Status:
COMPLETED
An Observational Study of the Use of Siltuximab (SYLVANT) in Patients Diagnosed With COVID-19 Infection Who Have Developed Serious Respiratory Complications
Lead Sponsor:
A.O. Ospedale Papa Giovanni XXIII
Conditions:
Severe Acute Respiratory Syndrome (ARDS) Secondary to SARS-COV-2 Infection
Eligibility:
All Genders
18+ years
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 s...
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- Active infection of bacterial or viral (non-Covid-19) origin
- Treatment with other anti-interleukin therapy
Key Trial Info
Start Date :
March 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 8 2020
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04322188
Start Date
March 19 2020
End Date
May 8 2020
Last Update
June 1 2020
Active Locations (1)
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1
ASST - Papa Giovanni XXIII
Bergamo, Italy, 24127