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
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..
| Medienart: |
|
|---|
Klinische Studie| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
2022 |
| Enthalten in: |
ClinicalTrials.gov - (2022) vom: 15. März Zur Gesamtaufnahme - year:2022 |
|---|
| Sprache: |
Englisch |
|---|
| Links: |
Volltext [kostenfrei] |
|---|
| Themen: |
610 |
|---|
| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: March 15, 2022, Last downloaded: ClinicalTrials.gov processed this data on March 28, 2022, Last updated: March 30, 2022 |
|---|
| Study ID: |
NCT05279391 |
|---|---|
| Veröffentlichungen zur Studie: |
|
| fisyears: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
CTG008266166 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | CTG008266166 | ||
| 003 | DE-627 | ||
| 005 | 20230425193641.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 220316s2022 xx |||||o 00| ||eng c | ||
| 035 | |a (DE-627)CTG008266166 | ||
| 035 | |a (UBBS_Klinische_Studien)NCT05279391 | ||
| 035 | |a (UBBS_Klinische_Studien)87/08-04-2020 | ||
| 035 | |a (UBBS_Klinische_Studien)16210/20-04-2021 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 245 | 1 | 0 | |a Combination of Inhaled DNase, Baricitinib and Tocilizumab in Severe COVID-19 |b Combined Administration of Inhaled DNase, Baricitinib and Tocilizumab as Rescue Treatment in Severe COVID-19 Patients |
| 264 | 1 | |c 2022 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: March 15, 2022, Last downloaded: ClinicalTrials.gov processed this data on March 28, 2022, Last updated: March 30, 2022 | ||
| 520 | |a 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. | ||
| 650 | 2 | |a COVID-19 | |
| 650 | 2 | |a Respiratory Insufficiency | |
| 650 | 4 | |a Medical Condition: COVID-19 Severe Respiratory Failure | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Recruiting | |
| 650 | 4 | |a 610 | |
| 773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2022) vom: 15. März |
| 773 | 1 | 8 | |g year:2022 |g day:15 |g month:03 |
| 856 | 4 | 0 | |u https://clinicaltrials.gov/show/NCT05279391 |z kostenfrei |3 Volltext |
| 912 | |a GBV_CTG | ||
| 912 | |a SSG-OLC-PHA | ||
| 951 | |a AR | ||
| 952 | |j 2022 |b 15 |c 03 | ||