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

SARS-Cov-2 Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• COVID-19
• Pneumonia
• Pneumonia, Viral
• SARS-Cov-2

• NCT number: NCT04619693
• Study type: Observational
• Source: University Hospital, Montpellier
• Status: Terminated
• Start date: November 18, 2020
• Completion date: October 6, 2021