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Trial record 1 of 1 for:    NCT04322188
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An Observational Case-control Study of the Use of Siltuximab in ARDS Patients Diagnosed With COVID-19 Infection (SISCO)

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ClinicalTrials.gov Identifier: NCT04322188
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Giuseppe Gritti, A.O. Ospedale Papa Giovanni XXIII

Brief Summary:

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


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

Detailed Description:

This is a single-center observational case control study in Italy that follows the use of treatment with siltuximab in patients with COVID-19 who have developed serious respiratory complications. Retrospective data collection will be carried out on those patients who have received the drug through the compassionate use program.

Patients receiving siltuximab 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 not treated in an ICU setting and are not on mechanical ventilation, while 25% will form Cohort B and consists of patients in an ICU setting who are receiving invasive ventilation.

Each patient will be matched to a consented control patient receiving treatment other than siltuximab for their condition.

Match Criteria

Patients and controls will be matched according to the following criteria:

  • Age (by decades)
  • Sex (M/F)
  • P/F fraction (<100, 100-150 or >150) at baseline
  • Antiviral therapy Procedures outlined in this protocol are based on the compassionate use program, where patients are 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 for 30 days following start of COVID-19 treatment via ventilation (either mechanical or non-invasive).

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: An Observational Case-control 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
Estimated Primary Completion Date : May 19, 2020
Estimated Study Completion Date : May 19, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Siltuximab

Group/Cohort
Cohort A
Patients in Cohort A are treated with siltuximab in a non-ICU setting Each patient will have a matched control receiving standard treatment without siltuximab.
Cohort B
patients in Cohort B are treated with siltuximab in an ICU setting Each patient will have a matched control receiving standard treatment without siltuximab.



Primary Outcome Measures :
  1. 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

  2. Cohort B: reduction of mortality [ Time Frame: 30 days ]
    reduction of mortality


Secondary Outcome Measures :
  1. Cohort A Reduction of the need of time of ventilatory support [ Time Frame: 1 month ]
  2. Cohort B Percentage of patients that undergo to tracheostomy [ Time Frame: 1 month ]
  3. Cohort B Improvement of the lung function assessed by radiologic findings [ Time Frame: 1 month ]


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

Patients receiving siltuximab 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 not treated in an ICU setting and are not on mechanical ventilation, while 25% will form Cohort B and consists of patients in an ICU setting who are receiving invasive ventilation.

Each patient will be matched to a consented control patient receiving treatment other than siltuximab for their condition

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. For Cohort A only: subjects are eligible if they are enrolled and treated within 48 hours from the beginning of NIV (non invasive ventilation) or CPAP(continous positive airway pressure)
  5. For Cohort B only: subjects are eligible if they are enrolled and treated within 48 hours from the beginning of invasive ventilation

Exclusion Criteria:

1. Active infection of bacterial or viral (non COVID-19) origin


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


Contacts
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Contact: GIUSEPPE GRITTI, MD +39.0352673684 g.gritti@asst-pg23.it
Contact: ALESSANDRO RAMBALDI, MD +39.0352673683 arambaldi@asst-pg23.it

Locations
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Italy
ASST - Papa Giovanni XXIII Recruiting
Bergamo, Italy, 24127
Contact: Alessandro Rambaldi, MD    +39 035 2673683 ext 3683    arambaldi@asst-pg23.it   
Contact: Giuseppe Gritti, MD    +39 035 2673679 ext 3679    g.gritti@asst-pg23.it   
Sub-Investigator: FABIANO DI MARCO, MD         
Sub-Investigator: IVANO RIVA, MD         
Sub-Investigator: DIEGO RIPAMONTI, MD         
Sponsors and Collaborators
A.O. Ospedale Papa Giovanni XXIII
Investigators
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Principal Investigator: Giuseppe GRITTI, MD ASST PAPA GIOVANNI XXIII

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 0.9 16th March 2020
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 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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Infection
Communicable Diseases
Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases