Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT04619693
Status:
TERMINATED
Last Update Posted:
2021-12-17
First Post:
2020-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers for Dexamethasone Response in Sars-Cov-2 / COVID-19 Pneumonia
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
Determination of Biomarkers for the Prediction of Dexamethasone Response in Sars-Cov-2 / COVID-19 Pneumonia
Status:
TERMINATED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty of recruitment with the increase of the vaccination against COVID19
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CortiCORONA
Brief Summary:
The primary objective of this study is to demonstrate (at the time of admission) biomarkers of interest (Human Plasma BAK125 panel + interferon panel) for dexamethasone responders versus non-responders in SARS-CoV-2 hypoxemic pneumonia.
The secondary objectives are to describe and compare between groups:
* The number of days without mechanical ventilation
* The need for mechanical ventilation
* 28-day mortality
* Progression towards acute respiratory distress syndrome (ARDS)
* Change in the qSOFA score
* Length of hospitalization
* The change in the extent of lesions on thoracic computed tomography scan between inclusion and D7 (or the day of discharge from hospital if \<D7)
* Change in biomarkers on D0, D2, D4, D7 (NFS, liver tests (ASAT, ALAT), Creatinine, Albumin, CRP, D-dimers, Ferritin, LDH, lymphocyte phenotyping)
* Demonstrate other biomarkers of interest from the usual management (NFS, liver function tests (ASAT, ALAT), Creatinine, Albumin, CRP, D-dimers, Ferritin, LDH, lymphocyte phenotyping)
* Change in biomarkers evaluated by mass spectrometry (on a blood sample) on D0 and D7 +/- 2 days
* The initial viral load (within 48 hours preceding D0) and at D7 of inclusion estimated from the nasopharyngeal SARS-CoV-2 RT-PCR
* Initial SARS-CoV-2 serology and on D7 from inclusion
* The A38G polymorphism of the gene coding for Club Cell Secretory Protein (CCSP) for each patient
* Short-term complications related to corticosteroid therapy
* The quantitative and qualitative impact of corticosteroid therapy on lymphocytes from patients with COVID-19.
The secondary objectives are to describe and compare between groups:
* The number of days without mechanical ventilation
* The need for mechanical ventilation
* 28-day mortality
* Progression towards acute respiratory distress syndrome (ARDS)
* Change in the qSOFA score
* Length of hospitalization
* The change in the extent of lesions on thoracic computed tomography scan between inclusion and D7 (or the day of discharge from hospital if \<D7)
* Change in biomarkers on D0, D2, D4, D7 (NFS, liver tests (ASAT, ALAT), Creatinine, Albumin, CRP, D-dimers, Ferritin, LDH, lymphocyte phenotyping)
* Demonstrate other biomarkers of interest from the usual management (NFS, liver function tests (ASAT, ALAT), Creatinine, Albumin, CRP, D-dimers, Ferritin, LDH, lymphocyte phenotyping)
* Change in biomarkers evaluated by mass spectrometry (on a blood sample) on D0 and D7 +/- 2 days
* The initial viral load (within 48 hours preceding D0) and at D7 of inclusion estimated from the nasopharyngeal SARS-CoV-2 RT-PCR
* Initial SARS-CoV-2 serology and on D7 from inclusion
* The A38G polymorphism of the gene coding for Club Cell Secretory Protein (CCSP) for each patient
* Short-term complications related to corticosteroid therapy
* The quantitative and qualitative impact of corticosteroid therapy on lymphocytes from patients with COVID-19.
Detailed Description:
This is a prospective multicenter cohort of patients treated with the usual standard of care including systemic corticosteroid therapy with dexamethasone 6 mg / day.
INCLUSION (D0): The patients are examined on the day of their hospital admission. After an initial eligibility check and if interest is expressed by the patient, a specific inclusion visit is carried out.
FOLLOW-UP: Patients are clinically evaluated at least twice a day (Clinical examination, SpO2, vital signs) during hospitalization. Chest computed tomography and SARS-CoV-2 serology are performed on D0. Viral load is evaluated by the polymerase chain reaction which allowed the diagnosis of covid-19 in the 48 hours preceding D0 and on D7. The evaluation of conventional biomarkers of interest (blood count, hepatic assessment (ASAT, ALAT), serum creatinine, albuminemia, CRP, D-Dimers, LDH, Ferritin) are carried out on D0 (before the 1st dose of corticosteroids), D2 , J4 and J7. The evaluation of biomarkers of interest evaluated by mass spectrometry is carried out on D0 and D7 +/- 2 days.
A follow-up call on D28 is carried out (telephone call, collection of vital status and hospitalizations).
INCLUSION (D0): The patients are examined on the day of their hospital admission. After an initial eligibility check and if interest is expressed by the patient, a specific inclusion visit is carried out.
FOLLOW-UP: Patients are clinically evaluated at least twice a day (Clinical examination, SpO2, vital signs) during hospitalization. Chest computed tomography and SARS-CoV-2 serology are performed on D0. Viral load is evaluated by the polymerase chain reaction which allowed the diagnosis of covid-19 in the 48 hours preceding D0 and on D7. The evaluation of conventional biomarkers of interest (blood count, hepatic assessment (ASAT, ALAT), serum creatinine, albuminemia, CRP, D-Dimers, LDH, Ferritin) are carried out on D0 (before the 1st dose of corticosteroids), D2 , J4 and J7. The evaluation of biomarkers of interest evaluated by mass spectrometry is carried out on D0 and D7 +/- 2 days.
A follow-up call on D28 is carried out (telephone call, collection of vital status and hospitalizations).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: