News
First patient enrolled in NIH phase III trial to evaluate potential COVID-19 hyperimmune medicine. Takeda + CSL Behring
The CoVIg-19 Plasma Alliance, an unprecedented collaboration of leading plasma companies supported by global organizations outside the plasma industry, confirmed that patients are now being enrolled in the Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) Phase III clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The trial will evaluate the safety, tolerability and efficacy of an investigational anti-coronavirus hyperimmune intravenous immunoglobulin (H-Ig) medicine for treating hospitalized adults at risk for serious complications of COVID-19 disease. If successful, the Alliance’s H-Ig may become one of the earliest treatment options for hospitalized COVID-19 patients.
This global multi-center, double-blind, placebo-controlled, randomized trial will enroll 500 adult patients at up to 58 sites in the United States, Mexico and 16 other countries on five continents (utilizing the NIH’s global INSIGHT Network), who have been hospitalized for COVID-19 and have had symptoms for 12 days or fewer without life-threatening organ dysfunction or end-organ failure. Patients will receive remdesivir as standard of care, allowing the safety and efficacy of H-Ig to be evaluated when given along with remdesivir treatment. The investigational H-Ig materials for the trial will be provided by CSL Behring and Takeda on behalf of the CoVIg-19 Plasma Alliance, as well as by two other companies.
In an effort to help fight against the COVID-19 pandemic, the Alliance was created in April 2020 to help develop a potential plasma-derived therapy for people at risk for serious complications from COVID-19. The CoVIg-19 Plasma Alliance brings together world-leading plasma companies to work on the development of an investigational unbranded polyclonal anti-SARS-CoV-2 hyperimmune globulin medicine with the potential to treat patients who are at risk for serious complications from COVID-19.
The hyperimmune globulin is a high quality pharmaceutical product that contains purified, consistent, and concentrated levels of convalescent antibodies. The “I” and “g” in CoVIg-19 stand for immune globulin, which the CoVIg-19 Plasma Alliance will use to concentrate the antibodies into a potential medicine. The Alliance, formed by CSL Behring and Takeda, also includes the leading-edge expertise of founding members Biotest, BPL, LFB, and Octapharma, along with additional industry members ADMA Biologics, BioPharma Plasma, GC Pharma, Liminal BioSciences, National Bioproducts Institute and Sanquin. The Bill & Melinda Gates Foundation is providing advisory support. Microsoft is providing technology including the Alliance website and the Plasma Bot for donor recruitment. Organizations including Pall and Uber Health are also making contributions to the CoVIg-19 Plasma Alliance. Experts from the Alliance are collaborating across key aspects such as plasma collection, clinical trial development, and product manufacturing.
The study could be completed by the end of this year or in early 2021.
Condition: Coronavirus/COVID-19 Infection
Type: drug