<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/NCT04404062</url>
  </required_header>
  <id_info>
    <org_study_id>C20010</org_study_id>
    <nct_id>NCT04404062</nct_id>
  </id_info>
  <brief_title>Serological and PCR Testing for COVID-19</brief_title>
  <official_title>Serological and PCR Testing for SARS-CoV-2. A Prospective Study Assessing Infection, Immunity, and Asymptomatic Carriage of COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Richmond Research Institute</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Richmond Pharmacology Limited</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Richmond Pharmacology Limited</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>
      Richmond Research Institute (RRI) is applying existing and new COVID-19 PCR and antibody&#xD;
      tests to help develop methodologies which provide fast and accurate results. Infection with&#xD;
      coronavirus (SARS-CoV-2) is currently a worldwide pandemic and reliable testing for COVID-19&#xD;
      is crucial to understand who is infected and therefore a risk to others by spreading the&#xD;
      infection. RRI are currently carrying out the following tests:&#xD;
&#xD;
      A. Using a membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 in whole&#xD;
      blood, serum or plasma specimens helps to assess whether an individual has previously had the&#xD;
      virus and is potentially immune&#xD;
&#xD;
      B. Polymerase Chain Reaction (PCR) testing using an established method to check for active&#xD;
      SARS-CoV-2 infections.&#xD;
&#xD;
      C. Quantification of anti-SARS-CoV-2 IgG and IgM antibodies in whole blood samples.&#xD;
&#xD;
      The above tests are being used by RRI to follow infections (PCR) and immunity (IgG) in their&#xD;
      workforce, as well as their families (including children) and visitors to their site.&#xD;
&#xD;
      Collecting this data allows the gathering of epidemiological data on SARS-CoV-2 including&#xD;
      incidence, prevalence, information on asymptomatic carriers and efficacy of vaccination.&#xD;
      Furthermore, identifying individuals that are infected with SARS-CoV-2 has great potential to&#xD;
      improve health outcomes by allowing infected individuals to seek the correct medical&#xD;
      treatment as well as self-isolate and reduce transmission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a screening study to measure symptomatic and asymptomatic carriage of SARS-CoV-2 in&#xD;
      trial participants to help facilitate early detection of a second wave of SARS-CoV-2&#xD;
      infections. Specifically, this study aims to determine ; to assess the duration of immunity&#xD;
      by assessing the number and speed at which trial participants were infected and cleared the&#xD;
      virus with or without symptoms; and to determine the length of symptom onset in those with an&#xD;
      active infection; levels of IgG antibodies by demographics (sex, age, ethnicity, and&#xD;
      intensity of symptoms). Longitudinal assessment of antibody levels will additionally allow&#xD;
      for assessment of the efficacy of any vaccines adminstered. This study also seeks to explore&#xD;
      how many people are asymptomatic carriers. In addition, this study aims to help facilitate&#xD;
      the development a quantitative laboratory reference test for antibodies (IgG).&#xD;
&#xD;
      By using multiple different tests, it can be determined if a person is currently infected&#xD;
      with SARS-CoV-2 or whether they previously have been infected. This allows for the scanning&#xD;
      of people with asymptomatic carriage of the virus, which is important to help reduce the&#xD;
      spread of SARS-CoV-2 through contact with people unaware of infection.&#xD;
&#xD;
      Polymerase Chain Reaction (PCR) testing is routinely used to check for active SARS-CoV-2&#xD;
      infections. It measures whether viral RNA is present in an individual's system. All in-house&#xD;
      PCR tests are verified by an independent laboratory to check for false positives.&#xD;
&#xD;
      Using a membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 in whole&#xD;
      blood, serum or plasma specimens helps to assess whether an individual has previously had the&#xD;
      virus and is potentially immune. IgG and IgM detection components are separate allowing for&#xD;
      differential detection of each antibody.&#xD;
&#xD;
      To this date, 20904 PCR tests and 6848 antibody tests have been carried out in 2328&#xD;
      individuals, providing some interim data. Of the 20904 PCR tests, 17635 (84%) were negative&#xD;
      and 132 (1%) were negative. Of the 6848 antibody tests, 706 (10%) were positive for IgG only,&#xD;
      64 (1%) were positive for IgM only, and 351 (5%) were positive for both IgG and IgM. 5710&#xD;
      (83%) tests were negative.&#xD;
&#xD;
      Of those individuals with a positive PCR test, 53% reported fever during the previous two&#xD;
      months and 75% reported a loss of taste during the previous two months.&#xD;
&#xD;
      Interim results are shown in the medRxiv papers below:&#xD;
&#xD;
      https://www.medrxiv.org/content/10.1101/2020.12.08.20245894v2&#xD;
&#xD;
      https://www.medrxiv.org/content/10.1101/2021.04.09.21255200v1&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 16, 2020</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identification of carriers of SARS-CoV-2</measure>
    <time_frame>Through study completion, estimated 12 weeks</time_frame>
    <description>To identify trial participants who are symptomatic or asymptomatic carriers of SARS-CoV-2 by comparing the results of a blood finger stick test and reference laboratory tests to PCR testing for acute infection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determination of the duration of immunity to SARS-CoV-2</measure>
    <time_frame>Through study completion, estimated 12 weeks</time_frame>
    <description>To determine the duration of immunity of trial participants previously infected with SARS-CoV-2, measure differences in IgG antibodies by demographics including sex, ethnicity and age and investigate correlation between IgG antibody levels and intensity of symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of a quantitative laboratory reference test for the measurement of SARS-CoV-2</measure>
    <time_frame>Through study completion, estimated 12 weeks</time_frame>
    <description>Determination of the understanding of the quantity of IgG antibodies developed as a response to SARS-CoV-2 infection, and how these antibody levels decrease over time. Antibody titres will be measured in infected individuals, over multiple days and correlated with disease parameters. This will facilitate the development of a quantitative laboratory reference test for IgG antibodies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exploration of SARS-CoV-2 epidemiology</measure>
    <time_frame>Through study completion, estimated 12 weeks</time_frame>
    <description>To help develop a quantitative laboratory reference test for antibodies (IgG) to gain an understanding of quantity of antibodies that people develop and how these decrease over time.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2500</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Trial Participants</arm_group_label>
    <description>Male and female participants aged 5-70 years</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Membrane-based immunoassay kit</intervention_name>
    <description>The kit is a qualitative membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens. IgG and IgM detection components are separate allowing for differential detection of each antibody.</description>
    <arm_group_label>Trial Participants</arm_group_label>
    <other_name>Covid-19 Rapid Test Kit</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Quantitative antibody Tests</intervention_name>
    <description>Antibody titres will be measured from whole blood samples taken from volunteers.</description>
    <arm_group_label>Trial Participants</arm_group_label>
    <other_name>Antibody titre</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PCR Test</intervention_name>
    <description>PCR tests will be conducted on throat swabs taken from volunteers.</description>
    <arm_group_label>Trial Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants are individuals who are screened upon entry to the Richmond Pharmacology unit.&#xD;
        These individuals may be employees of Richmond Pharmacology, volunteers for other&#xD;
        concurrent studies, or members of the public.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged 5 to 70 years.&#xD;
&#xD;
          -  An understanding, ability, and willingness to fully comply with the project procedures&#xD;
             and restrictions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not applicable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jorg Taubel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Richmond Pharmacology Limited</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jorg Taubel, MD</last_name>
    <phone>+44(0)2070425800</phone>
    <email>j.taubel@richmondpharmacology.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ulrike Lorch, MD</last_name>
    <phone>+44(0)2038482005</phone>
    <email>u.lorch@richmondpharmacology.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Richmond Pharmacology Ltd. 1a Newcomen St, London Bridge</name>
      <address>
        <city>London</city>
        <zip>SE1 1YR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Keith Berelowitz, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Jorg Taubel, MD FFPM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>March 29, 2023</last_update_submitted>
  <last_update_submitted_qc>March 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2023</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Immunoglobulins</mesh_term>
  </intervention_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/NCT04404062
org study id: C20010
nct id: NCT04404062
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Richmond Research Institute (RRI) is applying existing and new COVID-19 PCR and antibody
      tests to help develop methodologies which provide fast and accurate results. Infection with
      coronavirus (SARS-CoV-2) is currently a worldwide pandemic and reliable testing for COVID-19
      is crucial to understand who is infected and therefore a risk to others by spreading the
      infection. RRI are currently carrying out the following tests:

