WithdrawnPhase 3

Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients With COVID-19 (SARS-CoV-2 Infection)

Stopped: Study abandoned due to drug billing issues

United States0Started 2020-04-07

Plain-language summary

This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis with SARS-CoV-2 by the currently available assays (Food and Drug Administration \[FDA\] approved) * Should be hospitalized and exhibit at least one of the following predictors of mortality * Age \>= 65 years * Current smoker (smoked \>= 100 cigarettes in life and actively smoking) * Chronic obstructive pulmonary disease (COPD) * Diabetes * Hypertension * Coronary artery disease * Cerebrovascular accident (CVA) * Chronic renal disease (creatinine of \>= 2 mg/dl) * Cancer * Patients that have C-reactive protein (CRP) \>= 10 mg/L * D-dimer \>= 0.5 mg/L * Procalcitonin \>= 0.5 mg/L * Lactate dehydrogenase (LDH) \>= upper limit of normal (ULN) * Patients or authorized family member willing to sign informed consent to participate in this study Exclusion Criteria: * Pregnant or lactating women * Hypersensitivity to tocilizumab * Patients or authorized family member unwilling to sign informed consent to participate in this study * Uncontrolled tuberculosis, or any uncontrolled fungal infection (eg: candidemia)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

7-day length of invasive mechanical ventilation (MV)

Timeframe: Up to 7 days

30-day mortality rate

Timeframe: Up to 30-day after randomization

Trial details

NCT IDNCT04361552

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-02

View on ClinicalTrials.gov More Cerebrovascular Accident trials