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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04377659
• Other study ID #: 20-185
• Status: Terminated
• Phase: Phase 2
• Start date: May 1, 2020
• Est. completion date: October 28, 2022

Study information

• Verified date: October 2022
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: October 28, 2022
• Est. primary completion date: October 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Infections
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center