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

Phase 2TerminatedNCT04377659

Memorial Sloan Kettering Cancer Center9 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID-19

Interventions

TocilizumabDRUG

Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

Progression of Respiratory Failure or Death

The primary endpoint for this cohort is progression of respiratory failure (binary yes/no while hospitalized). Progression of respiratory failure will be defined as a sustained increase in oxygen requirement (FiO2) or need for intubation/mechanical ventilation.

Time frame: 14 days

Data from ClinicalTrials.gov

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