NCT04474236

Brief Summary

The QUICK study main aim is to assess the predictive value at Day 1, of a model built on lung ultrasound (LUS) and clinical data, both recorded at hospital admission of COVID-19 patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

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

May 27, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2021

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

9 months

First QC Date

July 7, 2020

Last Update Submit

May 28, 2021

Conditions

Keywords

COVID-19Acute Respiratory FailureTriageLung UltrasoundCT scan

Outcome Measures

Primary Outcomes (1)

  • Area Under the Curve (AUC) of a predictive model built on LUS and clinical (Q-SOFA, SpiO2/FiO2) data

    Area Under the Curve (AUC) of a predictive model at 24h from hospital admission (Favorable vs Unfavorable), built on LUS (12 thoracic regions) and clinical (Q-SOFA, SpiO2/FiO2) data recorded at hospital admission.

    Day 1

Secondary Outcomes (2)

  • Area Under the Curve (AUC) of a predictive model built on CT scan and clinical (Q-SOFA, SpiO2/FiO2) data

    Day 1

  • mortality

    Day 28

Study Arms (1)

COVID-19 patients

Adult (\> 18 years) with Proven COVID-19 (specific PCR from respiratory track sample)

Other: thoracic lung ultrasound

Interventions

Patients will be recruited the day of their hospital admission. All patients will be assessed by thoracic Computed Tomography scan then immediately before/after CT scan, patients will be clinically assessed (Q-SOFA, SpiO2/FiO2) and a lung ultrasound evaluation (mean time of evaluation 7 min +/- 3 min; fully respect of COVID-19 barrier measures) will be performed by an investigator. Patients clinical status and outcomes will be extracted from patient's medical file at day 1 and day 28 from patient's admission by investigators blinded from previously recorded lung ultrasound data.

COVID-19 patients

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pilot study

You may qualify if:

  • Adult (\> 18 years).
  • Proven COVID-19 (specific PCR from respiratory track sample)
  • CT scan prescribed by physician in charge, independently of research.
  • Patients consent (or surrogate decision maker's consent in case of need).

You may not qualify if:

  • Reduction or cessation of active treatment.
  • Patient under guardianship, tutelage measure or judicial protection
  • Patient deprived of liberty by judicial order
  • No French health insurance.
  • Pregnancy or nursing woman.
  • Enrolled in another trial evaluating thoracic imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Benjamine SARTON, ph

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2020

First Posted

July 16, 2020

Study Start

May 27, 2020

Primary Completion

March 7, 2021

Study Completion

March 7, 2021

Last Updated

June 1, 2021

Record last verified: 2021-05

Locations