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TERMINATED
NCT04479358
PHASE2

Low-dose Tocilizumab Versus Standard of Care in Hospitalized Patients With COVID-19

Sponsor: University of Chicago

View on ClinicalTrials.gov

Summary

Tocilizumab is an effective treatment for severe coronavirus disease 2019 (Covid-19) pneumonia and related inflammation. Given limited global supplies, clarification of the optimal tocilizumab dose is critical. We conducted an open-label, randomized, controlled trial evaluating two different dose levels of tocilizumab in Covid-19 (40mg and 120mg). Randomization was stratified on remdesivir and corticosteroid at enrollment. The primary outcome was the time to recovery. The key secondary outcome was 28-day mortality.

Official title: COVIDOSE-2: A Multi-center, Randomized, Controlled Phase 2 Trial Comparing Early Administration of Low-dose Tocilizumab to Standard of Care in Hospitalized Patients With COVID-19 Pneumonitis Not Requiring Invasive Ventilation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

85

Start Date

2020-09-10

Completion Date

2025-02-10

Last Updated

2026-06-08

Healthy Volunteers

No

Conditions

Interventions

DRUG

Tocilizumab

Tocilizumab 40mg

DRUG

Tocilizumab

Tocilizumab 120mg

OTHER

Standard of Care

Tocilizumab-Free Standard of Care

OTHER

Standard of Care

Tocilizumab 400mg or 8mg/kg

Locations (1)

University of Chicago Medicine

Chicago, Illinois, United States