Combination of Inhaled DNase, Baricitinib and Tocilizumab in Severe COVID-19
Combined Administration of Inhaled DNase, Baricitinib and Tocilizumab as Rescue Treatment in Severe COVID-19 Patients
2 other identifiers
interventional
150
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 25, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedFirst Submitted
Initial submission to the registry
March 11, 2022
CompletedFirst Posted
Study publicly available on registry
March 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 15, 2022
March 1, 2022
1.1 years
March 11, 2022
March 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In-hospital mortality rate
To investigate whether the combined administration of inhaled DNase, Baricitinib and Tocilizumab, as a rescue treatment, reduces the in-hospital mortality rate in COVID-19 patients with severe respiratory failure compared to standard of care and other immunomodulatory treatments.
Through study completion, an average of 1 year
Secondary Outcomes (3)
Intubation rate
Through study completion, an average of 1 year
Days of hospitalization
Through study completion, an average of 1 year
Overall mortality rate
Follow-up (max: 52 weeks)
Study Arms (4)
SOC
ACTIVE COMPARATORPatients included in this arm treated with the standard of care (SOC), including dexamethasone plus heparin, with or without the addition of antibiotics and remdesivir
TOCI
ACTIVE COMPARATORPatients included in this arm treated with the SOC plus Tocilizumab (single IV dose: 8mg/kg)
ANA
ACTIVE COMPARATORPatients 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)
COMBI
ACTIVE COMPARATORPatients included in this arm treated with the SOC plus the combination of Tocilizumab, Baricitinib and inhaled DNase (COMBI) as a rescue treatment.
Interventions
IV administration of Anakinra 200 mg/twice daily for 3-6 days, then 100 mg/twice daily, for up to 10 days in total.
4 mg per os once daily, for up to 14 days (2 mg if GFR: 30 to \<60 ml/min/1.73 m2)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Internal Medicine, First Department of Internal Medicine
Study Record Dates
First Submitted
March 11, 2022
First Posted
March 15, 2022
Study Start
October 25, 2020
Primary Completion
November 30, 2021
Study Completion
December 31, 2023
Last Updated
March 15, 2022
Record last verified: 2022-03