<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/NCT04453553</url>
  </required_header>
  <id_info>
    <org_study_id>285524</org_study_id>
    <nct_id>NCT04453553</nct_id>
  </id_info>
  <brief_title>CICERO- A Care Home Study of COVID-19</brief_title>
  <official_title>COVID-19 in Vitro Diagnostic Near-patient Testing in Care Environments Using a Cluster Randomised Open-label Trial Design in an East London Care Home Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen Mary University of London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen Mary University of London</source>
  <oversight_info>
    <has_dmc>Yes</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 primary objective of the study is to determine whether, at 21 days, care homes that&#xD;
      implemented near-patient daily testing have a lower rate of confirmed CoV-2 infections than&#xD;
      care homes following the DHSC standard of care testing of symptomatic residents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Accurate, rapid, near-patient testing systems, such as q16+CoV-2, allow for daily routine&#xD;
      testing of residents, and of staff and visitors prior to entering the care home.&#xD;
&#xD;
      Daily CoV-2 PCR testing with high analytical sensitivity (e.g., 2 copies per 8 µl sample) may&#xD;
      detect infected residents and visitors before clinical symptoms are apparent. Earlier&#xD;
      detection may lead to earlier implementation of the UK standard of care protocol for&#xD;
      Infection prevention and control measures, thereby preventing the asymptomatic infected&#xD;
      individuals from introducing and/or transmitting CoV-2 within the care home. This should&#xD;
      reduce the transmission by:&#xD;
&#xD;
      Preventing the introduction of the virus into care homes from external visitors e.g., GPs&#xD;
      (Inward transmission) Preventing the spread of the virus within care homes and preventing&#xD;
      cluster development (internal transmission) Preventing the outward spread of the virus from&#xD;
      within care homes by infection of external visitors (Outward transmission)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Change in government policy on testing&#xD;
  </why_stopped>
  <start_date type="Actual">July 2, 2020</start_date>
  <completion_date type="Actual">October 27, 2020</completion_date>
  <primary_completion_date type="Actual">October 27, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>randomised cluster trial of care homes</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No masking will be used as the study arms have different testing patterns</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>CoV-2 Infection after 21 days</measure>
    <time_frame>21 days</time_frame>
    <description>The cumulative number of confirmed cases of CoV-2 infection after 21 days, measured by PCR detection of CoV-2, within the care home residents, staff and visitors</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CoV-2 Infection after 14 days</measure>
    <time_frame>14 days</time_frame>
    <description>The cumulative number of confirmed cases of CoV-2 infection after 14 days, measured by PCR detection of CoV-2, within the care home residents, staff and visitors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cases of suspected or confirmed CoV-2 infection</measure>
    <time_frame>14 days</time_frame>
    <description>The cumulative number of suspected or confirmed cases of CoV-2 infection after 14 days, within the care home residents, staff and visitors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalisation and death</measure>
    <time_frame>21 days and 40 days</time_frame>
    <description>The cumulative number of confirmed COVID-19-related hospitalisations and deaths of care home residents, staff and visitors after 21 and 40 days.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">461</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Screening for COVID-19 via nasopharyngeal swab taken at day 0 and 14</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Near Patient Testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Screening for COVID-19 via nasopharyngeal swab taken at day 0 and 14, with the addition of daily nasal swabs tested via rapid test system</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Q16 testing</intervention_name>
    <description>Nasal swab tested on a rapid near patient device</description>
    <arm_group_label>Near Patient Testing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Nasopharyngeal swab and main laboratory</intervention_name>
    <description>Standard of care testing</description>
    <arm_group_label>Standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persons resident or requiring access to the care home&#xD;
&#xD;
          -  Capable of giving written informed consent, or if appropriate, having an acceptable&#xD;
             individual capable of giving consent on the participant's behalf.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Persons not providing informed consent or withdrawing consent at any time during the&#xD;
             study.&#xD;
&#xD;
          -  Persons requiring urgent and immediate access to the care home, for example medical&#xD;
             staff attending emergency visits.&#xD;
&#xD;
          -  Persons unable to provide nasal or oropharyngeal swabs for medical reasons.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joanne Martin</last_name>
    <role>Study Chair</role>
