Serum IL-6 and Soluble IL-6 Receptor in Severe COVID-19 Pneumonia Treated With Tocilizumab

Sponsor
University Hospital for Infectious Diseases, Croatia
Study ID
NCT04359667
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a single arm, prospective, observational, single center study to assess the role of interleukin-6 (IL-6) and soluble interleukin 6 receptor (sIL-6R) as predictors of efficacy and safety outcomes in patients with severe coronavirus disease (COVID-19) pneumonia treated with tocilizumab. At least 30 patients will be enrolled who are diagnosed with severe COVID-19 pneumonia and meet the entry criteria.

Key Dates

Start date
Jun 16, 2020
Status verified
Jun 2020
Primary completion
Apr 16, 2021
Completion
May 15, 2021

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: tocilizumab
    one infusion of TCZ 8 mg/kg i.v., with a maximum dose of 800 mg, and SOC treatment according to local guidelines (hydroxychloroquine or/and lopinavir/ritonavir or/and remdesivir).

Primary Outcome Measure

serum interleukin-6 and soluble interleukin-6 receptor as biomarkers of clinical outcomes in patients with severe coronavirus disease (COVID-19) pneumonia treated with tocilizumab [ Time Frame: baseline ]

Central Contacts

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