RE: Phase 317 Nov 2020 19:10
Now it makes sense.. The reason we weren't told is because we were tol...well in a fashion...because this UK Phase 3 is the extension listed in the original hospital and home trial details. We were told about the International trial because that is in fact new news.
Randomised double-blind placebo-controlled
Pilot phase - 100 patients randomised in the hospital setting, 120 patients randomised in the home setting.
Pivotal phase - estimated at an additional 100 to 300 patients per arm, but the actual number will be determined after the data review at the end of the Pilot phase
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blind
Primary Purpose:
Treatment
Official Title:
A Randomised Double-blind Placebo-controlled Trial to Determine the Safety and Efficacy of Inhaled SNG001 (IFN-ß1a for Nebulisation) for the Treatment of Patients With Confirmed SARS-CoV-2 Infection
Actual Study Start Date :
March 16, 2020
Estimated Primary Completion Date :
February 1, 2021
Estimated Study Completion Date :
May 31, 2021'