Characteristics and Outcome of Patients With COVID-19 in... | NCT05077319

Studies
Characteristics and Outcome of Patients With COVID-19 in ICUs in South Tyrol

NCT05077319

Sponsor

Institute of Mountain Emergency Medicine

Status

Completed

Last Update Posted

Oct 14, 2021Actual

Enrollment

550Actual

Phase

Not provided

Conditions

COVID-19
COVID-19 Acute Respiratory Distress Syndrome

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 5, 2020Actual

Primary Completion Date

Sep 20, 2021Actual

Completion Date

Oct 4, 2021Actual

First Submitted Date

Oct 4, 2021

First Submission Date that Met QC Criteria

Oct 12, 2021

First Posted Date

Oct 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2021

Last Update Posted Date

Oct 14, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Simon Rauch, Senior researcher; MD, PhD, Institute of Mountain Emergency MedicinePrincipal Investigator

Lead Sponsor

Institute of Mountain Emergency MedicineOTHER

Collaborators

Name	Class
Azienda Sanitaria dell'Alto Adige	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators retrospectively investigate the epidemiology, clinical characteristics and therapeutic interventions of patients with COVID-19 associated respiratory failure admitted to the intensive care units in South Tyrol, Italy.

Detailed Description

In this observational, retrospective study the epidemiology, characteristics, therapeutic interventions and outcome of patients with COVID-19 associated respiratory failure admitted to the intensive care units in South Tyrol, Italy, are assessed. Data extracted from the medical patients' records include type and duration of respiratory support (high-flow nasal oxygen, non-invasive ventilation, invasive ventilation), need for tracheostomy, vasopressor needs, antibiotic therapy, corticosteroid treatment, laboratory values (interleukin-6, C-reactive protein, procalcitonin, D-dimer, lymphocyte count), lengths of stay in the ICU and mortality.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

550Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Mortality (dead/alive) at discharge from the ICU is defined as primary outcome	Through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients admitted to the intensive care units in South Tyrol due to COVID-19 associated respiratory failure

Exclusion Criteria:

SARS-CoV-2 patients admitted to the intensive care units in South Tyrol for other pathologies (i.e., not respiratory failure)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients admitted to the intensive care units in South Tyrol due to COVID-19 associated respiratory failure

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Simon Rauch, MD, PhD	Institute of Mountain Emergency Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eurac research		Bolzano		39100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided