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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04377659
Recruitment Status : Recruiting
First Posted : May 6, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

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.




Primary Outcome Measures :
  1. Progression of respiratory failure or death [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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 with receiving ongoing steroid therapy are eligible

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
  • Patients on treatment with remdesivir
  • Concurrent initiation of steroid therapy is not allowed
  • Patients with uncrontroled malignant disease, with a life expectancy of 3 months or less

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377659


Contacts
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Contact: Boglarka Gyurkocza, MD 646-608-3768 gyurkocb@mskcc.org
Contact: Ann Jubowski, MD 646-608-3782 jakubowa@mskcc.org

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Boglarka Gyurkocza, MD    646-608-3768      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Boglarka Gyurkocza, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04377659    
Other Study ID Numbers: 20-185
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
COVD-19
Tocilizumab
Respiratory infection
20-185
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
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Infection
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases