CytoDyn Inc. (OTCMKTS: CYDY) has released preliminary results following the unblinding of data from the COVID-19 long-haulers clinical study.
CytoDyn reports the initial results of the leronlimab study in COVID-19 long-haulers.
The goal of this clinical trial was to establish if leronlimab, given as a weekly subcutaneous injection, was safe and effective in those who had prolonged COVID-19 symptoms. Change in daily COVID-19-related symptom severity score from baseline to Day 56 was the primary endpoint. The progression of COVID-19-related symptoms by Day 56 relative to baseline was a secondary endpoint. Throughout the 56-day evaluation period, patients self-reported their symptoms daily and had them recorded electronically.
The company’s COO and Clinical Development Head, Chris Recknor, said that the preliminary results showed that the leronlimab patient group improved more than the placebo group in 18 of the 24 COVID-19 symptoms. However, due to the small sample size of 56 patients, the study was not designed to show statistically significant differences. Still, clinically meaningful improvements in leronlimab over placebo were observed for several symptoms: runny/ stuffy nose, cough, shortness of breath, fast heartbeat, and chest tightness.
No safety issues were reported in the leronlimab study.
Sore throat, exertional malaise, nausea, anxiety, and vomiting were the only symptoms that did not change clinically. However, diarrhea was worse in patients who received leronlimab than in the placebo group. Biomarkers are being evaluated at multiple timepoints to help discover reasons for response and better understand leronlimab’s mechanism of action. There were no unfavorable safety signals in this trial, as there had been earlier ones with leronlimab. Recknor said that following the completion of the final analysis, they would meet with the FDA to discuss the next course of action.
CEO Nader Pourhassan said that before the commencement of the study, the FDA had informed the company that the long-haulers study was exploratory. Therefore a follow-up study will follow the following approval.
 Releases Promising Results of Leronlimab Study In COVID-19 Longhaulers){kind=link}