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CytoDyn announced the Top-line results from its recently completed, randomized, double-blind, Phase 2 trial for COVID-19 patients with mild-to-moderate symptoms. CytoDyn will submit its Top-line Report for this trial to the U.S. Food and Drug Administration for review later this week. The Top-line Report revealed the following information: Clinical improvement assessed by change in total clinical symptom score: In patients with Total Clinical Symptom Score of greater than or equal to 4 at baseline: At Day 3, more subjects treated with leronlimab reported improvement in total clinical symptom score compared to the placebo group. The subgroup analysis indicates that among patients with more symptoms at baseline, those who received leronlimab had a greater treatment effect than patients who received the placebo. The National Early Warning Score is an objective scale developed by the Royal College of Physicians to identify patients at risk for rapid clinical deterioration requiring critical care intervention. NEWS2, is being used as an endpoint in several other COVID-19 clinical trials, including CytoDyn's severe-to-critical COVID-19 Phase 3 trial. It measures clinical parameters including respiratory rate, oxygen saturation, supplemental oxygen, temperature, systolic blood pressure, heart rate, and level of consciousness. In all treated patients, at the End of Treatment, patients in the leronlimab group were more than twice as likely to experience a beneficial improvement in scores compared to patients in the placebo group. Similar, statistically significant, results were observed at Day 3 and Day 14 in the analysis of per protocol population. The incidence, frequency, and severity of adverse events and serious adverse events were lower in the leronlimab group compared to the placebo group. Patients treated with placebo were more than twice as likely to experience SAEs or AEs compared to patients treated with leronlimab.