CYDY - CytoDyn gets regulatory clearance for protocol change in COVID-19 trial

CytoDyn (CYDY) has announced that the FDA has accepted its amended protocol for adding an open-label extension to its Phase 3 trial (CD12) for Vyrologix™ (leronlimab-PRO 140) in severe-to-critically ill COVID-19.Last week, the company said it was on track to submit the amended protocol to the FDA on December 28, and upon regulatory clearance, each CD12 participating clinical trial site would have the option of enrolling additional qualified patients, with all patients receiving leronlimab.For physicians seeking access to leronlimab under an eIND for COVID-19 patients, the agency has issued specific guidance with the eIND first required to meet the inclusion/exclusion criteria of the CD12 study.Several patient subgroups will be excluded from eIND authorization: those with mild/moderate COVID-19, mechanically ventilated with PEEP <15 cmH20 with Pa02/FiO2 >150 mmHg, and on vasopressors >48 hours.Meanwhile, a research manuscript, the results of which were based on four critically ill COVID-19 patients treated with leronlimab under eIND, has also

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CytoDyn gets regulatory clearance for protocol change in COVID-19 trial