<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/NCT04468217</url>
  </required_header>
  <id_info>
    <org_study_id>PRO-02</org_study_id>
    <nct_id>NCT04468217</nct_id>
  </id_info>
  <brief_title>Evaluation of an Alternative Method of Obtaining Viral RNA for the Detection of SARS-CoV-2 Virus Using PCR</brief_title>
  <official_title>Evaluation of an Alternative Method of Obtaining Viral RNA for the Detection of SARS-CoV-2 Virus Using PCR</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neurognos</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neurognos</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 current coronavirus disease pandemic has posed a problem and a challenge for health&#xD;
      systems globally. In the framework of a pandemic, a diagnosis is a key tool in containing and&#xD;
      monitoring disease outbreaks.&#xD;
&#xD;
      In this pandemic, the qPCR technique has become vitally important in virus detection, due to&#xD;
      its wide detection and quantification range, and the high levels of sensitivity and&#xD;
      specificity it presents. The methodology for diagnosing coronavirus by qPCR requires the&#xD;
      prior extraction of viral genetic material, which is carried out using commercial kits&#xD;
      created for this purpose. Currently, the high demand for supplies to carry out this technique&#xD;
      has generated reagent shortage problems, including commercial kits for the extraction of&#xD;
      viral genetic material.&#xD;
&#xD;
      This research aims to evaluate a solution called AAA-Safe and its method, developed to&#xD;
      optimize the diagnostic process, eliminating and replacing the viral RNA extraction stage. We&#xD;
      hope that this alternative can be implemented in any molecular diagnostic laboratory, in&#xD;
      order to speed up the delivery of a fast and safe diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This analytical and non-interventional study will evaluate the performance of a new workflow&#xD;
      for the detection of SARS-CoV-2 viral RNA from samples of nasopharyngeal, oropharyngeal,&#xD;
      buccal, nasal and saliva mucosa using as transport medium the propietary AAA-Safe solution,&#xD;
      in 150 volunteers in two different locations. The first sampling location will be held in a&#xD;
      private clinic, where healthcare professionals will be enrolled. The second sampling location&#xD;
      will be held at an essential services company, where samples will be taken by employees who&#xD;
      voluntarily want to participate in the study.&#xD;
&#xD;
      All volunteers will be informed of all aspects of this protocol and must sign an informed&#xD;
      consent before there participation. All the information associated with the samples requested&#xD;
      will be duly anonymized in order to protect the identity of the volunteers.&#xD;
&#xD;
      The extracted samples will be processed and analyzed to obtain the detection limit of the&#xD;
      diagnostic flow by implementing the developed solution and to establish the clinical&#xD;
      performance in terms of sensitivity and specificity of the technique.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 2, 2020</start_date>
  <completion_date type="Anticipated">September 25, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of an alternative method of obtaining viral RNA for the detection of SARS-CoV-2 virus in nasopharyngeal samples.</measure>
    <time_frame>3 months</time_frame>
    <description>Two workflows for the detection of SARS-CoV-2 will be compared:&#xD;
Gold Standard: Obtaining nasopharyngeal sample in validated transport medium, RNA extraction by columns and qPCR.&#xD;
Alternative method: Obtaining nasopharyngeal sample in AAA-Safe proprietary transport medium, alternative method of extraction and qPCR.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of an alternative method of obtaining viral RNA for the detection of SARS-CoV-2 virus in oropharyngeal, nasal, buccal and saliva samples</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Establish a sample bank of nasopharyngeal, oropharyngeal, nasal, buccal and saliva mucosa for future analytical validations of new solutions associated with the detection of the SARS-CoV-2 virus.</measure>
    <time_frame>3 month</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>COVID</condition>
  <condition>SARS-CoV2</condition>
  <condition>Corona Virus Infection</condition>
  <arm_group>
    <arm_group_label>Subjects with positive test to SARS-COV2</arm_group_label>
    <description>Employees of critical services companies and healthcare workers with a positive test to SARS-COV2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects with negative test to SARS-COV2</arm_group_label>
    <description>Employees of critical services companies and healthcare workers with a negative test to SARS-COV2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Obtainment of nasopharyngeal, oropharyngeal, buccal, nasal and saliva samples</intervention_name>
    <description>Each patient will undergo a sample collection where two nasopharyngeal samples will be obtained, one of them with lysis buffer as the transport medium and the other with the AAA-Safe solution as the transport medium. Oropharyngeal, buccal, nasal, and salivary samples will also be obtained using AAA-Safe as the transport medium</description>
    <arm_group_label>Subjects with negative test to SARS-COV2</arm_group_label>
    <arm_group_label>Subjects with positive test to SARS-COV2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Two groups can be identified within the study population:&#xD;
&#xD;
          -  The first group are health professionals (nurses, doctors, kinesiologists, etc.) who&#xD;
             are working in healthcare centers during the current pandemic.&#xD;
&#xD;
          -  The second group are employees of an essential services company.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years and older&#xD;
&#xD;
          -  Volunteer able to understand and sign the informed consent&#xD;
&#xD;
          -  Healthcare professionals&#xD;
&#xD;
          -  Essential services company workers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Older than 75 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Laboratorio Neurognos</name>
      <address>
        <city>Santiago</city>
        <state>Providencia</state>
        <zip>7500000</zip>
        <country>Chile</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>José Miguel Vega Soto</last_name>
      <phone>931021487</phone>
      <email>contacto@neurognos.com</email>
    </contact>
    <investigator>
      <last_name>Alejandro Bisquertt Zavala</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>David Chamorro Veloso</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 10, 2020</last_update_submitted>
  <last_update_submitted_qc>July 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Diagnostics</keyword>
  <keyword>RNA Extraction</keyword>
  <keyword>COVID</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04468217
org study id: PRO-02
nct id: NCT04468217
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current coronavirus disease pandemic has posed a problem and a challenge for health
      systems globally. In the framework of a pandemic, a diagnosis is a key tool in containing and
      monitoring disease outbreaks.

