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NCT04377659 Clinical Trial

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
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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