5 April 2021 - - A Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin clinical trial sponsored and funded by the US-based National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, did not meet its endpoints, The CoVIg-19 Plasma Alliance said.

No serious safety signals were raised in the trial.

The study aimed to determine whether an investigational anti-coronavirus hyperimmune intravenous immunoglobulin medicine (referred to by the Alliance as CoVIg-19) could reduce the risk of disease progression when added to standard of care treatment including remdesivir in hospitalized adult patients at risk for serious complications.

Analyses remain ongoing and NIAID and the INSIGHT Network intend to publish the full results of the trial soon.

Following the outcome of the ITAC trial, the CoVIg-19 Plasma Alliance's work now concludes.

The one-year collaboration involving organizations from across the world has strengthened relationships within and outside the industry, enabled a renewed perspective toward pragmatic regulation based on scientific evidence and need, and provided a well-defined, legally compliant framework for future collaborative opportunities to address urgent public health needs.

The Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin clinical trial is a global, multi-center, double-blind, placebo-controlled, randomized trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

It was designed to test the safety, tolerability and efficacy of a combination treatment regimen for coronavirus disease 2019 (COVID-19) consisting of the antiviral remdesivir along with an anti-coronavirus hyperimmune intravenous immunoglobulin, which contains a highly concentrated solution of antibodies that neutralize SARS-CoV-2.

The antibodies in the H-Ig come from the liquid portion of blood, or plasma, donated by healthy people who have recovered from COVID-19.

Through the NIAID-funded INSIGHT Network, the study team enrolled nearly 600 adult patients at 63 sites in the United States and 10 other countries on five continents.

Volunteers were eligible for the trial if they had been hospitalized for COVID-19 and had symptoms for 12 days or fewer without life-threatening organ dysfunction or end-organ failure.

Four companies provided investigational H-Ig materials for the trial, including CSL Behring and Takeda on behalf of the CoVIg-19 Plasma Alliance, as well as Emergent BioSolutions and Grifols. Further information about the ITAC trial is available at ClinicalTrials.gov under study identifier NCT04546581.

In an effort to help fight against the COVID-19 pandemic, the CoVIg-19 Plasma Alliance was formed in April 2020 to help develop a potential plasma-derived therapy for people at risk for serious complications from COVID-19.

The Alliance brought together world-leading plasma companies to work on the development of an investigational unbranded polyclonal anti-SARS-CoV-2 hyperimmune globulin medicine intended for the treatment of patients at risk for serious complications from COVID-19.

The hyperimmune globulin, known as CoVIg-19, is a high-quality pharmaceutical product that contains purified, consistent and concentrated levels of convalescent antibodies.

Co-founded by CSL Behring (OTC: CSLLY) and Takeda (OTC: TKPHF), the Alliance also included BioPharma Plasma, Biotest, GC Pharma, LFB, National Bioproducts Institute, Octapharma and Sanquin. The Bill and Melinda Gates Foundation provided advisory support.

Microsoft (NASDAQ: MSFT) provided technology including the Alliance website and the Plasma Bot for donor recruitment. Organizations including Pall and Uber Health also made in-kind contributions to the Alliance.

The Alliance is also part of "The Fight Is In Us" campaign, a coalition seeking to mobilize tens of thousands of people in the United States who have recovered from COVID-19 to donate their blood plasma.