Tocilizumab to Prevent Clinical Decompensation in Hospitalized, Non-critically Ill Patients With COVID-19 Pneumonitis (COVIDOSE)
Clara Health

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.

Inpatient trial

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.