Status:
TERMINATED
Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out whether the study drug tocilizumab is an effective treatment for COVID-19 infection.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04377659
Start Date
May 1 2020
End Date
October 28 2022
Last Update
May 28 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065