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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2022-10-28

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.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intubation/Mechanical Ventilation

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

Group Type EXPERIMENTAL

Tocilizumab

Intervention Type DRUG

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.

Respiratory Support

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

Group Type EXPERIMENTAL

Tocilizumab

Intervention Type DRUG

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.

Interventions

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Tocilizumab

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.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No