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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

Boston research team says it has enrolled a diverse group in Moderna’s coronavirus vaccine study

The hospital is among 90 sites testing to see whether the prospective vaccine made by Moderna is safe and protects people against the coronavirus. The Cambridge biotech’s vaccine is among 11 candidates worldwide that have entered late-stage clinical trials.

“We want our study and enrollment to be representative of the epidemic and the communities disproportionately impacted,” said Baden, who is also one of three leaders of the national study.

Since the study began in the first week of August, Brigham and Women’s has recruited “many hundreds” of participants, he said, adding that he was not free to say exactly how many. Recruitment is continuing and is likely to be completed in “weeks, if not sooner,” Baden said.

Half the participants enrolled nationwide will receive the vaccine candidate, and half will get a placebo, in two injections 28 days apart. Then researchers will watch to see if those who received the vaccine are less likely to get infected. The majority of the Boston participants have received both injections, Baden said.

Some 40 percent of the Boston enrollees are people with health conditions that put them at higher risk of severe infection, and more than 25 percent are elderly, Baden said.

Moderna, like all of the other vaccine makers, wants to make sure it gathers adequate information on the vaccine’s effectiveness among the people most affected by the epidemic, which has disproportionately struck people who are Black and Latino, as well as those with underlying conditions such as heart or lung disease.

Nationwide, the Moderna study has enrolled 28,000 of the 30,000 participants needed to evaluate the vaccine, and 33 percent identify as nonwhite, according to a statement from the company.

The company did not provide a breakdown of which groups are represented in the 33 percent, but Reuters reported earlier this week that 7 percent of enrollees are Black.

Black people comprise 12.3 percent of the nation’s population and 21.1 percent of those who died of COVID-19, according to a recent analysis by National Public Radio. Latino people account for 17.8 percent of the population and 21.1 percent of COVID-19 deaths, NPR found.

Moderna has urged the clinical sites “to further emphasize outreach to diverse populations, even if those efforts impact the speed of enrollment,” its statement said. A spokesperson said these efforts have led to “a modest delay in enrollment completion” but probably will not affect the timing of initial results.

Meanwhile, Moderna’s weekly enrollment data show improvements in recruiting diverse participants; among those who signed up during the week of Sept. 28, 49 percent were Hispanic or Latino people, and 26 percent were Black people.

At Brigham and Women’s, the study team has drawn upon long-established relationships in communities hardest-hit by COVID-19, said Dr. Paulette Chandler, who is leading community education and engagement for the vaccine trial.

“People trust us because they come to us for health care,” she said. The hospital also has a community advisory board established during its decades of work on HIV vaccines. “They served