BOOMWed Jul 29 02:52:27 2020 EDT
July 29 -- Revive Therapeutics (OTCPK:RVVTF) has submitted an IND to the FDA seeking signoff on a confirmatory Phase 3 clinical trial evaluating Bucillamine in patients with mild-to-moderate COVID-19. Unless something unexpected happens, the study will launch in Q3.
The primary endpoint of the 800-subject trial is the proportion of patients receiving Bucillamine on top of standard-of-care (SOC) treatment who are alive and hospitalized/not-hospitalized and who have died through day 28 compared to those receiving placebo plus SOC.
An interim analysis will be performed after 210 patients have been treated and followed for 28 days.
Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has been marketed for the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years.
Provided by 2016 INTERCONTINENTAL EXCHANGE INC