Takeda-led COVID-19 plasma treatment enters clinical trial with first patient
TOKYO (Reuters) - Japan's Takeda Pharmaceutical Co announced on Friday that an alliance of drug manufacturers it leads has enrolled its first patient in a worldwide clinical trial of a blood plasma treatment for COVID-19 after months of delays in regulation.
The group's Phase 3 study, known as the CoVIg Plasma Alliance, aims to enroll 500 adult patients from the United States, Mexico and 16 other countries, according to a statement.
Patients will receive remeadivir from Gilead Science Inc. in addition to plasma treatment provided by CSL Behring, Takeda, and two other companies.
"We are confident that the clinical trial data will be available before the end of the year," said Bill Mezzanotte, CSL Behring's chief medical officer, in the press release.
The group set a goal of starting the clinical trial in July but was delayed pending regulatory approval. The National Institutes of Health in the US is the sponsor of the study.
The alliance, which also includes the German Biotest AG and Octapharma Plasma, is working on a hyperimmune globulin therapy obtained from blood plasma. It offers a standardized dose of antibodies and need not be limited to patients with matching blood types.
The World Health Organization has called for caution with plasma treatments for COVID-19, stating that their effects are "of poor quality" even if the US has given emergency approval for such therapies.
Testing and making the treatments are also prone to blood plasma shortages from people who have recovered from COVID-19. In its press release, the CoVIg Plasma Alliance asked these people to consider donating their plasma.
(Reporting by Rocky Swift; Editing by Kenneth Maxwell and Christopher Cushing)
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