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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

Trial Profile

An Observational Study of the Use of Siltuximab (SYLVANT) in Patients Diagnosed With COVID-19 Infection Who Have Developed Serious Respiratory Complications

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 02 Jun 2020

At a glance

  • Drugs Siltuximab (Primary)
  • Indications Adult respiratory distress syndrome; COVID 2019 infections
  • Focus Expanded access; Therapeutic Use
  • Acronyms SISCO
  • Most Recent Events

    • 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.
    • 01 Apr 2020 Interim results (n=21) presented in the EUSA Pharma media release.

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 -

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 Ergomed; 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

Respiratory distress syndrome: 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

Respiratory distress syndrome: 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

Respiratory distress syndrome: 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

  1. 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

Authors

Author Total Publications First Author Last Author
EUSA Pharma 1 1 1

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
ALESSANDRO RAMBALDI, MD
+39.0352673683
arambaldi@asst-pg23.it
show details
-
DIEGO RIPAMONTI, MD ASST - Papa Giovanni XXIII Italy
FABIANO DI MARCO, MD ASST - Papa Giovanni XXIII Italy
Giuseppe Gritti, MD
+39 035 2673679 3679
g.gritti@asst-pg23.it
show details
, 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
-
-
Papa Giovanni XXIII Hospital
-
-

Trial History

Event Date Event Type Comment
02 Jun 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 02 Jun 2020
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

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. 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
  3. 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
  4. Ergomed. Ergomed Announces Provision of Clinical Research Services for COVID-19 Clinical Study. Media-Rel 2020;.

    Media Release
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