Protein Electrophoresis as a Tool for Complications Prediction in COVID-19 Hospitalised Patients
Protein Electrophoresis as a Tool for Complications Prediction in COVID-19 Hospitalised Patients
The inflammation is central in COVID-19 infections. Our aim is to evaluate the clinical value
 of measuring inflammation by using serum protein electrophoresis (SPE). SPE evaluation of
 inflammation should be able to predict outcome, follow up evolution or treatment efficacy in
 patients with coronavirus infection and thus anticipate their evolution to severe viral
 infection and allow an optimal clinical management. SPE inflammation diagnostics will be
 benchmarked with other diagnostics of inflammation, currently used more routinely.
In late December 2019, an outbreak of an emerging respiratory disease (COVID-19) caused by a
 novel coronavirus named SARS-CoV-2 began in Wuhan City, Hubei Province, China and quickly
 spread in a substantial number of countries. The epidemic was declared a pandemic by the Word
 Health Organization (WHO) on 12 March 2020. SARS-CoV-2 has demonstrated the capability to
 spread rapidly, leading to significant impacts on healthcare systems and causing societal
 disruption.

 Both clinical and epidemiological features of patients with COVID-19 have recently been
 reported, demonstrating that the SARS-CoV-2 infection can be asymptomatic in some cases or
 symptomatic in others. Symptomatology usually begins as mild with fever, fatigue, dry cough,
 and occasional dyspnea. In a minority of patients, a sudden onset of severe symptoms may
 develop 5-8 days into the illness including shortness of breath, pneumonitis, acute
 respiratory distress syndrome (ARDS) and multi organ dysfunction leading to intensive care
 unit (ICU) admission and high mortality. In some cases, accumulating evidence suggests that
 severe COVID-19 symptoms could be due to a cytokine storm syndrome. As of May 3rd 2020, the
 virus had infected 3,349,786 patients worldwide with more than 238,600 deaths, more often
 among older patients with underlying health conditions.

 With caseloads overwhelming hospitals and resources stretched thin in this surging pandemic
 (high demand for oxygen, prolonged ventilation and even extracorporeal membrane oxygenation
 (ECMO), particularly for patients with acute ARDS), there is an urgent need to enhance
 clinical skills in order to predict from the many mild cases those few that will progress to
 critical illness allowing a more efficient resource allocation and clinical management.

 Several studies on patient blood have described features that were most predictive of ARDS.
 These studies showed that severe cases, compared to mild cases, had : 1) older age; 2)
 abnormalities in chest scanning (CT) such as multiple patch-like shadows and ground glass
 opacity; 3) organ and coagulation dysfunction with a higher levels of alanine
 aminotransferase (ALT), lactate dehydrogenase (LDH), C-reactive protein (CRP), ferritin and
 D-dimer; 4) as well as markedly higher levels of immunological characteristics such as IL-2R,
 IL-6, IL-10, and TNF- α ; 5) and an absolute T lymphocytes (CD4+ and CD8+ T cells) number
 markedly lower in nearly all severe cases. These observations suggest that severity and
 mortality might be due to virally driven systemic hyperinflammation secondary to failure of
 the immune response to control infection (as shown for other viruses).

 With this study we want to caracterize the predictive performance of the serum inflammation
 profiles by protein electrophoresis, associated with clinical, radiological and biological
 risk factors for worsening. This study is a prospective, observational study conducted on
 patients hospitalized for an infection with the SARS-CoV-2 virus.
Inclusion Criteria:

 -  Male of female aged 18 or over

 -  Patients with at least one of the following diagnostic criteria, allowing to suspect
 an infection by the virus SARS-CoV- 2 :

 -  Clinical picture with fever, and/or exertional dyspnea, and/or PO2 < 80mmHg

 -  And/or chest scanner very suggestive or compatible with a COVID-19 infection

 -  And/or a RT-PCR positive result already known

 -  Hospitalized patient in a COVID-19 medical unit, based on one or several diagnostic
 elements described

 -  Possibility to collect blood and urine samples as described in protocol

 -  Patients informed of the study, having understood it, and who didn't oppose to their
 participation

 Exclusion Criteria:

 -  Clinical condition justifying immediate hospitalization in the intensive care unit

 -  During the initial patient management, an immediate need of oxygen requiring
 intubation and/or oxygen supply greater than 6 liters / minute

 -  Patients under legal protection

 -  Pregnant or breastfeeding women