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

Primary Purpose

COVID-19

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tocilizumab
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVD-19, Tocilizumab, Respiratory infection, 20-185, Memorial Sloan Kettering Cancer Center

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intubation/Mechanical Ventilation

Respiratory Support

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2020
Last Updated
May 9, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04377659
Brief Title
Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Based on two large, multicenter, randomized trials showed no benefit to tocilizumab in this setting and study has been closed.
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
October 28, 2022 (Actual)
Study Completion Date
October 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVD-19, Tocilizumab, Respiratory infection, 20-185, Memorial Sloan Kettering Cancer Center

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intubation/Mechanical Ventilation
Arm Type
Experimental
Arm Description
Progression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation
Arm Title
Respiratory Support
Arm Type
Experimental
Arm Description
In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression of Respiratory Failure or Death
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boglarka Gyurkocza, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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