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

NCT05279391 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-03-15

No results posted yet for this 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.

Conditions

  • COVID-19 Severe Respiratory Failure

Interventions

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.

Sponsors & Collaborators

  • Democritus University of Thrace

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-25
Primary Completion
2021-11-30
Completion
2023-12-31

Countries

  • Greece

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05279391 on ClinicalTrials.gov