Clinical trial NCT04322188: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Acute Respiratory Syndrome (ARDS) Secondary to SARS-COV-2 Infection
Keywords: SARS-COV-2
ARDS
COVID-19
Lead sponsor: A.O. Ospedale Papa Giovanni XXIII
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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).

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

Primary outcomes:
measure: mortality in siltuximab treated patients
timeFrame: 30 days
Secondary outcomes:
measure: the need of invasive ventilation in siltuximab patients Reduction of the need of time of ventilatory support
timeFrame: 30 days
measure: clinical course of patients treated with siltuximab Percentage of patients that undergo to tracheostomy
timeFrame: 30 days
measure: Safety Improvement of the lung function assessed by radiologic findings
timeFrame: 30 days
measure: the effect on inflammatory parameters
timeFrame: 30 days
measure: Correlation of outcomes with IL-6 levels
timeFrame: 30 days
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: ASST - Papa Giovanni XXIII
Study officials:
affiliation: ASST PAPA GIOVANNI XXIII
name: Giuseppe GRITTI, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zumla A, Hui DS, Azhar EI, Memish ZA, Maeurer M. Reducing mortality from 2019-nCoV: host-directed therapies should be an option. Lancet. 2020 Feb 22;395(10224):e35-e36. doi: 10.1016/S0140-6736(20)30305-6. Epub 2020 Feb 5. No abstract available.
citation: ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.