An Observational Case-control Study of the Use of Siltuximab in ARDS Patients Diagnosed With COVID-19 Infection (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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04322188|
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : March 31, 2020
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|
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.
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).
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|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|
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.
patients in Cohort B are treated with siltuximab in an ICU setting Each patient will have a matched control receiving standard treatment without siltuximab.
- 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
- 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 ]
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
|Contact: GIUSEPPE GRITTI, MDemail@example.com|
|Contact: ALESSANDRO RAMBALDI, MDfirstname.lastname@example.org|
|ASST - Papa Giovanni XXIII||Recruiting|
|Bergamo, Italy, 24127|
|Contact: Alessandro Rambaldi, MD +39 035 2673683 ext 3683 email@example.com|
|Contact: Giuseppe Gritti, MD +39 035 2673679 ext 3679 firstname.lastname@example.org|
|Sub-Investigator: FABIANO DI MARCO, MD|
|Sub-Investigator: IVANO RIVA, MD|
|Sub-Investigator: DIEGO RIPAMONTI, MD|
|Principal Investigator:||Giuseppe GRITTI, MD||ASST PAPA GIOVANNI XXIII|