<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/NCT04425044</url>
  </required_header>
  <id_info>
    <org_study_id>Au015</org_study_id>
    <nct_id>NCT04425044</nct_id>
  </id_info>
  <brief_title>AiM Covid Self Monitoring</brief_title>
  <official_title>Efficacy of AiM Covid Self Monitoring in Detecting Infection of COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarogyam UK</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Warwick</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>NMP Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mothers Touch Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aarogyam UK</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 objectives of this study are to test the level of accuracy of the prediction models that&#xD;
      could be used as a 'digital test' to evaluate whether an individual is infected with&#xD;
      COVID-19, based on their symptoms reported in the &quot;AiM COVID-19&quot; app&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 12, 2020</start_date>
  <completion_date type="Actual">May 28, 2020</completion_date>
  <primary_completion_date type="Actual">May 18, 2020</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>Fever</measure>
    <time_frame>1 day</time_frame>
    <description>Self reported body temperature (Degrees Celsius)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Shortness of Breath</measure>
    <time_frame>1 day</time_frame>
    <description>Self reported shortness of breath symptom (tick box)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cough</measure>
    <time_frame>1 day</time_frame>
    <description>Self reported cough symptom (tick box)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sore Throat</measure>
    <time_frame>1 day</time_frame>
    <description>Self reported soar throat symptom (tick box)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache</measure>
    <time_frame>1 day</time_frame>
    <description>Self reported headache symptom (tick box)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscle/ Joint Pain</measure>
    <time_frame>1 day</time_frame>
    <description>Self reported muscle/ joint pain symptom (tick box)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diarrhoea</measure>
    <time_frame>1 day</time_frame>
    <description>Self reported diarrhoea symptom (tick box)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vomiting/ Nausea</measure>
    <time_frame>1 day</time_frame>
    <description>Self reported vomiting/ nausea symptom (tick box)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Runny Nose</measure>
    <time_frame>1 day</time_frame>
    <description>Self reported runny nose symptom (tick box)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loss of Smell/Taste</measure>
    <time_frame>1 day</time_frame>
    <description>Self reported loss of smell/ taste symptom (tick box)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other symptoms</measure>
    <time_frame>1 day</time_frame>
    <description>Self reported other symptoms (tick box)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>AiM Covid</arm_group_label>
    <description>Self Monitoring of symptoms in AiM Covid App</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Other</intervention_name>
    <description>No Intervention</description>
    <arm_group_label>AiM Covid</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Anyone worried about heath status relating with infection of COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants resident in India&#xD;
&#xD;
          -  Voluntary completion of the self-test and evaluation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People can not use mobile app&#xD;
&#xD;
          -  Below 18 years old&#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_official>
    <last_name>Vishwes Kulkarni</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Warwick</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mothers Touch Foundation</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NMP Medical Research Institite</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 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>
  <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/NCT04425044
org study id: Au015
nct id: NCT04425044
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objectives of this study are to test the level of accuracy of the prediction models that
      could be used as a 'digital test' to evaluate whether an individual is infected with
      COVID-19, based on their symptoms reported in the "AiM COVID-19" app
observational model: Cohort
time perspective: Prospective
measure: Fever
time frame: 1 day
description: Self reported body temperature (Degrees Celsius)
measure: Shortness of Breath
time frame: 1 day
description: Self reported shortness of breath symptom (tick box)
measure: Cough
time frame: 1 day
description: Self reported cough symptom (tick box)
measure: Sore Throat
time frame: 1 day
description: Self reported soar throat symptom (tick box)
measure: Headache
time frame: 1 day
description: Self reported headache symptom (tick box)
measure: Muscle/ Joint Pain
time frame: 1 day
description: Self reported muscle/ joint pain symptom (tick box)
measure: Diarrhoea
time frame: 1 day
description: Self reported diarrhoea symptom (tick box)
measure: Vomiting/ Nausea
time frame: 1 day
description: Self reported vomiting/ nausea symptom (tick box)
measure: Runny Nose
time frame: 1 day
description: Self reported runny nose symptom (tick box)
measure: Loss of Smell/Taste
time frame: 1 day
description: Self reported loss of smell/ taste symptom (tick box)
measure: Other symptoms
time frame: 1 day
description: Self reported other symptoms (tick box)
arm group label: AiM Covid
description: Self Monitoring of symptoms in AiM Covid App
intervention type: Other
intervention name: Other
description: No Intervention
arm group label: AiM Covid
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Vishwes Kulkarni
role: Principal Investigator
affiliation: University of Warwick
facility: 
facility: 
country: India
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: Undecided