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

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ClinicalTrials.gov Identifier: NCT04414059
Recruitment Status : Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Elsan

Brief Summary:
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.

Condition or disease
SARS-CoV 2 Hospitalisation-Associated Infection

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.

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Study Type : Observational
Estimated Enrollment : 155 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Complications Risk Factors in Patients Hospitalized for COVID-19 Infection: Role of Proteins Electrophoresis
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : August 2021



Primary Outcome Measures :
  1. Complications onset [ Time Frame: Up to 3 weeks ]
    hospitalisation in Intensive Care Unit OR Oxygen needs > 6 L/min OR death whatever the cause


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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)

  5. 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

  6. 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

  7. 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


Biospecimen Retention:   Samples Without DNA
Blood and urine samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414059


Contacts
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Contact: Shahnaz KLOUCHE (0)1 58 56 41 71 ext +33 klouche@elsan.care
Contact: Johanna MIMOUNI (0)1 56 69 16 45 ext +33 mimouni@elsan.care

Locations
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France
Clinique de l'Estrée
Stains, France
Contact: Stéphane DI MASCIO, MD    (0)1 49 71 71 71 ext +33    stephanedimascio@gmail.com   
Principal Investigator: Stephane DI MASCIO, MD         
Sponsors and Collaborators
Elsan
Additional Information:
Publications:

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Responsible Party: Elsan
ClinicalTrials.gov Identifier: NCT04414059    
Other Study ID Numbers: COVELEC
2020-A01376-33 ( Other Identifier: ID-RCB )
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elsan:
COVID-19
Additional relevant MeSH terms:
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Infection