      A. Using a membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 in whole
      blood, serum or plasma specimens helps to assess whether an individual has previously had the
      virus and is potentially immune

      B. Polymerase Chain Reaction (PCR) testing using an established method to check for active
      SARS-CoV-2 infections.

      C. Quantification of anti-SARS-CoV-2 IgG and IgM antibodies in whole blood samples.

      The above tests are being used by RRI to follow infections (PCR) and immunity (IgG) in their
      workforce, as well as their families (including children) and visitors to their site.

      Collecting this data allows the gathering of epidemiological data on SARS-CoV-2 including
      incidence, prevalence, information on asymptomatic carriers and efficacy of vaccination.
      Furthermore, identifying individuals that are infected with SARS-CoV-2 has great potential to
      improve health outcomes by allowing infected individuals to seek the correct medical
      treatment as well as self-isolate and reduce transmission.
This is a screening study to measure symptomatic and asymptomatic carriage of SARS-CoV-2 in
      trial participants to help facilitate early detection of a second wave of SARS-CoV-2
      infections. Specifically, this study aims to determine ; to assess the duration of immunity
      by assessing the number and speed at which trial participants were infected and cleared the
      virus with or without symptoms; and to determine the length of symptom onset in those with an
      active infection; levels of IgG antibodies by demographics (sex, age, ethnicity, and
      intensity of symptoms). Longitudinal assessment of antibody levels will additionally allow
      for assessment of the efficacy of any vaccines adminstered. This study also seeks to explore
      how many people are asymptomatic carriers. In addition, this study aims to help facilitate
      the development a quantitative laboratory reference test for antibodies (IgG).

      By using multiple different tests, it can be determined if a person is currently infected
      with SARS-CoV-2 or whether they previously have been infected. This allows for the scanning
      of people with asymptomatic carriage of the virus, which is important to help reduce the
      spread of SARS-CoV-2 through contact with people unaware of infection.

      Polymerase Chain Reaction (PCR) testing is routinely used to check for active SARS-CoV-2
      infections. It measures whether viral RNA is present in an individual's system. All in-house
      PCR tests are verified by an independent laboratory to check for false positives.

      Using a membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 in whole
      blood, serum or plasma specimens helps to assess whether an individual has previously had the
      virus and is potentially immune. IgG and IgM detection components are separate allowing for
      differential detection of each antibody.

      To this date, 20904 PCR tests and 6848 antibody tests have been carried out in 2328
      individuals, providing some interim data. Of the 20904 PCR tests, 17635 (84%) were negative
      and 132 (1%) were negative. Of the 6848 antibody tests, 706 (10%) were positive for IgG only,
      64 (1%) were positive for IgM only, and 351 (5%) were positive for both IgG and IgM. 5710
      (83%) tests were negative.

      Of those individuals with a positive PCR test, 53% reported fever during the previous two
      months and 75% reported a loss of taste during the previous two months.

      Interim results are shown in the medRxiv papers below:

      https://www.medrxiv.org/content/10.1101/2020.12.08.20245894v2

      https://www.medrxiv.org/content/10.1101/2021.04.09.21255200v1
observational model: Cohort
time perspective: Prospective
measure: Identification of carriers of SARS-CoV-2
time frame: Through study completion, estimated 12 weeks
description: To identify trial participants who are symptomatic or asymptomatic carriers of SARS-CoV-2 by comparing the results of a blood finger stick test and reference laboratory tests to PCR testing for acute infection
measure: Determination of the duration of immunity to SARS-CoV-2
time frame: Through study completion, estimated 12 weeks
description: To determine the duration of immunity of trial participants previously infected with SARS-CoV-2, measure differences in IgG antibodies by demographics including sex, ethnicity and age and investigate correlation between IgG antibody levels and intensity of symptoms
measure: Development of a quantitative laboratory reference test for the measurement of SARS-CoV-2
time frame: Through study completion, estimated 12 weeks
description: Determination of the understanding of the quantity of IgG antibodies developed as a response to SARS-CoV-2 infection, and how these antibody levels decrease over time. Antibody titres will be measured in infected individuals, over multiple days and correlated with disease parameters. This will facilitate the development of a quantitative laboratory reference test for IgG antibodies
measure: Exploration of SARS-CoV-2 epidemiology
time frame: Through study completion, estimated 12 weeks
description: To help develop a quantitative laboratory reference test for antibodies (IgG) to gain an understanding of quantity of antibodies that people develop and how these decrease over time.
arm group label: Trial Participants
description: Male and female participants aged 5-70 years
intervention type: Diagnostic Test
intervention name: Membrane-based immunoassay kit
description: The kit is a qualitative membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens. IgG and IgM detection components are separate allowing for differential detection of each antibody.
arm group label: Trial Participants
other name: Covid-19 Rapid Test Kit
intervention type: Diagnostic Test
intervention name: Quantitative antibody Tests
description: Antibody titres will be measured from whole blood samples taken from volunteers.
arm group label: Trial Participants
other name: Antibody titre
intervention type: Diagnostic Test
intervention name: PCR Test
description: PCR tests will be conducted on throat swabs taken from volunteers.
arm group label: Trial Participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jorg Taubel, MD
role: Principal Investigator
affiliation: Richmond Pharmacology Limited
last name: Jorg Taubel, MD
phone: +44(0)2070425800
email: j.taubel@richmondpharmacology.com
last name: Ulrike Lorch, MD
phone: +44(0)2038482005
email: u.lorch@richmondpharmacology.com
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Antibodies
mesh term: Immunoglobulins