NCT04619693

Biomarkers for Dexamethasone Response in Sars-Cov-2 / COVID-19 Pneumonia

Determination of Biomarkers for the Prediction of Dexamethasone Response in Sars-Cov-2 / COVID-19 Pneumonia

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 79 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Pneumonia, Viral
• SARS-Cov-2

Timeline

• Start date: 2020-11-18
• Primary completion: 2021-10-06
• Completion: 2021-10-06
• First posted: 2020-11-06
• Last updated: 2021-12-17

Locations

2 sites across 1 country: France