Combination of Inhaled DNase, Baricitinib and Tocilizumab in Severe COVID-19
COVID-19 Severe Respiratory Failure
About this trial
This is an interventional treatment trial for COVID-19 Severe Respiratory Failure focused on measuring COVID-19, Respiratory failure, Inhaled DNase, Baricitinib, Tocilizumab, Low molecular weight heparin, Dexamethasone, Anakinra
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- University Hospital of AlexandroupolisRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
SOC
TOCI
ANA
COMBI
Patients included in this arm treated with the standard of care (SOC), including dexamethasone plus heparin, with or without the addition of antibiotics and remdesivir
Patients included in this arm treated with the SOC plus Tocilizumab (single IV dose: 8mg/kg)
Patients included in this arm treated with the SOC plus Anakinra (200mg twice daily IV for 3-6 days, then 100 mg/twice daily, for up to 10 days in total)
Patients included in this arm treated with the SOC plus the combination of Tocilizumab, Baricitinib and inhaled DNase (COMBI) as a rescue treatment.