This study will assess the pharmacodynamics, pharmacokinetics, safety and efficacy of two different doses of tocilizumab (TCZ) in combination with standard-of-care (SOC) in hospitalized adult participants with moderate to severe COVID-19 pneumonia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
97
Participants will receive IV TCZ.
Mayo Clinic - Arizona
Phoenix, Arizona, United States
Area Under the Curve From Day 0-28 (AUC0-d28) of Tocilizumab)
Time frame: Days 0-28. Participants received a second dose within 8-24 hours after the initial infusion of TCZ at the discretion of the investigator upon clinically significant demonstration of worsening signs or symptoms.
Maximum Serum Concentration (Cmax) of Tocilizumab
Time frame: Baseline - Day 60. Participants received a second dose within 8-24 hours after the initial infusion of TCZ at the discretion of the investigator upon clinically significant demonstration of worsening signs or symptoms.
Clearance (CL) of Tocilizumab
Time frame: Baseline - Day 60. Participants received a second dose within 8-24 hours after the initial infusion of TCZ at the discretion of the investigator upon clinically significant demonstration of worsening signs or symptoms.
Volume of the Central Compartment (Vc) of Tocilizumab
Time frame: Baseline - Day 60. Participants received a second dose within 8-24 hours after the initial infusion of TCZ at the discretion of the investigator upon clinically significant demonstration of worsening signs or symptoms.
Serum Concentration of C-reactive Protein (CRP) Following Administration of IV TCZ
Time frame: Baseline - Day 60
Serum Concentration of Ferritin Following Administration of IV TCZ
Time frame: Baseline - Day 60
Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R) Following Administration of IV TCZ
Time frame: Baseline - Day 60
Serum Concentration of Interleukin-6 (IL-6) Following Administration of IV TCZ
Time frame: Baseline - Day 60
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Pecentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: Up to Day 60
Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) (COVID-19) Viral Load Over Time
Time frame: Baseline - Day 60
Time to Real-Time Polymerase Chain Reaction (RT-PCR) Virus Negativity
Time to Real-Time Polymerase Chain Reaction (RT-PCR) virus negativity was defined as the number of days from the first dose of study drug to when a negative RT-PCR SARS-CoV-2 assessment result was observed. Results are presented as a cumulative incidence function (CIF) with death as a competing risk.
Time frame: Up to Day 28
Proportion of Participants With Any Post-Treatment Infection
Time frame: Up to Day 60