<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/NCT04405492</url>
  </required_header>
  <id_info>
    <org_study_id>APHP200556</org_study_id>
    <nct_id>NCT04405492</nct_id>
  </id_info>
  <brief_title>Evaluation of Rapid Diagnostic Solutions, Serological and Molecular Tests for COVID-19</brief_title>
  <acronym>ERap-COV</acronym>
  <official_title>Evaluation of Rapid Diagnostic Solutions, Serological and Molecular Tests for COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      Prospective study for clinical performance evaluation of COVID-19 diagnostic tests: detection&#xD;
      of anti-SARS-CoV-2 antibodies by RDTs or ELISA (manual or automated), rapid diagnostic tests&#xD;
      based on antigen detection, molecular or proteomic testing of SARS-CoV-2 (sensitivity,&#xD;
      specificity, predictive values)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since initially reported in Wuhan, China, in late December 2019, the outbreak of SARS-CoV-2&#xD;
      (severe acute respiratory syndrome coronavirus 2) has spread globally, stressing many health&#xD;
      systems especially intensive care unit (ICU) capacities thus resulting in high mortality. On&#xD;
      16 March 2020, WHO Director-General called on all countries to ramp up their testing programs&#xD;
      as the best way to slow the advance of the coronavirus pandemic. Although the current gold&#xD;
      standard for COVID-19 diagnosis remains real time reverse transcription-polymerase chain&#xD;
      reaction (rRT-PCR), this technique has many shortcomings such as low sensitivity on&#xD;
      nasopharyngeal swabs (70%). Multiple diagnostic test manufacturers have developed and begun&#xD;
      selling rapid and easy-to-use devices. Before these tests can be recommended, they must be&#xD;
      validated in the appropriate populations and settings.&#xD;
&#xD;
      Funded by French Defense Innovation Agency (AID), ERap-CoV is a prospective clinical study&#xD;
      which aims to assess clinical performances of serological and antigenic assays for the&#xD;
      diagnosis of SARS-CoV-2 infection, in comparison with current diagnostic tests on the market&#xD;
      (immunological, proteomic, molecular). The ERap-CoV research will extend the clinical&#xD;
      validation of the first NG-Test IgM-IgG COVID-19 point-of-care immunodiagnostic test (NG&#xD;
      Biotech), which has shown excellent biological performance, compatible with the&#xD;
      recommendations of the Haute Autorité de Santé (HAS) for serological assays (sensitivity&gt; 90%&#xD;
      and specificity&gt; 98%, 15 days after symptoms) (1). Finally, AID funding will be used to&#xD;
      develop 100% French-made serological and antigenic RDTs in less than a year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 25, 2020</start_date>
  <completion_date type="Anticipated">March 25, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 25, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical performance of several diagnostic tests : tests based either on detection of the virus SARS-CoV-2 or detection of human antibodies generated in response to infection</measure>
    <time_frame>Total duration of the study is 10 months</time_frame>
    <description>Tests based on detection of the virus SARS-CoV-2 (antigenic rapid tests, molecular tests, proteomic tests): sensibility and specificity compared to RT-PCR (Ct) in salivary samples and nasopharyngeal swabs from patients and cargivers included in the study&#xD;
Tests based on detection of human antibodies generated in response to infection (rapid immunodiagnostic tests, ELISA): sensibility and specificity compared to RT-PCR (Ct) and ELISA (antibody titer) in blood or serum from patients and cargivers included in the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity and specificity of immunological, antigenic, molecular and proteomic tests according to symptom duration, stage of the disease: asymptomatic, ambulatory, hospitalized, ventilated</measure>
    <time_frame>Total duration of the study is 10 months</time_frame>
    <description>Hospitalized patients, positive or suspected of SARS-CoV-2 infection are included in the study. Medical data related to COVID-19 infection will be recorded.&#xD;
Caregivers will be asked information about their health status related to a possible COVID-19 infection: symptoms if any, symptoms duration, severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the incidence of infection among hospital caregivers, time to seroconversion according to clinical form, medium-term antibody persistence</measure>
    <time_frame>Caregivers will be included in the study for 9 months. After inclusion (Day 0), follow-up visits at Day 15, 1 Month, 3 Months, 6 Months, 9 Months will be done.</time_frame>
    <description>At each visit, participants will be asked information about their health status and their contacts with COVID-19 patients. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken. Point-of-care devices will be tested during the visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity and specificity of immunodiagnostic tests according to the sample used (serum and capillary blood) and according to the duration of the symptoms</measure>
    <time_frame>Total duration of the study is 10 months</time_frame>
    <description>Blood samples (capillary and venous) will be taken for serology testing from hospitalized patients, positive or suspected of SARS-CoV-2 infection and from hospital caregivers exposed to SARS-CoV-2. Participants will be asked information about their health status and medical data related to COVID-19 infection will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity and specificity of antigenic rapid tests, molecular tests, proteomic tests according to the sample used (salivary samples or nasopharyngeal swabs) and according to the duration of the symptoms</measure>
    <time_frame>Total duration of the study is 10 months</time_frame>
    <description>Blood samples (capillary and venous) will be taken for serology testing from hospitalized patients, positive or suspected of SARS-CoV-2 infection and from hospital caregivers exposed to SARS-CoV-2. Participants will be asked information about their health status and medical data related to COVID-19 infection will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suitability of rapid tests in view of its intended purpose for self-testing</measure>
    <time_frame>4 months</time_frame>
    <description>Two rapid tests (NG Biotech) allowing anti-SRAS-CoV-2 antibodies detection from a fingerpick blood sample and antigen detection from a salivary sample will be provided in 3 pharmacies of Ile de France. The inclusion of lay persons will be carried out in pharmacies by investigators of the recruiting centers (Bacteriology and Virology departments). After inclusion, one of the tests will be given to the participant for self-testing. After performing the test, the participant will complete a questionnaire to give a feedback on the test usability and the result obtained.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">1210</enrollment>
  <condition>SARS-CoV 2</condition>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Population 1 : Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hospitalized patients, positive or suspected of SARS-CoV-2 infection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Population 2 : Hospital caregivers exposed to SARS-CoV-2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Longitudinal study of a hospital caregiver cohort</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Population 3 : Lay users</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Suitability of rapid test in view of its intended purpose for self-testing</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling.</intervention_name>
    <description>After inclusion, demographic and medical data will be collected. Evaluated point-of-care devices will be tested immediately. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken. Clinical samples will be stored in a dedicated biobank. Other SARS-CoV-2 diagnostic tests will be evaluated in the laboratory on the different clinical samples retrieved from the biobank.&#xD;
For all antigenic, molecular and serological tests evaluated, the reference method will be real-time RT-PCR as well as the result of medical imaging carried out as part of patient care.</description>
    <arm_group_label>Population 1 : Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling.</intervention_name>
    <description>After inclusion, demographic and medical data will be collected. Point-of-care devices will be tested immediately. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken (D0). A follow-up at D15, M1, M3, M6, M9 will be done. At each visit, participants will be asked information about their health status and their contacts with COVID-19 patients. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken. Point-of-care devices will be tested during the visit.&#xD;
Cinical samples will be stored in a dedicated biobank. Other SARS-CoV-2 diagnostic tests will be evaluated in the laboratory on the different samples retrieved from the biobank.&#xD;
For all antigenic, molecular and serological tests evaluated, the reference method will be real-time RT-PCR as well as the result of medical imaging carried out as part of patient care.</description>
    <arm_group_label>Population 2 : Hospital caregivers exposed to SARS-CoV-2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Capillary and salivary sampling</intervention_name>
    <description>Two rapid tests (NG Biotech) allowing anti-SRAS-CoV-2 antibodies detection from a fingerpick blood sample and antigen detection from a salivary sample will be provided in 3 pharmacies of Ile de France. The inclusion of lay persons will be carried out in pharmacies by investigators of the recruiting centers (Bacteriology and Virology departments). After inclusion, one of the tests will be given to the participant for self-testing. After performing the test, the participant will complete a questionnaire to give a feedback on the test usability and the result obtained.</description>
    <arm_group_label>Population 3 : Lay users</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Common criteria for the 3 populations :&#xD;
&#xD;
          -  Persons over 18 years of age&#xD;
&#xD;
          -  Beneficiary or person entitled to a social security scheme&#xD;
&#xD;
        Population 1 (Patients) :&#xD;
&#xD;
          -  Patients presenting for hospital admission on suspicion of SARS-Cov-2 infection based&#xD;
             on the WHO definition and local guidelines&#xD;
&#xD;
          -  Patient or relative/trusted person who has been informed about the study and has given&#xD;
             informed consent.&#xD;
