Novant Health to begin COVID-19 clinical trials

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(COVID-19) positive blood sample in front of a computer screen displaying the flag of United States on April 06, 2020 in Izmir, Turkey. Mehmet Emin Menguarslan / Anadolu Agency (Getty)

CHARLOTTE, N.C. — CytoDyn Inc. announced Wednesday that Novant Health is the first site in the southeastern United States to initiate its Phase 2 clinical trial for COVID-19 patients with mild-to-moderate symptoms.

Novant Health is the second clinical trial site in the nation.

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 and 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.

For COVID-19: 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.

Background context: it typically takes a research site anywhere from 3 to 6 months to get a clinical trial up and running. In approximately four 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.”

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