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Novant Health launches clinical trial on coronavirus patients
First hospital in Southeast to participate
Published Wednesday, April 8, 2020 10:13 am
by Ashley Mahoney | The Charlotte Post

Novant Health is the first hospital company in the Southeast to initiate a Phase 2 clinical trial for COVID-19 patients.

CytoDyn, a late-stage biotechnology company, is partnering with Novant for trials with mild- to moderate symptoms. CytoDyn is the developer of leronlimab, a CCR5 antagonist, or chemokine receptor, with potential for treatment of COVID-19. Novant is the second hospital company in the nation to participate in the trials.

The trial’s second phase is designed to test the safety and efficiency of leronlimab in patients with mild-to-moderate documented cases of COVID-19. It is a randomized, double blind, placebo-controlled study that calls for 75 patients at a maximum of 10 centers across the country. Establishing a clinical trial typically takes at least three months, but it took four days at Novant Health. Participants are anticipated to have a six-week treatment window.

“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, Novant’s vice president of research and innovation. “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.”

CytoDyn received a fast track designation from the Food and Drug Administration for leronlimab, first in combination with antiretroviral therapy for HIV-infected patients, then for metastatic triple-negative breast cancer. FDA cleared the way for commencement of the Phase 2 COVID-19 trial on March 31.

A handful of patients with severe cases of COVID-19 received leronlimab in New York under an emergency investigational new drug application from the FDA.

“Based upon the results we have seen with several New York patients, we are hopeful that leronlimab can provide a benefit to patients throughout the country,” CytoDyn President and CEO Nader Pourhassan said in a statement.







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