Tocilizumab for Patients With Cancer and COVID-19 Disease

Part of paid clinical trials in Rockville, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04370834
Phase
PHASE2
Status
Terminated

Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Malignant Solid Neoplasm
  • Pneumonia
  • Pneumonitis
  • Severe Acute Respiratory Distress Syndrome
  • Symptomatic COVID-19 Infection Laboratory-Confirmed

Eligibility Criteria

Sex
ALL
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 28, 2020
Status verified
Jan 2025
Primary completion
Jan 14, 2021
Completion
Jan 14, 2021

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Other (tocilizumab)
    Patients receive tocilizumab 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.

Primary Outcome Measure

Number of Participants With at Least 1 Point Reduction in Score on 7-category Clinical Status Ordinal Scale [ Time Frame: Day 14 after tocilizumab administration ]

Locations (5)

FacilityCityStateZIPSite coordinators
National Cancer InstituteRockvilleMaryland20850-
Summerlin Hospital Medical CenterLas VegasNevada89144-
University Medical Center of Southern NevadaLas VegasNevada89102-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
Valley Medical CenterRentonWashington98055-

Find similar trials in Rockville, MD

By research site
National Cancer Institute· Rockville, MDSummerlin Hospital Medical Center· Las Vegas, NVUniversity Medical Center of Southern Nevada· Las Vegas, NVUniversity of Oklahoma Health Sciences Center· Oklahoma City, OKValley Medical Center· Renton, WA

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