&#xD;
        Population 2 (Caregivers) :&#xD;
&#xD;
          -  Caregivers exposed to COVID-19 in the course of their duties in the clinical&#xD;
             departments of the Bicêtre and Paul Brousse hospitals.&#xD;
&#xD;
          -  Caregiver who gave informed consent.&#xD;
&#xD;
        Population 3 (Lay Users) :&#xD;
&#xD;
          -  Clients presenting themselves in one of the volunteer dispensary pharmacies located in&#xD;
             the Île-de-France region, who will be called &quot;lay users&quot;.&#xD;
&#xD;
          -  Presentation on a study site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Common criteria for the 3 populations:&#xD;
&#xD;
        - Person subject to a justice protection measure&#xD;
&#xD;
        Population 1 (Patients):&#xD;
&#xD;
          -  Refusal to participate by the patient / support person or close friend&#xD;
&#xD;
          -  Patient not speaking French and not accompanied by a translator&#xD;
&#xD;
          -  Patient under guardianship or curatorship&#xD;
&#xD;
          -  Person under AME (State medical aid)&#xD;
&#xD;
        Population 2 (Caregivers):&#xD;
&#xD;
        - Refusal to participate&#xD;
&#xD;
        Population 3 (lay users):&#xD;
&#xD;
          -  Refusal to participate&#xD;
&#xD;
          -  Person not speaking French and not accompanied by a translator&#xD;
&#xD;
          -  Person under AME (State medical aid)&#xD;
&#xD;
          -  Person out of state to consent, under guardianship or curatorship&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Thierry Naas</last_name>
    <phone>+33145212986</phone>
    <email>thierry.naas@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anne-Marie Roque-Afonso</last_name>
    <phone>+33145593720</phone>
    <email>anne-marie.roque@aphp.fr</email>
  </overall_contact_backup>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 25, 2020</last_update_submitted>
  <last_update_submitted_qc>May 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT04405492
org study id: APHP200556
nct id: NCT04405492
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective study for clinical performance evaluation of COVID-19 diagnostic tests: detection
      of anti-SARS-CoV-2 antibodies by RDTs or ELISA (manual or automated), rapid diagnostic tests
      based on antigen detection, molecular or proteomic testing of SARS-CoV-2 (sensitivity,
      specificity, predictive values)
Since initially reported in Wuhan, China, in late December 2019, the outbreak of SARS-CoV-2
      (severe acute respiratory syndrome coronavirus 2) has spread globally, stressing many health
      systems especially intensive care unit (ICU) capacities thus resulting in high mortality. On
      16 March 2020, WHO Director-General called on all countries to ramp up their testing programs
      as the best way to slow the advance of the coronavirus pandemic. Although the current gold
      standard for COVID-19 diagnosis remains real time reverse transcription-polymerase chain
      reaction (rRT-PCR), this technique has many shortcomings such as low sensitivity on
      nasopharyngeal swabs (70%). Multiple diagnostic test manufacturers have developed and begun
      selling rapid and easy-to-use devices. Before these tests can be recommended, they must be
      validated in the appropriate populations and settings.

      Funded by French Defense Innovation Agency (AID), ERap-CoV is a prospective clinical study
      which aims to assess clinical performances of serological and antigenic assays for the
      diagnosis of SARS-CoV-2 infection, in comparison with current diagnostic tests on the market
      (immunological, proteomic, molecular). The ERap-CoV research will extend the clinical
      validation of the first NG-Test IgM-IgG COVID-19 point-of-care immunodiagnostic test (NG
      Biotech), which has shown excellent biological performance, compatible with the
      recommendations of the Haute Autorité de Santé (HAS) for serological assays (sensitivity> 90%
      and specificity> 98%, 15 days after symptoms) (1). Finally, AID funding will be used to
      develop 100% French-made serological and antigenic RDTs in less than a year.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Clinical performance of several diagnostic tests : tests based either on detection of the virus SARS-CoV-2 or detection of human antibodies generated in response to infection
time frame: Total duration of the study is 10 months
description: Tests based on detection of the virus SARS-CoV-2 (antigenic rapid tests, molecular tests, proteomic tests): sensibility and specificity compared to RT-PCR (Ct) in salivary samples and nasopharyngeal swabs from patients and cargivers included in the study
Tests based on detection of human antibodies generated in response to infection (rapid immunodiagnostic tests, ELISA): sensibility and specificity compared to RT-PCR (Ct) and ELISA (antibody titer) in blood or serum from patients and cargivers included in the study
measure: Sensitivity and specificity of immunological, antigenic, molecular and proteomic tests according to symptom duration, stage of the disease: asymptomatic, ambulatory, hospitalized, ventilated
time frame: Total duration of the study is 10 months
description: Hospitalized patients, positive or suspected of SARS-CoV-2 infection are included in the study. Medical data related to COVID-19 infection will be recorded.
