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

NCT04619693 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 79

Last updated 2021-12-17

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Clement Boissin, MD · University Hospital, Montpellier

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-18
Primary Completion
2021-10-06
Completion
2021-10-06

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04619693 on ClinicalTrials.gov