A Phase-II, Open-Label, Randomized, Multicenter Study to Investigate the Pharmacodynamics, Pharmacokinetics, Safety, and Efficacy of 8 mg/kg or 4mg/kg Intravenous Tocilizumab in Patients With Moderate to Severe COVID-19 Pneumonia
Overview
- Phase
- Phase 2
- Intervention
- Tociliuzumab
- Conditions
- COVID-19 Pneumonia
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 97
- Locations
- 24
- Primary Endpoint
- Area Under the Curve From Day 0-28 (AUC0-d28) of Tocilizumab)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
TCZ 4 mg/kg
Participants will receive IV tocilizumab (TCZ) at a dose of 4 mg/kg in addition to standard-of-care treatment.
Intervention: Tociliuzumab
TCZ 8 mg/kg
Participants will receive intravenous (IV) tocilizumab (TCZ) at a dose of 8 mg/kg in addition to standard-of-care treatment.
Intervention: Tociliuzumab
Outcomes
Primary Outcomes
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.
Serum Concentration of Ferritin Following Administration of IV TCZ
Time Frame: Baseline - Day 60
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 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
Secondary Outcomes
- Pecentage of Participants With Adverse Events(Up to Day 60)
- 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)
- Proportion of Participants With Any Post-Treatment Infection(Up to Day 60)