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Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug3038 use and exposure to disinfectants during the coronavirus pandemic Wiki 1.00
drug2533 Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses) Wiki 1.00

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 Unicenter, Randomized, Open-label Clinical Trial on the Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19

unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19.

NCT04435717 Covid19 Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 Drug: Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses)

Primary Outcomes

Description: Average increase in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.

Measure: Change in IL-12 values in the 3 study groups from the start of treatment (D0) and on days D + 1 and D + 3.

Time: Day1 and Day3.

Secondary Outcomes

Description: Percentage of patients per group with progression of pneumonia in Day3, Day 7 and Day28

Measure: Progression of pneumonia

Time: Day3, Day7 and Day28

Description: Proportion of patients with PaO2 / FiO2 <300 (or SatO2 / FiO2 ≤315) at some point in the evolution.

Measure: PaO2/FiO2

Time: Day3, Day7 and Day28

Description: cause mortality to 28 days after started treatment

Measure: cause mortality to 28 days after started treatment

Time: Day3, Day7 and Day28

Description: Length of hospital stay

Measure: Length of hospital stay

Time: Day3, Day7 and Day28

Description: Percentage of patients requiring Intensive Care Unit admission

Measure: patients requiring Intensive Care Unit admission

Time: Day3, Day7 and Day28

Description: IL-12 levels at Day 7

Measure: evolution of inflammatory parameters IL12

Time: Day0, Day3 and Day7

Description: IL-10, IL-1, IL-6, IL-17 and IFN-gamma levels on days Day 0, Day1, Day 3 and Day 7

Measure: evolution of inflammatory parameters IL-10, IL-1, IL-6, IL-17 and IFN-gamma

Time: Day0, Day3 and Day7

Description: Procalcitonin (PCT), levels on days Day0, Day1, Day3 and Day 7 7

Measure: evolution of inflammatory parameters Procalcitonin (PCT),

Time: Day0, Day3 and Day7

Description: C-reactive protein (PCR),levels on days Day0, Day1, Day3 and Day 7 7

Measure: evolution of inflammatory parameters C-reactive protein (PCR),

Time: Day0, Day3 and Day7

Description: D-dimer levels on days Day0, Day1, Day3 and Day 7 7

Measure: evolution of inflammatory parameters D-dimer

Time: Day0, Day3 and Day7

Description: ferritin levels on days Day0, Day1, Day3 and Day 7 7

Measure: evolution of inflammatory parameters and ferritin

Time: Day0, Day3 and Day7

Description: Cmin,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.

Measure: pharmacokinetics of tocilizumab Cmin

Time: Day0, Day1 Day3 and Day7

Description: Cmax,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.

Measure: pharmacokinetics of tocilizumab Cmax

Time: days Day0, Day1 Day3 and Day7

Description: Cmedia,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.

Measure: pharmacokinetics of tocilizumab Cmedia

Time: days Day0, Day1 Day3 and Day7

Description: Tmax,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.

Measure: pharmacokinetics of tocilizumab Tmax

Time: days Day0, Day1 Day3 and Day7

Description: AUC,on Day0, Day1, Day3 and Day7. On day 0 (D0), blood samples will be collected 12 hours after the infusion of each dose of tocilizumab in both experimental treatment groups.

Measure: pharmacokinetics of tocilizumab AUC

Time: days Day0, Day1 Day3 and Day7

Description: Serious and non-serious adverse events.

Measure: Adverse event

Time: days Day0, Day3, Day7 and Day28

Description: Adverse events to cause the treatment interruption.

Measure: Adverse event to cause the treatment interruption.

Time: days Day0, Day3, Day7 and Day28

Description: Abnormalities in laboratory findings unrelated to COVID-19 disease.

Measure: Adverse event Abnormalities in laboratory

Time: days Day0, Day3, Day7 and Day28

No related HPO nodes (Using clinical trials)