<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/NCT04442165</url>
  </required_header>
  <id_info>
    <org_study_id>AfriCoVER</org_study_id>
    <nct_id>NCT04442165</nct_id>
  </id_info>
  <brief_title>Characterising Transmission of SARS-CoV-2 in a Peri-urban Population in Mozambique</brief_title>
  <acronym>AfriCoVER</acronym>
  <official_title>Characterising Transmission of SARS-CoV-2 in a Peri-urban Population in Mozambique Using Population-based (Sero)Surveillance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Tropical Medicine, Belgium</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European and Developing Countries Clinical Trials Partnership (EDCTP)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto Nacional de Saude, Mozambique</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institut de Recherche pour le Developpement</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>UMC Utrecht</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institute of Tropical Medicine, Belgium</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>
      A population-based COVID19 surveillance in a household cohort will be set-up using an&#xD;
      existing Household demographic surveillance system (HDSS). From any individual in this&#xD;
      population with any respiratory symptom or loss of smell or taste, with or without fever,&#xD;
      investigators will collect a respiratory specimen and test these for SARS-CoV-2 virus, during&#xD;
      12 months. Demographic, epidemiological and clinical data of possible cases and of the source&#xD;
      population will be recorded at baseline.&#xD;
&#xD;
      An age-stratified serial sero-survey will be conducted at baseline in a subset of the&#xD;
      population in the population-based COVID19 surveillance, and at 3, 6 and 12 months, after&#xD;
      confirmation of community transmission.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will use the established HDSS to set up population-based COVID19&#xD;
      surveillance in a household cohort. From any individual in this population with any&#xD;
      respiratory symptom or loss of smell or taste, with or without fever, investigators will&#xD;
      collect a respiratory specimen and test these for SARS-CoV-2 virus by PCR, during 12 months.&#xD;
      These cases will be identified through bi-weekly household visits, through an alert system&#xD;
      involving community leaders and HDSS interviewers, or when presenting with symptoms at&#xD;
      healthcare centres or the referral hospital. Demographic, epidemiological and clinical data&#xD;
      (comorbidities, medication, obesity, HIV, TB, smoking) of possible cases and of the source&#xD;
      population will be recorded at baseline; recent illness, potential risk exposure of each&#xD;
      household member (including duration and type) to SARS-CoV-2 positive individuals, uptake of&#xD;
      measures to reduce exposure/transmission, and barriers to the uptake of such measures, will&#xD;
      be recorded/updated during every household visit.&#xD;
&#xD;
      An age-stratified serial sero-survey will be conducted at baseline in a subset of the&#xD;
      population in the population-based COVID19 surveillance, and at 3, 6 and 12 months, after&#xD;
      confirmation of community transmission.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 15, 2020</start_date>
  <completion_date type="Anticipated">August 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2023</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>COVID-19 disease incidence rate (symptomatic infections per month)</measure>
    <time_frame>12 months</time_frame>
    <description>Estimate the COVID-19 incidence rate over a 12 month period in peri-urban Maputo</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19 related hospitalization rate due to SARS-CoV-2</measure>
    <time_frame>12 months</time_frame>
    <description>Estimate the hospitalization rate related to SARS-CoV-2 over a 12 month period in peri-urban Maputo</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Case (disease) fatality risk (percent) due to SARS-CoV-2</measure>
    <time_frame>12 months</time_frame>
    <description>Estimate the COVID-19 case fatality of cases detected during a 12 month period in peri-urban Maputo</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion asymptomatic infections, by age group</measure>
    <time_frame>12 months</time_frame>
    <description>Estimate the proportion of infections that are asymptomatic, by age group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2 infection annual attack rate (percent)</measure>
    <time_frame>12 months</time_frame>
    <description>Estimate the attack rate of SARS-CoV-2 infection during 12 months in peri-urban Maputo</description>
  </primary_outcome>
  <primary_outcome>
    <measure>SARS-CoV-2 infection fatality risk</measure>
    <time_frame>12 months</time_frame>
    <description>Estimate the SARS-CoV-2 infection fatality of infections detected during a 12 month period in peri-urban Maputo</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infection fatality of SARS-CoV-2 infection.</measure>
    <time_frame>12 months</time_frame>
    <description>Estimate the infection fatality of SARS-CoV-2 infection in peri-urban Maputo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serial interval number of SARS-CoV-2 infection</measure>
    <time_frame>12 months</time_frame>
    <description>Estimate the serial interval number of SARS-CoV-2 infection in peri-urban Maputo.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reproduction number of SARS-CoV-2 infection</measure>
    <time_frame>12 months</time_frame>
    <description>Estimate the reproduction number of SARS-CoV-2 infection in peri-urban Maputo.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between anti-coronavirus (endemic coronavirus or SARS-CoV-2) antibody titers and reinfection</measure>
    <time_frame>12 months</time_frame>
    <description>Analyze the correlation between anti-coronavirus (endemic coronavirus or SARS-CoV-2) antibody titers and reinfection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibody titers against SARS-CoV-2 over time</measure>
    <time_frame>12 months</time_frame>
    <description>Measure antibody titers against SARS-CoV-2 over time</description>
  </secondary_outcome>
  <enrollment type="Actual">15393</enrollment>
  <condition>COVID-19</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  Nasal swabs (for all possible Covid-19cases)&#xD;
&#xD;
        -  Dried Blood Spots (only in a subset of the population, 2400 individuals)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The Polana Caniço-HDSS (Health- and Demographic Surveillance System) has been established&#xD;
        since 2017. In total, 2108 households (defined as residents of the same building, sharing a&#xD;
        cooking area) have been enrolled in the HDSS. All members residing in the household for at&#xD;
        least 3 months (infants, children, adults, elderly) are enrolled in the HDSS.&#xD;
&#xD;
        All households in the HDSS (2108 during the last round, in 2019) consenting to participate&#xD;
        in the study will be visited biweekly by a trained HDSS interviewer, following the same&#xD;
        procedures as in routine HDSS rounds, specified in the HDSS protocol (Instituto Nacional de&#xD;
        Saude, 2016). We assume the same number of households will consent to participate as in&#xD;
        other HDSS rounds.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any individual enrolled in the Polana Caniço-HDSS: All members residing in the&#xD;
             household for at least 3 months (infants, children, adults, elderly), regardless of&#xD;
             age, underlying conditions, medical history, infection or disease status or history&#xD;
&#xD;
          -  Able and willing to provide written informed consent: by the household head for the&#xD;
             surveillance; by each selected participant for the sero-survey.&#xD;
&#xD;
        No Exclusion Criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc-Alain Widdowson, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Tropical Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>INS</name>
      <address>
        <city>Maputo</city>
        <country>Mozambique</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mozambique</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04442165
org study id: AfriCoVER
nct id: NCT04442165
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A population-based COVID19 surveillance in a household cohort will be set-up using an
      existing Household demographic surveillance system (HDSS). From any individual in this
      population with any respiratory symptom or loss of smell or taste, with or without fever,
      investigators will collect a respiratory specimen and test these for SARS-CoV-2 virus, during
      12 months. Demographic, epidemiological and clinical data of possible cases and of the source
      population will be recorded at baseline.

      An age-stratified serial sero-survey will be conducted at baseline in a subset of the
      population in the population-based COVID19 surveillance, and at 3, 6 and 12 months, after
      confirmation of community transmission.
The investigators will use the established HDSS to set up population-based COVID19
      surveillance in a household cohort. From any individual in this population with any
      respiratory symptom or loss of smell or taste, with or without fever, investigators will
      collect a respiratory specimen and test these for SARS-CoV-2 virus by PCR, during 12 months.
      These cases will be identified through bi-weekly household visits, through an alert system
      involving community leaders and HDSS interviewers, or when presenting with symptoms at
      healthcare centres or the referral hospital. Demographic, epidemiological and clinical data
      (comorbidities, medication, obesity, HIV, TB, smoking) of possible cases and of the source
      population will be recorded at baseline; recent illness, potential risk exposure of each
      household member (including duration and type) to SARS-CoV-2 positive individuals, uptake of
      measures to reduce exposure/transmission, and barriers to the uptake of such measures, will
      be recorded/updated during every household visit.

      An age-stratified serial sero-survey will be conducted at baseline in a subset of the
      population in the population-based COVID19 surveillance, and at 3, 6 and 12 months, after
      confirmation of community transmission.
observational model: Cohort
time perspective: Prospective
measure: COVID-19 disease incidence rate (symptomatic infections per month)
time frame: 12 months
description: Estimate the COVID-19 incidence rate over a 12 month period in peri-urban Maputo
measure: COVID-19 related hospitalization rate due to SARS-CoV-2
time frame: 12 months
description: Estimate the hospitalization rate related to SARS-CoV-2 over a 12 month period in peri-urban Maputo
measure: Case (disease) fatality risk (percent) due to SARS-CoV-2
time frame: 12 months
description: Estimate the COVID-19 case fatality of cases detected during a 12 month period in peri-urban Maputo
measure: Proportion asymptomatic infections, by age group
time frame: 12 months
description: Estimate the proportion of infections that are asymptomatic, by age group
measure: SARS-CoV-2 infection annual attack rate (percent)
time frame: 12 months
description: Estimate the attack rate of SARS-CoV-2 infection during 12 months in peri-urban Maputo
measure: SARS-CoV-2 infection fatality risk
time frame: 12 months
description: Estimate the SARS-CoV-2 infection fatality of infections detected during a 12 month period in peri-urban Maputo
measure: Infection fatality of SARS-CoV-2 infection.
time frame: 12 months
description: Estimate the infection fatality of SARS-CoV-2 infection in peri-urban Maputo.
measure: Serial interval number of SARS-CoV-2 infection
time frame: 12 months
description: Estimate the serial interval number of SARS-CoV-2 infection in peri-urban Maputo.
measure: Reproduction number of SARS-CoV-2 infection
time frame: 12 months
description: Estimate the reproduction number of SARS-CoV-2 infection in peri-urban Maputo.
measure: Correlation between anti-coronavirus (endemic coronavirus or SARS-CoV-2) antibody titers and reinfection
time frame: 12 months
description: Analyze the correlation between anti-coronavirus (endemic coronavirus or SARS-CoV-2) antibody titers and reinfection
measure: Antibody titers against SARS-CoV-2 over time
time frame: 12 months
description: Measure antibody titers against SARS-CoV-2 over time
-  Nasal swabs (for all possible Covid-19cases)

        -  Dried Blood Spots (only in a subset of the population, 2400 individuals)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marc-Alain Widdowson, Dr
role: Principal Investigator
affiliation: Institute of Tropical Medicine
facility: 
country: Mozambique
responsible party type: Sponsor
sharing ipd: Undecided