CytoDyn’s CRO in Brazil Met with ANVISA to Modify CD16 Trial for Critically Ill COVID-19 Patients to Expedite Interim Analysis After 51 Patients, Potentially in 1Q2022
By comparison, in the previous CD12 trial (a phase 3 trial for COVID-19 severe-to-critical ill patients) in the USA, patients received only two weekly doses of 700 mg of leronlimab via sub-cutaneous injections.
- By comparison, in the previous CD12 trial (a phase 3 trial for COVID-19 severe-to-critical ill patients) in the USA, patients received only two weekly doses of 700 mg of leronlimab via sub-cutaneous injections.
- The primary endpoint in this study was based on the valuable information we had generated from the past CD12 trial.
- The p-value for length of hospital stay for the critically ill patients who were on invasive mechanical ventilator or ECMO was 0.005.
- The primary endpoint of the CD16 trial in Brazil is Time to Recovery, which is similar to this endpoint.