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First Patient Enrolled in NIH Phase 3 Trial to Evaluate Potential COVID-19 Hyperimmune Medicine

The Alliance’s anti-COVID-19 Hyperimmune Globulin (CoVIg-19) medicine is under evaluation as part of the trial and may become one of the earliest treatments for hospitalized individuals at risk for serious complications of COVID-19

The CoVIg-19 Plasma Alliance urges anyone who has recovered from COVID-19 to consider donating plasma. To learn more, please visit TheFightIsInUs.org. 

OSAKA, Japan and KING OF PRUSSIA, Pa., Oct. 8, 2020 /PRNewswire/ — The CoVIg-19 Plasma Alliance, an unprecedented collaboration of leading plasma companies supported by global organizations outside the plasma industry, today confirmed that patients are now being 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). 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.

The first patient has been enrolled in NIH Phase 3 trial to evaluate CovIg-19 Plasma Alliance’s potential COVID-19 hyperimmune medicine.
The first patient has been enrolled in NIH Phase 3 trial to evaluate CovIg-19 Plasma Alliance’s potential COVID-19 hyperimmune medicine.

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. 

“The rapid progress we’ve made since we initiated this program just a few months ago to reach this key milestone of enrolling patients in the trial is a powerful testament to the collaboration, determination and innovation taking place across the biomedical community as we work to fight the COVID-19 pandemic,” said Julie Kim, President of Plasma-Derived Therapies Business Unit, Takeda and co-leader of the CoVIg-19 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, which contains vital antibodies that have fought off the disease and could help others do the same.”

“When we created the CoVIg-19 Plasma Alliance in April, the goal was to partner to accelerate our timelines so that we could develop and deliver a reliable and sustainable treatment option for people suffering the impact of COVID-19 and to support countries around the world in their efforts to fight the current pandemic,” said Bill Mezzanotte, MD, MPH, Executive Vice President, Head of Research and Development and Chief Medical Officer, CSL Behring and co-leader of

NIH whistleblower quits, says administration ‘ignores scientific expertise’

Dr. Rick Bright says if we don’t figure out the coronavirus now we could have a challenging winter.

Dr. Rick Bright has officially quit his position at the National Institutes of Health.

Not only has the immunologist quit, he says it’s because the Trump administration didn’t listen to the scientific evidence available to stop the spread of the coronavirus, per The Guardian. He also says his plan to develop a testing infrastructure for the country was ignored.

Read More: Cynthia Bailey defends having 250 guests at wedding despite COVID-19

The doctor used to lead a team at the Biomedical Advanced Research and Development Authority, a department of the U.S. Health and Human Services. The agency, responsible for helping fight public health conditions such as bioterrorism attacks and pandemics, is currently working on a coronavirus vaccine.

Bright was transferred this spring and believes it’s retaliation for refusing to sign on to the decision to give New Yorkers hydroxychloroquine, the malaria drug Trump claimed as a COVID-19 remedy. He also claims senior NIH executives ignored his suggestion to provide healthcare workers with N95 respirator masks around the time the pandemic started.

Dr. Richard Bright, former director of the Biomedical Advanced Research and Development Authority, testifies during a House Energy and Commerce Subcommittee on Health hearing to discuss protecting scientific integrity in response to the coronavirus outbreak on Thursday, May 14, 2020. in Washington, DC. Warning that COVID-19 could make ‘2020 will be the darkest winter in modern history,’ Rick Bright, former director of the Biomedical Advanced Research and Development Authority has filed a federal whistleblower complaint alleging he was fired for opposing the use of a drug promoted by President Donald Trump as a potential coronavirus treatment. (Photo by Greg Nash-Pool/Getty Images)
Dr. Richard Bright, former director of the Biomedical Advanced Research and Development Authority, testifies during a House Energy and Commerce Subcommittee on Health hearing to discuss protecting scientific integrity in response to the coronavirus outbreak on Thursday, May 14, 2020. in Washington, DC. Warning that COVID-19 could make ‘2020 will be the darkest winter in modern history,’ Rick Bright, former director of the Biomedical Advanced Research and Development Authority has filed a federal whistleblower complaint alleging he was fired for opposing the use of a drug promoted by President Donald Trump as a potential coronavirus treatment. (Photo by Greg Nash-Pool/Getty Images)

He went public with the complaint he filed in May about his COVID-19 warnings being ignored.  

“I was pressured to let politics and cronyism drive decisions over the opinions of the best scientists we have in government,” Bright said on a call per CNN, after filing the complaint.

When he testified before Congress in May, Bright said the US could undergo the darkest winter of modern history if it did not formulate a strategy to combat the virus.

Read More: Cuomo orders lockdown for parts of NYC after COVID-19 uptick

Dr. Bright’s attorneys Debra Katz and Lisa Banks said in a statement, “Dr. Bright was forced to leave his position at NIH because he can no longer sit idly by and work for an administration that ignores scientific expertise, overrules public health guidance, and disrespects career scientists, resulting in the sickness and death of hundreds of thousands of Americans.”

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