Takeda's COVID-19 plasma treatment enters Phase 3 trial; first patients being treated

Takeda Pharmaceuticals entered the NIH Phase 3 Clinical Trial on October 8 to evaluate a potential anti-SARS-CoV-2 hyperimmune globulin (H-IG) that will be used to treat severe and high-risk individuals with COVID-19. Takeda’s CoVIg-19 plasma alliance therapy would urge the recovered COVID-19 patients to consider donating plasma in a collaboration of the global organizations and plasma industry. In a press release, the firm said that it enrolled in the ‘Inpatient Treatment with Anti-Coronavirus Immunoglobulin’ (ITAC) Phase 3 clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). 

According to Takeda, phase 3 trials are aimed at evaluating the safety, tolerability, and efficacy of the anti-coronavirus hyperimmune intravenous immunoglobulin (H-Ig). This treatment could be extremely effective for hospitalized adults at risk of the development of severe symptoms and serious health complications from the COVID-19. If the results of the trial turn out promising, Takeda-Alliance’s H-Ig will become one of the earliest treatment options to minimize the flaring virus symptoms in seriously ill COVID positive patients.

The placebo-controlled trial involves over 500 volunteers across the United States, in nearly 58 sites, Mexico, and 16 other countries built using NIH’s global INSIGHT Network. Patients who have reported severe symptoms and have been hospitalized for COVID-19 for 12 days with no organ dysfunctioning risks were enrolled. 

“Patients will receive remdesivir as the standard of care, allowing the safety and efficacy of H-Ig to be evaluated when given along with remdesivir treatment,” Takeda said in the release.

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The treatment will be administered under CSL Behring and Takeda, as an initiative of the CoVIg-19 Plasma Alliance. “This study will help us understand how CoVIg-19 could potentially become an important therapeutic option. To support our efforts, we encourage all those people who have recovered from COVID-19 to donate their plasma,” President of Plasma-Derived Therapies Business UnitTakeda and co-leader of the CoVIg-19 Alliance, Julie Kim said in the release.

'New hope' with this therapy

In the release, Kim said that the plasma of recovered patients contained the vital antibodies that combat the disease which makes it a reliable and sustainable treatment option against COVID-19. Executive Vice President, Head of Research and Development and Chief Medical Officer, CSL Behring and co-leader of the CoVIg-19 Alliance, Bill Mezzanotte said that the CoVIg-19 Plasma Alliance developed in April will minimize the impact of COVID-19 symptoms that make the patient’s suffering worse worldwide. The unprecedented collaboration, with support from the NIH, could bring new hope with this therapy to reduce the health consequences, he added. 

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