NCT05279391

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Democritus University of Thrace · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19 Severe Respiratory Failure

Interventions

Type	Name	Description
DRUG	Dexamethasone	Dexamethasone 6-8 mg once daily
DRUG	Low molecular weight heparin	Therapeutic doses of LMWH (e.g. Tinzaparin 175IU/kg)
DRUG	Anakinra 100Mg/0.67Ml Inj Syringe	IV administration of Anakinra 200 mg/twice daily for 3-6 days, then 100 mg/twice daily, for up to 10 days in total.
DRUG	Tocilizumab	IV administration of Tocilizumab as a single dose of 8mg/kg
DRUG	Baricitinib	4 mg per os once daily, for up to 14 days (2 mg if GFR: 30 to \<60 ml/min/1.73 m2)
DRUG	Dornase Alfa Inhalant Product	Inh. 2,500 U/twice daily, for up to 14 days.

Timeline

• Start date: 2020-10-25
• Primary completion: 2021-11-30
• Completion: 2023-12-31
• First posted: 2022-03-15
• Last updated: 2022-03-15

Locations

1 site across 1 country: Greece