Efficacy of Tocilizumab on Patients With COVID-19

Conditions

• SARS-CoV 2

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Tocilizumab — DRUG
  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)
• Placebos — DRUG
  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)

Study Details

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.

Key Dates

Start date

Apr 20, 2020

Status verified

Jul 2021

Primary completion

Jul 13, 2020

Completion

Aug 27, 2020

Study Design

Enrollment

243 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tocilizumab
  Review effect of Tocilizumab on multi-organ dysfunction in a phase 3 randomized controlled trial among hospitalized patients with COVID-19 infection. Participants will receive an intravenous (IV) injection of 8 mg/kg (not to exceed 800 mg) tocilizumab.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.
• Placebo Comparator: Standard of care plus placebo
  Participants will receive an placebo intravenous (IV) injection of 8 mg/kg (not to exceed 800 mg).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.

Primary Outcome Measure

Mechanical Ventilation or Death [ Time Frame: 28 days ]

Locations (3)

Find similar trials in Boston, MA

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