Glycosylated Ferritin in SARS-CoV-2 Infection in Hospitalized COVID-19 Patients Clinical Trial
Official title:
Interest of the Dosage of Ferritin / Glycosylated Ferritin in COVID-19
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.
| Status | Recruiting |
| Enrollment | 57 |
| Est. completion date | December 31, 2020 |
| Est. primary completion date | September 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - Not applicable |
| Country | Name | City | State |
|---|---|---|---|
| France | hopital de la Croix Rousse | Lyon 4 | Rhone Alpes |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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; | the time point is measured one time (biological analysis) at the beginning of the hospitalization ie: day 0 (retrospective analysis). |