Combination of Inhaled DNase, Baricitinib and Tocilizumab in Severe COVID-19
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
In patients with COVID-19, severe hypoxemic respiratory failure (SRF) leading to invasive
mechanical ventilation (IMV), raises the mortality rate substantially. Thus, the management
of patients with SRF to avoid intubation and intensive care admission is a challenging and
crucial issue.
This study describes, as rescue/compassionate treatment, a therapeutic protocol based on the
multi-mechanistic nature of severe COVID-19, using the combination of inhaled DNase,
Baricitinib and Tocilizumab on top of standard of care (SOC) consisting of heparin and
dexamethasone. COVID-19 patients with SRF who were treated with SOC, SOC plus Anakinra (ANA),
and SOC plus Tocilizumab (TOCI) will be studied as comparators. Primary endpoint will be the
reduction of the in-hospital mortality rate, whereas secondary endpoints concern intubation
rate, days of hospitalization and overall survival as derived from the last follow-up visit,
either in-office or remote.
This is a non-randomized, open-label, study, conducted in the First Department of Internal
Medicine, University Hospital of Alexandroupolis, Greece.