NCT04411368

Brief Summary

This is an observational study to evaluate the clinical impact of respiratory virus in the patients with acute respiratory failure

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
540

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 27, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

June 2, 2020

Status Verified

May 1, 2020

Enrollment Period

2.6 years

First QC Date

May 27, 2020

Last Update Submit

May 30, 2020

Conditions

Acute Respiratory FailureAcute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

  • Rate of respiratory viral infections

    Rate of respiratory viral infections in patients with acute respiratory failure

    within 24 hours after intensive care unit (ICU) admission

Secondary Outcomes (2)

  • ICU mortality rate

    Through study completion, an average of 1 year

  • Hospital mortality rate

    Through study completion, an average of 1 year

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with presentation to ICU with critical illness compatible with acute respiratory failrue. \* Definition of acute respiratory failure: Patients who met one of following criteria 1. SaO2 \< 90% on room air 2. SaO2 \< 92% on \> 6L/min of oxygen 3. Respiratory rates \> 30/min, or sign of respiratory distress

You may qualify if:

  • Male or female aged ≥ 19 years
  • Written informed consent by the patient or legally authorized representative
  • Critical illness consistent with acute respiratory failure, to be enrolled within 24 hours of presentation

You may not qualify if:

  • No informed consent
  • A patient who is judged to be unable to make a voluntary decision by understanding information about this research due to cognitive vulnerability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal aspirates, Sputum

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Jongmin Lee

    Seoul St. Mary's Hospital

    STUDY DIRECTOR

Central Study Contacts

Jongmin Lee, Ph.D

CONTACT

+821063007128dibs03@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 27, 2020

First Posted

June 2, 2020

Study Start

June 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

June 2, 2020

Record last verified: 2020-05

Locations

KR(1)