Covid 19 Research using Clinical Trials (Home Page)
SiltuximabWiki
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug794 | Streptokinase Wiki | 0.71 |
| drug879 | Unfractionated heparin Wiki | 0.71 |
| drug883 | Usual Care Wiki | 0.35 |
| drug46 | Anakinra Wiki | 0.27 |
| drug507 | Methylprednisolone Wiki | 0.25 |
| drug854 | Tocilizumab Wiki | 0.18 |
Correlated MeSH Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D055371 | Acute Lung Injury NIH | 0.11 |
| D013577 | Syndrome NIH | 0.11 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.11 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.09 |
| D011014 | Pneumonia NIH | 0.06 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.05 |
| D018352 | Coronavirus Infections NIH | 0.04 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 2 clinical trials
Clinical Trials
1 Phase 2, Randomized, Open-label Study to Compare Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID19 Pneumonia
In our center up to 25% of the hospitalized patients with COVID-19 progress and need an intensive care unit. It is urgent to find measures that can avoid this progression to severe stages of the disease. We hypothesize that the use of anti-inflammatory drugs used at the time they start hyperinflammation episodes could improve symptoms and prognosis of patients and prevent their progression sufficiently to avoid their need for be admitted to an Intensive Care Unit.
NCT04329650 COVID-19 Drug: Siltuximab Drug: Methylprednisolone MeSH:Pneumonia
HPO:Pneumonia
Primary Outcomes
Measure: Proportion of patients requiring ICU admission at any time within the study period. Time: 29 days
Secondary Outcomes
Measure: Days of stay in the ICU during the study period. Time: 29 days
Measure: Days until resolution of fever defined as body temperature (axillary ≤ 36.6 ° C, oral ≤ 37.2 ° C, or rectal or tympanic ≤ 37.8 ° C) for at least 48 hours, without administration of antipyretics or until hospital discharge. Time: 29 days
Measure: Proportion of patients with a worsening requirement of supplemental oxygen at 29 days. days. Time: 29 days
Measure: Days with hypoxemia (SpO2 <93% in ambient air or requiring oxygen supplemental or mechanical ventilation support) at 29 days. Time: 29 days
Measure: Proportion of patients using mechanical ventilation at 29 days. Time: 29 days
Measure: Days with use of mechanical ventilation at 29 days. Time: 29 days
Measure: Days until the start of use of mechanical ventilation, non-invasive ventilation or use of high flow nasal cannula (if the patient have not previously required these interventions at the inclusion of the study) at 29 days. Time: 29 days
Measure: Days of hospitalization among survivors at 29 days. Time: 29 days
Measure: Mortality rate from any cause at 29 days. Time: 29 days
Measure: Proportion of patients with serious adverse events at 29 days. Time: 29 days
Measure: Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic with grade 4 neutropenia (count neutrophil absolute <500 / mm3) at 29 days. Time: 29 days
Measure: Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic at 29 days. Time: 29 days
Measure: Proportion of patients with grade 2 or higher adverse reactions related to the infusion of the sudy treatments at 29 days. Time: 29 days
Measure: Proportion of patients with hypersensitivity reactions of grade 2 or higher related to the administration of the study treatments at 29 days. Time: 29 days
Measure: Proportion of patients with gastrointestinal perforation at 29 days. Time: 29 days
Measure: Proportion of patients with secondary severe infections confirmed by laboratory or worsening of existing infections at 29 days. Time: 29 days
Measure: Changes from baseline in plasma leukocyte levels at days 1, 3, 5, 7 and 9. Time: Days 1, 3, 5, 7 and 9
Measure: Changes from baseline in plasma hemoglobin levels at days 1, 3, 5, 7 and 9. Time: Days 1, 3, 5, 7 and 9
Measure: Changes from baseline in plasma platelet at days 1, 3, 5, 7 and 9. Time: Days 1, 3, 5, 7 and 9
Measure: Changes from baseline in plasma creatinine levels at days 1, 3, 5, 7 and 9. Time: Days 1, 3, 5, 7 and 9
Measure: Changes from baseline in plasma total bilirubin levels at days 1, 3, 5, 7 and 9. Time: Days 1, 3, 5, 7 and 9
Measure: Proportion of patients with ALT≥ 3 times ULN (for patients with initial values normal) or> 3 times ULN AND at least 2 times more than the initial value (for patients with abnormal initial values) at days 1, 3, 5, 7 and 9. Time: Days 1, 3, 5, 7 and 9
Measure: Changes from baseline in plasma biomarkers (PCR, lymphocytes, ferritin, d-dimer and LDH) at days 1, 3, 5, 7 and 9. Time: Days 1, 3, 5, 7 and 9
Measure: Changes from baseline in chest Rx at days 1, 3 and 5. Time: Days 1, 3 and 5
