TOKYO (Reuters) – Takeda Pharmaceutical Co of Japan said Friday that an alliance of drug brands he administers had enrolled his first patient in a global clinical trial of a blood plasma remedy for COVID-19 after months of regulatory delays.
The group’s Phase 3 trial, known as the CoVIg Plasma Alliance, aims to recruit 500 adult patients from the United States, Mexico and 16 countries, according to a statement.
Patients will be treated with Remdesivir for plasma treatment from Gilead Science Inc. , which will be through CSL Behring, Takeda and two other companies.
“We hope that knowledge of the clinical trial will be available before the end of the year,” said Bill Mezzanotte, CSL Behring’s leading medical officer, in the statement.
The organization aimed to begin the clinical trial in July, but was delayed pending regulatory approval. The U. S. National Institutes of Health sponsor the trial.
The alliance, which also includes German corporations Biotest AG and Octapharma Plasma, is running in a treatment with hyperimmunoglobulins derived from blood plasma, which gives a standardized dose of antibodies and does not want to be limited to patients whose blood equipment corresponds.
The World Health Organization has called for caution on plasma remedies for COVID-19, saying that evidence of their effectiveness is of “low quality,” even though the United States has issued emergency authorization for such therapies.
Testing and the production of remedies are also vulnerable to shortages of blood plasma in others who have recovered from COVID-19. In its publication, CoVIg Plasma Alliance suggested that those other people donate their plasma.
(Reporting through Rocky Swift; Editing through Kenneth Maxwell and Christopher Cushing)