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Tocilizumab Versus Baricitinib in Patients With Severe COVID-19

Primary Purpose

COVID-19

Status

Recruiting

Phase

Not Applicable

Locations

Greece

Study Type

Interventional

Intervention

Tocilizumab

Baricitinib

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Acute Respiratory Distress Syndrome, PaO2/FiO2, Tocilizumab, Baricitinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- COVID-19, PaO2/FiO2<200

Exclusion Criteria:

- Age<18 years, Pregnancy, Glomerular filtration rate<30, Application of mechanical ventilation prior patients' transfer to our Hospital

Sites / Locations

University Hospital of Patras, Department of Respiratory MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

tocilizumab

baricitinib

Arm Description

tocilizumab plus usual care

baricitinib plus usual care

Outcomes

Primary Outcome Measures

Mechanical ventilation or death by day 28

Secondary Outcome Measures

Time to discharge over the 28-day period

World Health Organization scale at day 10 [range from 0 (not infected) to 10 (dead)]

Full Information

NCT ID

NCT05082714

First Posted

October 18, 2021

Last Updated

April 5, 2022

Sponsor

University Hospital of Patras

1. Study Identification

Unique Protocol Identification Number

NCT05082714

Brief Title

Tocilizumab Versus Baricitinib in Patients With Severe COVID-19

Official Title

Tocilizumab Versus Baricitinib in Hospitalized Patients With Severe COVID-19: an Open-label, Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 18, 2021 (Actual)

Primary Completion Date

May 2022 (Anticipated)

Study Completion Date

May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital of Patras

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

The aim of this study is to investigate whether baricitinib is non-inferior to tocilizumab in severe COVID-19.

Detailed Description

Patients with COVID-19 will be assigned to one of the two arms on 1:1 ratio based on the time point that PaO2/FiO2<200 will be observed. Patients aged 18 years or older with PaO2/FiO2 <200 at any time during their hospitalization will be included in the analysis irrespective of values in inflammatory markers, such as CRP and ferritin. Exclusion criteria will be: age<18 years, pregnancy, glomerular filtration rate<30 and application of mechanical ventilation prior patients' transfer to our Hospital. Each patient or the patient's legally authorized representative provided written or witnessed oral informed consent. Day 1 will be considered the first day that PaO2/FiO2<200 will be identified. Treatment with either tocilizumab or baricitinib will start from day 1. Primary and secondary outcomes will be assessed in the days described below. This study aims to investigate whether baricitinib is non-inferior to tocilizumab in patients with severe COVID-19. Two hundred fifty one (n=251) patients will be enrolled based on the following assumptions: 1) HR θ 1, 2) HR θο 1.5, 3) overall probability of event (primary end point) 0.6 (based on previous records of our hospital), 4) power 80%, 5) type I error α 5%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

COVID-19, Acute Respiratory Distress Syndrome, PaO2/FiO2, Tocilizumab, Baricitinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Non-inferiority trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

251 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

tocilizumab

Arm Type

Experimental

Arm Description

tocilizumab plus usual care

Arm Title

baricitinib

Arm Type

Experimental

Arm Description

baricitinib plus usual care

Intervention Type

Drug

Intervention Name(s)

Tocilizumab

Intervention Description

tocilizumab 8mg/kg single infusion (a second infusion within 48 hours can be applied upon clinician's discretion)

Intervention Type

Drug

Intervention Name(s)

Baricitinib

Intervention Description

The baricitinib intervention consists of baricitinib at a dose of 4 mg/day (given daily for up to 14 days or until discharge from hospital, whichever occurred first); however, 2 mg/day will be given if the patient has a baseline eGFR of 30 to less than 60 mL/min/1·73 m2

Primary Outcome Measure Information:

Title

Mechanical ventilation or death by day 28

Time Frame

day 28

Secondary Outcome Measure Information:

Title

Time to discharge over the 28-day period

Time Frame

day 28

Title

World Health Organization scale at day 10 [range from 0 (not infected) to 10 (dead)]

Time Frame

day 10

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - COVID-19, PaO2/FiO2<200 Exclusion Criteria: - Age<18 years, Pregnancy, Glomerular filtration rate<30, Application of mechanical ventilation prior patients' transfer to our Hospital

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Argyris Tzouvelekis

Phone

+306944840010

argyrios.tzouvelekis@fleming.gr

First Name & Middle Initial & Last Name or Official Title & Degree

Theodoros Karampitsakos

Phone

+306978245568

thodoriskarampitsakos@gmail.com

Facility Information:

Facility Name

University Hospital of Patras, Department of Respiratory Medicine

City

Patras

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Argyris Tzouvelekis

Phone

+306944840010

argyrios.tzouvelekis@fleming.gr

First Name & Middle Initial & Last Name & Degree

Theodoros Karampitsakos

Phone

+306972815658

thodoriskarampitsakos@gmail.com

First Name & Middle Initial & Last Name & Degree

Argyris Tzouvelekis

First Name & Middle Initial & Last Name & Degree

Theodoros Karampitsakos

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

data will be available upon request

Learn more about this trial

Tocilizumab Versus Baricitinib in Patients With Severe COVID-19

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