CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

Best available treatmentWiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug2198 Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA] Wiki 1.00
drug2199 Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA] 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)