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Efficacy of Tocilizumab on Patients With COVID-19

NCT04356937 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2021-07-27

Study results available
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Summary

This is a randomized, double blind, multi-center study to evaluate the effects of tocilizumab compared to placebo on patient outcomes in participants with confirmed SARS-CoV-2 infection and evidence of systemic inflammation.

The aim of this study is to test the effect of Tocilizumab on multi-organ dysfunction in a phase 3 randomized controlled trial among hospitalized patients with COVID-19 infection.

Specifically, as compared to placebo, we will test whether tocilizumab is associated with a reduction in multi-organ dysfunction among hospitalized COVID-19 adult patients with elevated inflammatory measures. Multi-organ dysfunction will be measured as the incidence of the following composite endpoint (mechanical ventilation, renal replacement therapy, mechanical support, need for inotropes or vasopressors, liver dysfunction (increased bilirubin), and all-cause mortality). We will also assess multiple pre-specified secondary (exploratory) endpoints and safety endpoints.

We hypothesize that, as compared to placebo, tocilizumab will reduce transfer to the ICU, need for mechanical ventilation, increase rates of hospital discharge in patients diagnosed with severe COVID-19 infection and evidence of exaggerated inflammatory response.

Conditions

  • SARS-CoV 2

Interventions

DRUG

Tocilizumab

Patients will receive the standard treatment for COVID-19 per MGH guidance and also be randomized (2:1) to one of the following arms: 1. Tocilizumab 8mg x 1 (n=185) 2. Standard of care/Placebo (n=93)

DRUG

Placebos

Patients will receive the standard treatment for COVID-19 per MGH guidance and also be randomized (2:1) to one of the following arms: 1. Tocilizumab 8mg x 1 (n=185) 2. Standard of care/Placebo (n=93)

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • John H Stone, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-20
Primary Completion
2020-07-13
Completion
2020-08-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04356937 on ClinicalTrials.gov