Tocilizumab in Hospitalized, Non-critically Ill Patients With COVID-19 Pneumonitis (COVIDOSE)
Sponsored by University of Chicago
Coronavirus disease-2019 (COVID-19) has a quoted inpatient mortality as high as 25%. This high mortality may be driven by hyperinflammation resembling cytokine release syndrome (CRS), offering the hope that therapies targeting the interleukin-6 (IL-6) axis therapies commonly used to treat CRS can be used to reduce COVID-19 mortality.
Retrospective analysis of severe to critical COVID-19 patients receiving tocilizumab demonstrated that the majority of patients had rapid resolution (i.e., within 24-72 hours following administration) of both clinical and biochemical signs (fever and CRP, respectively) of hyperinflammation with only a single tocilizumab dose.
About COVID-19
Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China.
How is this study designed?
Study Type: Interventional (Clinical Trial) Estimated Enrollment: 50 participants Primary Purpose: Treatment Actual Study Start Date: April 4, 2020 Estimated Study Completion Date: December 2020
Who is this study for?
Inclusion Criteria*:
- Adults ≥ 18 years of age
- Admitted as an inpatient to University of Chicago Medicine
- Fever, documented in electronic medical record and defined as: T ≥ 38*C by any conventional clinical method (forehead, tympanic, oral, axillary, rectal)
- Positive test for active SARS-CoV-2 infection
Exclusion Criteria*:
- Known history of Hepatitis B or Hepatitis C.
- Pregnant patients
* Additional criteria apply. Please speak with the study team for further information.
What should I expect?
Arm 1: Group A Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if evidence of clinical worsening or lack of C-reactive protein response.
Arm 2: Group B Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
Second dose is provisioned if evidence of clinical worsening or lack of C-reactive protein response.
Have questions or need help?
For general questions about COVID-19 clinical trials, please email [email protected] For study specific inquiries, submit the interest form and you'll be connected to the team.