PREdiction of DIagnosed Covid-19 infecTion in IUC Patients (PREDICT)

• ClinicalTrials.gov Identifier: NCT04327180
• Recruitment Status: Unknown
• First Posted: March 30, 2020
• Last Update Posted: April 6, 2020
• Sponsor: University Hospital, Lille
• Information provided by (Responsible Party): University Hospital, Lille

Study Description

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.

Condition or disease
Infection Viral; Coronavirus; ARDS; Pneumonia

Study Design

• Study Type: Observational
• Estimated Enrollment: 500 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: PCR-COVID-19 Predictors of Positivity in Patients Admitted to ICU for Respiratory Infection: A Prospective Observational Cohort Study
• Actual Study Start Date: March 30, 2020
• Estimated Primary Completion Date: September 2021
• Estimated Study Completion Date: September 2021

Groups and Cohorts

Group/Cohort
patients suspected of infection with COVID-19.; Patients included with positive PCR and patients with negative PCR included

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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.

Contacts and Locations

Contacts

Contact: Julien Poissy, MD,PhD; 0320444495 ext +33; julien.poissy@chru-lille.fr

Locations

France

Hôpital Roger Salengro, ICU, CHU Lille; Recruiting

Lille, France, 59037

Contact 0320445962

Principal Investigator: Julien Poissy, MD,PhD

Sub-Investigator: Julien Goutay, MD

Sub-Investigator: Morgan Caplan, MD

Sub-Investigator: Philippe Mathurin, MD,PhD

Sub-Investigator: Sophie Susen, MD,PhD

Sub-Investigator: Martine Remy-Jardin, MD,PhD

Sponsors and Collaborators

University Hospital, Lille

Investigators

• Principal Investigator: Julien Poissy, MD,PhD; University Hospital, Lille

More Information

• Responsible Party: University Hospital, Lille
• ClinicalTrials.gov Identifier: NCT04327180
• Other Study ID Numbers: 2020_20; 2020-A00763-36 ( Other Identifier: ID-RCB number,ANSM )
• First Posted: March 30, 2020
• Last Update Posted: April 6, 2020
• Last Verified: April 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:

critical care; biology of infectious agent

Additional relevant MeSH terms:

Infections; Communicable Diseases; Virus Diseases; Disease Attributes; Pathologic Processes