Infection ViralBIOCOVUNCT04341792
Predictive Biomarkers of Secondary Aggravation in Covid-19 Suspect Patient
An observational study of Infection Viral and Coronavirus, run by University Hospital, Lille at 1 site in France.
Trial summary
There is no predictive tool for patients admitted to the emergency department with a suspicion of Covid-19 that will worsen secondarily and require a heavy lifting. In a context of saturation of the healthcare system by the pandemic at Covid-19,it is essential to identify specific, accessible prognostic markers via… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection Viral, Coronavirus, COVID-19
- How many people
- 373 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2020to 12 Nov 2020
- 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: Adult population presenting to the emergency department during this pandemic period with symptoms suggestive of Covid-19 infection with no other probable diagnosis.
Who may be able to join
- Clinical criteria for suspicion of Covid-19 in an epidemic period
- Consultation in the emergency departement
- Non-opposition agree
Who cannot join
- impairment related to another identified cause than Covid-19, in particular a rapid diagnostic test flu-positive
- Severe patient from the outset with transfer to intensive care within 12 hours of admission to the Emergency Department
- No social security coverage (beneficiary or entitled person)
- Poor understanding of French
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Biomarkers of Secondary Aggravation in Covid-19 Suspect Patient Admitted to Emergency Departments During an Epidemic
There is no predictive tool for patients admitted to the emergency department with a suspicion of Covid-19 that will worsen secondarily and require a heavy lifting.
In a context of saturation of the healthcare system by the pandemic at Covid-19,it is essential to identify specific, accessible prognostic markers via minimally invasive sampling with low risk of infection for personnel caregiver, for optimal allocation of resuscitation resources.
This study proposes to evaluate the biological markers of routine care known to be associated with resuscitation admission in relation to hospitalization on conventional service for the prediction of worsening of patients admitted to the emergencies for Covid-19.
- Conditions
- Infection Viral, Coronavirus, COVID-19
- Keywords
- infection viral, biological risk factor, coronavirus, covid-19
- Medical subject headings
- Virus Diseases, Coronavirus Infections, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of secondary aggravation
Secondary aggravation is defined as :
- a re-hospitalization or
- aggravation in hospitalization : development or increase in oxygen dependency, hemodynamic failure, and/or respiratory, death
Measured: an average at 30 days (- 2 days +3 days) of admission to the emergency department
Secondary outcomes (4)
Change of standart biological parameters
the number of leukocytes, lymphocytes, neutrophil polynuclear cells, CRP, fibrinogen, and the D-dimers.
Measured: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department
Change of Von willebrand factor (vWF) changes over time
Measured: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department
Change of the Factor VIII (FVIII)
Measured: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department
Prevalence of positivity of COVID-19 virus measured by PCR or serology
Measured: an average at 30 days (- 2 days +3 days) of admission to the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start11 Apr 2020
- Primary completion12 Nov 2020
- Study completion12 Nov 2020
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
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine Garrigue, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341792
- Sponsor's protocol ID
- 2020_33
- Other IDs
- 2020-A00906-33
- Acronym
- BIOCOVU
- Status last verified
- Dec 2025
- First submitted
- 7 Apr 2020
- Last updated
- 23 Dec 2025
- 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 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Biomarkers of Secondary Aggravation in Covid-19 Suspect Patient Admitted to Emergency Departments During an Epidemic
- ClinicalTrials.gov ID
- NCT04341792
- Acronym / sponsor ID
- BIOCOVU / 2020_33
- Conditions
- Infection Viral, Coronavirus, COVID-19
- Keywords
- infection viral, biological risk factor, coronavirus, covid-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 11 Apr 2020 (actual)
- Primary completion
- 12 Nov 2020 (actual)
- Study completion
- 12 Nov 2020 (actual)
- First posted
- 10 Apr 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.
There is no predictive tool for patients admitted to the emergency department with a suspicion of Covid-19 that will worsen secondarily and require a heavy lifting.
In a context of saturation of the healthcare system by the pandemic at Covid-19,it is essential to identify specific, accessible prognostic markers via minimally invasive sampling with low risk of infection for personnel caregiver, for optimal allocation of resuscitation resources.
This study proposes to evaluate the biological markers of routine care known to be associated with resuscitation admission in relation to hospitalization on conventional service for the prediction of worsening of patients admitted to the emergencies for Covid-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population presenting to the emergency department during this pandemic period with symptoms suggestive of Covid-19 infection with no other probable diagnosis.
Key inclusion criteria (3 listed)
- Clinical criteria for suspicion of Covid-19 in an epidemic period
- Consultation in the emergency departement
- Non-opposition agree
Key exclusion criteria (5 listed)
- impairment related to another identified cause than Covid-19, in particular a rapid diagnostic test flu-positive
- Severe patient from the outset with transfer to intensive care within 12 hours of admission to the Emergency Department
- No social security coverage (beneficiary or entitled person)
- Poor understanding of French
- 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
Rate of secondary aggravation
Time frame: an average at 30 days (- 2 days +3 days) of admission to the emergency department
Secondary aggravation is defined as : * a re-hospitalization or * aggravation in hospitalization : development or increase in oxygen dependency, hemodynamic failure, and/or respiratory, death
4 secondary outcomes
Change of standart biological parameters
Time frame: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department
Change of Von willebrand factor (vWF) changes over time
Time frame: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department
Change of the Factor VIII (FVIII)
Time frame: Between baseline and an average at 30 days (- 2 days +3 days) of admission to the emergency department
Prevalence of positivity of COVID-19 virus measured by PCR or serology
Time frame: an average at 30 days (- 2 days +3 days) of admission to the emergency department
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 23 Dec 2025.
- 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.
Delphine Garrigue, MD 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 3 inclusion and 5 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 23 Dec 2025. 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?
Rate of secondary aggravation (time frame: an average at 30 days (- 2 days +3 days) of admission to the emergency department). 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 NCT04341792, 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 23 Dec 2025.