Tocilizumab for Patients With Cancer and COVID-19 Disease

Pneumonia Clinical Trial

Official title: Tocilizumab in Hospitalized Cancer Patients With Coronavirus 2019 (SARS-CoV-2) and Severe Complications of Coronavirus Disease 19 (COVID-19)

Status Terminated

Clinical Trial Summary

This phase II expanded access trial will study how well tocilizumab works in reducing the serious symptoms including pneumonitis (severe acute respiratory distress) in patients with cancer and COVID-19. COVID-19 is caused by the SARS-CoV-2 virus. COVID-19 can be associated with an inflammatory response by the immune system which may also cause symptoms of COVID-19 to worsen. This inflammation may be called "cytokine storm," which can cause widespread problems in the body. Tocilizumab is a medicine designed to block the action of a protein called interleukin-6 (IL-6) that is involved with the immune system and is known to be a key factor for problems with excessive inflammation. Tocilizumab is effective in treating "cytokine storm" from a type of cancer immunotherapy and may be effective in reducing the inflammatory response and "cytokine storm" seen in severe COVID-19 disease. Treating the inflammation may help to reduce symptoms, improve the ability to breathe without a breathing machine (ventilator), and prevent patients from having more complications.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To enhance access to tocilizumab for patients who cannot participate in the randomized COVACTA trial with specific emphasis on patients with cancer, especially those who belong to high-risk and minority populations and children.

II. To provide observations on clinical outcomes associated with tocilizumab administration in cancer patients with severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19) disease.

SECONDARY OBJECTIVE:

I. To estimate the proportion of patients whose level of institutional care does not further escalate following administration of tocilizumab.

EXPLORATORY OBJECTIVES:

I. To estimate the number of days intensive care unit (ICU) patients spent in the ICU.

II. To evaluate the mortality rate of patients:

IIa. 30-day and 60-day mortality in patients in the ICU.

IIb. Evaluate the 14-, 30- and 60-day mortality rate following infusion of tocilizumab.

III. To evaluate overall survival.

IV. To describe the proportion of patients progressing to ventilator support after tocilizumab therapy.

V. Evaluate the clinical course following administration of tocilizumab.

Va. To evaluate the development of additional infections.

Vb. To evaluate the side effects following tocilizumab.

Vc. To evaluate impact on inflammatory markers.

VI. Evaluate the duration of time:

VIa. To removal from mechanical ventilator support.

VIb. To step-down of institutional care requirements.

VIc. To discharge from the ICU to lower level.

VId. To hospital discharge.

VIe. To resolution of clinical symptoms.

VIf. To time of defervescence.

VIg. To normalization of disease-related laboratory abnormalities.

VII. Exploratory biologic correlates.

VIIa. To evaluate cytokine levels pre and post-tocilizumab, specifically evaluating IL-6.

VIIb. To evaluate SARS-coronavirus (CoV)-2 viral loads pre and post-tocilizumab.

VIIc. To determine the pharmacokinetics of tocilizumab in order to facilitate exposure-response analysis.

VIId. To correlate clinical outcomes with changes in cytokine levels and SARS-CoV-2 viral loads.

OUTLINE:

Patients receive tocilizumab intravenously (IV) over 60 minutes. A second dose may be given if there is sustained or recurrent fever, no decrease or not more than a 1-category improvement on the 7-category ordinal scale (only stabilization or partial improvement following first dose), or a >= 1-category worsening on the 7-category ordinal scale from nadir.

After completion of study treatment, patients are followed up for at least 60 days, and, when possible, up to 1 year. ;

Related Conditions & MeSH terms

• Acute Lung Injury
• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Neoplasms
• Pneumonia
• Pneumonitis
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Severe Acute Respiratory Distress Syndrome
• Symptomatic COVID-19 Infection Laboratory-Confirmed

• NCT number: NCT04370834
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Terminated
• Phase: Phase 2
• Start date: May 28, 2020
• Completion date: January 14, 2021