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

University Hospital Center (CHU)

Status: Terminated

Conditions: SARS-Cov-2; Pneumonia, Viral

Study type: Observational

Funder types: Other

Identifiers

NCT04619693

PHRCI-20-013 (Other Grant/Funding Number)

RECHMPL20_0292

2020-A0206-33 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hospitalization for SARS-COV-2 pneumonia
• SARS-COV-2 infection proven by polymerase chain reaction (Nasopharyngeal or other respiratory sampling (expectoration, tracheal aspiration, bronchoalveolar lavage fluid)
• Presence of at least one of the following clinical signs of infectious pneumonia: fever (>38°C), cough, dyspnoea, thoracic pain, crackling/rales
• Presence of at least one of the following on a lung computed tomography scan performed within two days of inclusion/randomisation: uni- or bilateral ground glass opacities, consolidations, alveolar condensations, inter- or intra-lobular reticulations, crazy paving
• Indication for dexamethasone corticotherapy (defined by the presence of hypoxemia with room-air SpO2 <94% or a requirement for oxygen therapy to maintain Sp02 >94%)

Exclusion criteria

• Systemic long-term anti-inflammatory treatment (corticosteroids or anti-interleukins) for chronic disease
• Systemic corticosteroid treatment in the 15 days preceding the eligibility visit (for disease other than COVID-19)
• Systemic corticosteroid treatment for COVID-19 started more than 48h before the eligibility visit
• Absolute contraindication for systemic corticosteroid treatment
• Aside from the current acute episode, life expectancy of <6 months
• Patient unable to comply with all study procedures (e.g. contraindication for thoracic scans or bloodwork)
• Protected populations according to the French public health code (Pregnant, parturient or lactating women; adults under any form of guardianship; prisoners or persons under any form of judicial protection)
• Potential interference from other studies (Participation in any clinical trial of an investigational agent or procedure within one month prior to screening or during the study; exclusion period determined by another study.)
• It is impossible to correctly inform the patient (e.g. language barrier)
• Absence of free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research)
• Non-beneficiary of the French social security, single-payer health insurance system

Trial design

79 participants in 1 patient group

The study population

Description:

The study population corresponds to patients hospitalized for proven SARS-COV-2 pneumonia with an indication (hypoxemia) for dexamethasone (see eligibility criteria)