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
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 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
Clinique du Parc
Montpellier, France
University Hospitals of Montpellier
Montpellier, France
Clement Boissin, MD, Study Director
University Hospital, Montpellier