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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 (SISCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04322188
Recruitment Status : Completed
First Posted : March 26, 2020
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Giuseppe Gritti, A.O. Ospedale Papa Giovanni XXIII

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

This observational study will collect data from patients treated with siltuximab program for treatment of SARS-CoV-2 infection complicated with serious respiratory complications.

This observational study will group the patients into two cohorts receiving siltuximab..

Outcome of patients will be compared to a cohort of patients receiving standard treatment without siltuximab.

The patients will be divided into 2 cohorts. Those contained in Cohort A were treated after the use of continuous positive airways pressure (CPAP) or non-invasive ventilation (NIV). Patients in Cohort B were treated after intubation


Condition or disease
Severe Acute Respiratory Syndrome (ARDS) Secondary to SARS-COV-2 Infection

Detailed Description:

This is a single-center observational cohort study that follows the use of treatment with siltuximab in patients with COVID-19 who have developed serious respiratory complications, defined by the need of ventilation (either invasive or non-invasive). Retrospective data collection will be carried out on those patients who have received siltuximab as a treatment for their Covid-19 and patients enrolled in ReCOVID19-2020, a retrospective study enrolling consecutive patients with a confirmed diagnosis of COVID-19 (interstitial pneumonia and positive test for SARS-COV-2) and who received standard treatment and who were hospitalized from 23 February up to 13 March 2020 at Papa Giovanni XXIII hospital.

The control cohort of the cohort study 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.Patients that will be included will be divided into 2 cohorts, and per current estimation split in a 3:1 ratio: 75% will be in Cohort A as treated with CPAP/NIV, while 25% will form Cohort B and consists of patients in an ICU setting who are receiving mechanical ventilation.

Procedures outlined in this protocol are based on how the patients were managed as per clinicians' best judgement and best practice. No clinical procedures are required by this observational protocol. Data on the procedures already performed during the routine diagnosis and treatment of COVID-19 patients will be collected. The list of clinical and laboratory parameters is provided to direct data collection for this observational study (as available in the medical records).

During their hospitalization, patients will be monitored as per standard hospital practice or as per national (emergency) guidelines in accordance with extraordinary circumstances relating to the COVID-19 outbreak. After discharge, patients will be asked to provide (from their primary health care providers) relevant laboratory results and safety information for approximately 30 days following the start of COVID-19 treatment via ventilation (either mechanical or non-invasive).

Study Design
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Study Type : Observational
Actual Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: An Observational Study of the Use of Siltuximab (SYLVANT) in Patients Diagnosed With COVID-19 Infection Who Have Developed Serious Respiratory Complications
Actual Study Start Date : March 19, 2020
Actual Primary Completion Date : May 8, 2020
Actual Study Completion Date : May 8, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Siltuximab

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. mortality in siltuximab treated patients [ Time Frame: 30 days ]
    The main objective of this study is to evaluate mortality in siltuximab treated patients and compare the results with the control cohort


Secondary Outcome Measures :
  1. the need of invasive ventilation in siltuximab patients Reduction of the need of time of ventilatory support [ Time Frame: 30 days ]
    Assess the need of invasive ventilation in siltuximab patients treated in cohort A and compare the results with the control cohort

  2. clinical course of patients treated with siltuximab Percentage of patients that undergo to tracheostomy [ Time Frame: 30 days ]
    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

  3. Safety Improvement of the lung function assessed by radiologic findings [ Time Frame: 30 days ]
    Safety of siltuximab treatment

  4. the effect on inflammatory parameters [ Time Frame: 30 days ]
    Evaluate the effect of siltuximab on inflammatory parameters (CRP)

  5. Correlation of outcomes with IL-6 levels [ Time Frame: 30 days ]
    Correlation of outcomes with IL-6 levels


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The control cohort of the cohort study 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.Patients that will be included into this observational study will be divided into 2 cohorts, and per current estimation split in a 3:1 ratio: 75% will be in Cohort A as treated with CPAP/NIV, while 25% will form Cohort B and consists of patients in an ICU setting who are receiving mechanical ventilation.
Criteria

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)

Exclusion Criteria:

  1. Active infection of bacterial or viral (non-Covid-19) origin
  2. Treatment with other anti-interleukin therapy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322188


Locations
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Italy
ASST - Papa Giovanni XXIII
Bergamo, Italy, 24127
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
Investigators
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Principal Investigator: Giuseppe GRITTI, MD ASST PAPA GIOVANNI XXIII
More Information
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Publications:

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Responsible Party: Giuseppe Gritti, Principal Investigator, A.O. Ospedale Papa Giovanni XXIII
ClinicalTrials.gov Identifier: NCT04322188    
Other Study ID Numbers: v 2 22nd April 2020
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Giuseppe Gritti, A.O. Ospedale Papa Giovanni XXIII:
SARS-COV-2
ARDS
COVID-19
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Severe Acute Respiratory Syndrome
Disease Attributes
Pathologic Processes
Pneumonia, Viral
Pneumonia
 Respiratory Tract Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases