<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04414059</url>
  </required_header>
  <id_info>
    <org_study_id>COVELEC</org_study_id>
    <secondary_id>2020-A01376-33</secondary_id>
    <nct_id>NCT04414059</nct_id>
  </id_info>
  <brief_title>Protein Electrophoresis as a Tool for Complications Prediction in COVID-19 Hospitalised Patients</brief_title>
  <acronym>COVELEC</acronym>
  <official_title>Complications Risk Factors in Patients Hospitalized for COVID-19 Infection: Role of Proteins Electrophoresis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Elsan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Elsan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The inflammation is central in COVID-19 infections. Our aim is to evaluate the clinical value&#xD;
      of measuring inflammation by using serum protein electrophoresis (SPE). SPE evaluation of&#xD;
      inflammation should be able to predict outcome, follow up evolution or treatment efficacy in&#xD;
      patients with coronavirus infection and thus anticipate their evolution to severe viral&#xD;
      infection and allow an optimal clinical management. SPE inflammation diagnostics will be&#xD;
      benchmarked with other diagnostics of inflammation, currently used more routinely.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In late December 2019, an outbreak of an emerging respiratory disease (COVID-19) caused by a&#xD;
      novel coronavirus named SARS-CoV-2 began in Wuhan City, Hubei Province, China and quickly&#xD;
      spread in a substantial number of countries. The epidemic was declared a pandemic by the Word&#xD;
      Health Organization (WHO) on 12 March 2020. SARS-CoV-2 has demonstrated the capability to&#xD;
      spread rapidly, leading to significant impacts on healthcare systems and causing societal&#xD;
      disruption.&#xD;
&#xD;
      Both clinical and epidemiological features of patients with COVID-19 have recently been&#xD;
      reported, demonstrating that the SARS-CoV-2 infection can be asymptomatic in some cases or&#xD;
      symptomatic in others. Symptomatology usually begins as mild with fever, fatigue, dry cough,&#xD;
      and occasional dyspnea. In a minority of patients, a sudden onset of severe symptoms may&#xD;
      develop 5-8 days into the illness including shortness of breath, pneumonitis, acute&#xD;
      respiratory distress syndrome (ARDS) and multi organ dysfunction leading to intensive care&#xD;
      unit (ICU) admission and high mortality. In some cases, accumulating evidence suggests that&#xD;
      severe COVID-19 symptoms could be due to a cytokine storm syndrome. As of May 3rd 2020, the&#xD;
      virus had infected 3,349,786 patients worldwide with more than 238,600 deaths, more often&#xD;
      among older patients with underlying health conditions.&#xD;
&#xD;
      With caseloads overwhelming hospitals and resources stretched thin in this surging pandemic&#xD;
      (high demand for oxygen, prolonged ventilation and even extracorporeal membrane oxygenation&#xD;
      (ECMO), particularly for patients with acute ARDS), there is an urgent need to enhance&#xD;
      clinical skills in order to predict from the many mild cases those few that will progress to&#xD;
      critical illness allowing a more efficient resource allocation and clinical management.&#xD;
&#xD;
      Several studies on patient blood have described features that were most predictive of ARDS.&#xD;
      These studies showed that severe cases, compared to mild cases, had : 1) older age; 2)&#xD;
      abnormalities in chest scanning (CT) such as multiple patch-like shadows and ground glass&#xD;
      opacity; 3) organ and coagulation dysfunction with a higher levels of alanine&#xD;
      aminotransferase (ALT), lactate dehydrogenase (LDH), C-reactive protein (CRP), ferritin and&#xD;
      D-dimer; 4) as well as markedly higher levels of immunological characteristics such as IL-2R,&#xD;
      IL-6, IL-10, and TNF- α ; 5) and an absolute T lymphocytes (CD4+ and CD8+ T cells) number&#xD;
      markedly lower in nearly all severe cases. These observations suggest that severity and&#xD;
      mortality might be due to virally driven systemic hyperinflammation secondary to failure of&#xD;
      the immune response to control infection (as shown for other viruses).&#xD;
&#xD;
      With this study we want to caracterize the predictive performance of the serum inflammation&#xD;
      profiles by protein electrophoresis, associated with clinical, radiological and biological&#xD;
      risk factors for worsening. This study is a prospective, observational study conducted on&#xD;
      patients hospitalized for an infection with the SARS-CoV-2 virus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 10, 2021</start_date>
  <completion_date type="Actual">September 10, 2022</completion_date>
  <primary_completion_date type="Actual">May 10, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Complications onset</measure>
    <time_frame>Up to 3 weeks</time_frame>
    <description>hospitalisation in Intensive Care Unit OR Oxygen needs &gt; 6 L/min OR death whatever the cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk value associated with each risk factor as identified at the end of the main study analysis</measure>
    <time_frame>Up to 3 weeks</time_frame>
    <description>Risk quantification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predictive performance and risk associated with each individual protein fraction</measure>
    <time_frame>Up to 3 weeks</time_frame>
    <description>Correlation between complications onset (as defined by hospitalisation in Intensive Care Unit OR Oxygen needs &gt; 6 L/min OR death whatever the cause) and individual protein fraction value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-patient kinetics evolution of the electrophoresis curves</measure>
    <time_frame>Up to 3 weeks</time_frame>
    <description>Evolution over time of the serum quantity of each individual protein fraction (6 fractions studied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intra-patient kinetics evolution of biological risk factors</measure>
    <time_frame>Up to 3 weeks</time_frame>
    <description>Evolution over time of the serum quantity of each biological risk factor (as defined for the study)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-expert reproducibility analysis of electrophoretic inflammatory profiles centrally reviewed</measure>
    <time_frame>After study completion, estimated 10 months after first patient enrolled</time_frame>
    <description>Central review of each serum protein electrophoresis curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contribution of urinary electrophoresis inflammation profiles in the interpretation of serum electrophoresis curves</measure>
    <time_frame>Up to 3 weeks</time_frame>
    <description>Urine samples at admission, every 4 days and at complications onset</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exploratory biological objective: Definition of a more detailed electrophoretic inflammatory profile</measure>
    <time_frame>After study completion, estimated 10 months after first patient enrolled</time_frame>
    <description>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</description>
  </secondary_outcome>
  <enrollment type="Actual">200</enrollment>
  <condition>SARS-CoV 2</condition>
  <condition>Hospitalisation-Associated Infection</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and urine samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients ≥ 18 years old hospitalized in a Covid-19 medical unit for a suspected or&#xD;
        confirmed SARS-CoV2 infection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male of female aged 18 or over&#xD;
&#xD;
          -  Patients with at least one of the following diagnostic criteria, allowing to suspect&#xD;
             an infection by the virus SARS-CoV- 2 :&#xD;
&#xD;
               -  Clinical picture with fever, and/or exertional dyspnea, and/or PO2 &lt; 80mmHg&#xD;
&#xD;
               -  And/or chest scanner very suggestive or compatible with a COVID-19 infection&#xD;
&#xD;
               -  And/or a RT-PCR positive result already known&#xD;
&#xD;
          -  Hospitalized patient in a COVID-19 medical unit, based on one or several diagnostic&#xD;
             elements described&#xD;
&#xD;
          -  Possibility to collect blood and urine samples as described in protocol&#xD;
&#xD;
          -  Patients informed of the study, having understood it, and who didn't oppose to their&#xD;
             participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical condition justifying immediate hospitalization in the intensive care unit&#xD;
&#xD;
          -  During the initial patient management, an immediate need of oxygen requiring&#xD;
             intubation and/or oxygen supply greater than 6 liters / minute&#xD;
&#xD;
          -  Patients under legal protection&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinique de l'Estrée</name>
      <address>
        <city>Stains</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Vauban</name>
      <address>
        <city>Valenciennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020</url>
    <description>Media briefing on COVID-19 from the WHO's Director General (11 March 2020)</description>
  </link>
  <link>
