Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Terminated; Phase 2

Conditions: COVID-19

Treatments: Drug: Tocilizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04377659

20-185

Details and patient eligibility

About

The purpose of this study is to find out whether the study drug tocilizumab is an effective treatment for COVID-19 infection.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Intubation/Mechanical Ventilation

Experimental group

Description:

Progression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation

Treatment:

Drug: Tocilizumab

Respiratory Support

Experimental group

Description:

In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)

Treatment:

Drug: Tocilizumab