<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/NCT04404179</url>
  </required_header>
  <id_info>
    <org_study_id>CovJ</org_study_id>
    <nct_id>NCT04404179</nct_id>
  </id_info>
  <brief_title>Setting up a COVID-19 Care Facility at a Prison in Pakistan</brief_title>
  <official_title>Setting up a COVID-19 Care Facility at a Prison in Pakistan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Services Institute of Medical Sciences, Pakistan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Services Institute of Medical Sciences, Pakistan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Presenting outline of the steps taken by our team to set up a Covid Care facility within the&#xD;
      Prison setting. The facility was set up at Camp Jail (Lahore District Jail) located on&#xD;
      Ferozpur Road, Lahore.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prisoner brought to Camp Jail developed symptoms of and later tested positive for COVID-19.&#xD;
      This lead to almost 527 contacts. An outbreak was expected. To manage the situation , a&#xD;
      COVID-19 Care Facility was established within the prison. The study describes the steps taken&#xD;
      by the team to set up this facility.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 27, 2020</start_date>
  <completion_date type="Actual">May 2, 2020</completion_date>
  <primary_completion_date type="Actual">May 2, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Recovery</measure>
    <time_frame>30 days</time_frame>
    <description>Confirmed by double negative PCR results of specimen obtained via nasopharyngeal swabs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Death of any of the patients who had tested positive at the Camp Jail</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ICU admission</measure>
    <time_frame>30 days</time_frame>
    <description>Any patient requiring admission to intensive care unit due to developing symptoms</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">69</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>CASE</arm_group_label>
    <description>59 COVID-19 POSITIVE PRISONERS WHO UNDERWENT TREATMENT AT THE COVID-19 CARE FACILITY AT CAMP JAIL.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>COVID-19 FACILITY</intervention_name>
    <description>A COVID-19 facility was setup within the Prison. All positive prisoners were managed in the facility. If further intervention was required they were to be shifted to Services Hospital , Lahore.</description>
    <arm_group_label>CASE</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study population consisted of the prisoners who after being exposed to a suspected COVID-19&#xD;
        patient tested positive on screening. a total of 59 prisoners were detected by screening.&#xD;
        They were included in the study. 10 COVID-19 prisoners shifted to Camp Jail were also&#xD;
        latter included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - All COVID-19 positive prisoners within the Camp Jail&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient being shifted to any other facility (except designated)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Camp Jail / COVID-19 CARE FACILITY/ SIMS</name>
      <address>
        <city>Lahore</city>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 24, 2020</study_first_submitted>
  <study_first_submitted_qc>May 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Services Institute of Medical Sciences, Pakistan</investigator_affiliation>
    <investigator_full_name>Usman Ismat Butt</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Prison</keyword>
  <keyword>Pakistan</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/NCT04404179
org study id: CovJ
nct id: NCT04404179
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Presenting outline of the steps taken by our team to set up a Covid Care facility within the
      Prison setting. The facility was set up at Camp Jail (Lahore District Jail) located on
      Ferozpur Road, Lahore.
A prisoner brought to Camp Jail developed symptoms of and later tested positive for COVID-19.
      This lead to almost 527 contacts. An outbreak was expected. To manage the situation , a
      COVID-19 Care Facility was established within the prison. The study describes the steps taken
      by the team to set up this facility.
observational model: Case-Only
time perspective: Prospective
measure: Recovery
time frame: 30 days
description: Confirmed by double negative PCR results of specimen obtained via nasopharyngeal swabs
measure: Mortality
time frame: 30 days
description: Death of any of the patients who had tested positive at the Camp Jail
measure: ICU admission
time frame: 30 days
description: Any patient requiring admission to intensive care unit due to developing symptoms
arm group label: CASE
description: 59 COVID-19 POSITIVE PRISONERS WHO UNDERWENT TREATMENT AT THE COVID-19 CARE FACILITY AT CAMP JAIL.
intervention type: Other
intervention name: COVID-19 FACILITY
description: A COVID-19 facility was setup within the Prison. All positive prisoners were managed in the facility. If further intervention was required they were to be shifted to Services Hospital , Lahore.
arm group label: CASE
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Services Institute of Medical Sciences, Pakistan
investigator full name: Usman Ismat Butt
investigator title: Assistant Professor
mesh term: COVID-19
sharing ipd: No