Infection ViralPREDICTNCT04327180
PREdiction of DIagnosed Covid-19 infecTion in IUC Patients
An observational study of Infection Viral and Coronavirus, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection Viral, Coronavirus, ARDS
- How many people
- 368 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2020to 30 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PCR-COVID-19 Predictors of Positivity in Patients Admitted to ICU for Respiratory Infection: A Prospective Observational Cohort Study
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.
Read more
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
- Medical subject headings
- Virus Diseases, Coronavirus Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients suspected of infection with COVID-19. | Patients included with positive PCR and patients with negative PCR included |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 24 hours of admission to ICU
Secondary outcomes (16)
Coinfections
Assessment of viral, bacterial, fungal and parasitic rate in confirmed and unconfirmed patients for COVID-19
Measured: during ICU stay, up to 28 days
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)
Measured: during ICU stay, up to 28 days
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).
Measured: during ICU stay, up to 28 days
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%.
Measured: at admission
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
Measured: during ICU stay, up to 28 days
Number of days on vasopressive amines
Measured: during ICU stay, up to 28 days
Occurrence of an event of venous or arterial thromboembolic disease
Measured: during ICU stay, up to 28 days
Number of days with extra renal treatment (ERA)
Measured: during ICU stay, up to 28 days
Number of patients alive after ICU stay less than 28 days will be tracked
Measured: At 28 day
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.
Measured: at 9 months +/- 3 months after ICU stay
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
Measured: at 9 months +/- 3 months after ICU stay
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
Measured: at 9 months +/- 3 months after ICU stay
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
Measured: at 9 months +/- 3 months after ICU stay
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
Measured: at 9 months +/- 3 months after ICU stay
Correlation between number of patient deaths and all predictors for Covid-19 including anamnestic, clinical, biological, radiological parameters
Measured: until day 28 after admission of ICU
Viral clearance
Evolution of viral clearance in nasal and depp PCR during ICU
Measured: through study completion, an average of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start30 Mar 2020
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infection ViralStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Poissy, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327180
- Sponsor's protocol ID
- 2020_20
- Other IDs
- 2020-A00763-36
- Acronym
- PREDICT
- Status last verified
- Dec 2023
- First submitted
- 25 Mar 2020
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 Dec;281:110609. doi: 10.1016/j.clim.2025.110609. Epub 2025 Oct 13.
PubMed 41093046
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCR-COVID-19 Predictors of Positivity in Patients Admitted to ICU for Respiratory Infection: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04327180
- Acronym / sponsor ID
- PREDICT / 2020_20
- Conditions
- Infection Viral, Coronavirus, ARDS, Pneumonia
- Keywords
- critical care, biology of infectious agent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 30 Mar 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients suspected of infection with COVID-19. | – | –Patients included with positive PCR and patients with negative PCR included |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
16 secondary outcomes
Coinfections
Time frame: during ICU stay, up to 28 days
Respiratory dysfunction requiring mechanical ventilation
Time frame: during ICU stay, up to 28 days
Sequential Organ Failure Assessment (SOFA) Score
Time frame: during ICU stay, up to 28 days
SAPS II score
Time frame: at admission
Disseminated Intravascular Coagulation (DIC) score
Time frame: during ICU stay, up to 28 days
Number of days on vasopressive amines
Time frame: during ICU stay, up to 28 days
Occurrence of an event of venous or arterial thromboembolic disease
Time frame: during ICU stay, up to 28 days
Number of days with extra renal treatment (ERA)
Time frame: during ICU stay, up to 28 days
Number of patients alive after ICU stay less than 28 days will be tracked
Time frame: At 28 day
Short Form 36
Time frame: at 9 months +/- 3 months after ICU stay
Hospital anxiety and depression scale (HADS)
Time frame: at 9 months +/- 3 months after ICU stay
Impact of Event Scale - revised (IES-R)
Time frame: at 9 months +/- 3 months after ICU stay
Post-traumatic stress disorder Checklist version DSM-5 (PSL-5)
Time frame: at 9 months +/- 3 months after ICU stay
Modified Medical Research Council (MMRC) Dyspnea Scale
Time frame: at 9 months +/- 3 months after ICU stay
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
Viral clearance
Time frame: through study completion, an average of 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Derived from this study: PubMed 41093046Ledoult 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 Dec;281:110609. doi: 10.1016/j.clim.2025.110609. Epub 2025 Oct 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien Poissy, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection Viral and Coronavirus, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04327180, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.