CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug2199 Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA] Wiki 1.00
drug337 Best available treatment Wiki 1.00

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D000437 Alcoholism NIH 0.58
D019966 Substance-Related Disorders NIH 0.38

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 Clinical Trial of Sarilumab in Adults Hospitalized With COVID-19 Presenting Cytokine Release Syndrome

Early administration of sarilumab in hospitalized patients infected with COVID-19 who have pulmonary infiltrates and are at high risk of unfavorable evolution could decrease/prevent progression to acute respiratory distress syndrome (ARDS) requiring high flow nasal oxygenation (HFNO) or either invasive or non-invasive mechanical ventilation.

NCT04357860 SARS-CoV 2 SARS Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA] Drug: Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA] Drug: Best available treatment

Primary Outcomes

Description: Proportion of patients requiring or time (in days) until required: High flow nasal oxygenation (HFNO) Non-invasive mechanical ventilation type BiPAP Non-invasive mechanical ventilation type CPAP Invasive mechanical ventilation

Measure: Ventilation requirements

Time: At day 28 or when the subject is discharged (whichever occurs first)

Secondary Outcomes

Description: Crude mortality at 28 days

Measure: Crude mortality

Time: At day 28 or when the subject is discharged (whichever occurs first)

Description: Time to clinical improvement: defined as the mean change or time in days from randomization to any of the following criteria: (i) improvement of two points on the ordinal scale of 7 points of severity or, (ii) hospital discharge with lifetime. The criteria reached before are used. The 7 point gravity scale includes the following categories: - Not hospitalized with normal activity - Not hospitalized but unable to have normal activity - Hospitalized, without requiring oxygen supplementation - Hospitalized, requiring oxygen supplementation - Hospitalized, requiring ONAF, non-invasive mechanical ventilation or both - Hospitalized requiring ECMO, invasive mechanical ventilation or both - Death

Measure: Time to clinical improvement

Time: At day 28 or when the subject is discharged (whichever occurs first)

Description: Time (in days) until improvement in oxygenation for at least 48 hours: Time to verify an increase in the SpO2 / FiO2 ratio with respect to the worst SpO2 / FiO2 prior to treatment with Sarilumab and stratified according to levels of IL-6 or DD Time to absence of oxygen requirement to maintain saturation in ambient air ≥ 93% Number of days in need of supplemental oxygen

Measure: Time until improvement in oxygenation

Time: At day 28 or when the subject is discharged (whichever occurs first)

Description: Proportion of patients requiring invasive mechanical ventilation in the trial

Measure: Proportion of patients requiring invasive mechanical ventilation

Time: At day 28 or when the subject is discharged (whichever occurs first)

Description: Proportion of patients having negative COVID-19 CRP at each visit of the trial

Measure: Proportion of patients having negative COVID-19 CRP at each visit

Time: At day 28 or when the subject is discharged (whichever occurs first)

Description: Mean of serum cytokine levels: the panel of cytokines to quantify; IL1-��, IL1-β, IL6, IL8, IL10, IL12, IL18, IL38, INFɣ, TNF��, CCL2, CCL3, CCL4, MIF and PAI-1

Measure: Mean of serum cytokine levels

Time: At day 28 or when the subject is discharged (whichever occurs first)

Description: Incidence of adverse events related to medication and its administration

Measure: Adverse events related to medication and its administration

Time: At day 28 or when the subject is discharged (whichever occurs first)

Description: Incidence in the appearance of serious bacterial, fungal or opportunistic infections in the subjects

Measure: Incidence in the appearance of serious bacterial, fungal or opportunistic infections

Time: At day 28 or when the subject is discharged (whichever occurs first)

Description: Incidence of perforation of the gastrointestinal tract in subjects

Measure: Incidence of perforation of the gastrointestinal tract

Time: At day 28 or when the subject is discharged (whichever occurs first)

Description: Leukocyte and neutrophil count mean

Measure: Leukocyte and neutrophil count

Time: At day 28 or when the subject is discharged (whichever occurs first)

Description: Mean hemoglobin levels

Measure: Hemoglobin levels

Time: At day 28 or when the subject is discharged (whichever occurs first)

Description: Platelet count mean

Measure: Platelet count

Time: At day 28 or when the subject is discharged (whichever occurs first)

Description: Average levels of creatinemia

Measure: Levels of creatinemia

Time: At day 28 or when the subject is discharged (whichever occurs first)

Description: Average bilirubin levels

Measure: Bilirubin levels

Time: At day 28 or when the subject is discharged (whichever occurs first)

Description: ALT and AST average levels

Measure: ALT and AST levels

Time: At day 28 or when the subject is discharged (whichever occurs first)

No related HPO nodes (Using clinical trials)