PREdiction of DIagnosed Covid-19 infecTion in IUC Patients

NCT ID: NCT04327180

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

368 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-30

Study Completion Date

2021-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Coronavirus 2019 (COVID-19) is a respiratory tropism virus transmitted through droplets emitted into the environment of infected persons. The symptoms can be extremely varied and the course can range from spontaneous healing without sequelae to death.

Currently, the diagnosis of certainty for resuscitation patients (by definition "severe") is based on searching for a fragment of virus genetic material within the epithelial cells of the respiratory tree, up and/or down, by PCR.

It is to be expected that the epidemic peak will make it difficult (if not impossible) to respect the stereotypical path that is currently in place, due to the lack of space in the specific unit. This will require optimization of care pathways and use of the specific sectors.

It is therefore necessary to define the simple criteria, available from the moment patients are admitted, to predict the result of the COVID-19 PCR.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infection Viral Coronavirus ARDS Pneumonia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

critical care biology of infectious agent

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patients suspected of infection with COVID-19.

Patients included with positive PCR and patients with negative PCR included

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All patient admitted in ICU Lille Hospital and hospitalized in the unit "Emergent Biological Risk" (REB) before a suspicion of infection with COVID-19
* Clinical infectious syndrome: fever (\>38°C) or hypothermia ( 36°C), chill, fever at home
* a severe respiratory table defined by:
* Oxygen demand \> 3 L/min in the presence of significant comorbidity (pregnancy, chronic respiratory disease, chronic heart disease, hemopathy, cirrhosis) or \> 6 L/min in the absence of comorbidity
* or a respiratory rate \> 30 cycles per minute
* the need for mechanical, invasive or non-invasive ventilation
* the need for humidified high-flow oxygen therapy

Exclusion Criteria

* Patient already included in study for first stay
* Cirrhosis CHILD C
* Major surgery in the last 7 days Minor patient
* Patient under guardianship or curatorship
* Refusal to participate
* No social security coverage.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Julien Poissy, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hôpital Roger Salengro, ICU, CHU Lille

Lille, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Ledoult E, Guerrier T, Dubucquoi S, Figeac M, Villenet C, Daunou B, Behal H, Pokeerbux MR, Machet T, Koether V, Collet A, Launay D; Lille Covid Research network (LICORNE). Dual role of plasmablasts as immune regulators or amplifiers in COVID-19. Clin Immunol. 2025 Oct 13;281:110609. doi: 10.1016/j.clim.2025.110609. Online ahead of print.

Reference Type DERIVED
PMID: 41093046 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-A00763-36

Identifier Type: OTHER

Identifier Source: secondary_id

2020_20

Identifier Type: -

Identifier Source: org_study_id