CORONAVIRUS INFECTIONSCOVIDsFlt1NCT04394195
sFlt1: a Biomarker of Organ Dysfunction in Critically-ill Patients With COVID-19?
An observational study of CORONAVIRUS INFECTIONS, run by CHU de Reims at 1 site in France.
Trial summary
Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) The management of critically-ill patients with organ failure due to COVID-19 represents a major healthcare burden. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CORONAVIRUS INFECTIONS
- What is being tested?
- measurement of circulating sFlt1 concentration
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2020to 1 Sep 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: All adult patients with COVID-19 hospitalized in University Hospital of Reims
Who may be able to join
- Patient with documented COVID-19 (positive PCR)
- Hospitalized in University Hospital of Reims
- Patient or family who have previously consented
Who cannot join
- Patient <18 yo
- Patient not insured under the French social security
Trial locations and contacts
1 site in 1 country.
About this study
Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) The management of critically-ill patients with organ failure due to COVID-19 represents a major healthcare burden. While endothelial inflammation has been reported in these patients, the pathophysiological mechanisms remain incompletely elucidated.
Read the detailed description
Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures. (Limit : 32 000 characters)
The soluble fms-like tyrosine kinase 1 (SFlt1) is the soluble form of VEGF-A receptor 1 (VEGFR1). By linking VEGF-A with a high affinity, sFlt1 blocks the VEGF-A / VEFR1 axis and impairs endothelial homeostasis. Its production increases during inflammation. We hypothesize that sFlt1 is upregulated and correlates with endothelial dysfunction and outcomes in critically-ill patients with COVID-19.
- Conditions
- CORONAVIRUS INFECTIONS
- Being tested
- measurement of circulating sFlt1 concentration
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of circulating sFlt1 concentrationOther
blood circulating sFlt1 concentration will be determined
| Study group | Role | What they receive |
|---|---|---|
| patients with COVID-19 infection | patients with COVID-19 infection Receives: Other: measurement of circulating sFlt1 concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between concentration of circulating sFlt1 and use of vasopressor
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start3 Apr 2020
- Primary completion1 May 2020
- Study completion1 Sep 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 CORONAVIRUS INFECTIONSStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394195
- Sponsor's protocol ID
- PO20043*
- Acronym
- COVIDsFlt1
- Status last verified
- Mar 2021
- First submitted
- 16 May 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dupont V, Kanagaratnam L, Goury A, Poitevin G, Bard M, Julien G, Bonnivard M, Champenois V, Noel V, Mourvillier B, Nguyen P. Excess Soluble fms-like Tyrosine Kinase 1 Correlates With Endothelial Dysfunction and Organ Failure in Critically Ill Coronavirus Disease 2019 Patients. Clin Infect Dis. 2021 May 18;72(10):1834-1837. doi: 10.1093/cid/ciaa1007.
PubMed 32672790
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- sFlt1: a Biomarker of Organ Dysfunction in Critically-ill Patients With COVID-19?
- ClinicalTrials.gov ID
- NCT04394195
- Acronym / sponsor ID
- COVIDsFlt1 / PO20043*
- Conditions
- CORONAVIRUS INFECTIONS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 19 May 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.
Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) The management of critically-ill patients with organ failure due to COVID-19 represents a major healthcare burden. While endothelial inflammation has been reported in these patients, the pathophysiological mechanisms remain incompletely elucidated.
Detailed description
Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures. (Limit : 32 000 characters)
The soluble fms-like tyrosine kinase 1 (SFlt1) is the soluble form of VEGF-A receptor 1 (VEGFR1). By linking VEGF-A with a high affinity, sFlt1 blocks the VEGF-A / VEFR1 axis and impairs endothelial homeostasis. Its production increases during inflammation. We hypothesize that sFlt1 is upregulated and correlates with endothelial dysfunction and outcomes in critically-ill patients with COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with COVID-19 infection | – | Other: measurement of circulating sFlt1 concentrationpatients with COVID-19 infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with COVID-19 hospitalized in University Hospital of Reims
Key inclusion criteria (3 listed)
- Patient with documented COVID-19 (positive PCR)
- Hospitalized in University Hospital of Reims
- Patient or family who have previously consented
Key exclusion criteria (2 listed)
- Patient <18 yo
- Patient not insured under the French social security
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of circulating sFlt1 concentrationblood circulating sFlt1 concentration will be determined | Other | patients with COVID-19 infection |
Primary outcome
Association between concentration of circulating sFlt1 and use of vasopressor
Time frame: 14 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 1 Apr 2021.
- Derived from this study: PubMed 32672790Dupont V, Kanagaratnam L, Goury A, Poitevin G, Bard M, Julien G, Bonnivard M, Champenois V, Noel V, Mourvillier B, Nguyen P. Excess Soluble fms-like Tyrosine Kinase 1 Correlates With Endothelial Dysfunction and Organ Failure in Critically Ill Coronavirus Disease 2019 Patients. Clin Infect Dis. 2021 May 18;72(10):1834-1837. doi: 10.1093/cid/ciaa1007.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 CORONAVIRUS INFECTIONS, run by CHU de Reims 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 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: finished, as of the sponsor's last update on 1 Apr 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?
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?
Association between concentration of circulating sFlt1 and use of vasopressor (time frame: 14 days). 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 NCT04394195, 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 1 Apr 2021.