Atrium Health Helps Pave Path Toward Clinical Research as a Care Option Targeting COVID-19 with Three New Clinical Trials Offering Outpatient Hope

Atrium Health Helps Pave Path Toward Clinical Research as a Care Option Targeting COVID-19 with Three New Clinical Trials Offering Outpatient Hope

Atrium Health, formerly the Carolinas HealthCare System, has been active on multiple fronts battling COVID-19. The nonprofit network of over 40 hospitals and over 900 care locations in North Carolina, South Carolina, and Georgia have also emerged as a leading player in the Southeast—if not nationwide—in the nascent but critically important clinical research as a care option movement. Research emerged as a critical care option to COVID-19, given there is now only one formally U.S. FDA approved product targeting COVID-19 (remdesivir) for hospitalized patients, and two others accepted (including dexamethasone) for more severe cases involving hospitalized patients who require breathing support as well as convalescent plasma via emergency use authorization. Much research deals with hospitalized patients, but the vast majority of COVID-19 patients are outpatient situations. Hence, Atrium Health launched three outpatient-focused clinical trials that happen to be the only such trials in the entire region. They include 1) Gilead Remdesivir for outpatient use, 2) Regeneron Trial, and 3) Regeneron Prophylaxis Trial. Atrium Heath seeks to demonstrate via these trials that these therapies can prevent hospitalization due to COVID-19, while in parallel reducing the development of symptomatic COVID-19 infection in adults over 18 years of age. Atrium Health now seeks at least 15 people per trial.

The Clinical Trials

The Gilead PINETREE Remdesivir Outpatient Trial evaluates the effectiveness of Remdesivir in adults diagnosed with COVID-19, with the goal to prevent hospitalization due to COVID-19. Those who have tested positive for COVID-19 in the last 96 hours and have a risk factor in developing severe diseases, such as diabetes, heart, lung, liver, or kidney disease, are obese, have active cancer, or are immunocompromised are able to enroll. To participate in the trials, the treatment will need to be started no later than seven days after developing COVID-19 symptoms. Remdesivir has been released by the FDA for emergency use in hospitalized patients with COVID-19 but has not been available to treat and prevent disease progression outside of the hospital until now. Follow the link.

The Regeneron Outpatient Trial consists of one dose of monoclonal antibody against the SARS-CoV2 spike protein and aims to prevent hospitalization or medical visits for COVID-19. Criteria for this study include those who have tested positive for COVID-19 in the last 72 hours. To participate in the trials, the treatment will need to be started no later than seven days after developing symptoms for COVID-19. 

The Regeneron Prophylaxis Outpatient Trial is aimed at those who have had a household contact who tested positive for COVID-19 in the last 72 hours and aims to reduce the development of symptomatic COVID-19 infection. Criteria also includes not residing in a nursing home and not being pregnant or breastfeeding. The study will entail one dose of monoclonal antibody against the SARS-CoV2 spike protein. To participate in the trials, the treatment will need to be started no later than three days after the household contact has tested positive for COVID-19. 

As a nationally recognized leader in shaping health outcomes through innovative research, education, and compassionate patient care at hundreds of care locations throughout the Carolinas and Georgia, Atrium Health is bringing the most advanced therapies to patients and anticipates the treatment trials will guide physicians closer towards identifying additional safe and effective treatments. To date, Atrium Health has conducted eight clinical trials to fight the COVID-19 pandemic and will open a ninth trial in the coming months for inpatient studies.

Atrium Health Voluntary COVID-19 Vaccine Registry

Atrium Health has developed a voluntary vaccine research registry allowing people to learn more about vaccine research and development. This is, of course, important given the COVID-19 pandemic. Atrium Health shares more information via the link.

About Atrium Health

Serving patients and the community in the southeast U.S., including North Carolina, South Carolina, and Georgia, this dynamic healthcare organization now known as Atrium Health, a network of hospitals and associated centers and clinics, has been in operation since 1940 when they opened Charlotte Memorial Hospital. They have grown to over 40 hospitals and 900 care locations and now represent not only one of the nation’s largest healthcare organizations, but also the largest primary care network in the region, connecting patients with on-demand care as well as world-class specialists.

Atrium Health recently announced a $3.4 billion investment into Wake Forest Baptist Health and its communities.

On Oct. 10, TrialSite reported that Atrium Health would take in Wake Forest Baptist Health to form a single enterprise called Atrium Health. Both health systems, renowned for their clinical expertise and in combination with the school of medicine, offer a transformative situation for education, patient-centered research, and innovation, defining the next generation of clinical excellence.

Lead Research/Investigator

Christopher Polk, M.D., infectious disease physician

Call to Action: If interested and fit the enrollment criteria, potential patients can learn more information about Atrium Health’s COVID-19 treatment trials by calling 704-667-5316, asking their provider or nurse with Atrium Health’s COVID-19 Virtual Hospital to email [email protected], or email directly. For more information about Atrium Health’s COVID-19 research registry, call 833-451-1188 or email [email protected]