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

NCT04479358 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2026-03-30

Study results available
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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.

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

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Pankti D Reid, MD, MPH · University of Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-10
Primary Completion
2024-03-01
Completion
2025-02-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04479358 on ClinicalTrials.gov