2 A Prospective, Randomized, Factorial Design, Interventional Study to Compare the Safety and Efficacy of Combinations of Blockade of Interleukin-6 Pathway and Interleukin-1 Pathway to Best Standard of Care in Improving Oxygenation and Short- and Long-term Outcome of COVID-19 Patients With Acute Hypoxic Respiratory Failure and Systemic Cytokine Release Syndrome
Primary Outcomes
Measure: Proportion of patients requiring ICU admission at any time within the study period. Time: 29 daysSecondary Outcomes
Measure: Days of stay in the ICU during the study period. Time: 29 daysMeasure: Days until resolution of fever defined as body temperature (axillary ≤ 36.6 ° C, oral ≤ 37.2 ° C, or rectal or tympanic ≤ 37.8 ° C) for at least 48 hours, without administration of antipyretics or until hospital discharge. Time: 29 days
Measure: Proportion of patients with a worsening requirement of supplemental oxygen at 29 days. days. Time: 29 days
Measure: Days with hypoxemia (SpO2 <93% in ambient air or requiring oxygen supplemental or mechanical ventilation support) at 29 days. Time: 29 days
Measure: Proportion of patients using mechanical ventilation at 29 days. Time: 29 days
Measure: Days with use of mechanical ventilation at 29 days. Time: 29 days
Measure: Days until the start of use of mechanical ventilation, non-invasive ventilation or use of high flow nasal cannula (if the patient have not previously required these interventions at the inclusion of the study) at 29 days. Time: 29 days
Measure: Days of hospitalization among survivors at 29 days. Time: 29 days
Measure: Mortality rate from any cause at 29 days. Time: 29 days
Measure: Proportion of patients with serious adverse events at 29 days. Time: 29 days
Measure: Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic with grade 4 neutropenia (count neutrophil absolute <500 / mm3) at 29 days. Time: 29 days
Measure: Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic at 29 days. Time: 29 days
Measure: Proportion of patients with grade 2 or higher adverse reactions related to the infusion of the sudy treatments at 29 days. Time: 29 days
Measure: Proportion of patients with hypersensitivity reactions of grade 2 or higher related to the administration of the study treatments at 29 days. Time: 29 days
Measure: Proportion of patients with gastrointestinal perforation at 29 days. Time: 29 days
Measure: Proportion of patients with secondary severe infections confirmed by laboratory or worsening of existing infections at 29 days. Time: 29 days
Measure: Changes from baseline in plasma leukocyte levels at days 1, 3, 5, 7 and 9. Time: Days 1, 3, 5, 7 and 9
Measure: Changes from baseline in plasma hemoglobin levels at days 1, 3, 5, 7 and 9. Time: Days 1, 3, 5, 7 and 9
Measure: Changes from baseline in plasma platelet at days 1, 3, 5, 7 and 9. Time: Days 1, 3, 5, 7 and 9
Measure: Changes from baseline in plasma creatinine levels at days 1, 3, 5, 7 and 9. Time: Days 1, 3, 5, 7 and 9
Measure: Changes from baseline in plasma total bilirubin levels at days 1, 3, 5, 7 and 9. Time: Days 1, 3, 5, 7 and 9
Measure: Proportion of patients with ALT≥ 3 times ULN (for patients with initial values normal) or> 3 times ULN AND at least 2 times more than the initial value (for patients with abnormal initial values) at days 1, 3, 5, 7 and 9. Time: Days 1, 3, 5, 7 and 9
Measure: Changes from baseline in plasma biomarkers (PCR, lymphocytes, ferritin, d-dimer and LDH) at days 1, 3, 5, 7 and 9. Time: Days 1, 3, 5, 7 and 9
Measure: Changes from baseline in chest Rx at days 1, 3 and 5. Time: Days 1, 3 and 5
The purpose of this study is to test the safety and effectiveness of individually or simultaneously blocking IL-6 and IL-1 versus standard of care on blood oxygenation and systemic cytokine release syndrome in patients with COVID-19 coronavirus infection and acute hypoxic respiratory failure and systemic cytokine release syndrome
NCT04330638 COVID-19 Other: Usual Care Drug: Anakinra Drug: Siltuximab Drug: Tocilizumab
Primary Outcomes
Description: defined as the time from randomization to either an improvement of two points on a six-category ordinal scale or discharge from the hospital: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized
Measure: Time to Clinical Improvement Time: at day 15Secondary Outcomes
Description: defined as independece from supplemental oxygen
Measure: Time to improvement in oxygenation Time: during hospital admission (up to 28 days)Description: defined by Pa02/FiO2 ratio while breading room air
Measure: Mean change in oxygenation Time: day 1, day 15 or hospital discharge, whichever is firstMeasure: Number of days with hypoxia Time: during hospital admission (up to 28 days)
Measure: Number of days of supplemental oxygen use Time: during hospital admission (up to 28 days)
