RE:RE:RE:RE:RE:RE:Algernon Announces Enrollment of First Patient in 2b/3 HumanUnicorn9000 wrote: The trial will begin as a Phase 2b study of an aggregate of 150 patients. With positive preliminary data, the clinical trial will move directly into a Phase 3 trial. The data will determine the number of expected patients needed to reach statistical significance in the Phase 3 trial.
Patients will be randomized in a one-to-one manner and will either be treated using an existing standard of care, or standard of care plus Ifenprodil 60 mg (taken as one 20 mg tablet three-times daily) for one arm or standard of care plus Ifenprodil 120 mg (taken as two 20 mg tablets three-times daily) for two weeks.
Over the testing period, doctors will observe whether there is an improvement in a number of secondary endpoints, including mortality, blood oxygen levels, time spent in intensive care and time to mechanical ventilation.
Trial Start Date
Enrollment of the 1st patient for the Phase 2b/3 study is expected before the end of July 2020. It is difficult to assess at this time what the enrollment rate for the study will be across all countries and all sites selected. After the study begins, the Company will make an assessment of the enrollment rate and will provide an update to the market on a projected completion date as well as when the data will be expected.
Coming out with a double barrel approach - two nr's in one day --- is good. Just a little puzzled with this second one though. They called a halt as opposed to what they did with the first. Both headlines refer to "enrollment of first patient" and the first identifies New Zealand as being the location. The second release does not name any particular location as identifying "enrollment of first patient".
4 countries named for Covid trials but S. Korea not named. The wording is such that it could include more than 4.