    <affiliation>Queen Mary University London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Mary University London</name>
      <address>
        <city>London</city>
        <zip>E1 2ES</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Public Health England. Outbreaks in Care Homes in England. Cumulative data to 17th May 2020</citation>
  </reference>
  <reference>
    <citation>University of Cambridge, MRC Biostatistics Unit. Nowcasting and Forecasting of COVID-19</citation>
  </reference>
  <reference>
    <citation>Comas-Herrera A and Zalakain J. Mortality associated with COVID-19 outbreaks in care homes: early international evidence. 12th April 2020</citation>
  </reference>
  <reference>
    <citation>McMichael TM, Currie DW, Clark S, Pogosjans S, Kay M, Schwartz NG, Lewis J, Baer A, Kawakami V, Lukoff MD, Ferro J, Brostrom-Smith C, Rea TD, Sayre MR, Riedo FX, Russell D, Hiatt B, Montgomery P, Rao AK, Chow EJ, Tobolowsky F, Hughes MJ, Bardossy AC, Oakley LP, Jacobs JR, Stone ND, Reddy SC, Jernigan JA, Honein MA, Clark TA, Duchin JS; Public Health-Seattle and King County, EvergreenHealth, and CDC COVID-19 Investigation Team. Epidemiology of Covid-19 in a Long-Term Care Facility in King County, Washington. N Engl J Med. 2020 May 21;382(21):2005-2011. doi: 10.1056/NEJMoa2005412. Epub 2020 Mar 27.</citation>
    <PMID>32220208</PMID>
  </reference>
  <reference>
    <citation>Kimball A, Hatfield KM, Arons M, James A, Taylor J, Spicer K, Bardossy AC, Oakley LP, Tanwar S, Chisty Z, Bell JM, Methner M, Harney J, Jacobs JR, Carlson CM, McLaughlin HP, Stone N, Clark S, Brostrom-Smith C, Page LC, Kay M, Lewis J, Russell D, Hiatt B, Gant J, Duchin JS, Clark TA, Honein MA, Reddy SC, Jernigan JA; Public Health - Seattle &amp; King County; CDC COVID-19 Investigation Team. Asymptomatic and Presymptomatic SARS-CoV-2 Infections in Residents of a Long-Term Care Skilled Nursing Facility - King County, Washington, March 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 3;69(13):377-381. doi: 10.15585/mmwr.mm6913e1.</citation>
    <PMID>32240128</PMID>
  </reference>
  <reference>
    <citation>Roxby AC, Greninger AL, Hatfield KM, Lynch JB, Dellit TH, James A, Taylor J, Page LC, Kimball A, Arons M, Schieve LA, Munanga A, Stone N, Jernigan JA, Reddy SC, Lewis J, Cohen SA, Jerome KR, Duchin JS, Neme S. Detection of SARS-CoV-2 Among Residents and Staff Members of an Independent and Assisted Living Community for Older Adults - Seattle, Washington, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 10;69(14):416-418. doi: 10.15585/mmwr.mm6914e2.</citation>
    <PMID>32271726</PMID>
  </reference>
  <reference>
    <citation>World Health Organisation (WHO). Coronavirus disease 2019 (COVID-19) situation report 73. 2020</citation>
  </reference>
  <reference>
    <citation>Mizumoto K, Kagaya K, Zarebski A, Chowell G. Estimating the asymptomatic proportion of coronavirus disease 2019 (COVID-19) cases on board the Diamond Princess cruise ship, Yokohama, Japan, 2020. Euro Surveill. 2020 Mar;25(10):2000180. doi: 10.2807/1560-7917.ES.2020.25.10.2000180. Erratum In: Euro Surveill. 2020 Jun;25(22):</citation>
    <PMID>32183930</PMID>
  </reference>
  <reference>
    <citation>Sheridan C. Fast, portable tests come online to curb coronavirus pandemic. Nat Biotechnol. 2020 May;38(5):515-518. doi: 10.1038/d41587-020-00010-2. No abstract available.</citation>
    <PMID>32203294</PMID>
  </reference>
  <reference>
    <citation>Department of Health &amp; Social Care. COVID-19: Our Action Plan for Adult Social Care. 15th April 2020</citation>
  </reference>
  <reference>
    <citation>He X, Lau EHY, Wu P, Deng X, Wang J, Hao X, Lau YC, Wong JY, Guan Y, Tan X, Mo X, Chen Y, Liao B, Chen W, Hu F, Zhang Q, Zhong M, Wu Y, Zhao L, Zhang F, Cowling BJ, Li F, Leung GM. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med. 2020 May;26(5):672-675. doi: 10.1038/s41591-020-0869-5. Epub 2020 Apr 15. Erratum In: Nat Med. 2020 Sep;26(9):1491-1493.</citation>
    <PMID>32296168</PMID>
  </reference>
  <reference>
    <citation>Foundation for Innovative New Diagnostics. SARS-CoV-2 Molecular Assay Evaluation: Results</citation>
  </reference>
  <reference>
    <citation>Primerdesign™ Ltd. Primerdesign Ltd COVID-19 genesig® Real-Time PCR assay. Instructions for Use. Issue 1.01. 20th March 2020. Available at: https://www.fda.gov/media/136309/download (page 21)</citation>
  </reference>
  <reference>
    <citation>Ip DKM, Lau LLH, Chan KH, Fang VJ, Leung GM, Peiris MJS, Cowling BJ. The Dynamic Relationship Between Clinical Symptomatology and Viral Shedding in Naturally Acquired Seasonal and Pandemic Influenza Virus Infections. Clin Infect Dis. 2016 Feb 15;62(4):431-437. doi: 10.1093/cid/civ909. Epub 2015 Oct 30.</citation>
    <PMID>26518469</PMID>
  </reference>
  <reference>
    <citation>NHS, PHE, DHSC and CQC. Admission and Care of Patients during COVID-19 Incident in a Care Home. 2nd April 2020. Version 1.</citation>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2023</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>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04453553
org study id: 285524
nct id: NCT04453553
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The primary objective of the study is to determine whether, at 21 days, care homes that
      implemented near-patient daily testing have a lower rate of confirmed CoV-2 infections than
      care homes following the DHSC standard of care testing of symptomatic residents.
