Covid19NeutroVIDNCT04930757
Involvement of Polymorphonuclear Neutrophils and Platelets in Severe Form of COVID-19
An observational study of Covid19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective is to quantify the population of reverse migrating neutrophils in patients with COVID-19. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2021to Apr 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients hospitalized in intensive care with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab.
Who may be able to join
- Patients admitted to the intensive care units of Saint-Antoine, Tenon and Pitié-Salpêtrière hospitals (Paris, France)
- With moderate to severe respiratory distress syndrome and SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab
- informed and not opposed to participation in research
- included within 4 hours following the paatient's admission
Who cannot join
- Patients under guardianship / curatorship
- Patients under AME
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Intensive care department, Hôpital Saint Antoine
Paris, 75012
Hafid AIT-OUFELLA, Professor, 01 49 28 23 15, hafid.aitoufella@aphp.fr
Carole ELBIM, Doctor, 06 60 80 85 98, carole.elbim@sorbonne-universite.fr
About this study
The main objective is to quantify the population of reverse migrating neutrophils in patients with COVID-19.
Read the detailed description
This is a non-interventional transversal research whose main objective is to quantify the population of reverse migrating neutrophils in patients with COVID-19.
Design:
A multicentric (3 sites) clinical trial
Sample size :
200 patients
Population concerned:
Patients hospitalized in intensive care with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab.
Duration of participation (treatment + follow-up): until the patient is discharged from the ICU and within 2 months top.
No interim analysis is planned. Analysis will be performed at the end of the study.
- Conditions
- Covid19
- Keywords
- Covid19, Neutrophils, Platelet aggregation activation, Clinical scores, SAPS II ("simplified acute physiology"), SOFA ("Sequential Organ Failure Assessment"), Global respiratory and non-respiratory scores
- Medical subject headings
- COVID-19
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 with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab. | Patients hospitalized in intensive care with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of circulating neutrophils in reverse migration
Percentage of circulating neutrophils in reverse migration determined on a sample taken during the admission of COVID 19 patients to Intensive Care Units by flow cytometry: the samples will be incubated for 45 minutes with anti-human CXCR1, CD11c, CD11b, and CD62L antibodies. Erythrocytes will be lysed and fixed leukocytes will be analyzed by flow cytometry.
Measured: Within 4 hours following the patient admission in Intensive Care Units (ICU).
Secondary outcomes (4)
Analysis of neutrophils and platelets
The analysis of neutrophils and platelets, and of the inflammatory environment will be carried out on a sample taken on admission of patients to Intensive Care Units
- Phenotypic and functional analysis of neutrophils
- Measurement of the oxidative explosion
- Measurement of neutrophil apoptosis
- Measurement of intravascular NETosis
- Analysis of platelet aggregation and activation
- Quantification of the fraction of immature platelets (IPF)
- Contribution of platelets to clot stiffness
- ELISA assay of soluble platelet activation markers
- Measurement of D-Dimers, von Willebrand factor, thrombin-antithrombin complex (TAT), α2-Plasmin-Plasmin-inhibitor
Measured: Within 4 hours following the patient admission in Intensive Care Units (ICU).
SAPS II score
Assessment of the link between phenotypic and functional markers of neutrophils on admission to the ICU.
The severity of the disease is determined using clinical scores (SAPS II ("simplified acute physiology") and SOFA ("Sequential Organ Failure Assessment") (global SOFA, respiratory and non-respiratory) scores; these scores will be assessed during the period of hospitalization in Intensive Care Units. An association between these 2 scores (SAPSII and SOFA scores) and the neutrophil markers will be sought.
Measured: From admission to the follow-up visits (Day 3, Day 7 and as part of usual care every 7 days until the patient is discharged and within 2 months top).
SOFA score
Assessment of the link between phenotypic and functional markers of neutrophils on admission to the ICU.
The severity of the disease is determined using clinical scores (SAPS II ("simplified acute physiology") and SOFA ("Sequential Organ Failure Assessment") (global SOFA, respiratory and non-respiratory) scores; these scores will be assessed during the period of hospitalization in Intensive Care Units. An association between these 2 scores (SAPSII and SOFA scores) and the neutrophil markers will be sought.
Measured: From admission to the follow-up visits (Day 3, Day 7 and as part of usual care every 7 days until the patient is discharged and within 2 months top).
Mortality rate
The mortality occurring within 2 months of admission of patients to an ICU will also be assessed.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start4 Feb 2021
- Primary completionFeb 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafid AIT-OUFELLA, Professor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04930757
- Sponsor's protocol ID
- APHP210061
- Acronym
- NeutroVID
- Status last verified
- Jun 2021
- First submitted
- 14 May 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Involvement of Polymorphonuclear Neutrophils and Platelets in Severe Form of COVID-19
- ClinicalTrials.gov ID
- NCT04930757
- Acronym / sponsor ID
- NeutroVID / APHP210061
- Conditions
- Covid19
- Keywords
- Covid19, Neutrophils, Platelet aggregation activation, Clinical scores, SAPS II ("simplified acute physiology"), SOFA ("Sequential Organ Failure Assessment"), Global respiratory and non-respiratory scores
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- Feb 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 18 Jun 2021 (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.
The main objective is to quantify the population of reverse migrating neutrophils in patients with COVID-19.
Detailed description
This is a non-interventional transversal research whose main objective is to quantify the population of reverse migrating neutrophils in patients with COVID-19.
Design:
A multicentric (3 sites) clinical trial
Sample size :
200 patients
Population concerned:
Patients hospitalized in intensive care with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab.
Duration of participation (treatment + follow-up): until the patient is discharged from the ICU and within 2 months top.
No interim analysis is planned. Analysis will be performed at the end of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab. | – | –Patients hospitalized in intensive care with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients hospitalized in intensive care with SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab.
Key inclusion criteria (4 listed)
- Patients admitted to the intensive care units of Saint-Antoine, Tenon and Pitié-Salpêtrière hospitals (Paris, France)
- With moderate to severe respiratory distress syndrome and SARS-CoV-2 infection confirmed by RT-PCR from a nasopharyngeal swab
- informed and not opposed to participation in research
- included within 4 hours following the paatient's admission
Key exclusion criteria (2 listed)
- Patients under guardianship / curatorship
- Patients under AME
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
Percentage of circulating neutrophils in reverse migration
Time frame: Within 4 hours following the patient admission in Intensive Care Units (ICU).
Percentage of circulating neutrophils in reverse migration determined on a sample taken during the admission of COVID 19 patients to Intensive Care Units by flow cytometry: the samples will be incubated for 45 minutes with anti-human CXCR1, CD11c, CD11b, and CD62L antibodies. Erythrocytes will be lysed and fixed leukocytes will be analyzed by flow cytometry.
4 secondary outcomes
Analysis of neutrophils and platelets
Time frame: Within 4 hours following the patient admission in Intensive Care Units (ICU).
SAPS II score
Time frame: From admission to the follow-up visits (Day 3, Day 7 and as part of usual care every 7 days until the patient is discharged and within 2 months top).
SOFA score
Time frame: From admission to the follow-up visits (Day 3, Day 7 and as part of usual care every 7 days until the patient is discharged and within 2 months top).
Mortality rate
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
Hafid AIT-OUFELLA, Professor principal investigator
Assistance Publique - Hôpitaux de Paris
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 Covid19, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hafid AIT-OUFELLA, Professor (01 49 28 23 15, hafid.aitoufella@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of circulating neutrophils in reverse migration (time frame: Within 4 hours following the patient admission in Intensive Care Units (ICU).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2021.