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

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

Official Title
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A Phase II Study of IL-6 Receptor Antagonist Tocilizumab to Prevent Respiratory Failure and Death in Patients With Severe COVID-19 Infection

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Tocilizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intubation/Mechanical Ventilation<br>Progression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation | Drug: Tocilizumab<br>* 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.<br>|
| Experimental: Respiratory Support<br>In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP) | Drug: Tocilizumab<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVD-19, Tocilizumab, Respiratory infection, 20-185, Memorial Sloan Kettering Cancer Center