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Tocilizumab InjectionWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


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Name (Synonyms) Correlation

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.08

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Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials


1 Multicenter Study on the Efficacy and Tolerability of Tocilizumab in the Treatment of Patients With COVID-19 Pneumonia

This study project includes a single-arm phase 2 study and a parallel observational cohort study, enrolling patients with COVID-19 pneumonia.

NCT04317092 COVID-19 Pneumonia Drug: Tocilizumab Injection
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: 1-month mortality is defined as the ratio of patients who will alive after 1month from study start out of those registered at baseline

Measure: One-month mortality rate

Time: up to 1 month

Secondary Outcomes

Description: IL-6 levels will be assessed using commercial ELISA method.

Measure: Interleukin-6 level

Time: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month

Description: Lymphocyte count assessed by routinely used determination of blood count

Measure: Lymphocyte count

Time: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month

Description: CRP is assessed by routinely used determination of CRP

Measure: CRP (C-reactive protein) level

Time: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month

Description: calculated from arterial blood gas analyses (values from 300 to 100)

Measure: PaO2 (partial pressure of oxygen) / FiO2 (fraction of inspired oxygen, FiO2) ratio (or P/F ratio)

Time: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month

Description: It evaluates 6 variables, each representing an organ system (one for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems), and scored from 0 (normal) to 4 (high degree of dysfunction/failure). Thus, the maximum score may range from 0 to 24.

Measure: Change of the SOFA (Sequential Organ Failure Assessment)

Time: baseline, during treatment (cycle 1 and 2 every 12 hours) up to 1 month

Description: graded according to CTCAE citeria (v5.0)

Measure: Number of participants with treatment-related side effects as assessed by Common Terminology Criteria for Adverse Event (CTCAE) version 5.0

Time: during treatment and up to 30 days after the last treatment dose

Description: Thoracic CT scan or Chest XR

Measure: Radiological response

Time: at baseline (optional), after seven days and if clinically indicated (up to 1 month)

Description: Days of hospitalization

Measure: Duration of hospitalization

Time: from baseline up to patient's discharge (up to 1 month)

Description: time to invasive mechanical ventilation (if not previously initiated) calculated from baseline to intubation

Measure: Remission of respiratory symptoms

Time: up to 1 month

Description: time to definitive extubation calculated from intubation (any time occurred) to extubation in days

Measure: Remission of respiratory symptoms

Time: up to 1 month

Description: time to independence from non-invasive mechanical ventilation calculated in days

Measure: Remission of respiratory symptoms

Time: up to 1 month

Description: time to independence from oxygen therapy in days

Measure: Remission of respiratory symptoms

Time: up to 1 month


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