Severe Acute Respiratory Syndrome (ARDS) Secondary to SARS-COV-2 InfectionSISCONCT04322188
An Observational Study of the Use of Siltuximab (SYLVANT) in Patients Diagnosed With COVID-19 Infection Who Have Developed Serious Respiratory Complications
An observational study of Severe Acute Respiratory Syndrome (ARDS) Secondary to SARS-COV-2 Infection, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.
Trial 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.. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Acute Respiratory Syndrome (ARDS) Secondary to SARS-COV-2 Infection
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 19 Mar 2020to 8 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Clinical and radiological diagnosis of pulmonary infection by COVID-19
- Positive microbiological evidence of SARS-CoV-2 infection
- Diagnosis of acute respiratory distress syndrome clinical panel in accordance with Berlin 2012 criteria
- Need of non-invasive ventilation (NIV or CPAP) or invasive ventilation (intubation)
Who cannot join
- Active infection of bacterial or viral (non-Covid-19) origin
- Treatment with other anti-interleukin therapy
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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).
- Keywords
- SARS-COV-2, ARDS, COVID-19
- Medical subject headings
- Severe Acute Respiratory Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
this is an observational study. No intervention is applicable; patients are managed as per clinicians' best judgement and best practice
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality in siltuximab treated patients
The main objective of this study is to evaluate mortality in siltuximab treated patients and compare the results with the control cohort
Measured: 30 days
Secondary outcomes (5)
the need of invasive ventilation in siltuximab patients Reduction of the need of time of ventilatory support
Assess the need of invasive ventilation in siltuximab patients treated in cohort A and compare the results with the control cohort
Measured: 30 days
clinical course of patients treated with siltuximab Percentage of patients that undergo to tracheostomy
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
Measured: 30 days
Safety Improvement of the lung function assessed by radiologic findings
Safety of siltuximab treatment
Measured: 30 days
the effect on inflammatory parameters
Evaluate the effect of siltuximab on inflammatory parameters (CRP)
Measured: 30 days
Correlation of outcomes with IL-6 levels
Correlation of outcomes with IL-6 levels
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start19 Mar 2020
- Primary completion8 May 2020
- Study completion8 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe Acute Respiratory Syndrome (ARDS) Secondary to SARS-COV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIII
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Gritti, A.O. Ospedale Papa Giovanni XXIII
- Investigators
- Giuseppe GRITTI, MD, Principal investigator, ASST PAPA GIOVANNI XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322188
- Sponsor's protocol ID
- v 2 22nd April 2020
- Acronym
- SISCO
- Status last verified
- May 2020
- First submitted
- 24 Mar 2020
- Last updated
- 1 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32035018ARDS 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.
PubMed 22797452
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of the Use of Siltuximab (SYLVANT) in Patients Diagnosed With COVID-19 Infection Who Have Developed Serious Respiratory Complications
- ClinicalTrials.gov ID
- NCT04322188
- Acronym / sponsor ID
- SISCO / v 2 22nd April 2020
- Keywords
- SARS-COV-2, ARDS, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- A.O. Ospedale Papa Giovanni XXIIIUniversity, hospital or other
- Study start
- 19 Mar 2020 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Clinical and radiological diagnosis of pulmonary infection by COVID-19
- Positive microbiological evidence of SARS-CoV-2 infection
- Diagnosis of acute respiratory distress syndrome clinical panel in accordance with Berlin 2012 criteria
- Need of non-invasive ventilation (NIV or CPAP) or invasive ventilation (intubation)
Key exclusion criteria (2 listed)
- Active infection of bacterial or viral (non-Covid-19) origin
- Treatment with other anti-interleukin therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| this is an observational study. No intervention is applicable; patients are managed as per clinicians' best judgement and best practice | Other | Group 2, group 1 |
Primary outcome
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
5 secondary outcomes
the need of invasive ventilation in siltuximab patients Reduction of the need of time of ventilatory support
Time frame: 30 days
clinical course of patients treated with siltuximab Percentage of patients that undergo to tracheostomy
Time frame: 30 days
Safety Improvement of the lung function assessed by radiologic findings
Time frame: 30 days
the effect on inflammatory parameters
Time frame: 30 days
Correlation of outcomes with IL-6 levels
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Background: PubMed 32035018Zumla 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.
- Background: PubMed 22797452ARDS 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe GRITTI, MD principal investigator
ASST PAPA GIOVANNI XXIII
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Acute Respiratory Syndrome (ARDS) Secondary to SARS-COV-2 Infection, run by A.O. Ospedale Papa Giovanni XXIII at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality in siltuximab treated patients (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04322188, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.