Phase II, prospective, interventional, single-arm, multicentric, open label trial, with a
parallel retrospective collection of data on not treated patients from IRCCS, San Raffaele
Scientific Institute included in the institutional observational study.
A sample of 50 patients with COVID-19 pneumonia will allow to detect an absolute reduction in
the rate of Respiratory-failure at day+14 after treatment of 20%, assuming that the actual
rate of failure in the corresponding not treated patients is 70% (alpha=5%, power=90%,
two-sided test). The software PASS15 was used for calculations.
The study will also include a parallel retrospective group of temporally concomitant patients
from IRCCS, San Raffaele Scientific Institute, who did not receive an experimental treatment
and who are enrolled in an already IRB approved observational study