Protein Electrophoresis as a Tool for Complications Prediction in COVID-19 Hospitalised Patients (COVELEC)

October 18, 2022 updated by: Elsan

Complications Risk Factors in Patients Hospitalized for COVID-19 Infection: Role of Proteins Electrophoresis

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Stains, France
        • Clinique de l'Estrée
      • Valenciennes, France
        • Clinique Vauban

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients ≥ 18 years old hospitalized in a Covid-19 medical unit for a suspected or confirmed SARS-CoV2 infection.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications onset
Time Frame: Up to 3 weeks
hospitalisation in Intensive Care Unit OR Oxygen needs > 6 L/min OR death whatever the cause
Up to 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk value associated with each risk factor as identified at the end of the main study analysis
Time Frame: Up to 3 weeks
Risk quantification
Up to 3 weeks
Predictive performance and risk associated with each individual protein fraction
Time Frame: Up to 3 weeks
Correlation between complications onset (as defined by hospitalisation in Intensive Care Unit OR Oxygen needs > 6 L/min OR death whatever the cause) and individual protein fraction value
Up to 3 weeks
Intra-patient kinetics evolution of the electrophoresis curves
Time Frame: Up to 3 weeks
Evolution over time of the serum quantity of each individual protein fraction (6 fractions studied)
Up to 3 weeks
Intra-patient kinetics evolution of biological risk factors
Time Frame: Up to 3 weeks
Evolution over time of the serum quantity of each biological risk factor (as defined for the study)
Up to 3 weeks
Inter-expert reproducibility analysis of electrophoretic inflammatory profiles centrally reviewed
Time Frame: After study completion, estimated 10 months after first patient enrolled
Central review of each serum protein electrophoresis curve
After study completion, estimated 10 months after first patient enrolled
Contribution of urinary electrophoresis inflammation profiles in the interpretation of serum electrophoresis curves
Time Frame: Up to 3 weeks
Urine samples at admission, every 4 days and at complications onset
Up to 3 weeks
Exploratory biological objective: Definition of a more detailed electrophoretic inflammatory profile
Time Frame: After study completion, estimated 10 months after first patient enrolled
Biobank with serum samples for the implementation, at the end of the study, of a high-resolution capillary electrophoresis technique enabling each serum protein to be viewed individually
After study completion, estimated 10 months after first patient enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elsan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2021

Primary Completion (Actual)

May 10, 2022

Study Completion (Actual)

September 10, 2022

Study Registration Dates

First Submitted

June 1, 2020

First Submitted That Met QC Criteria

June 2, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVELEC
  • 2020-A01376-33 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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