CytoDyn files protocol with FDA for Phase 2 leronlimab trial in 'long-hauler' coronavirus patients

CytoDyn Inc (OTCQB:CYDY) announced Tuesday it filed a protocol with the US Food and Drug Administration (FDA) to conduct a Phase 2 clinical trial for leronlimab as a treatment for COVID-19 patients suffering from long-hauler symptoms. The plan is to enroll 102 patients at as many as 10 sites. The study will have an interim analysis after half of the patients are enrolled, and CytoDyn will be able to report the results. Published studies and surveys conducted by patient groups indicate 50% to 80% of patients continue to have troublesome symptoms three months after the onset of COVID-19 — even after tests no longer detect the virus in their body.  READ: CytoDyn gets $25M in convertible debt deal to fund license applications, coronavirus trials for leronlimab According to the Journal of the American Medical Association, researchers estimate about 10% of COVID-19 patients become long-haulers. Common symptoms include coughing, chronic fatigue, body aches, joint pain, heart issues, shortness of breath, loss of taste and smell, difficulty sleeping, headaches and brain fog.  For some people, the company said, the lingering symptoms are nothing like the original symptoms when they were first infected with COVID-19.  CytoDyn’s protocol for its Phase 2 COVID-19 long-haulers trial is titled, ”A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Leronlimab in Patients Experiencing Prolonged Coronavirus Disease 2019 (COVID-19) Symptoms [Long-Haulers].”  “We are very pleased to be able to finalize this protocol and submit today,” CEO Nader Pourhassan said in a statement. “If successful, this Phase 2 trial could potentially allow leronlimab to be the first treatment for patients experiencing these debilitating symptoms and perhaps their only hope for full recovery. We have become very knowledgeable of leronlimab’s potential for COVID-19 patients due to our completed Phase 2 trial for mild-to-moderate symptoms, for which a complete report has been submitted to a very reputable journal for publication.” Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com Follow him on Twitter @andrew_kessel