Caregivers will be asked information about their health status related to a possible COVID-19 infection: symptoms if any, symptoms duration, severity.
measure: Description of the incidence of infection among hospital caregivers, time to seroconversion according to clinical form, medium-term antibody persistence
time frame: Caregivers will be included in the study for 9 months. After inclusion (Day 0), follow-up visits at Day 15, 1 Month, 3 Months, 6 Months, 9 Months will be done.
description: At each visit, participants will be asked information about their health status and their contacts with COVID-19 patients. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken. Point-of-care devices will be tested during the visit.
measure: Sensitivity and specificity of immunodiagnostic tests according to the sample used (serum and capillary blood) and according to the duration of the symptoms
time frame: Total duration of the study is 10 months
description: Blood samples (capillary and venous) will be taken for serology testing from hospitalized patients, positive or suspected of SARS-CoV-2 infection and from hospital caregivers exposed to SARS-CoV-2. Participants will be asked information about their health status and medical data related to COVID-19 infection will be recorded.
measure: Sensitivity and specificity of antigenic rapid tests, molecular tests, proteomic tests according to the sample used (salivary samples or nasopharyngeal swabs) and according to the duration of the symptoms
time frame: Total duration of the study is 10 months
description: Blood samples (capillary and venous) will be taken for serology testing from hospitalized patients, positive or suspected of SARS-CoV-2 infection and from hospital caregivers exposed to SARS-CoV-2. Participants will be asked information about their health status and medical data related to COVID-19 infection will be recorded.
measure: Suitability of rapid tests in view of its intended purpose for self-testing
time frame: 4 months
description: Two rapid tests (NG Biotech) allowing anti-SRAS-CoV-2 antibodies detection from a fingerpick blood sample and antigen detection from a salivary sample will be provided in 3 pharmacies of Ile de France. The inclusion of lay persons will be carried out in pharmacies by investigators of the recruiting centers (Bacteriology and Virology departments). After inclusion, one of the tests will be given to the participant for self-testing. After performing the test, the participant will complete a questionnaire to give a feedback on the test usability and the result obtained.
arm group label: Population 1 : Patients
arm group type: Experimental
description: Hospitalized patients, positive or suspected of SARS-CoV-2 infection
arm group label: Population 2 : Hospital caregivers exposed to SARS-CoV-2
arm group type: Experimental
description: Longitudinal study of a hospital caregiver cohort
arm group label: Population 3 : Lay users
arm group type: Experimental
description: Suitability of rapid test in view of its intended purpose for self-testing
intervention type: Device
intervention name: Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling.
description: After inclusion, demographic and medical data will be collected. Evaluated point-of-care devices will be tested immediately. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken. Clinical samples will be stored in a dedicated biobank. Other SARS-CoV-2 diagnostic tests will be evaluated in the laboratory on the different clinical samples retrieved from the biobank.
For all antigenic, molecular and serological tests evaluated, the reference method will be real-time RT-PCR as well as the result of medical imaging carried out as part of patient care.
arm group label: Population 1 : Patients
intervention type: Device
intervention name: Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling.
description: After inclusion, demographic and medical data will be collected. Point-of-care devices will be tested immediately. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken (D0). A follow-up at D15, M1, M3, M6, M9 will be done. At each visit, participants will be asked information about their health status and their contacts with COVID-19 patients. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken. Point-of-care devices will be tested during the visit.
Cinical samples will be stored in a dedicated biobank. Other SARS-CoV-2 diagnostic tests will be evaluated in the laboratory on the different samples retrieved from the biobank.
For all antigenic, molecular and serological tests evaluated, the reference method will be real-time RT-PCR as well as the result of medical imaging carried out as part of patient care.
arm group label: Population 2 : Hospital caregivers exposed to SARS-CoV-2
intervention type: Device
intervention name: Capillary and salivary sampling
description: Two rapid tests (NG Biotech) allowing anti-SRAS-CoV-2 antibodies detection from a fingerpick blood sample and antigen detection from a salivary sample will be provided in 3 pharmacies of Ile de France. The inclusion of lay persons will be carried out in pharmacies by investigators of the recruiting centers (Bacteriology and Virology departments). After inclusion, one of the tests will be given to the participant for self-testing. After performing the test, the participant will complete a questionnaire to give a feedback on the test usability and the result obtained.
arm group label: Population 3 : Lay users
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Thierry Naas
phone: +33145212986
email: thierry.naas@aphp.fr
last name: Anne-Marie Roque-Afonso
phone: +33145593720
email: anne-marie.roque@aphp.fr
responsible party type: Sponsor
mesh term: COVID-19