Accurate, rapid, near-patient testing systems, such as q16+CoV-2, allow for daily routine
      testing of residents, and of staff and visitors prior to entering the care home.

      Daily CoV-2 PCR testing with high analytical sensitivity (e.g., 2 copies per 8 µl sample) may
      detect infected residents and visitors before clinical symptoms are apparent. Earlier
      detection may lead to earlier implementation of the UK standard of care protocol for
      Infection prevention and control measures, thereby preventing the asymptomatic infected
      individuals from introducing and/or transmitting CoV-2 within the care home. This should
      reduce the transmission by:

      Preventing the introduction of the virus into care homes from external visitors e.g., GPs
      (Inward transmission) Preventing the spread of the virus within care homes and preventing
      cluster development (internal transmission) Preventing the outward spread of the virus from
      within care homes by infection of external visitors (Outward transmission)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomised cluster trial of care homes
primary purpose: Diagnostic
masking: None (Open Label)
masking description: No masking will be used as the study arms have different testing patterns
measure: CoV-2 Infection after 21 days
time frame: 21 days
description: The cumulative number of confirmed cases of CoV-2 infection after 21 days, measured by PCR detection of CoV-2, within the care home residents, staff and visitors
measure: CoV-2 Infection after 14 days
time frame: 14 days
description: The cumulative number of confirmed cases of CoV-2 infection after 14 days, measured by PCR detection of CoV-2, within the care home residents, staff and visitors.
measure: Cases of suspected or confirmed CoV-2 infection
time frame: 14 days
description: The cumulative number of suspected or confirmed cases of CoV-2 infection after 14 days, within the care home residents, staff and visitors.
measure: Hospitalisation and death
time frame: 21 days and 40 days
description: The cumulative number of confirmed COVID-19-related hospitalisations and deaths of care home residents, staff and visitors after 21 and 40 days.
arm group label: Standard of care
arm group type: Active Comparator
description: Screening for COVID-19 via nasopharyngeal swab taken at day 0 and 14
arm group label: Near Patient Testing
arm group type: Experimental
description: Screening for COVID-19 via nasopharyngeal swab taken at day 0 and 14, with the addition of daily nasal swabs tested via rapid test system
intervention type: Diagnostic Test
intervention name: Q16 testing
description: Nasal swab tested on a rapid near patient device
arm group label: Near Patient Testing
intervention type: Diagnostic Test
intervention name: Nasopharyngeal swab and main laboratory
description: Standard of care testing
arm group label: Standard of care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 130 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Joanne Martin
role: Study Chair
affiliation: Queen Mary University London
facility: 
country: United Kingdom
citation: Public Health England. Outbreaks in Care Homes in England. Cumulative data to 17th May 2020
citation: University of Cambridge, MRC Biostatistics Unit. Nowcasting and Forecasting of COVID-19
citation: Comas-Herrera A and Zalakain J. Mortality associated with COVID-19 outbreaks in care homes: early international evidence. 12th April 2020
citation: McMichael TM, Currie DW, Clark S, Pogosjans S, Kay M, Schwartz NG, Lewis J, Baer A, Kawakami V, Lukoff MD, Ferro J, Brostrom-Smith C, Rea TD, Sayre MR, Riedo FX, Russell D, Hiatt B, Montgomery P, Rao AK, Chow EJ, Tobolowsky F, Hughes MJ, Bardossy AC, Oakley LP, Jacobs JR, Stone ND, Reddy SC, Jernigan JA, Honein MA, Clark TA, Duchin JS; Public Health-Seattle and King County, EvergreenHealth, and CDC COVID-19 Investigation Team. Epidemiology of Covid-19 in a Long-Term Care Facility in King County, Washington. N Engl J Med. 2020 May 21;382(21):2005-2011. doi: 10.1056/NEJMoa2005412. Epub 2020 Mar 27.
