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

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

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Drug: Tocilizumab

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Boglarka Gyurkocza, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): October 28, 2022
• Study Completion (Actual): October 28, 2022

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Tocilizumab; Memorial Sloan Kettering Cancer Center; Respiratory infection; COVD-19; 20-185
• Additional Relevant MeSH Terms: Respiratory Tract Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Respiratory Insufficiency; Infections
• Other Study ID Numbers: 20-185

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No