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Completed

NCT Number: NCT04327180

PREdiction of DIagnosed Covid-19 infecTion in IUC Patients

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.

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Key information

Conditions

Infection Viral ARDS Coronaviridae Infections Coronavirus Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Roger Salengro, ICU, CHU Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

    Time frame: within 24 hours of admission to ICU

Secondary outcomes

  1. Coinfections

    Time frame: during ICU stay, up to 28 days

    Assessment of viral, bacterial, fungal and parasitic rate in confirmed and unconfirmed patients for COVID-19

  2. Respiratory dysfunction requiring mechanical ventilation

    Time frame: during ICU stay, up to 28 days

    it will be reported the evolution of respiratory dysfunction in patients infected with COVID-19 admitted to ICU during their stay and requiring mechanical ventilation (during, Pao2/FIO2 ratio,,features of artificial ventilation features of extra-bodied respiratory assistance)

  3. Sequential Organ Failure Assessment (SOFA) Score

    Time frame: during ICU stay, up to 28 days

    the SOFA assessment is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from 0 (normal) to 4 (high degree of dysfunction/failure).

  4. SAPS II score

    Time frame: at admission

    APS II was designed to measure the severity of disease for patients admitted to Intensive care units 24 hours after admission to the ICU, the measurement has been completed and resulted in an integer point score between 0 and 163 and a predicted mortality between 0% and 100%.

  5. Disseminated Intravascular Coagulation (DIC) score

    Time frame: during ICU stay, up to 28 days

    The DIC Score was developed by the The International Society of Thrombosis and Haemostasis (ISTH.) The DIC score calculator accounts of the following four parameters.Each of the four parameters evaluated above have values that are weighted with a number of points varying from 0 to 3. By summing the points given to the choices, a final result between 0 and 8 is obtained

  6. Number of days on vasopressive amines

    Time frame: during ICU stay, up to 28 days

  7. Occurrence of an event of venous or arterial thromboembolic disease

    Time frame: during ICU stay, up to 28 days

  8. Number of days with extra renal treatment (ERA)

    Time frame: during ICU stay, up to 28 days

  9. Number of patients alive after ICU stay less than 28 days will be tracked

    Time frame: At 28 day

  10. Short Form 36

    Time frame: at 9 months +/- 3 months after ICU stay

    measuring the long-term impact of confirmed COVID-19 infection. assessment of quality of life according to 8 areas: physical activity (and related limitations), body pain, perception of one's own health, mental health (and related limitations), social life and vitality.

  11. Hospital anxiety and depression scale (HADS)

    Time frame: at 9 months +/- 3 months after ICU stay

    The scale allows to detect anxiety and depression using 14 items rated from 0-3.

    Measuring the long-term impact of confirmed COVID-19 infection

  12. Impact of Event Scale - revised (IES-R)

    Time frame: at 9 months +/- 3 months after ICU stay

    22-item self-report measure that assesses subjective distress caused by traumatic events Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) Measuring the long-term impact of confirmed COVID-19 infection

  13. Post-traumatic stress disorder Checklist version DSM-5 (PSL-5)

    Time frame: at 9 months +/- 3 months after ICU stay

    Question the stressful experience or event, followed by 20 multiple-choice questions.

    Measuring the long-term impact of confirmed COVID-19 infection

  14. Modified Medical Research Council (MMRC) Dyspnea Scale

    Time frame: at 9 months +/- 3 months after ICU stay

    The mMRC Dyspnea Scale stratifies severity of dyspnea in respiratory diseases Measuring the long-term impact of confirmed COVID-19 infection

  15. Correlation between number of patient deaths and all predictors for Covid-19 including anamnestic, clinical, biological, radiological parameters

    Time frame: until day 28 after admission of ICU

  16. Viral clearance

    Time frame: through study completion, an average of 28 days

    Evolution of viral clearance in nasal and depp PCR during ICU

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

PCR-COVID-19 Predictors of Positivity in Patients Admitted to ICU for Respiratory Infection: A Prospective Observational Cohort Study

Acronym: PREDICT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 30, 2020
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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