A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 Pneumonia
- Conditions
- COVID-19 Pneumonia
- Interventions
- Drug: Tociliuzumab
- Registration Number
- NCT04363736
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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 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 C-reactive Protein (CRP) Following Administration of IV TCZ Baseline - Day 60 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
Trial Locations
- Locations (24)
St Joseph's Regional Medical Center
🇺🇸Wayne, New Jersey, United States
St. Jude Medical Center
🇺🇸Fullerton, California, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Renown Institute for Heart & Vascular Health
🇺🇸Reno, Nevada, United States
Mercy St. Vincent Medical Center
🇺🇸Toledo, Ohio, United States
Michael E. DeBakey VA Medical Center
🇺🇸Houston, Texas, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Allegheny Health Network (Pittsburg PA)
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
LAC + USC Medical Center
🇺🇸Los Angeles, California, United States
Mayo Clinic - Arizona
🇺🇸Phoenix, Arizona, United States
USC Keck Medical Center of USC
🇺🇸Los Angeles, California, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Advocate Lutheran General Hospital
🇺🇸Park Ridge, Illinois, United States
Medstar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
SUNY Downstate Medical Center.
🇺🇸Brooklyn, New York, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Jamaica Hospital Medical Center
🇺🇸Jamaica, New York, United States
Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
Houston Methodist Sugar Land Hospital
🇺🇸Sugar Land, Texas, United States