NCT04485338

Brief Summary

To assess the prognostic performance of the RALE score with respect to duration of ventilation, and to describe changes in the RALE score over time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 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

First Submitted

Initial submission to the registry

July 23, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

5 months

First QC Date

July 23, 2020

Last Update Submit

February 15, 2022

Conditions

Covid19

Keywords

Chest radiographyRALEscoreRadiographic Assessment of Lung EdemaICUinvasively ventilated

Outcome Measures

Primary Outcomes (1)

  • The prognostic capacity of the Radiographic Assessment of Lung Edema (RALE) score of the first CXR under invasive ventilation in patients with severe COVID-19.

    90 days

Secondary Outcomes (2)

  • The prognostic capacity of changes in the RALE score of consecutive CXRs under invasive ventilation in patients with severe COVID-19

    90 days

  • Number of ventilator-free day and alive at day 28 (VFD)

    28 days

Eligibility Criteria

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

Severe COVID-19 patients under invasive ventilation who received as part of standard care and routine imaging.

You may qualify if:

  • Admitted to an ICU participating in this study between December 1, 2019 and May 31, 2020
  • Having had received invasive ventilation
  • Having had received at least one chest radiograph under invasive ventilation
  • Confirmed novel coronavirus diseases (COVID-19)

You may not qualify if:

  • \- Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC location AMC

Amsterdam, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Marcus J. Schultz, Prof.

    Amsterdam University Medical Centers, location 'AMC'

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. M.J. Schultz, MD PhD

Study Record Dates

First Submitted

July 23, 2020

First Posted

July 24, 2020

Study Start

August 1, 2020

Primary Completion

December 31, 2020

Study Completion

September 1, 2021

Last Updated

February 16, 2022

Record last verified: 2022-02

Locations

NL(1)