Novant Health to begin COVID-19 clinical trials with CytoDyn’s Leronlimab

Published 7:23 pm Friday, May 8, 2020

SALISBURY — Novant Health says it will be the first in the Southeast to initiate a phase two clinical trial for COVID-19 patients with mild-to-moderate illness.

It is the second clinical trial site in the nation, according to a statement.

The clinical trial is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of leronlimab in patients with mild to moderate COVID-19 illness.

CytoDyn, a Washington-based biotechnology company, has already been cleared by the Food and Drug Administration to administer leronlimab to 54 severely and critically ill COVID-19 patients. It is used to treat HIV and some breast cancers.

Patients enrolled in this trial are expected to be administered leronlimab for two weeks with the primary endpoint being the mortality rate at 28 days and a secondary endpoint of mortality rate at 14 days. CytoDyn will perform an interim analysis of the data from 50 patients.

“We’re grateful for our partnership with CytoDyn and the opportunity to bring cutting edge, innovative and investigative treatments to our community,” said Dr. Eric Eskioglu, executive vice president and chief medical officer for Novant Health.

Eskioglu said since initiating the leronlimab mild/moderate last month, Novant Health has screened nearly 400 patients for eligibility.  A number of these patients have been enrolled and treated on the mild/moderate clinical trial.

“Expanding treatment options for our more critically ill patients is a vital step in our fight against COVID-19. We are encouraged by early reports of efficacy of leronlimab from critically ill patients treated under an Emergency Use IND (Investigational New Drug) and we are eagerly awaiting the full results of both blinded studies for leronlimab in the near future from CytoDyn,” Eskioglu said.