Sponsor: Blade Therapeutics, Inc | Status: Recruiting
Start Date: 05/04/2020 | End Date: -
Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Antiviral Activity of BLD-2660 in Hospitalized Subjects with Recently Diagnosed COVID-19 Compared to Standard of Care Treatment
Primary Investigator: R. Gentry Wilkerson, MD, FACEP, FAAEM
Dana Beach (email@example.com)
Kyra Lasko (firstname.lastname@example.org)
Youssef Annous (email@example.com)
Objectives: To Evaluate the Safety and Antiviral Activity of BLD-2660 in Hospitalized Subjects with Recently Diagnosed COVID-19 Compared to Standard of Care Treatment
Study design: This is a Phase 2 randomized, double-blind, placebo-controlled multicenter study designed to evaluate BLD-2660 as add-on to standard of care (SOC) therapy in hospitalized subjects with recently diagnosed COVID-19 compared to SOC treatment. The study will include a Screening period, a Treatment period, and a Follow-up period. On Day 1, eligible subjects who have signed an informed consent form will be randomized in 2:1 ratio to one of 2 treatment groups. All subjects will receive either study drug or placebo in combination with SOC over 10 days (through Day 10/end of treatment) or until hospital discharge, if sooner. Subjects will be followed for at least 18 days after the last dose of study drug on Days 14, 21 and 28. Subjects will be contacted 60 days post-study to collect information on mortality and forced vital capacity (FVC).
1- Time to recovery as defined by no longer requiring oxygen support or hospital discharge, whichever occurs first
2- Change in oxygenation in hospitalized adults with COVID-19 treated with BLD-2660. Measured by change from baseline to Day 10 or hospital discharge, if sooner, in the ratio of peripheral hemoglobin oxygen saturation to fraction of inspired oxygen (SpO2/FiO2)
1- Safety and Tolerability: incidence of TEAEs and serious adverse events (SAEs)
2- Change in oxygenation while hospitalized & during follow-up visits.
Keywords: SARS-CoV-2, COVID-19, Calpain, Calpain inhibitors