      In this pandemic, the qPCR technique has become vitally important in virus detection, due to
      its wide detection and quantification range, and the high levels of sensitivity and
      specificity it presents. The methodology for diagnosing coronavirus by qPCR requires the
      prior extraction of viral genetic material, which is carried out using commercial kits
      created for this purpose. Currently, the high demand for supplies to carry out this technique
      has generated reagent shortage problems, including commercial kits for the extraction of
      viral genetic material.

      This research aims to evaluate a solution called AAA-Safe and its method, developed to
      optimize the diagnostic process, eliminating and replacing the viral RNA extraction stage. We
      hope that this alternative can be implemented in any molecular diagnostic laboratory, in
      order to speed up the delivery of a fast and safe diagnosis.
This analytical and non-interventional study will evaluate the performance of a new workflow
      for the detection of SARS-CoV-2 viral RNA from samples of nasopharyngeal, oropharyngeal,
      buccal, nasal and saliva mucosa using as transport medium the propietary AAA-Safe solution,
      in 150 volunteers in two different locations. The first sampling location will be held in a
      private clinic, where healthcare professionals will be enrolled. The second sampling location
      will be held at an essential services company, where samples will be taken by employees who
      voluntarily want to participate in the study.

      All volunteers will be informed of all aspects of this protocol and must sign an informed
      consent before there participation. All the information associated with the samples requested
      will be duly anonymized in order to protect the identity of the volunteers.

      The extracted samples will be processed and analyzed to obtain the detection limit of the
      diagnostic flow by implementing the developed solution and to establish the clinical
      performance in terms of sensitivity and specificity of the technique.
observational model: Case-Control
time perspective: Prospective
measure: Evaluation of an alternative method of obtaining viral RNA for the detection of SARS-CoV-2 virus in nasopharyngeal samples.
time frame: 3 months
description: Two workflows for the detection of SARS-CoV-2 will be compared:
Gold Standard: Obtaining nasopharyngeal sample in validated transport medium, RNA extraction by columns and qPCR.
Alternative method: Obtaining nasopharyngeal sample in AAA-Safe proprietary transport medium, alternative method of extraction and qPCR.
measure: Evaluation of an alternative method of obtaining viral RNA for the detection of SARS-CoV-2 virus in oropharyngeal, nasal, buccal and saliva samples
time frame: 3 months
measure: Establish a sample bank of nasopharyngeal, oropharyngeal, nasal, buccal and saliva mucosa for future analytical validations of new solutions associated with the detection of the SARS-CoV-2 virus.
time frame: 3 month
arm group label: Subjects with positive test to SARS-COV2
description: Employees of critical services companies and healthcare workers with a positive test to SARS-COV2.
arm group label: Subjects with negative test to SARS-COV2
description: Employees of critical services companies and healthcare workers with a negative test to SARS-COV2.
intervention type: Diagnostic Test
intervention name: Obtainment of nasopharyngeal, oropharyngeal, buccal, nasal and saliva samples
description: Each patient will undergo a sample collection where two nasopharyngeal samples will be obtained, one of them with lysis buffer as the transport medium and the other with the AAA-Safe solution as the transport medium. Oropharyngeal, buccal, nasal, and salivary samples will also be obtained using AAA-Safe as the transport medium
arm group label: Subjects with negative test to SARS-COV2
arm group label: Subjects with positive test to SARS-COV2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Chile
responsible party type: Sponsor
mesh term: Coronavirus Infections
sharing ipd: Undecided