Clinical trial · Interventional
Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection
A Phase II Study of IL-6 Receptor Antagonist Tocilizumab to Prevent Respiratory Failure and Death in Patients With Severe COVID-19 Infection
NCT04377659CI-TRIAL-00090203terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Based on two large, multicenter, randomized trials showed no benefit to tocilizumab in this setting and study has been closed.
Summary
Brief summary (as posted)
The purpose of this study is to find out whether the study drug tocilizumab is an effective treatment for COVID-19 infection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| COVID-19 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tocilizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intubation/Mechanical Ventilation
- description
- Progression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation
- interventionNames
- Drug: Tocilizumab
- type
- EXPERIMENTAL
- label
- Respiratory Support
- description
- In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)
- interventionNames
- Drug: Tocilizumab
Primary outcomes (1)
- measure
- Progression of Respiratory Failure or Death
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient or designated proxy willing and able to provide informed consent prior to enrollment in the study. * COVID-19 PCR positive on nasopharyngeal swab * Aged \>/= 18 years old * Patient hospitalized with newly diagnosed documented severe COVID-19 infection: with respiratory rate \>/= 30 breaths/min OR peripheral capillary oxygen saturation (SpO2) \< 93% on room air for nonintubated pts. * Fever of 38.5 C or suspected respiratory infection * IL-6 level \>/= 80 pcg/ml * Cohort #1 - non intubated Cohort #2 - intubated * Women of childbearing potential must have a negative serum or urine pregnancy test * Patients receiving ongoing steroid therapy are eligible * Patients will be allowed to receive concurrent or sequential treatment with remdesivir Exclusion Criteria: * Patients with uncontrolled systemic fungal and bacterial infections * Patients with latent tuberculosis * Patients with known hypersensitivity to tocilizumab or any component of the formulation * Concurrent initiation of steroid therapy is not allowed * Patients with uncrontroled malignant disease, with a life expectancy of 3 months or less
References
Publications (0)
Data not yet available
No reference posted for this study.