Atrium Health Offers Three New Treatment Trials for COVID-19
Patients can enroll in first and only outpatient trials available in region
CHARLOTTE, N.C., Oct. 20, 2020 – Atrium Health has launched three new COVID-19 treatment clinical trials, which are the only outpatient treatment trials available in the region to address the COVID-19 virus. Currently there are no FDA-approved medicines specifically for the treatment of COVID-19.
All for outpatient use, the first trial is the Gilead Remdesivir Trial, the second is the Regeneron Trial and the third is the Regeneron Prophylaxis Trial. The objectives of the trials are to prevent hospitalization due to COVID-19 and to reduce development of symptomatic COVID-19 infection in adults over 18 years of age. The clinical trials are now open with Atrium Health looking to enroll at least 15 people per trial. Those participating in the trials will have provider visits that may be a combination of in-person and at-home visits.
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 to develop severe disease, such as diabetes, heart, lung, liver or kidney disease, are obese, or 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 for treatment and prevention of disease progression outside of the hospital until now. Learn more about the Remdisivir outpatient trial.
The Regeneron Outpatient Trial consists of one dose of monoclonal antibody against SARS-CoV2 spike protein and is aimed at preventing hospitalization or medical visits for COVID-19. Criteria for this study includes 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 from COVID-19. Learn more about the specific Regeneron trial.
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 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 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. Learn more about the specific Regeneron Prophylaxis trial.
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 COVIDstudy@atriumhealth.org, or emailing directly.
“We are working diligently to find therapies and treatments for those affected by the COVID-19 virus,” said Christopher Polk, MD, infectious disease physician at Atrium Health and principal investigator on the study. “Atrium Health is at the forefront of COVID-19 vaccine and treatment research and by investing in these trials, we are able to give hope to patients with this illness and find a variety of treatments that can help.”
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 to 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.
In addition, Atrium Health’s voluntary vaccine research registry allows people to learn more about vaccine research and development. People who take part in the registry may be invited to participate in COVID-19 vaccine trials in the future and will be provided with convenient access to trials should they be interested. For more information about Atrium Health’s COVID-19 research registry, call 833-451-1188, visit AtriumHealth.org/COVIDVACCINE or email STRIVEVaccineRegistry@atriumhealth.org