CHARLOTTE, N.C. — CytoDyn has announced that Novant Health will be second clinical trial site to initiate its Phase 2 trial for coronavirus patients. Novant is the first site in the southeastern United States.
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Novant Health described the clinical trial as a “randomized, double blind, placebo-controlled study." It will be used to evaluate the safety and efficiency of leronlimab in those with mild to moderate symptoms.
The trial calls for 75 patients in up to 10 centers around the United States.
Several patients with COVID-19 in New York were able to get Leronlimab because of an emergency investigational new drug granted by the FDA.
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The FDA cleared it for a Phase 2 trial for COVID-19 patients with mild to moderate symptoms on March 31. Officials said patients who enter the clinical trial have a treatment window of six weeks.
Officials said it typically takes a research site anywhere from three to six months to get a clinical trial running.
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At Novant Health, they were able to get the clinical trial running in four days.
“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,” Mark King, vice president of research & innovation at Novant Health said. “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.”