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Tociliuzumab

Phase 2

COVID-19 Pneumonia | Small molecule | Infectious Disease |Roche Holding AG|Last Updated: Aug 31, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment97

FDA Designations

No designations recorded

Clinical trial landscape

Tociliuzumab · 1 trial · 1 indication

Phase 2 1
NCT04363736A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 PneumoniaCOVID-19 Pneumonia
COMPLETED97 Analytics
PHASE2COMPLETED
A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 Pneumonia
COVID-19 Pneumonia
NCT0436373697
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Study Endpoints

Primary Endpoints

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.
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 Ferritin 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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TCZ 8 mg/kgACTIVE_COMPARATORParticipants will receive intravenous (IV) tocilizumab (TCZ) at a dose of 8 mg/kg in addition to standard-of-care treatment.
TCZ 4 mg/kgEXPERIMENTALParticipants will receive IV tocilizumab (TCZ) at a dose of 4 mg/kg in addition to standard-of-care treatment.

Interventions

NameTypeDescription
TociliuzumabDRUGParticipants will receive IV TCZ.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria * Hospitalization with COVID-19 pneumonia confirmed by a positive polymerase chain reaction (PCR) of any specimen \[e.g., respiratory, blood, urine, stool, and other bodily fluids\]) and evidence of pneumonia on chest X-ray or computed tomography scan * For severe patients, SpO2 ...

Countries:United States
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Frequently asked questions about Tociliuzumab

What is Tociliuzumab used for in COVID-19 Pneumonia?

Tociliuzumab is an investigational small molecule being studied for the treatment of moderate to severe COVID-19 pneumonia. It is currently in Phase 2 clinical development, with one completed trial involving 97 participants in the United States. The drug has not been approved and remains under investigation.

Who makes Tociliuzumab?

Tociliuzumab is being developed by Roche Holding AG, a company traded under the ticker RHHBY. The drug is in Phase 2 clinical development for COVID-19 pneumonia, with a completed trial in the United States. Roche is responsible for the ongoing research and potential commercialization of this investigational therapy.

What phase is Tociliuzumab in?

Tociliuzumab is in Phase 2 clinical development. It has completed one Phase 2 trial for moderate to severe COVID-19 pneumonia, with 97 participants enrolled. The drug is investigational and has not been approved by regulatory authorities. Further clinical studies may be needed to establish its safety and efficacy.

What clinical trials is Tociliuzumab in?

Tociliuzumab has one completed clinical trial, identified as NCT04363736, titled "A Study to Investigate Intravenous Tocilizumab in Participants With Moderate to Severe COVID-19 Pneumonia." This Phase 2 trial enrolled 97 participants in the United States and was active-controlled, meaning it compared the drug against an active treatment.

Is Tociliuzumab FDA approved?

Tociliuzumab is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for COVID-19 pneumonia. The drug has completed one clinical trial, but it remains under study and has not received regulatory approval for any use. Its safety and efficacy have not been fully established.