Status:
UNKNOWN
Combination of Inhaled DNase, Baricitinib and Tocilizumab in Severe COVID-19
Lead Sponsor:
Democritus University of Thrace
Conditions:
COVID-19 Severe Respiratory Failure
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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 S...
Eligibility Criteria
Inclusion
- adult patients ≥18 years old, of any gender
- positive polymerase-chain-reaction (PCR) test for SARS-CoV-2 RNA in nasopharyngeal swab
- pulmonary infiltrates suggestive of COVID-19
- severe respiratory failure (SRF) as defined by PaO2/FiO2\<100 mm Hg
- written informed consent from the patients or legal representatives for the current compassionate therapeutic protocol.
Exclusion
- need for intubation/IMV during the first 24 hours after the initiation of treatment
- multi-organ failure,
- systemic co-infection
- SRF due to cardiac failure or fluid overload
- glomerular filtration rate (GFR) \<30 ml/min/1.73 m2)
- any stage IV solid tumor or immunosuppression due to hematological disorders
- any immunosuppressive therapy and/or chemotherapy during the last 30 days
- low patient's functional performance as defined by a Palliative Performance Scale (PPS) score ≤30%
- pregnancy.
Key Trial Info
Start Date :
October 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05279391
Start Date
October 25 2020
End Date
December 31 2023
Last Update
March 15 2022
Active Locations (1)
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1
University Hospital of Alexandroupolis
Alexandroupoli, Evros, Greece, 68100