PREdiction of DIagnosed Covid-19 infecTion in IUC Patients

NCT04327180 | Completed

• 2 other identifiers: 2020_202020-A00763-36
• Study Type: observational
• Target: 368
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infection Viral; Coronavirus; ARDS; Pneumonia

Keywords

critical care; biology of infectious agent

Outcome Measures

Primary Outcomes (1)

• Correlation between nasal and deep PCR positivity for Covid-19 patients performed and all predictors for Covid-19 patients performed within 24 hours of admission to ICU

  within 24 hours of admission to ICU

Secondary Outcomes (16)

• Coinfections

  during ICU stay, up to 28 days

• Respiratory dysfunction requiring mechanical ventilation

  during ICU stay, up to 28 days

• Sequential Organ Failure Assessment (SOFA) Score

  during ICU stay, up to 28 days

• SAPS II score

  at admission

• Disseminated Intravascular Coagulation (DIC) score

  during ICU stay, up to 28 days

Study Arms (1)

patients suspected of infection with COVID-19.

Patients included with positive PCR and patients with negative PCR included

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The selection of patients will be carried out by a Doctor of Medicine practising within the ICU Lille Hospital taking care of patients suspected of infection with COVID-19.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Roger Salengro, ICU, CHU Lille

Lille, 59037, France

Location

Related Publications (1)

• 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.

  PMID: 41093046 DERIVED

MeSH Terms

Conditions

Virus Diseases; Coronavirus Infections; Pneumonia

Condition Hierarchy (Ancestors)

Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Julien Poissy, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: March 30, 2020
• Study Start: March 30, 2020
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: December 6, 2023

Record last verified: 2023-12

Locations

FR (1)