An Observational Study of the Use of Siltuximab (SYLVANT) in Patients Diagnosed With COVID-19 Infection Who Have Developed Serious Respiratory Complications
Latest Information Update: 04 Nov 2021
At a glance
- Drugs Siltuximab (Primary)
- Indications Adult respiratory distress syndrome; COVID 2019 infections
- Focus Expanded access; Therapeutic Use
- Acronyms SISCO
- 17 Dec 2020 Results published in the EUSA Pharma Media Release.
- 28 May 2020 Status changed from recruiting to completed.
- 01 Apr 2020 According to an Ergomed media release, a manuscript is in preparation for submission to a leading medical journal.
Most Recent Events
Trial Overview
Purpose
This observational study will collect data from patients treated under a compassionate use programme with siltuximab (SYLVANT); patients diagnosed with COVID-19 infection who have developed serious respiratory complications. This observational study will group the patients into two cohorts receiving siltuximab. Patients in Cohort A are treated in a non-ICU setting and patients in Cohort B are in an ICU setting. Each patient will have a matched control receiving standard treatment without siltuximab
Primary Endpoints
mortality in siltuximab treated patients
description: The main objective of this study is to evaluate mortality in siltuximab treated patients and compare the results with the control cohort
time_frame: 30 days
Cohort B: reduction of mortality
description: reduction of mortality
time_frame: 30 days
Other Endpoints
the need of invasive ventilation in siltuximab patients Reduction of the need of time of ventilatory support
description: Assess the need of invasive ventilation in siltuximab patients treated in cohort A and compare the results with the control cohort
time_frame: 30 days
clinical course of patients treated with siltuximab Percentage of patients that undergo to tracheostomy
description: Describe the clinical course of patients treated with siltuximab (Cohort A and B) in terms of ventilatory support and compare the results with the control cohort
time_frame: 30 days
Safety Improvement of the lung function assessed by radiologic findings
description: Safety of siltuximab treatment
time_frame: 30 days
the effect on inflammatory parameters
description: Evaluate the effect of siltuximab on inflammatory parameters (CRP)
time_frame: 30 days
Correlation of outcomes with IL-6 levels
description: Correlation of outcomes with IL-6 levels
time_frame: 30 days [1]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| Adult respiratory distress syndrome | treatment | - |
| COVID 2019 infections | treatment | - |
Biomarker
| NCT Number | Biomarker Name | Biomarker Function |
|---|---|---|
| NCT04322188 | C-reactive protein (CRP) | Outcome Measure |
| Interleukin-6 (IL-6) | Outcome Measure |
Subjects
- Subject Type patients
-
Number
Planned: 50
Actual: 220
- Sex male & female
- Age Group ≥ 18 years
Patient Inclusion Criteria
1. Clinical and radiological diagnosis of pulmonary infection by COVID-19 2. Positive microbiological evidence of SARS-CoV-2 infection 3. Diagnosis of acute respiratory distress syndrome clinical panel in accordance with Berlin 2012 criteria 4. Need of non-invasive ventilation (NIV or CPAP) or invasive ventilation (intubation)
Patient Exclusion Criteria
1. Active infection of bacterial or viral (non-Covid-19) origin 2. Treatment with other anti-interleukin therapy
Trial Details
Identifiers
| Identifier | Owner |
|---|---|
| NCT04322188 | ClinicalTrials.gov: US National Institutes of Health |
| v2 22nd-April2020 | - |
Organisations
- Affiliations EUSA Pharma
Trial Dates
-
Initiation Dates
Actual : 19 Mar 2020
-
Primary Completion Dates
Planned : 19 May 2020
Actual : 08 May 2020
-
End Dates
Planned : 19 May 2020
Actual : 08 May 2020
Other Details
- Design cohort; observational; retrospective
- Phase of Trial Phase IV
- Location Italy
- Focus Expanded access; Therapeutic Use
Interventions
| Drugs | Route | Formulation |
|---|---|---|
| SiltuximabPrimary Drug | Intravenous | Infusion |
group 1
Patients in Cohort A were treated with siltuximab after the use of continuous positive airways pressure (CPAP) or non-invasive ventilation (NIV). Patients in Cohort B were treated after intubation
Group 2
The control cohort will include all the patients with pneumonia/ARDS in need of non-invasive ventilation (CPAP or NIV) or intubation and not receiving experimental treatments in the ReCOVID-19-2020
Results
Therapeutic efficacy
SARS-COV-2 acute respiratory disease: Interim data from 21 patients treated with siltuximab in an observational case-control study showed that 33% of patients experienced a clinical improvement with a reduced need for oxygen support and 43% of patients's condition were stabilized, indicating no clinically relevant changes. 76% of patients treated with siltuximab had either stable or improved disease. The trial is conducted in 50 patients with severe acute respiratory syndrome (ARDS) secondary to SARS-COV-2 infections [2] .
Adverse events
SARS-COV-2 acute respiratory disease: Interim data from 21 patients treated with siltuximab in an observational case-control study showed that worsening of the disease was seen in 14% of patients, however 5% of patient died and 5% experienced a cerebrovascular event. The trial is conducted in 50 patients with severe acute respiratory syndrome (ARDS) secondary to SARS-COV-2 infections [2] .