PMID: 32220208
citation: Kimball A, Hatfield KM, Arons M, James A, Taylor J, Spicer K, Bardossy AC, Oakley LP, Tanwar S, Chisty Z, Bell JM, Methner M, Harney J, Jacobs JR, Carlson CM, McLaughlin HP, Stone N, Clark S, Brostrom-Smith C, Page LC, Kay M, Lewis J, Russell D, Hiatt B, Gant J, Duchin JS, Clark TA, Honein MA, Reddy SC, Jernigan JA; Public Health - Seattle & King County; CDC COVID-19 Investigation Team. Asymptomatic and Presymptomatic SARS-CoV-2 Infections in Residents of a Long-Term Care Skilled Nursing Facility - King County, Washington, March 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 3;69(13):377-381. doi: 10.15585/mmwr.mm6913e1.
PMID: 32240128
citation: Roxby AC, Greninger AL, Hatfield KM, Lynch JB, Dellit TH, James A, Taylor J, Page LC, Kimball A, Arons M, Schieve LA, Munanga A, Stone N, Jernigan JA, Reddy SC, Lewis J, Cohen SA, Jerome KR, Duchin JS, Neme S. Detection of SARS-CoV-2 Among Residents and Staff Members of an Independent and Assisted Living Community for Older Adults - Seattle, Washington, 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 10;69(14):416-418. doi: 10.15585/mmwr.mm6914e2.
PMID: 32271726
citation: World Health Organisation (WHO). Coronavirus disease 2019 (COVID-19) situation report 73. 2020
citation: Mizumoto K, Kagaya K, Zarebski A, Chowell G. Estimating the asymptomatic proportion of coronavirus disease 2019 (COVID-19) cases on board the Diamond Princess cruise ship, Yokohama, Japan, 2020. Euro Surveill. 2020 Mar;25(10):2000180. doi: 10.2807/1560-7917.ES.2020.25.10.2000180. Erratum In: Euro Surveill. 2020 Jun;25(22):
PMID: 32183930
citation: Sheridan C. Fast, portable tests come online to curb coronavirus pandemic. Nat Biotechnol. 2020 May;38(5):515-518. doi: 10.1038/d41587-020-00010-2. No abstract available.
PMID: 32203294
citation: Department of Health & Social Care. COVID-19: Our Action Plan for Adult Social Care. 15th April 2020
citation: He X, Lau EHY, Wu P, Deng X, Wang J, Hao X, Lau YC, Wong JY, Guan Y, Tan X, Mo X, Chen Y, Liao B, Chen W, Hu F, Zhang Q, Zhong M, Wu Y, Zhao L, Zhang F, Cowling BJ, Li F, Leung GM. Temporal dynamics in viral shedding and transmissibility of COVID-19. Nat Med. 2020 May;26(5):672-675. doi: 10.1038/s41591-020-0869-5. Epub 2020 Apr 15. Erratum In: Nat Med. 2020 Sep;26(9):1491-1493.
PMID: 32296168
citation: Foundation for Innovative New Diagnostics. SARS-CoV-2 Molecular Assay Evaluation: Results
citation: Primerdesign™ Ltd. Primerdesign Ltd COVID-19 genesig® Real-Time PCR assay. Instructions for Use. Issue 1.01. 20th March 2020. Available at: https://www.fda.gov/media/136309/download (page 21)
citation: Ip DKM, Lau LLH, Chan KH, Fang VJ, Leung GM, Peiris MJS, Cowling BJ. The Dynamic Relationship Between Clinical Symptomatology and Viral Shedding in Naturally Acquired Seasonal and Pandemic Influenza Virus Infections. Clin Infect Dis. 2016 Feb 15;62(4):431-437. doi: 10.1093/cid/civ909. Epub 2015 Oct 30.
PMID: 26518469
citation: NHS, PHE, DHSC and CQC. Admission and Care of Patients during COVID-19 Incident in a Care Home. 2nd April 2020. Version 1.
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No