NCT05077319

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

1.5 years

First QC Date

October 4, 2021

Last Update Submit

October 12, 2021

Conditions

COVID-19COVID-19 Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Mortality (dead/alive) at discharge from the ICU is defined as primary outcome

    Through study completion, an average of 1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eurac research

Bolzano, 39100, Italy

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Simon Rauch, MD, PhD

    Institute of Mountain Emergency Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher; MD, PhD

Study Record Dates

First Submitted

October 4, 2021

First Posted

October 14, 2021

Study Start

March 5, 2020

Primary Completion

September 20, 2021

Study Completion

October 4, 2021

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

IT(1)