Immunogenicity
SARS-COV-2 acute respiratory disease: Interim data from 21 patients treated with siltuximab in an observational case-control study showed that the C-reactive protein (CRP) levels declined from baseline through to day 5 following treatment with siltuximab in all patients with sufficient recorded values (100%, 16/16). This level of reduction was maintained in those patients (100%, 16/16) seven days after receiving treatment with siltuximab. Reduction in CRP is considered a robust surrogate for indicating the efficacy of IL-6 inhibition. The trial is conducted in 50 patients with severe acute respiratory syndrome (ARDS) secondary to SARS-COV-2 infections [2] .
Publications
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EUSA Pharma. EUSA Pharma and Papa Giovanni XXIII Hospital, Italy, Provide Interim Analysis Data for Siltuximab-Treated COVID-19 Patients from the SISCO Study. Media-Rel 2020;.
Media Release -
EUSA Pharma. EUSA Pharma Announces First Patient Enrolled in a Randomised Phase 3 Clinical Trial Investigating Siltuximab in Hospitalised Patients with COVID-19- or Another Respiratory Virus Infection-Associated Acute Respiratory Distress Syndrome (ARDS). Media-Rel 2020;.
Media Release
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
|
ALESSANDRO RAMBALDI, MD
+39.0352673683
show details
arambaldi@asst-pg23.it |
-
|
|
| DIEGO RIPAMONTI, MD | ASST - Papa Giovanni XXIII | Italy |
| FABIANO DI MARCO, MD | ASST - Papa Giovanni XXIII | Italy |
|
Giuseppe Gritti, MD
+39 035 2673679 3679
show details
g.gritti@asst-pg23.it |
, ASST - Papa Giovanni XXIII, ASST PAPA GIOVANNI XXIII | Italy |
| IVANO RIVA, MD | ASST - Papa Giovanni XXIII | Italy |
Centres
| Centre Name | Location | Trial Centre Country |
|---|---|---|
| - |
-
|
-
|
| ASST - Papa Giovanni XXIII | Bergamo | Italy |
| ASST PAPA GIOVANNI XXIII |
-
|
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| Papa Giovanni XXIII Hospital |
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Trial History
| Event Date | Event Type | Comment |
|---|---|---|
| 17 Dec 2020 | Results | Results published in the EUSA Pharma Media Release. Updated 23 Dec 2020 |
| 02 Jun 2020 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 02 Jun 2020 |
| 01 Jun 2020 | Biomarker Update | Biomarkers information updated Updated 04 Nov 2021 |
| 28 May 2020 | Status change - completed | Status changed from recruiting to completed. Updated 02 Jun 2020 |
| 01 Apr 2020 | Other trial event | According to an Ergomed media release, a manuscript is in preparation for submission to a leading medical journal. Updated 03 Apr 2020 |
| 01 Apr 2020 | Interim results | Interim results (n=21) presented in the EUSA Pharma media release. Updated 03 Apr 2020 |
| 30 Mar 2020 | Other trial event | New Source identified and integrated(ClinicalTrials.gov:NCT04322188) Updated 30 Mar 2020 |
| 19 Mar 2020 | New trial record | New trial record Updated 19 Mar 2020 |
| 18 Mar 2020 | Other trial event | According to an Ergomed media release, this company is providing clinical research services for the study and has been integrally involved in the design and implementation of the study from a clinical and operational perspective. Updated 20 Mar 2020 |
| 18 Mar 2020 | Other trial event | According to an EUSA Pharma media release, initial data from this study are expected in late March 2020. Updated 19 Mar 2020 |
| 18 Mar 2020 | Other trial event | According to an EUSA Pharma media release, Professor Alessandro Rambaldi is the study sponsor-investigator. Updated 19 Mar 2020 |
| 18 Mar 2020 | Other trial event | According to an EUSA Pharma media release, the company announced the initiation of the Papa Giovanni XXIII Hospital sponsored study of siltuximab for the treatment of patients with COVID-19 who have developed serious respiratory complications. Updated 19 Mar 2020 |
Table of Contents
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
EUSA Pharma. EUSA Pharma and Papa Giovanni XXIII Hospital, Italy, Provide Interim Analysis Data for Siltuximab-Treated COVID-19 Patients from the SISCO Study. Media-Rel 2020;.
Media Release -
EUSA Pharma. EUSA Pharma and the Papa Giovanni XXIII Hospital, Bergamo, Italy Announce Initiation of an Observational Case-control Study of Siltuximab in Patients with COVID-19 who have Developed Serious Respiratory Complications. Media-Rel 2020;.
Media Release -
EUSA Pharma. EUSA Pharma Announces First Patient Enrolled in a Randomised Phase 3 Clinical Trial Investigating Siltuximab in Hospitalised Patients with COVID-19- or Another Respiratory Virus Infection-Associated Acute Respiratory Distress Syndrome (ARDS). Media-Rel 2020;.
Media Release -
Ergomed. Ergomed Announces Provision of Clinical Research Services for COVID-19 Clinical Study. Media-Rel 2020;.
Media Release
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