NCT04941092

Brief Summary

Since the beginning of the SARS CoV 2 pandemia, the SARS CoV 2 was frequently compared with the seasonal influenza virus. However, few studies compared patients presenting acute respiratory distress syndrome (ARDS) induced by these viruses, with results being discordant. Our study means to compare mortality and morbidity of patients hospitalized in an intensive care unit (ICU) with ARDS induced by SARS CoV-2 and seasonal influenza.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
157

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

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

June 1, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2021

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2021

Completed
Last Updated

July 12, 2022

Status Verified

July 1, 2022

Enrollment Period

1 month

First QC Date

June 24, 2021

Last Update Submit

July 8, 2022

Conditions

ARDSCOVID-19 Acute Respiratory Distress SyndromeInfluenza

Keywords

ards

Outcome Measures

Primary Outcomes (1)

  • mortality

    at 28 days

Secondary Outcomes (5)

  • length of stay in ICU

    at 28 days

  • length of mechanical ventilation

    at 28 days

  • length of vasopressors

    at 28 days

  • length of extrarenal epuration

    at 28 days

  • amount of drugs for sedation

    at 28 days

Study Arms (2)

patients with ARDS induced by SARS CoV 2

Other: no intervention

patients with ARDS induced by influenza

Other: no intervention

Interventions

no interventionOTHER

no intervention, retrospective comparison

patients with ARDS induced by SARS CoV 2patients with ARDS induced by influenza

Eligibility Criteria

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

patients hospitalized in Intensive Care Unit Hopital Central, Regional University Hospital of Nancy, France \- hospitalized between 2009 and 2019 if influenza and in 2020 if SARS CoV 2

You may qualify if:

  • patients hospitalized in ICU
  • under mechanical ventilation
  • presenting an ARDS according to the Berlin definition
  • induced by either influenza or SARS CoV 2

You may not qualify if:

  • pregnant women
  • mechanical ventilation\>48 hours before admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Nancy, 54000, France

Location

MeSH Terms

Conditions

Influenza, HumanAcute Lung Injury

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesLung InjuryLung Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 24, 2021

First Posted

June 28, 2021

Study Start

June 1, 2021

Primary Completion

July 10, 2021

Study Completion

July 10, 2021

Last Updated

July 12, 2022

Record last verified: 2022-07

Locations

FR(1)