Low-dose Tocilizumab for COVID-19
(COVIDOSE-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests different doses of tocilizumab, a medication that might help people with severe COVID-19 pneumonia recover faster by reducing inflammation. The trial seeks to identify the most effective dose, given limited supplies. Participants will receive either a smaller dose, a larger dose, or standard care to determine which option best aids recovery and reduces the chance of death within 28 days. Those hospitalized with COVID-19, who have a fever and lung problems visible in scans, might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
You may need to stop taking certain medications to participate in this trial. Specifically, you cannot be on certain immunosuppressive agents, some targeted therapies, or scheduled antipyretic medications like acetaminophen or ibuprofen. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that tocilizumab is generally safe for COVID-19 patients. Studies have found that a single dose is usually well-tolerated, with only a small increase in blood urea nitrogen (BUN), a kidney function marker. In larger safety studies, 40% of patients using tocilizumab experienced infections, compared to 32% of those given a placebo. Serious infections were slightly less common in the placebo group at 23%, compared to 19% for those taking tocilizumab. These results suggest that while some risks exist, tocilizumab is considered safe enough for treating COVID-19 in certain situations.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about low-dose tocilizumab for COVID-19 because it offers a potentially safer and more targeted approach to managing inflammation without the high doses typically associated with more severe side effects. Unlike the standard treatments that primarily focus on antiviral or supportive care, tocilizumab specifically blocks the IL-6 receptor, a key player in the inflammatory response seen in severe COVID-19 cases. This targeted action could help reduce the overwhelming immune response that leads to complications, with the added benefit of using lower doses to minimize potential side effects. By exploring various low doses, researchers aim to find the sweet spot where effectiveness meets safety, possibly offering a more tolerable treatment option for patients.
What evidence suggests that this trial's treatments could be effective for COVID-19?
Studies have shown that tocilizumab can help treat severe COVID-19 pneumonia by reducing inflammation, a part of the body's response to infection. It achieves this by blocking a protein called interleukin-6. Some studies found that tocilizumab, especially when combined with steroids, can lower the risk of death in COVID-19 patients. In this trial, participants in Sub-study A will receive either 40mg or 120mg of tocilizumab, or no tocilizumab as part of the standard of care. Sub-study B will test doses of 40mg, 120mg, or a standard dose of 400mg or 8mg/kg. Initial findings suggest that even small doses, like 40mg or 120mg, might still be helpful. Overall, research supports tocilizumab as a useful option for managing severe COVID-19 symptoms.46789
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive low-dose tocilizumab or standard of care for COVID-19 pneumonitis
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for long-term outcomes and overall survival
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?
6
Treatment groups
Experimental Treatment
Active Control
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.
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.
Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 40mg.
Patient assigned to Sub-study A by primary treating physicians. Patient enrolled on trial sub-study A and randomized to receive tocilizumab 120mg.
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).
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 for the following indications:
- Rheumatoid Arthritis
- Systemic Juvenile Idiopathic Arthritis
- Polyarticular Juvenile Idiopathic Arthritis
- Giant Cell Arteritis
- Cytokine Release Syndrome
- COVID-19
- Rheumatoid Arthritis
- Systemic Juvenile Idiopathic Arthritis
- Polyarticular Juvenile Idiopathic Arthritis
- Giant Cell Arteritis
- Cytokine Release Syndrome
- COVID-19
- Rheumatoid Arthritis
- Systemic Juvenile Idiopathic Arthritis
- Polyarticular Juvenile Idiopathic Arthritis
- Giant Cell Arteritis
- Cytokine Release Syndrome
- COVID-19
- Rheumatoid Arthritis
- Systemic Juvenile Idiopathic Arthritis
- Polyarticular Juvenile Idiopathic Arthritis
- Giant Cell Arteritis
- Cytokine Release Syndrome
- COVID-19
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor
Citations
Efficacy Data for COVID-19 - ACTEMRA® (tocilizumab)
ACTEMRA Was Evaluated in 4 Clinical Studies That Included ~3,000 Patients Hospitalized With COVID-191,3-7. The efficacy of ACTEMRA for the treatment of ...
Low dose vs high dose tocilizumab in COVID-19 patients ...
Tocilizumab has been shown to decrease mortality when used concomitantly with steroids in COVID-19 with 8 mg/kg (max 800 mg) being the standard ...
Low-dose Tocilizumab Versus Standard of Care in ...
Study Overview. Brief Summary. Tocilizumab is an effective treatment for severe coronavirus disease 2019 (Covid-19) pneumonia and related inflammation.
Safety and efficacy of tocilizumab in COVID-19
This study confirms tocilizumab's position as a valuable therapeutic agent for COVID-19 complications while highlighting the necessity for judicious patient ...
Tocilizumab in Hospitalized Patients with Severe Covid-19 ...
The use of tocilizumab, a monoclonal antibody against the interleukin-6 receptor, has resulted in better outcomes in patients with severe Covid-19 pneumonia.
Important Safety Information - ACTEMRA® (tocilizumab)
In the pooled safety population, the rates of infection/serious infection events were 40%/19% in patients receiving ACTEMRA versus 32%/23% receiving placebo.
Safety of Tocilizumab in COVID-19 Patients and Benefit ...
All of these data indicated the safety of a single dose of tocilizumab in COVID-19 patients except the slight increase in the blood BUN level, which could ...
Important Safety Information | ACTEMRA® (tocilizumab)
Learn about the important safety information for ACTEMRA® (tocilizumab), a treatment option for RA, COVID-19, GCA, SSc-ILD, SJIA, and PJIA.
REVOKED_Genentech Actemra tocilizumab FAQs 12212022
FDA has authorized the emergency use of Actemra in certain children (2 years and less than 18 years of age) hospitalized with COVID-19 based ...
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