FirstHealth of the Carolinas made history last week when Moore Regional Hospital was the first site to enroll a patient into a clinical trial using a combination treatment regimen for COVID-19 consisting of the antiviral remdesivir and a highly concentrated solution of antibodies that neutralize SARS-CoV-2, the virus that causes COVID-19.
Gretchen Arnoczy, M.D., FirstHealth infectious diseases physician, is principal investigator of the trial at FirstHealth.
The study is taking place in hospitalized adults with COVID-19 in the United States, Mexico and 16 other countries on five continents. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring and funding the Phase 3 trial, called Inpatient Treatment with Anti-Coronavirus Immunoglobulin, or ITAC.
The antibody solution being tested in the ITAC trial is anti-coronavirus hyperimmune intravenous immunoglobulin, or hIVIG. The antibodies in anti-coronavirus hIVIG come from the liquid portion of blood, or plasma, donated by healthy people who have recovered from COVID-19. These antibodies are highly purified and concentrated so that the anti-coronavirus hIVIG consistently contains several times more neutralizing antibodies than typically found in the plasma of people who have recovered from COVID-19.
“This is different from convalescent plasma in that the amount of antibodies is standardized, and the antibodies that are being infused are known to neutralize the virus,” said Dr. Arnoczy. “It is hoped that by giving people with COVID-19 these ‘ready-made’ antibodies at the onset of COVID-19 symptoms, before the body makes a protective immune response on its own, it could enhance the body’s natural antibody response to COVID-19 and patients can recover more quickly and reduce the risk of serious illness and death.”
Study participants will be assigned at random to receive infusions of either anti-coronavirus hIVIG and remdesivir or a placebo and remdesivir. Neither the participants nor the study team will know who is receiving which treatment regimen.
Remdesivir is an investigational broad-spectrum antiviral discovered and developed by Gilead Sciences, Inc. of Foster City, California.
FirstHealth has been using remdesivir to treat hospitalized COVID-19 patients since May. The hospital also continues to treat patients with convalescent plasma.
“We are extremely excited for this partnership with the National Institutes of Health to be a site for the ITAC trial,” said Dr. Arnoczy. “There is such an urgent need to find safe and effective treatments for COVID-19, and we feel privileged to participate in research activities that aim to bring treatments and solutions to this crisis.”
For more information about the ITAC trial, visit ClinicalTrials.gov, study identifier NCT04546581.