85 Participants Needed

Low-dose Tocilizumab for COVID-19

(COVIDOSE-2 Trial)

GW
PD
Overseen ByPankti D Reid, MD, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

PD

Pankti D Reid, MD, MPH

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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.
You have a positive test for an active COVID-19 infection.
I can sign the consent form myself or have someone who can do it for me.
See 3 more

Exclusion Criteria

I have had Hepatitis B or C but am not currently undergoing treatment.
I have had a bone marrow or solid organ transplant.
Your absolute neutrophil count is less than 500 per microliter.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive low-dose tocilizumab or standard of care for COVID-19 pneumonitis

4 weeks
Weekly monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days
Bi-weekly follow-up visits

Long-term follow-up

Participants are monitored for long-term outcomes and overall survival

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Tocilizumab
Trial Overview 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.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Active Control
Group I: Sub-study B, Tocilizumab 40mgExperimental Treatment1 Intervention
Group II: Sub-study B, Tocilizumab 120mgExperimental Treatment1 Intervention
Group III: Sub-study A, Tocilizumab 40mgExperimental Treatment1 Intervention
Group IV: Sub-study A, Tocilizumab 120mgExperimental Treatment1 Intervention
Group V: Sub-study B, Tocilizumab 400mg or 8mg/kg Standard of CareActive Control1 Intervention
Group VI: Sub-study A, Tocilizumab-Free Standard of CareActive Control1 Intervention

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

🇪🇺
Approved in European Union as Actemra for:
🇺🇸
Approved in United States as Actemra for:
🇨🇦
Approved in Canada as Actemra for:
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Approved in Japan as Actemra for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+
Unbiased ResultsWe believe in providing patients with all the options.
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