the Prognostic Value of FerritinNCT04469153
Interest of the Dosage of Ferritin / Glycosylated Ferritin in COVID-19
An observational study of the Prognostic Value of Ferritin and Glycosylated Ferritin in SARS-CoV-2 Infection in Hospitalized COVID-19 Patients, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a new coronavirus responsible for the pandemic called coronavirus disease 2019 (COVID-19), which appeared in China in December 2019 and which has spread rapidly around the world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- the Prognostic Value of Ferritin, Glycosylated Ferritin in SARS-CoV-2 Infection in Hospitalized COVID-19 Patients
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2020to 31 Dec 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: Patient hospitalized in the internal medicine department of the Croix-Rousse hospital and positive for the SARS-COV 2 (nasopharyngeal sample, the test was appoved by the French national medical authorities).
Who may be able to join
- Patient hospitalized in the internal medicine department of the Croix-Rousse hospital and positive for the SARS-COV 2 (nasopharyngeal sample, the test was appoved by the French national medical authorities).
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
hopital de la Croix Rousse
Lyon 04, Auvergne-Rhône-Alpes, 69317
Yvan Jamilloux, 4 26 73 26 36 ext. +33
About this study
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a new coronavirus responsible for the pandemic called coronavirus disease 2019 (COVID-19), which appeared in China in December 2019 and which has spread rapidly around the world. Even if in the vast majority of viral infection results in a mild illness, it can also progress to a severe form with sometimes fatal consequences.
Indeed, clinical worsening, between the 7th and 10th days of the onset of symptoms, has been widely described since the start of the pandemic. This manifests itself at the biological level by hyperinflammation (VS, CRP, ferritin), coagulopathy (elevation of D-dimers, sometimes disseminated intravascular coagulation) and cell lysis (CPK, LDH).
Read more
At the same time, it was observed high levels of pro-inflammatory cytokines (IL-1β, IL-6, TNF-α, IL-18), suggestive of a cytokine storm, and the first studies on therapeutic management targeting these cytokines are currently underway in COVID-19.
Such a profile strongly recalls on the one hand the cytokine release syndrome (CRS, observed in CAR-T cell therapy in malignant hematology), and on the other hand the lymphohistiocytic activation syndrome (SALH). Systemic diseases, such as adult Still's disease and its pediatric side, can also be complicated by a cytokine storm, known as macrophagic activation syndrome (SAM, equivalent to secondary SALH). Under all these conditions, IL-1β, IL-18, IFN-γ and IL-6 seem to be key mediators of hyperinflammation.
Plasma ferritin is a biological marker of inflammation, long known, associated with various infectious, hematological and immunological conditions. An increase in ferritin levels has in particular been associated with an unfavorable development in certain infections such as influenza and certain authors have moreover shown an association between plasma ferritin and the evolution towards ARDS or death in patients. Its dosage is also used as a diagnostic tool for SAM, and could make it possible to differentiate the latter from severe sepsis in intensive care. Some authors have also noted it as a prognostic factor in Kawasaki disease or CRS.
The plasma dosage of ferritin, associated with that of its glycosylated fraction, could therefore be a diagnostic (difference between SAM and severe sepsis in intensive care), prognostic (evolution towards ARDS, mutation in intensive care, mortality) and therapeutic (indication of preemptive treatment with an inhibitor of IL-1 or IL6) in patients infected with SARS-CoV-2.
The objective of this study is to retrospectively assess the prognostic value of ferritin and glycosylated ferritin in SARS-CoV-2 infection in hospitalized.
- Conditions
- the Prognostic Value of Ferritin, Glycosylated Ferritin in SARS-CoV-2 Infection in Hospitalized COVID-19 Patients
- Being tested
- No intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological tests
- Keywords
- SARS-CoV-2, Ferritin, glycosylated ferritin, prognostic factor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological testsOther
No intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological tests
| Study group | Role | What they receive |
|---|---|---|
| SARS-COV 2 positive patient | 57 SARS-COV-2 positive patients followed during the SARS-COV 2 epidemic in the internal medicine department of the Croix-Rousse hospital. For each patient ferritin and glycosylated ferritin was analysed one time (biological analysis) at the entry of the hospitalization. Receives: Other: No intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of the prognostic value of ferritin in sars-cov2 positiv patients
ferritin level will be assess by approved serological tests (French national medical authorities). Ferritin analysis is considered abnormal when the level is > at 388 µg/L;
Measured: the time point is measured one time (biological analysis) at the beginning of the hospitalization ie: day 0 (retrospective analysis).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start29 Jun 2020
- Primary completion1 Sep 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Prognostic Value of FerritinStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469153
- Sponsor's protocol ID
- 2020_FerriGly COVID
- Status last verified
- Jul 2020
- First submitted
- 29 Jun 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Dosage of Ferritin / Glycosylated Ferritin in COVID-19
- ClinicalTrials.gov ID
- NCT04469153
- Acronym / sponsor ID
- 2020_FerriGly COVID
- Conditions
- the Prognostic Value of Ferritin, Glycosylated Ferritin in SARS-CoV-2 Infection in Hospitalized COVID-19 Patients
- Keywords
- SARS-CoV-2, Ferritin, glycosylated ferritin, prognostic factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 13 Jul 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.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a new coronavirus responsible for the pandemic called coronavirus disease 2019 (COVID-19), which appeared in China in December 2019 and which has spread rapidly around the world. Even if in the vast majority of viral infection results in a mild illness, it can also progress to a severe form with sometimes fatal consequences.
