Clinical trial · Interventional
Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients With COVID-19 (SARS-CoV-2 Infection)
Tociluzumab for Cytokine Release Syndrome With SARS-CoV-2: An Open-Labeled, Randomized Phase 3 Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study abandoned due to drug billing issues
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cerebrovascular Accident | — | UNRESOLVED | — |
| Chronic Obstructive Pulmonary Disease | — | UNRESOLVED | — |
| Chronic Renal Failure | — | UNRESOLVED | — |
| Coronary Artery Disease | — | UNRESOLVED | — |
| Diabetes Mellitus | — | UNRESOLVED | — |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| SARS Coronavirus 2 Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Tocilizumab | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (tocilizumab, standard of care)
- description
- Patients receive tocilizumab IV every 12 hours for up to 3 doses in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care.
- interventionNames
- Other: Best Practice
- Biological: Tocilizumab
- type
- ACTIVE_COMPARATOR
- label
- Arm II (standard of care)
- description
- Patients receive standard of care.
- interventionNames
- Other: Best Practice
Primary outcomes (2)
- measure
- 7-day length of invasive mechanical ventilation (MV)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available