Measure: Time to absence fever for more than 48h without antipyretics Time: during hospital admission (up to 28 days)
Measure: Number of days with fever Time: during hospital admission (up to 28 days)
Measure: Time to halving of CRP levels compared to peak value during trial Time: during hospital admission (up to 28 days)
Measure: Time to halving of ferritin levels compared to peak value during trial Time: during hospital admission (up to 28 days)
Measure: Incidence of AEs (Adverse Events) Time: during hospital admission (up to 28 days)
Measure: Incidence of SAEs (Serious Adverse Events) Time: during hospital admission (up to 28 days)
Measure: Duration of hospital stay Time: during hospital admission (up to 28 days)
Measure: Duration of hospital stay in survivors Time: during hospital admission (up to 28 days)
Description: Clinical sign score: 0( best) - 18 (worse)
Measure: Mean change in clinical sign score between day 1 and day 7 Time: day 1, day 7 or hospital discharge, whichever is firstDescription: Clinical sign score: 0( best) - 18 (worse)
Measure: Mean change in clinical sign score between day 1 and day 15 Time: day 1, day 15 or hospital discharge, whichever is firstDescription: Clinical sign score: 0( best) - 18 (worse)
Measure: Time to clinical sign score <6 maintained for 24h Time: during hospital admission (up to 28 days)Description: SOFA score: 0 (best) - 24 (worse)
Measure: Mean change of SOFA score (Sequential Organ Failure Assessment) between day 1 and day 7 Time: Day 1, day 7or hospital discharge, whichever is firstDescription: SOFA score: 0 (best) - 24 (worse)
Measure: Mean change of SOFA score between day 1 and day 15 Time: day 1, day 15 or hospital discharge, whichever is firstDescription: NEWS2 score: 0 (best) - 24 (worse)
Measure: Mean change NEWS2 (National Early Warning) score between day 1 and day 7 Time: day 1, day 7 or hospital discharge, whichever is firstDescription: NEWS2 score: 0 (best) - 24 (worse)
Measure: Mean change NEWS2 score between day 1 and day 15 Time: day 1, day 15 or hospital discharge, whichever is firstDescription: 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized
Measure: Percentage of patients reporting each severity rating on a 6-point ordinal scale in relation to serum IL-1 Time: at day 15 or hospital discharge, whichever is firstDescription: 6-point ordinal scale: Death Hospitalized, on invasive mechanical ventilation or ECMO; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen Not hospitalized
Measure: Percentage of patients reporting each severity rating on a 6-point ordinal scale in relation to serum IL-6 Time: at day 15 or hospital discharge, whichever is firstMeasure: Incidence of nosocomial bacterial or invasive fungal infection Time: during hospital admission (up to 28 days)
Description: defined by Hs (Hemophagocytic Syndrome) score
Measure: incidence of secondary haemophagocytic lymphohistiocytosis Time: during hospital admission (up to 28 days)Description: defined by Hs score
Measure: Incidence of secondary haemophagocytic lymphohistiocytosisscore in relation to serum IL-1 Time: during hospital admission (up to 28 days)Description: defined by Hs score
Measure: Incidence of secondary haemophagocytic lymphohistiocytosis in relation to serum IL-6 Time: during hospital admission (up to 28 days)Measure: Time to first use of high-flow oxygen devices, non-invasive or invasive mechanical ventilation in non-ventilated patients Time: during hospital admission (up to 28 days)
Measure: Time to first use of salvage systemic steroids in ventilated patients Time: during hospital admission (up to 28 days)
Measure: Number of ventilator free days Time: during hospital admission (up to 28 days)
Measure: Duration of mechanical ventilation in ventilated patients Time: during hospital admission (up to 28 days)
Measure: Duration of ICU stay in patients that enrolled in trial while already on invasive or non-invasive mechanical ventilation Time: during hospital admission (up to 28 days)
Measure: Time to progression to ARDS in ventilated patients Time: during hospital admission (up to 28 days)
Measure: Time to progression to ARDS in ventilated patients according to IL-1 Time: during hospital admission (up to 28 days)
Measure: Time to progression to ARDS in ventilated patients according to IL-6 Time: during hospital admission (up to 28 days)
Measure: All-cause mortality rate (excluding group that entered during ventilation) Time: during hospital admission (up to 28 days)
Measure: Percentage of patients in clinical status on 6-point Ordinal Scale Time: at 10-20 weeks follow-up
Measure: Incidence of lung function abnormalities Time: at 10-20 weeks follow-up
Measure: Incidence of lung fibrosis on chest CT scan Time: at 10-20 weeks follow-up
Measure: All-cause mortality rate Time: at 10-20 weeks follow-up