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Tocilizumab (TCZ)Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)


Name (Synonyms) Correlation
drug2941 oxyhydrogen Wiki 0.71
drug1715 Oxygen Wiki 0.41
drug1822 Placebo Wiki 0.08

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.04
D018352 Coronavirus Infections NIH 0.03

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.04

There are 2 clinical trials

Clinical Trials


1 A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Severe COVID-19 Pneumonia

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.

NCT04320615 COVID-19 Pneumonia Drug: Tocilizumab (TCZ) Drug: Placebo
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: Clinical Status Assessed Using a 7-Category Ordinal Scale

Time: Day 28

Secondary Outcomes

Measure: Time to Clinical Improvement (TTCI), Defined as a National Early Warning Score 2 (NEWS2) of Time: Up to 60 days

Measure: Time to Improvement of at Least 2 Categories Relative to Baseline on a 7-Category Ordinal Scale of Clinical Status

Time: Up to 60 days

Measure: Incidence of Mechanical Ventilation

Time: Up to 60 days

Measure: Ventilator-Free Days to Day 28

Time: Up to Day 28

Measure: Incidence of Intensive Care Unit (ICU) Stay

Time: Up to 60 days

Measure: Duration of ICU Stay

Time: Up to 60 days

Measure: Time to Clinical Failure

Time: From first dose to time of death, mechanical ventilation, ICU admission, or study withdrawal (whichever occurs first, for up to 60 days). If already in ICU on ventilation, failure = a one-category worsening on the ordinal scale, withdrawal, or death

Measure: Mortality Rate

Time: Days 7, 14, 21, 28, and 60

Measure: Time to Hospital Discharge

Time: Up to 60 days

Measure: Time to Recovery

Time: Up to 60 days

Measure: Duration of Time on Supplemental Oxygen

Time: Up to 60 days

Measure: Percentage of Participants with Adverse Events

Time: Up to 60 days

Measure: COVID-19 (SARS-CoV-2) Viral Load Over Time

Time: Up to 60 days

Measure: Time to Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) Virus Negativity

Time: Up to 60 days

Measure: Proportion of Participants with Post-Treatment Infection

Time: Up to 60 days

Measure: Serum Concentration of IL-6

Time: Up to 60 days

Measure: Serum Concentration of sIL-6R

Time: Up to 60 days

Measure: Serum Concentration of Ferritin

Time: Up to 60 days

Measure: Serum Concentration of C-Reactive Protein (CRP)

Time: Up to 60 days

Measure: Serum Concentration of TCZ

Time: Up to 60 days

2 CORON-ACT - a Multicenter, Double-blind, Randomized Controlled Phase II Trial on the Efficacy and Safety of Tocilizumab in the Treatment of Coronavirus Induced Disease (COVID-19)

The mortality rate of the disease caused by the corona virus induced disease (COVID-19) has been estimated to be 3.7% (WHO), which is more than 10-fold higher than the mortality of influenza. Patients with certain risk factors seem to die by an overwhelming reaction of the immune system to the virus, causing a cytokine storm with features of Cytokine-Release Syndrome (CRS) and Macrophage Activation Syndrome (MAS) and resulting in Acute Respiratory Distress Syndrome (ARDS). Several pro-inflammatory cytokines are elevated in the plasma of patients and features of MAS in COVID-19, include elevated levels of ferritin, d-dimer, and low platelets. There is increasing data that cytokine-targeted biological therapies can improve outcomes in CRS or MAS and even in sepsis. Tocilizumab (TCZ), an anti-IL-6R biological therapy, has been approved for the treatment of CRS and is used in patients with MAS. Based on these data, it is hypothesized that TCZ can reduce mortality in patients with severe COVID-19 prone to CRS and ARDS. The overall purpose of this study is to evaluate whether treatment with TCZ reduces the severity and mortality in patients with COVID-19.

NCT04335071 SARS-CoV-2 Infection Drug: Tocilizumab (TCZ) Drug: Placebo
MeSH:Coronavirus Infections

Primary Outcomes

Measure: Number of patients with ICU admission

Time: 7 days after randomisation

Measure: Number of patients with intubation

Time: 14 days after randomisation

Measure: Number of patients with death

Time: 28 days after randomisation

Secondary Outcomes

Description: Assessed by the 8-point WHO scale

Measure: Illness severity

Time: At days 2, 7, 14, 28 after randomisation

Description: Clinical improvement is defined as a ≥ 2-point improvement in the 8-point WHO scale

Measure: Number of patients with clinical improvement

Time: At days 2, 7, 14, 28 after randomisation

Description: Clinical improvement is defined as a ≥ 2-point improvement in the 8-point WHO scale

Measure: Time to clinical improvement (days)

Time: Up to day 28 after randomisation

Measure: Duration of hospitalization (days)

Time: Up to day 28 after randomisation

Measure: Time to ICU admission (days)

Time: Up to day 28 after randomisation

Measure: Duration of ICU stay

Time: Up to day 28 after randomisation

Measure: Time to intubation

Time: Up to day 28 after randomisation

Measure: Duration of mechanical ventilation (days)

Time: Up to day 28 after randomisation

Other Outcomes

Measure: Number of deaths

Time: Within 28 days after randomisation

Measure: Number of patients with ICU admission

Time: Within 28 days after randomisation

Measure: Number of patients with intubation

Time: Within 28 days after randomisation

Description: Events of special interest are defined as secondary infections, acute kidney failure, hepatic, and cardiac failure

Measure: Number of patients with events of special interest

Time: Within 28 days after randomisation

Measure: Number of patients with SAEs considered by the investigator to be at least probably related to the IMP

Time: Within 28 days after randomisation


Related HPO nodes (Using clinical trials)