Importantly, these interim results also met the FDA primary endpoint
-sustained clinical recovery,
the resolution of symptoms and
prevented the need for intensive care or invasive mechanical ventilation.
This is in accordance with FDA guidelines on the inclusion criteria
for the treatment of high-risk, COVID-19 infected patients
Phase II clinical trial is currently underway
Currently there are a further 19 patients undergoing this Phase IIa trial, with a maximum number of 50.
Ann: COVID-19 Interim Trial Results Meet All Primary Objectives, page-65
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