drugset / Trial / NCT04479358

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

NCT04479358

Phase 2 Terminated 85 enrolled University of Chicago
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-09-10
Primary completion
2024-03-01
Completion
2025-02-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody 40 mg
Subject Tocilizumab Monoclonal antibody 120 mg

Indications