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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

Tracking Information
First Submitted Date March 24, 2020
First Posted Date March 26, 2020
Last Update Posted Date June 1, 2020
Actual Study Start Date March 19, 2020
Actual Primary Completion Date May 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 28, 2020)
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
Original Primary Outcome Measures
 (submitted: March 25, 2020)
  • Cohort A: reduction of the need of invasive ventilation or 30-day mortality [ Time Frame: 30 days ]
    reduction of the need of invasive ventilation or 30-day mortality
  • Cohort B: reduction of mortality [ Time Frame: 30 days ]
    reduction of mortality
Change History
Current Secondary Outcome Measures
 (submitted: May 28, 2020)
  • 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
  • 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
  • Safety Improvement of the lung function assessed by radiologic findings [ Time Frame: 30 days ]
    Safety of siltuximab treatment
  • the effect on inflammatory parameters [ Time Frame: 30 days ]
    Evaluate the effect of siltuximab on inflammatory parameters (CRP)
  • Correlation of outcomes with IL-6 levels [ Time Frame: 30 days ]
    Correlation of outcomes with IL-6 levels
Original Secondary Outcome Measures
 (submitted: March 25, 2020)
  • Cohort A Reduction of the need of time of ventilatory support [ Time Frame: 1 month ]
  • Cohort B Percentage of patients that undergo to tracheostomy [ Time Frame: 1 month ]
  • Cohort B Improvement of the lung function assessed by radiologic findings [ Time Frame: 1 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study of the Use of Siltuximab (SYLVANT) in Patients Diagnosed With COVID-19 Infection Who Have Developed Serious Respiratory Complications
Official Title An Observational Study of the Use of Siltuximab (SYLVANT) in Patients Diagnosed With COVID-19 Infection Who Have Developed Serious Respiratory Complications
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

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Severe Acute Respiratory Syndrome (ARDS) Secondary to SARS-COV-2 Infection
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 28, 2020)
220
Original Estimated Enrollment
 (submitted: March 25, 2020)
50
Actual Study Completion Date May 8, 2020
Actual Primary Completion Date May 8, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04322188
Other Study ID Numbers v 2 22nd April 2020
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Giuseppe Gritti, A.O. Ospedale Papa Giovanni XXIII
Study Sponsor A.O. Ospedale Papa Giovanni XXIII
Collaborators Not Provided
Investigators
Principal Investigator: Giuseppe GRITTI, MD ASST PAPA GIOVANNI XXIII
PRS Account A.O. Ospedale Papa Giovanni XXIII
Verification Date May 2020