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Combination of Inhaled DNase, Baricitinib and Tocilizumab in Severe COVID-19

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clinicaltrials.gov/study/NCT05279391
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT052793910
Trial Recruitment Size
1500
Trial Sponsor
Democritus University of Thrace
Democritus University of Thrace
0
Clinical Trial Start Date
October 25, 2020
0
Primary Completion Date
November 30, 2021
0
Study Completion Date
December 31, 2023
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Intervention Name
Tocilizumab0
Baricitinib0
Low molecular weight heparin0
Dexamethasone0
Dornase Alfa Inhalant Product0
Anakinra 100Mg/0.67Ml Inj Syringe0
Interventional Trial Phase
Not Applicable0
Official Name
Combined Administration of Inhaled DNase, Baricitinib and Tocilizumab as Rescue Treatment in Severe COVID-19 Patients0
Last Updated
March 15, 2022
0
Allocation Type
Non-Randomized0
Intervention Model
Sequential Assignment0
Masking Type
None (Open Label)0
Study 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.

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