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Re: Meursault post# 21386

Wednesday, 12/30/2020 10:50:33 AM

Wednesday, December 30, 2020 10:50:33 AM

Post# of 36630
Based on the text below it seems the DSMB receives it's first set of data 42-45 days of treating 210 people. First Interim Analysis of 14 days plus 28 day follow up after the 2:1 randomization bet Bucil or Placebo. Looks to be ~mid Jan IF 210 treatment group is achieved.



Detailed Description:

This is a Phase 3, multi-center, randomized, double blind, placebo controlled, clinical study of bucillamine (2 dosage levels) in patients with mild-moderate COVID-19. Patients will be randomized 1:1:1 to receive bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID or placebo TID for up to 14 days. After the first interim analysis when a single dose is selected, patients will then be randomized 2:1 to the selected bucillamine dose or placebo The study will be overseen by an independent Data and Safety Monitoring Board (DSMB). Up to 10 centers in the United States will conduct this study.

2020!!!!!