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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

More Details

NCT ID
NCT04377659
Status
Terminated
Sponsor
Memorial Sloan Kettering Cancer Center

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.