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Monoclonal Antibodies

Low-dose Tocilizumab for COVID-19 (COVIDOSE-2 Trial)

Phase 2

Waitlist Available

Led By Pankti D Reid, MD, MPH

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hospitalized

Fever, documented in electronic medical record and defined as: T ≥ 38 degrees C by any conventional clinical method (forehead, tympanic, oral, axillary, rectal)

Must not have

History of bone marrow transplantation (including chimeric antigen receptor T-cell) or solid organ transplant

On active therapy with a Bruton's tyrosine kinase-targeted agent, which include the following: Acalabrutinib, Ibrutinib, Zanubrutinib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial found that tocilizumab was an effective treatment for severe Covid-19 pneumonia, with the highest dose having the best results.

Who is the study for?

This trial is for hospitalized adults over 18 with COVID-19, fever, and lung issues seen on X-rays or CT scans. They must have a positive SARS-CoV-2 test and be able to consent. People with severe liver disease, low blood counts, certain drug treatments (like immunosuppressives), other active infections, extreme liver enzyme levels, history of transplants or diverticulitis, those on strong heart drugs or ventilators can't join.

What is being tested?

The study tests two doses of Tocilizumab (40mg and 120mg) against standard care in patients with severe COVID-19 pneumonia. It's an open-label trial where recovery time is the main goal; survival after 28 days is also tracked. Patients are grouped by whether they're getting remdesivir or steroids too.

What are the potential side effects?

Tocilizumab may cause allergic reactions, elevated liver enzymes, lowered blood cell counts increasing infection risk, digestive tract perforation risks among others. The exact side effects depend on the patient's condition and dose received.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently in the hospital.

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I have had a fever of 38 degrees C or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a bone marrow or solid organ transplant.

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I am currently being treated with a medication targeting Bruton's tyrosine kinase.

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My doctors have diagnosed me with failure of multiple organs.

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I am currently taking a medication for my condition that targets JAK2.

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I have end-stage liver disease or am on the liver transplant list.

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I have been on biologic immunosuppressive therapy in the last 6 months.

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I currently have active diverticulitis.

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I am currently taking medication to increase my blood pressure or heart strength.

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I cannot stop taking fever-reducing medicines like acetaminophen or ibuprofen.

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I have had a gastrointestinal perforation in the past.

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I have a history of tuberculosis that could become active again.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to Recovery

Secondary study objectives

Achievement of Recovery

Biochemical Response: C-reactive Protein Response Rate

Clinical Response: Duration of Increased Supplemental Oxygen from Baseline

+10 more

Side effects data

From 2017 Phase 4 trial • 59 Patients • NCT02034474

11%

Low ANC

nausea

agranulocytosis

Inpatient admission

fatigue

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Tocilizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Sub-study B, Tocilizumab 40mgExperimental Treatment1 Intervention

Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 40mg.

Group II: Sub-study B, Tocilizumab 120mgExperimental Treatment1 Intervention

Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab 120mg.

Group III: Sub-study A, Tocilizumab 40mgExperimental Treatment1 Intervention

Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg.

Group IV: Sub-study A, Tocilizumab 120mgExperimental Treatment1 Intervention

Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg.

Group V: Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of CareActive Control1 Intervention

Patient assigned to Sub-study B by primary treating physicians. Patient enrolled on trial sub-study B and randomized to receive standard of care tocilizumab dose (400mg or 8mgkg).

Group VI: Sub-study A, Tocilizumab-Free Standard of CareActive Control1 Intervention

Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive no tocilizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

0 / 13Eligibility criteria met