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NCT04322188
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An Observational Study of the Use of Siltuximab (SYLVANT) in Patients Diagnosed With COVID-19 Infection Who Have Developed Serious Respiratory Complications |
Completed |
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Mar/19/2020 |
May/08/2020 |
- Alternative id - v 2 22nd April 2020
- Interventions -
- Study type - Observational
- Study results - No Results Available
- Locations - ASST - Papa Giovanni XXIII, Bergamo, Italy
- Study designs - Observational Model: Cohort|Time Perspective: Retrospective
- Enrollment - 220
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - mortality in siltuximab treated patients|the need of invasive ventilation in siltuximab patients Reduction of the need of time of ventilatory support|clinical course of patients treated with siltuximab Percentage of patients that undergo to tracheostomy|Safety Improvement of the lung function assessed by radiologic findings|the effect on inflammatory parameters|Correlation of outcomes with IL-6 levels
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NCT04329650
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Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID-19 Pneumonia |
Recruiting |
Phase 2 |
Apr/15/2020 |
May/20/2020 |
- Alternative id - SILCOR-COVID-19
- Interventions - Drug: Siltuximab|Drug: Methylprednisolone
- Study type - Interventional
- Study results - No Results Available
- Locations - Hospital Germans Trias i Pujol, Badalona, Spain|Hospital Clínic de Barcelona, Barcelona, Spain|Hospital Universitario de Salamanca, Salamanca, Spain|Hospital Universitari Mútua de Terrassa, Terrassa, Spain
- Study designs - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 200
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Proportion of patients requiring ICU admission at any time within the study period.|Days of stay in the ICU during the study period.|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.|Proportion of patients with a worsening requirement of supplemental oxygen at 29 days. days.|Days with hypoxemia (SpO2 <93% in ambient air or requiring oxygen supplemental or mechanical ventilation support) at 29 days.|Proportion of patients using mechanical ventilation at 29 days.|Days with use of mechanical ventilation at 29 days.|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.|Days of hospitalization among survivors at 29 days.|Mortality rate from any cause at 29 days.|Proportion of patients with serious adverse events at 29 days.|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.|Proportion of patients with invasive bacterial or fungal infections clinically significant or opportunistic at 29 days.|Proportion of patients with grade 2 or higher adverse reactions related to the infusion of the sudy treatments at 29 days.|Proportion of patients with hypersensitivity reactions of grade 2 or higher related to the administration of the study treatments at 29 days.|Proportion of patients with gastrointestinal perforation at 29 days.|Proportion of patients with secondary severe infections confirmed by laboratory or worsening of existing infections at 29 days.|Changes from baseline in plasma leukocyte levels at days 1, 3, 5, 7 and 9.|Changes from baseline in plasma hemoglobin levels at days 1, 3, 5, 7 and 9.|Changes from baseline in plasma platelet at days 1, 3, 5, 7 and 9.|Changes from baseline in plasma creatinine levels at days 1, 3, 5, 7 and 9.|Changes from baseline in plasma total bilirubin levels at days 1, 3, 5, 7 and 9.|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.|Changes from baseline in plasma biomarkers (PCR, lymphocytes, ferritin, d-dimer and LDH) at days 1, 3, 5, 7 and 9.|Changes from baseline in chest Rx at days 1, 3 and 5.
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NCT04330638
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Treatment of COVID-19 Patients With Anti-interleukin Drugs |
Completed |
Phase 3 |
Apr/03/2020 |
Apr/12/2021 |
- Alternative id - COV-AID
- Interventions - Other: Usual Care|Drug: Anakinra|Drug: Siltuximab|Drug: Tocilizumab
- Study type - Interventional
- Study results - No Results Available
- Locations - AZ Sint-Jan Brugge, Brugge, Belgium|University Hospital Saint-Pierre, Brussels, Belgium|Erasmus University Hospital, Brussels, Belgium|University Hospital Saint-Luc, Brussels, Belgium|University Hospital Antwerp, Edegem, Belgium|Ziekenhuis Oost-Limurg, Genk, Belgium|AZ Sint-Lucas, Gent, Belgium|University Hospital Ghent, Gent, Belgium|Jessa ZH, Hasselt, Belgium|University Hospital Brussels, Jette, Belgium|CHU Tivoli, La Louvière, Belgium|CHR de la Citadelle, Liège, Belgium|University Hospital Liège, Liège, Belgium|Cliniques Saint-Pierre Ottignies, Ottignies-Louvain-la-Neuve, Belgium|AZ Delta, Roeselare, Belgium
- Study designs - Allocation: Randomized|Intervention Model: Factorial Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
- Enrollment - 342
- Age - 18 Years and older (Adult, Older Adult)
- Outcome measures - Time to Clinical Improvement|Time to improvement in oxygenation|Mean change in oxygenation|Number of days with hypoxia|Number of days of supplemental oxygen use|Time to absence fever for more than 48h without antipyretics|Number of days with fever|Time to halving of CRP levels compared to peak value during trial|Time to halving of ferritin levels compared to peak value during trial|Incidence of AEs (Adverse Events)|Incidence of SAEs (Serious Adverse Events)|Duration of hospital stay|Duration of hospital stay in survivors|Mean change of SOFA score (Sequential Organ Failure Assessment) between day 1 and day 7|Mean change of SOFA score between day 1 and day 15|Percentage of patients reporting each severity rating on a 6-point ordinal scale in relation to serum IL-1|Percentage of patients reporting each severity rating on a 6-point ordinal scale in relation to serum IL-6|Incidence of nosocomial bacterial or invasive fungal infection|incidence of secondary haemophagocytic lymphohistiocytosis|Incidence of secondary haemophagocytic lymphohistiocytosisscore in relation to serum IL-1|Incidence of secondary haemophagocytic lymphohistiocytosis in relation to serum IL-6|Time to first use of high-flow oxygen devices, non-invasive or invasive mechanical ventilation in non-ventilated patients|Time to first use of salvage systemic steroids in ventilated patients|Number of ventilator free days|Duration of mechanical ventilation in ventilated patients|Duration of ICU stay in patients that enrolled in trial while already on invasive or non-invasive mechanical ventilation|Time to progression to ARDS in ventilated patients, according to the adapted Berlin criteria|Time to progression to ARDS in ventilated patients according to IL-1|Time to progression to ARDS in ventilated patients according to IL-6|All-cause mortality rate (excluding group that entered during ventilation)|Percentage of patients in clinical status on 6-point Ordinal Scale|Incidence of lung function abnormalities|Incidence of lung fibrosis on chest CT scan|All-cause mortality rate
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