    <url>https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200503-covid-19-sitrep-104.pdf?sfvrsn=53328f46_4</url>
    <description>Coronavirus disease situation report from the WHO (3 May 2020)</description>
  </link>
  <link>
    <url>https://www.medrxiv.org/content/10.1101/2020.02.08.20021212v2</url>
    <description>Caution on kidney dysfunctions of 2019-nCoV patients.</description>
  </link>
  <link>
    <url>http://techscience.com/cmc/v63n1/38464</url>
    <description>Towards an Artificial Intelligence Framework for Data-Driven Prediction of Coronavirus Clinical Severity</description>
  </link>
  <link>
    <url>https://solidarites-sante.gouv.fr/IMG/pdf/point_de_situation_coronavirus_du_29_avril.pdf</url>
    <description>Communiqué de presse de la Direction Générale de la Santé (29 Avril 2020)</description>
  </link>
  <link>
    <url>https://www.lemonde.fr/planete/article/2020/04/27/coronavirus-la-mortalite-en-reanimation-beaucoup-plus-forte-qu-annoncee-en-france_6037853_3244.html</url>
    <description>Coronavirus : la mortalité en réanimation beaucoup plus forte qu'annoncée en France (article du journal Le Monde du 27 Avril 2020)</description>
  </link>
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    <citation>Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775. Erratum In: JAMA. 2020 May 26;323(20):2098.</citation>
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  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>October 18, 2022</last_update_submitted>
  <last_update_submitted_qc>October 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04414059
org study id: COVELEC
secondary id: 2020-A01376-33
nct id: NCT04414059
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Case-Only
time perspective: Prospective
measure: Complications onset
time frame: Up to 3 weeks
description: hospitalisation in Intensive Care Unit OR Oxygen needs > 6 L/min OR death whatever the cause
measure: Risk value associated with each risk factor as identified at the end of the main study analysis
time frame: Up to 3 weeks
description: Risk quantification
measure: Predictive performance and risk associated with each individual protein fraction
time frame: Up to 3 weeks
description: 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
measure: Intra-patient kinetics evolution of the electrophoresis curves
time frame: Up to 3 weeks
description: Evolution over time of the serum quantity of each individual protein fraction (6 fractions studied)
measure: Intra-patient kinetics evolution of biological risk factors
time frame: Up to 3 weeks
description: Evolution over time of the serum quantity of each biological risk factor (as defined for the study)
measure: Inter-expert reproducibility analysis of electrophoretic inflammatory profiles centrally reviewed
time frame: After study completion, estimated 10 months after first patient enrolled
description: Central review of each serum protein electrophoresis curve
measure: Contribution of urinary electrophoresis inflammation profiles in the interpretation of serum electrophoresis curves
time frame: Up to 3 weeks
description: Urine samples at admission, every 4 days and at complications onset
measure: Exploratory biological objective: Definition of a more detailed electrophoretic inflammatory profile
time frame: After study completion, estimated 10 months after first patient enrolled
description: 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
Blood and urine samples
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: France
url: https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020
description: Media briefing on COVID-19 from the WHO's Director General (11 March 2020)
url: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200503-covid-19-sitrep-104.pdf?sfvrsn=53328f46_4
description: Coronavirus disease situation report from the WHO (3 May 2020)
url: https://www.medrxiv.org/content/10.1101/2020.02.08.20021212v2
description: Caution on kidney dysfunctions of 2019-nCoV patients.
url: http://techscience.com/cmc/v63n1/38464
description: Towards an Artificial Intelligence Framework for Data-Driven Prediction of Coronavirus Clinical Severity
url: https://solidarites-sante.gouv.fr/IMG/pdf/point_de_situation_coronavirus_du_29_avril.pdf
description: Communiqué de presse de la Direction Générale de la Santé (29 Avril 2020)
url: https://www.lemonde.fr/planete/article/2020/04/27/coronavirus-la-mortalite-en-reanimation-beaucoup-plus-forte-qu-annoncee-en-france_6037853_3244.html
description: Coronavirus : la mortalité en réanimation beaucoup plus forte qu'annoncée en France (article du journal Le Monde du 27 Avril 2020)
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responsible party type: Sponsor
mesh term: Infections
mesh term: COVID-19