A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 Pneumonia

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
TCZ 8 mg/kg	Tociliuzumab	Participants will receive intravenous (IV) tocilizumab (TCZ) at a dose of 8 mg/kg in addition to standard-of-care treatment.
TCZ 4 mg/kg	Tociliuzumab	Participants will receive IV tocilizumab (TCZ) at a dose of 4 mg/kg in addition to standard-of-care treatment.

Primary Outcome Measures

Name	Time	Method
Serum Concentration of C-reactive Protein (CRP) Following Administration of IV TCZ	Baseline - Day 60
Area Under the Curve From Day 0-28 (AUC0-d28) of Tocilizumab)	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	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 Ferritin Following Administration of IV TCZ	Baseline - Day 60
Clearance (CL) of Tocilizumab	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	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 Soluble Interleukin-6 Receptor (sIL-6R) Following Administration of IV TCZ	Baseline - Day 60
Serum Concentration of Interleukin-6 (IL-6) Following Administration of IV TCZ	Baseline - Day 60

Secondary Outcome Measures

Name	Time	Method
Pecentage of Participants With Adverse Events	Up to Day 60	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.
Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) (COVID-19) Viral Load Over Time	Baseline - Day 60
Time to Real-Time Polymerase Chain Reaction (RT-PCR) Virus Negativity	Up to Day 28	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.
Proportion of Participants With Any Post-Treatment Infection	Up to Day 60

Locations (24): Mayo Clinic - Arizona
🇺🇸
Phoenix, Arizona, United States
St. Jude Medical Center
🇺🇸
Fullerton, California, United States
LAC + USC Medical Center
🇺🇸
Los Angeles, California, United States
USC Keck Medical Center of USC
🇺🇸
Los Angeles, California, United States
Norwalk Hospital
🇺🇸
Norwalk, Connecticut, United States
Medstar Georgetown University Hospital
🇺🇸
Washington, District of Columbia, United States
Mayo Clinic
🇺🇸
Jacksonville, Florida, United States
Advocate Christ Medical Center
🇺🇸
Oak Lawn, Illinois, United States
Advocate Lutheran General Hospital
🇺🇸
Park Ridge, Illinois, United States
University of Maryland
🇺🇸
Baltimore, Maryland, United States
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Mayo Clinic - Arizona
🇺🇸Phoenix, Arizona, United States