Study Stopped
Based on two large, multicenter, randomized trials showed no benefit to tocilizumab in this setting and study has been closed.
Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection
A Phase II Study of IL-6 Receptor Antagonist Tocilizumab to Prevent Respiratory Failure and Death in Patients With Severe COVID-19 Infection
1 other identifier
interventional
9
1 country
1
Brief Summary
The purpose of this study is to find out whether the study drug tocilizumab is an effective treatment for COVID-19 infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 covid19
Started May 2020
Longer than P75 for phase_2 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2020
CompletedFirst Submitted
Initial submission to the registry
May 4, 2020
CompletedFirst Posted
Study publicly available on registry
May 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2022
CompletedResults Posted
Study results publicly available
June 5, 2023
CompletedMay 28, 2025
October 1, 2022
2.5 years
May 4, 2020
May 9, 2023
May 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Intubation/Mechanical Ventilation
EXPERIMENTALProgression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation
Respiratory Support
EXPERIMENTALIn cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Boglarka Gyurkocza, MD
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Boglarka Gyurkocza, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2020
First Posted
May 6, 2020
Study Start
May 1, 2020
Primary Completion
October 28, 2022
Study Completion
October 28, 2022
Last Updated
May 28, 2025
Results First Posted
June 5, 2023
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share
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.