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

Palo Alto (17 mi)

Overseen byPankti D Reid, MD, MPH

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Chicago

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 6 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am currently in the hospital.

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

Exclusion Criteria

I have had a bone marrow or solid organ transplant.

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

My doctors have diagnosed me with failure of multiple organs.

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

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

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

I currently have active diverticulitis.

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

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

I have had a gastrointestinal perforation in the past.

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

Treatment Details

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.

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.

Tocilizumab is already approved in European Union, United States, Canada, Japan, Australia for the following indications:

🇪🇺 Approved in European Union as Actemra for: