Plasma-Based COVID-19 Treatment Alliance Ends its Project as Trial Fails to Meet Endpoints

April 7, 2021
Pharmaceutical Technology Editors

A Phase III clinical trial of anti-coronavirus immunoglobulin did not meet its endpoints, concluding the year-long CoVIg-19 Plasma Alliance, Takeda and CSL Behring announced.

Takeda and CSL Behring, co-founders of the CoVIg-19 Plasma Alliance, announced on April 2, 2021 that a Phase III inpatient treatment with anti-coronavirus immunoglobulin clinical trial did not meet its endpoints. The year-long collaboration of the companies in the Alliance has ended with the end of the clinical trial, but it provides a framework for future collaboration, the companies said in the press release.

According to a Takeda press release, the trial, which was sponsored and funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, intended to determine whether CoVIg-19, an investigational anti-coronavirus hyperimmune intravenous immunoglobulin medicine, could lessen the risk of disease progression when added to standard care treatment including remdesivir in hospitalized adult patients at risk for serious complications.

“While the results of this particular clinical trial are disappointing, we are proud that as an industry we proactively and collaboratively pursued this work, and that the program may contribute to a growing understanding of this challenging virus and strategies for patient care,” said Bill Mezzanotte, MD, executive vice-president, head of Research and Development and chief medical officer, CSL Behring, and co-leader of the CoVIg-19 Alliance, in the press release. “Since we embarked on this development program, and throughout the pandemic, we have learned much from our scientific research. Importantly, we learned that as an industry we have the fortitude and capability to quickly work together for the greater good of human health.”

“We are especially proud that we pooled resources, brought our plasma expertise and infrastructure together at our own cost to benefit public health and added to our understanding of a complex field. We are extremely thankful to all those who collaborated day and night for one year in testing circumstances to develop and manufacture a potential solution for COVID-19, including those organizations from outside the industry who chose to support us,” added Julie Kim, president of Plasma-Derived Therapies Business Unit, Takeda and co-leader of the CoVIg-19 Alliance, in the press release. “We express our sincere gratitude to the COVID-19 survivors who generously donated their plasma to make our work possible, the patients who graciously participated in the trial, and to the regulatory and government agencies for their partnership and flexibility to support our efforts."

Source: Takeda