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Clinical trials could help in slowing the spread of the coronavirus

Near the beginning of April, the Food and Drug Administration granted a fast-track designation to CytoDyn Inc. to investigate whether a medication called leronlimab could be used to treat the coronavirus. Previously, leronlimab has been used in combination with medications to treat HIV and metastatic triple negative breast cancer.

Normally, it takes a research site months to get a clinical trial up and running. Given the urgency of the situation we’re currently facing, our team was able to activate the trial in only four days. As of early April, we were the second site in the country to initiate the trial and the only participating health system in the southeastern United States. 

We were able to respond so quickly because Novant Health has a dedicated clinical research team that works very closely with our providers. Together, we continuously evaluate trial opportunities for our patients and communities. Under normal circumstances, our team is focused on activating trials in oncology, heart and vascular, neurosciences, orthopedics, pediatrics and other areas.  The pandemic drove us to immediately pivot our resources to support COVID-19 trial activation.   

The study is double-blind, which means neither our team nor our patients will know if patients are receiving the standard level of care provided by their care team, or the standard level of care plus the investigational agent, leronlimab. In either case, patients will remain in the study for six weeks and will be followed closely by our clinical and research teams, as well as the trial sponsor, CytoDyn. 

Please continue to check this page for updates and adhere to state and federal guidelines. While clinical trials are an important step in combating the spread of the coronavirus, social distancing and preventive measures such as handwashing are still vitally important.