Indeed, clinical worsening, between the 7th and 10th days of the onset of symptoms, has been widely described since the start of the pandemic. This manifests itself at the biological level by hyperinflammation (VS, CRP, ferritin), coagulopathy (elevation of D-dimers, sometimes disseminated intravascular coagulation) and cell lysis (CPK, LDH).
At the same time, it was observed high levels of pro-inflammatory cytokines (IL-1β, IL-6, TNF-α, IL-18), suggestive of a cytokine storm, and the first studies on therapeutic management targeting these cytokines are currently underway in COVID-19.
Such a profile strongly recalls on the one hand the cytokine release syndrome (CRS, observed in CAR-T cell therapy in malignant hematology), and on the other hand the lymphohistiocytic activation syndrome (SALH). Systemic diseases, such as adult Still's disease and its pediatric side, can also be complicated by a cytokine storm, known as macrophagic activation syndrome (SAM, equivalent to secondary SALH). Under all these conditions, IL-1β, IL-18, IFN-γ and IL-6 seem to be key mediators of hyperinflammation.
Plasma ferritin is a biological marker of inflammation, long known, associated with various infectious, hematological and immunological conditions. An increase in ferritin levels has in particular been associated with an unfavorable development in certain infections such as influenza and certain authors have moreover shown an association between plasma ferritin and the evolution towards ARDS or death in patients. Its dosage is also used as a diagnostic tool for SAM, and could make it possible to differentiate the latter from severe sepsis in intensive care. Some authors have also noted it as a prognostic factor in Kawasaki disease or CRS.
The plasma dosage of ferritin, associated with that of its glycosylated fraction, could therefore be a diagnostic (difference between SAM and severe sepsis in intensive care), prognostic (evolution towards ARDS, mutation in intensive care, mortality) and therapeutic (indication of preemptive treatment with an inhibitor of IL-1 or IL6) in patients infected with SARS-CoV-2.
The objective of this study is to retrospectively assess the prognostic value of ferritin and glycosylated ferritin in SARS-CoV-2 infection in hospitalized.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS-COV 2 positive patient | – | Other: No intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological tests57 SARS-COV-2 positive patients followed during the SARS-COV 2 epidemic in the internal medicine department of the Croix-Rousse hospital. For each patient ferritin and glycosylated ferritin was analysed one time (biological analysis) at the entry of the hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient hospitalized in the internal medicine department of the Croix-Rousse hospital and positive for the SARS-COV 2 (nasopharyngeal sample, the test was appoved by the French national medical authorities).
Key inclusion criteria (1 listed)
- Patient hospitalized in the internal medicine department of the Croix-Rousse hospital and positive for the SARS-COV 2 (nasopharyngeal sample, the test was appoved by the French national medical authorities).
Key exclusion criteria (1 listed)
- Not applicable
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 |
|---|---|---|
| No intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological testsNo intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological tests | Other | SARS-COV 2 positive patient |
Primary outcome
assessment of the prognostic value of ferritin in sars-cov2 positiv patients
Time frame: the time point is measured one time (biological analysis) at the beginning of the hospitalization ie: day 0 (retrospective analysis).
ferritin level will be assess by approved serological tests (French national medical authorities). Ferritin analysis is considered abnormal when the level is > at 388 µg/L;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
Related trials for the Prognostic Value of Ferritin
Not yet recruitingObservational study
Prognostic Value of CAR, AFR and Ferritin in Non-M3 AML
Acute Myeloid Leukemia, Non-M3 Acute Myeloid Leukemia
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.
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 the Prognostic Value of Ferritin and Glycosylated Ferritin in SARS-CoV-2 Infection in Hospitalized COVID-19 Patients, run by Hospices Civils de Lyon 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 1 inclusion and 1 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 13 Jul 2020. 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 Maxime FAUTER (4 26 73 26 36 ext. +33, maxime.fauter@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of the prognostic value of ferritin in sars-cov2 positiv patients (time frame: the time point is measured one time (biological analysis) at the beginning of the hospitalization ie: day 0 (retrospective analysis).). 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 13 Jul 2020.