PREdiction of DIagnosed Covid-19 infecTion in IUC Patients

Pneumonia Clinical Trial

— PREDICT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04327180
• Other study ID #: 2020_20
• Secondary ID: 2020-A00763-36
• Status: Completed
• Start date: March 30, 2020
• Est. completion date: January 30, 2021

Study information

• Verified date: December 2023
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: January 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ARDS
• Communicable Diseases
• Coronavirus
• Infection Viral
• Infections
• Pneumonia
• Virus Diseases

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, ICU, CHU Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Coinfections	Assessment of viral, bacterial, fungal and parasitic rate in confirmed and unconfirmed patients for COVID-19	during ICU stay, up to 28 days
Secondary	Respiratory dysfunction requiring mechanical ventilation	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)	during ICU stay, up to 28 days
Secondary	Sequential Organ Failure Assessment (SOFA) Score	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).	during ICU stay, up to 28 days
Secondary	SAPS II score	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%.	at admission
Secondary	Disseminated Intravascular Coagulation (DIC) score	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	during ICU stay, up to 28 days
Secondary	Number of days on vasopressive amines		during ICU stay, up to 28 days
Secondary	Occurrence of an event of venous or arterial thromboembolic disease		during ICU stay, up to 28 days
Secondary	Number of days with extra renal treatment (ERA)		during ICU stay, up to 28 days
Secondary	Number of patients alive after ICU stay less than 28 days will be tracked		At 28 day
Secondary	Short Form 36	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.	at 9 months +/- 3 months after ICU stay
Secondary	Hospital anxiety and depression scale (HADS)	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	at 9 months +/- 3 months after ICU stay
Secondary	Impact of Event Scale - revised (IES-R)	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	at 9 months +/- 3 months after ICU stay
Secondary	Post-traumatic stress disorder Checklist version DSM-5 (PSL-5)	Question the stressful experience or event, followed by 20 multiple-choice questions.; Measuring the long-term impact of confirmed COVID-19 infection	at 9 months +/- 3 months after ICU stay
Secondary	Modified Medical Research Council (MMRC) Dyspnea Scale	The mMRC Dyspnea Scale stratifies severity of dyspnea in respiratory diseases Measuring the long-term impact of confirmed COVID-19 infection	at 9 months +/- 3 months after ICU stay
Secondary	Correlation between number of patient deaths and all predictors for Covid-19 including anamnestic, clinical, biological, radiological parameters		until day 28 after admission of ICU
Secondary	Viral clearance	Evolution of viral clearance in nasal and depp PCR during ICU	through study completion, an average of 28 days