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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04377659

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Tocilizumab	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

9 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2020

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: 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.
Experimental: Respiratory Support In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)	Drug: 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.

Arm

Intervention/Treatment

Experimental: 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

Drug: 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.

Experimental: Respiratory Support

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

Drug: Tocilizumab

Outcome Measures

Primary Outcome Measures

Progression of respiratory failure or death [14 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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