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

Phase 2

Terminated

• Conditions: COVID-19
• Interventions: Drug: Tocilizumab

• Registration Number: NCT04377659
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-06
• Status Verified: 2022-10
• Primary Completion: 2022-10-28
• Study Completion: 2022-10-28
• Results First Submitted: 2023-05-09
• Results First Submitted QC: 2023-05-09
• Results First Posted: 2023-06-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intubation/Mechanical Ventilation	Tocilizumab	Progression of respiratory failure in cohort #1 will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation
Respiratory Support	Tocilizumab	In cohort #2 progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)

Primary Outcome Measures

Name	Time	Method
Progression of Respiratory Failure or Death	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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States