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SirukumabWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug2321 Standard of Care (SOC) Wiki 0.58
drug2187 Saliva collection Wiki 0.45
drug1822 Placebo Wiki 0.06

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 Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical COVID-19 Disease

The purpose of this study is to evaluate the clinical response of sirukumab (administered as a single intravenous dose) plus standard of care (SOC) compared to placebo plus SOC in COVID-19.

NCT04380961 Severe or Critical Confirmed Coronavirus Disease (COVID)-19 Drug: Sirukumab Drug: Placebo Other: Standard of Care (SOC)
MeSH:Coronavirus Infections

Primary Outcomes

Description: Time to improvement is defined as an improvement of at least 2 categories relative to baseline on the 6-point ordinal clinical recovery scale. The 6-point ordinal clinical recovery scale provides 6 mutually exclusive conditions ordered from best to worst, and the score reflects the participant's worst situation on the day assessed. The ordinal clinical recovery scale categories are : not hospitalized (category 1); Hospitalization; not requiring supplemental oxygen (category 2); hospitalized, requiring low flow supplemental oxygen (category 3); hospitalized, on non-invasive pressure ventilation or high flow oxygen devices (category 4); hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO (category 5); death (category 6).

Measure: Time to Improvement of at Least 2 Categories Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale

Time: Up to Day 28

Secondary Outcomes

Description: Percentage of participants with an improvement of at Least 2 categories relative to baseline on the 6-point ordinal clinical recovery scale on Day 28 will be reported.

Measure: Percentage of Participants with an Improvement of at Least 2 Categories Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale on Day 28

Time: Day 28

Description: Percentage of participants with all-cause mortality will be reported.

Measure: Percentage of Participants with All-cause Mortality

Time: Up to Day 28

Description: A SAE is any adverse event (AE) that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product, is medically important.

Measure: Percentage of Participants with Serious Adverse Events (SAEs)

Time: Up to Day 28

Description: An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product.

Measure: Percentage of Participants with Related Adverse Events

Time: Up to Day 28

Description: Percentage of participants with severe or life-threatening, bacterial, invasive fungal, viral or opportunistic infections (other than severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2]) will be reported.

Measure: Percentage of Participants with Severe or Life Threatening Bacterial, Invasive Fungal, Viral or Opportunistic Infections

Time: Up to Day 28

Description: Percentage of participants with grade 3 (severe) or 4 (life-threatening) neutropenia will be reported.

Measure: Percentage of Participants with Grade 3 and 4 Neutropenia

Time: Up to Day 28

Description: Percentage of participants with grade 3 (severe) or 4 (life-threatening) lymphocytopenia will be reported.

Measure: Percentage of Participants with Grade 3 and 4 Lymphocytopenia

Time: Up to Day 28

Description: Percentage of participants with increased ALT >=3 times ULN combined with increased bilirubin >2 times ULN (up to Day 28) will be reported.

Measure: Percentage of Participants with Increased Alanine Aminotransferase (ALT) Greater than or equal to 3 Times Upper Limit of Normal (ULN) Combined with Increased Bilirubin > 2 Times ULN

Time: Up to Day 28

Description: Time to improvement of at least 1 category relative to baseline on the 6-point ordinal clinical recovery scale will be reported.

Measure: Time to Improvement of at least 1 Category Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale

Time: Up to Day 28

Description: Percentage of participants with an improvement of at Least 1 category relative to baseline on the 6-point ordinal clinical recovery scale on Day 28 will be reported.

Measure: Percentage of Participants with an Improvement of at Least 1 Category Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale on Day 28

Time: Day 28

Description: Time from study intervention to end of oxygen supplementation is defined as achieving category 1 or 2 on the 6-point ordinal clinical recovery scale.

Measure: Time from Study Intervention to end of Oxygen Supplementation

Time: Up to Day 28

Description: Time from study intervention to hospital discharge among the surviving participants will be reported.

Measure: Time from Study Intervention to Hospital Discharge Among the Surviving Participants

Time: Up to Day 28

Description: Total length of hospitalization (days from admission to hospital discharge) among the surviving participants will be reported.

Measure: Total Length of Hospitalization

Time: Up to Day 28

Description: Number of Ventilation free Days will be reported.

Measure: Number of Ventilation Free Days

Time: Up to Day 28

Description: Participant's clinical status at Day 7, 14, 21, 28 will be assessed by 6-point ordinal clinical recovery scale.

Measure: Participant's Clinical Status at Day 7, 14, 21, 28 as Assessed by 6-Point Ordinal Clinical Recovery Scale

Time: Day 7, 14, 21, 28

Description: Total time on invasive mechanical ventilation will be reported.

Measure: Total Time on Invasive Mechanical Ventilation

Time: Up to Day 28

Description: Percentage of participants with a worsening of at least 1 category on the 6-point ordinal clinical recovery scale over time (between Day 5 and Day 28) will be reported.

Measure: Percentage of Participants with a Worse Category Relative to Baseline on the 6-Point Ordinal Clinical Recovery Scale over Time

Time: From Day 5 up to Day 28

Description: Percentage participants on ECMO over time will be reported.

Measure: Percentage of Participants on Extracorporeal Membrane Oxygenation (ECMO) Over Time

Time: Up to Day 28

Description: Total time on ECMO will be reported.

Measure: Total Time on ECMO

Time: Up to Day 28

Description: Percentage of alive participants at Day 28, Week 8 and Week 16 will be reported.

Measure: Percentage of Alive Participants at Day 28, Week 8 and Week 16

Time: Day 28, Week 8 and Week 16

Description: Percentage of alive participants that required readmission (if previously discharged) at Week 8 and Week 16 will be reported.

Measure: Percentage of Alive Participants that Required Readmission at Week 8 and Week 16

Time: Week 8 and Week 16

Description: A SAE is any adverse event (AE) that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product, is medically important.

Measure: Percentage of Participants with Serious Adverse Events (SAEs)

Time: Up to Week 16

No related HPO nodes (Using clinical trials)