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

D

Democritus University of Thrace

Status

Unknown

Conditions

COVID-19 Severe Respiratory Failure

Treatments

Drug: Tocilizumab
Drug: Dexamethasone
Drug: Anakinra 100Mg/0.67Ml Inj Syringe
Drug: Low molecular weight heparin
Drug: Dornase Alfa Inhalant Product
Drug: Baricitinib

Study type

Interventional

Funder types

Other

Identifiers

NCT05279391
87/08-04-2020
16210/20-04-2021 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. adult patients ≥18 years old, of any gender
  2. positive polymerase-chain-reaction (PCR) test for SARS-CoV-2 RNA in nasopharyngeal swab
  3. pulmonary infiltrates suggestive of COVID-19
  4. severe respiratory failure (SRF) as defined by PaO2/FiO2<100 mm Hg
  5. written informed consent from the patients or legal representatives for the current compassionate therapeutic protocol.

Exclusion criteria

  1. need for intubation/IMV during the first 24 hours after the initiation of treatment
  2. multi-organ failure,
  3. systemic co-infection
  4. SRF due to cardiac failure or fluid overload
  5. glomerular filtration rate (GFR) <30 ml/min/1.73 m2)
  6. any stage IV solid tumor or immunosuppression due to hematological disorders
  7. any immunosuppressive therapy and/or chemotherapy during the last 30 days
  8. low patient's functional performance as defined by a Palliative Performance Scale (PPS) score ≤30%
  9. pregnancy.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

150 participants in 4 patient groups

SOC
Active Comparator group
Description:
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
Treatment:
Drug: Low molecular weight heparin
Drug: Dexamethasone
TOCI
Active Comparator group
Description:
Patients included in this arm treated with the SOC plus Tocilizumab (single IV dose: 8mg/kg)
Treatment:
Drug: Tocilizumab
Drug: Low molecular weight heparin
Drug: Dexamethasone
ANA
Active Comparator group
Description:
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)
Treatment:
Drug: Anakinra 100Mg/0.67Ml Inj Syringe
Drug: Low molecular weight heparin
Drug: Dexamethasone
COMBI
Active Comparator group
Description:
Patients included in this arm treated with the SOC plus the combination of Tocilizumab, Baricitinib and inhaled DNase (COMBI) as a rescue treatment.
Treatment:
Drug: Tocilizumab
Drug: Low molecular weight heparin
Drug: Baricitinib
Drug: Dexamethasone
Drug: Dornase Alfa Inhalant Product

Trial contacts and locations

1

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Central trial contact

Panagiotis Skendros, Associate Professor; Konstantinos Ritis, Professor

Data sourced from clinicaltrials.gov

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