Research and Development and Medical Director, CSL Behring and Co-Leader of the CoVIg-19 Alliance
We are especially proud to have pooled our resources, contributed our plasma expertise and infrastructure at our own expense for the benefit of public health, and added to our understanding of a complex field. We are extremely grateful to everyone who collaborated day and night for a year under test conditions to develop and manufacture a potential solution for COVID-19, including organizations outside of the industry who have chosen to support us. We express our sincere gratitude to the COVID-19 survivors who generously donated their plasma to make our work possible, to the patients who graciously participated in the trial, and to the regulatory and government agencies for their partnership and flexibility to support our efforts.
Julie Kim, President of the Plasma-Derived Therapies Business Unit, Takeda and co-leader of the CoVIg-19 Alliance
Following the results of the ITAC trial, the work of the Plasma CoVIg-19 Alliance is now ending. The one-year collaboration involving organizations around the world strengthened relationships inside and outside the industry, enabled a renewed perspective towards pragmatic regulation based on evidence and scientific needs, and provided a well-defined and legally compliant framework for future opportunities for collaboration with urgent public health needs.
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