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Novant will host clinical trial of COVID-19 drug called Leronlimab

April 8. Novant Health is the first health system in the southeastern United States to initiate a Phase 2 clinical trial for CytoDyn Inc.’s COVID-19 drug known as Leronlimab. The Phase 2 clinical trial is a randomized, double blind, placebo-controlled study to evaluate the safety and efficacy of Leronlimab in patients with mild to moderate documented COVID-19 illness.

The trial calls for 75 planned patients in up to 10 centers in the United States.

The FDA has granted a “Fast Track” designation to CytoDyn for two potential indications of Leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.

Leronlimab has been administered to a handful of severely ill patients with COVID-19 at a leading medical center in New York under an emergency IND recently granted by the FDA. On March 31, the FDA provided clearance for initiation of a Phase 2 trial to treat COVID-19 patients with mild to moderate symptoms. Patients enrolled in the Phase 2 clinical trial are expected to have a treatment window of approximately 6 weeks.

It typically takes a research site anywhere from 3 to 6 months to get a clinical trial up and running. In approximately 4 days, this clinical trial was able to open at Novant Health.

“Our research team’s partnership with CytoDyn has enabled us to enroll Novant Health patients in this trial just four days after our organizations first made contact,” said Mark King, vice president, research & innovation, Novant Health. “I am grateful for the opportunity to work alongside CytoDyn’s team of professionals, who share our commitment to swiftly finding the treatment our patients and communities need.”