NCT04354558

Brief Summary

Since the outbreak of a syndrome of acute respiratory distress associated to a novel coronavirus 2 (SARS-Cov2) that began in China, Europe and France have to face a sanitary emergency with critically care support when the patient evolves to an acute respiratory distress (ARDS). In the context of supply shortages (ventilators, bed capacities) that countries have to deal with, data were lacking of characteristics and outcomes of patients admitted to intensive care unit (ICU). the purpose of this project is to report the epidemiology and the outcomes of a French cohort of critically ill patients with SARS-Cov2

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 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

April 6, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

April 6, 2020

Last Update Submit

March 21, 2023

Conditions

Keywords

EpidemiologySars-CoV2COVID 19critical careprognosticsurvival

Outcome Measures

Primary Outcomes (5)

  • Variation of age between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU

    Variation of age between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU

    from day 1 of admission

  • Variation of medical history between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU

    Variation of medical history between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU

    from day 1 of admission

  • Variation of chronic drug used between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU

    Variation of chronic drug used between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU

    from day 1 of admission

  • Variation of chest CT scan at admission, between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU

    Variation of chest CT scan at admission, between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU

    from day 1 of admission

  • Variation of respiratory support at ICU admission, between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU

    Variation of respiratory support at ICU admission, between critically ill patients with SARS Cov2 admitted in ICU with non critically ill patients with SARS Cov2 admitted in ICU

    from day 1 of admission

Study Arms (2)

survival patients

The cohort will be dichotomised in survival/non-survival groups according to the issue during ICU stay

non-survival patients

The cohort will be dichotomised in survival/non-survival groups according to the issue during ICU stay

Eligibility Criteria

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

Critically ill patients with SARS Cov2 admitted in ICU

You may qualify if:

  • years old
  • patient with positive rRT PCR of SARS Cov2 on a sample of nasopharyngeal swab
  • admission in intensive care unit

You may not qualify if:

  • patient under 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

Related Publications (2)

  • Beyls C, Huette P, Viart C, Mestan B, Haye G, Guilbart M, Bernasinski M, Besserve P, Leviel F, Witte Pfister A, De Dominicis F, Jounieaux V, Berna P, Dupont H, Abou-Arab O, Mahjoub Y. Mortality of COVID-19 Patients Requiring Extracorporeal Membrane Oxygenation During the Three Epidemic Waves. ASAIO J. 2022 Dec 1;68(12):1434-1442. doi: 10.1097/MAT.0000000000001787. Epub 2022 Oct 2.

  • Beyls C, Hermida A, Bohbot Y, Martin N, Viart C, Boisgard S, Daumin C, Huette P, Dupont H, Abou-Arab O, Mahjoub Y. Automated left atrial strain analysis for predicting atrial fibrillation in severe COVID-19 pneumonia: a prospective study. Ann Intensive Care. 2021 Dec 7;11(1):168. doi: 10.1186/s13613-021-00955-w.

Biospecimen

Retention: SAMPLES WITHOUT DNA

alveolar liquid

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Osama Abou Arab, MD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 21, 2020

Study Start

July 1, 2020

Primary Completion

July 1, 2023

Study Completion

August 1, 2023

Last Updated

March 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations