Tocilizumab Versus Baricitinib in Patients With Severe COVID-19

NCT05082714 | Completed

• 1 other identifier: ATTKPATRASCOVID19
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mechanical ventilation or death by day 28

  day 28

Secondary Outcomes (2)

• Time to discharge over the 28-day period

  day 28

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

  day 10

Study Arms (2)

tocilizumab

EXPERIMENTAL

tocilizumab plus usual care

Drug: Tocilizumab

baricitinib

EXPERIMENTAL

baricitinib plus usual care

Drug: Baricitinib

Interventions

Tocilizumab DRUG

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

tocilizumab

Baricitinib DRUG

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

baricitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- COVID-19, PaO2/FiO2\<200

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital of Patras: lead

Study Sites (1)

University Hospital of Patras, Department of Respiratory Medicine

Pátrai, Greece

Location

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome

Interventions

tocilizumab; baricitinib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Respiratory Medicine, Head Department of Respiratory Medicine

Model Details: Non-inferiority trial

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 19, 2021
• Study Start: October 20, 2021
• Primary Completion: June 4, 2022
• Study Completion: June 4, 2022
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

GR (1)