NCT04619693: CortiCORONA

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

Terminated Last updated 17 December 2021

What this trial tests

trial in Pneumonia, Viral in 79 participants. Terminated before completion.

Timeline

18 November 2020

Primary endpoint
6 October 2021

6 October 2021

Quick facts

Lead sponsor	University Hospital, Montpellier
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	79
Start date	18 November 2020
Primary completion	6 October 2021
Estimated completion	6 October 2021
Sites	2 locations across France

Conditions studied

• Pneumonia, Viral — all drugs for Pneumonia, Viral →
• SARS-Cov-2 — all drugs for SARS-Cov-2 →

Sponsor

University Hospital, Montpellier

Who can join

18 and older, any sex, with Pneumonia, Viral or SARS-Cov-2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Corticosteroids for COVID-19 Therapy: Potential Implications on Tuberculosis.
   Gopalaswamy R, Subbian S. · · 2021 · cited 52× · PMID 33917321 · DOI 10.3390/ijms22073773
2. A close-up view of dynamic biomarkers in the setting of COVID-19: Striking focus on cardiovascular system.
   Rezabakhsh A, Sadat-Ebrahimi SR, Ala A, Nabavi SM, et al · · 2022 · cited 7× · PMID 34894069 · DOI 10.1111/jcmm.17122