Moore Regional Hospital of FirstHealth First to Enroll Patient in Global ITAC COVID-19 Clinical Trial

Moore Regional Hospital of FirstHealth First to Enroll Patient in Global ITAC COVID-19 Clinical Trial

Moore Regional Hospital, part of Carolinas’ health system FirstHealth, was the first trial site organization to enroll a patient in a clinical trial involving a regimen for COVID-19 including remdesivir and antibodies designed to neutralize COVID-19. Led by Principal Investigator Gretchen Arnoczy, MD, an infectious disease physician with FirstHealth, the accomplishment is monumental given the scope of this National Institute of Allergy and Infectious Diseases (NIAID) sponsored global multicenter clinical trial called Inpatient Treatment with Anti-Coronavirus Immunoglobulin or ITAC.

The Study

Sponsored by the University of Minnesota in collaboration with NIAID, NIH and the International Network for Strategic Initiatives in Global HIV Trials, this study’s protocol serves as a platform for investigating treatments for adult patients hospitalized for medical management of COVID-19 without related serious end-organ failure. Trials involve sites worldwide strategically selected to expedite enrollment.

In the study, the principal investigators will compare hyperimmune intravenous immunoglobulin (hiVIG) with matched placebo, when added to standard of care (SOC), for preventing further disease progression and mortality related to COVID-19. Standard of care will include remdesivir unless it is contraindicated for an individual patient.

The Regimen

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.

Significant Milestone

Moore Regional Hospital is to be commended to be the first site to enroll a patient in this large Phase 3 study involving 500 patients.

Investigator Point of View

Dr. Gretchen Arnoczy reports, “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.” The principal investigator continued, “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 health.”

About Moore Regional Hospital

Part of FirstHealth of the Carolinas, this 402-bed acute care, not-for-profit hospital services as a referral center for a 15-county region in the Carolinas. Located in Pinehurst, NC, it is the flagship hospital for FirstHealth of the Carolinas, the region’s first comprehensive health care network.

Lead Research/Investigator

Gretchen Arnoczy, MD