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An Observational Case-control Study of the Use of Siltuximab in ARDS Patients Diagnosed With COVID-19 Infection

2020-03-31 04:03:56 | BioPortfolio

Summary

This observational study will collect data from patients treated under a compassionate use programme with siltuximab (SYLVANT) 400mg; 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

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).

Study Design

Conditions

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

Location

ASST - Papa Giovanni XXIII
Bergamo
Italy
24127

Status

Recruiting

Source

A.O. Ospedale Papa Giovanni XXIII

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-03-31T04:03:56-0400

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