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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

79 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-18

Study Completion Date

2021-10-06

Brief Summary

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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

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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

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Pneumonia, Viral SARS-Cov-2

Keywords

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hypoxemic pneumonia corticosteroid glucocorticosteroid systemic corticosteroid COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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The study population

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clement Boissin, MD

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

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Clinique du Parc

Montpellier, , France

Site Status

University Hospitals of Montpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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2020-A0206-33

Identifier Type: OTHER

Identifier Source: secondary_id

PHRCI-20-013

Identifier Type: OTHER_GRANT