A group led by Takeda Pharmaceutical Co have completed test supplies of a blood plasma treatment for COVID-19, but pending regulator approval will likely prevent clinical trials from meeting a July start date.
The CoVIg-19 Plasma Alliance is ready to start shipping vials to study sites once the trial is approved by regulators in the United States, said Julie Kim, president of the plasma-derived therapies unit of Takeda.
The group had originally aimed to begin clinical trials in July. The National Institutes of Health in the U.S. is the trial sponsor, and is looking at study sites around the world, according to Kim, who also serves as co-leader of the alliance.
The alliance, which also includes Biotest AG, CSL Behring, and Octapharma Plasma, is working on a hyperimmune globulin therapy derived from convalescent plasma. It offers a standardized dose of antibodies and doesn't need to be limited to patients with matching blood types.
Clinical supplies of the treatment were produced at Takeda's facility in the U.S. state of Georgia and at CSL Behring's facility in Bern, Switzerland.
If the trials prove successful, the alliance expects to start submissions for regulatory authorization before the end of the year, Kim said.