<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/NCT04477213</url>
  </required_header>
  <id_info>
    <org_study_id>NMCHCW-COVID</org_study_id>
    <nct_id>NCT04477213</nct_id>
  </id_info>
  <brief_title>Risk Profiling of the Occupational Exposure of COVID-19 to Healthcare Workers.</brief_title>
  <official_title>Risk Profiling of the Occupational Exposure of COVID-19 to Healthcare Workers- A Multicentric Retrospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NMC Specialty Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NMC Specialty Hospital</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>
      The investigators propose to conduct a retrospective study to define and quantify the&#xD;
      variable occupational and non-occupational risk among various HCWs who got COVID-19 . The&#xD;
      investigators aim to determine the rates of acquisition of COVID-19, in the context of level&#xD;
      of exposure , adequacy of PPE use and other infection control measuresrecommended for&#xD;
      COVID-19 and also to define the risk of secondary disease transmission to other household&#xD;
      members of HCWs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Risk of transmission of COVID-19 virus to healthcare workers (HCWs) is matter of debate since&#xD;
      the start of this pandemic. In absence of adequate research, the transmission risk is based&#xD;
      on non-human studies, non-HCWs epidemiological studies and experiences from previous&#xD;
      pandemics or epidemics. The true magnitude of the risk to HCWs has not been clearly&#xD;
      estimated. In absence of good scientific data, general recommendations create confusion and&#xD;
      mistrust among HCWs. Besides lots of myth and misconceptions among the HCWs including&#xD;
      physician adds to emotional and physical challenge in reduction of nosocomial transmission of&#xD;
      COVID-19.&#xD;
&#xD;
      COVID-19 related lockdowns have disrupted the global supply-chain and good quality personal&#xD;
      protective equipment (PPE) has become an intense matter of discussion from the start of&#xD;
      pandemic. The rational use of PPE has become necessity to ensure sustained supply to those&#xD;
      who need it in the frontline. In absence of reliable risk assessment and management based on&#xD;
      true incidence calculation leads to either inadequate or overestimation of risk and&#xD;
      unjustified use of PPE. The reported global data for occupational risk of COVID -19 for HCW&#xD;
      varies greatly but it is reported to be higher than general populations. However, many of&#xD;
      these studies has significant limitations, like inadequate risk assessment, community&#xD;
      transmission is not accounted or all HCWs not included for analysis.&#xD;
&#xD;
      The investigators propose to conduct a retrospective study to define and quantify the&#xD;
      variable occupational and non-occupational risk among various HCWs, to determine the rates of&#xD;
      acquisition in the context of level of PPE use and other infection control measures&#xD;
      recommended for COVID-19 and also to define the risk of secondary disease transmission to&#xD;
      other household members of participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2021</start_date>
  <completion_date type="Actual">October 2, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</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>Rate of COVID-19 in healthcare workers (HCWs)</measure>
    <time_frame>6 months</time_frame>
    <description>Positive HCW divided by total exposed HCWs in that category X 100 Rate will be calculated in 4 different categories.&#xD;
Front line HCWs (doctors, nurses, respiratory therapist, physiotherapist, dialysis technician, patient assistant etc)&#xD;
Front line support staffs (Customer care, pharmacist, billing assistance, ambulance driver etc.),&#xD;
Clinical support staffs- (dietician, food service worker, laundry worker, housekeeping staffs, health record staffs- infection control team etc.)&#xD;
Non-clinical support staffs- (Administrative support staff.)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical severity of infection in HCWs</measure>
    <time_frame>Within 28 days of illness.</time_frame>
    <description>WHO Ordinal scale&#xD;
Uninfected No clinical or virological evidence of infection Score 0&#xD;
Ambulatory : No limitation of activities Score 1, Limitation Score 2.&#xD;
Hospitalised(Mild disease): No oxygen Score 3, Nasal prongs or Mask Score 4&#xD;
hospitalised (Severe disease): noninvasive ventilation/high flow nasal canula- score 5, Intubation and mechanical ventilation Score 6, mechanical ventilation and any other oxygen support like vasopressors Score 7&#xD;
dead score 8</description>
  </secondary_outcome>
  <enrollment type="Actual">286</enrollment>
  <condition>COVID19</condition>
  <condition>Healthcare Workers</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All Healthcare workers working actively in the included hospitals or clinics and are&#xD;
        confirmed positive with COVID-19&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1.2.1 All staffs that are currently working in included hospitals and clinic in 1.2.1.1&#xD;
        Laboratory confirmed positive case- A positive case is where COVID-19 virus is detected&#xD;
        through real time polymerase chain reaction (RT PCR) either through oropharyngeal or&#xD;
        nasopharyngeal swab which were conducted on HCWs based on national guidelines of UAE and&#xD;
        are based on either symptoms, or as part of contact tracing or history of recent&#xD;
        international travel.&#xD;
&#xD;
        1.2.1.2 Laboratory confirmed positive case with history of occupational exposure- through&#xD;
        contact tracing after an exposure to a known COVID -19 patient in a healthcare setting.&#xD;
&#xD;
        1.2.1.3 Laboratory confirmed positive case with no history of occupational exposure-&#xD;
        non-occupational exposures include situations where there was no probable workplace&#xD;
        exposure for the healthcare worker, and a community source for the infection through&#xD;
        household contact, travel, gathering in public places or visiting to affected area as most&#xD;
        likely source of exposure is identified.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Staff who refused to participate or withdraw there consent during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helen King, RN DMS MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Senior Vice President: Nursing &amp; Quality Corporate Quality &amp; Nursing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NMC Specialty Hospital, Al Nahda</name>
      <address>
        <city>Dubai</city>
        <country>United Arab Emirates</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Arab Emirates</country>
  </location_countries>
  <results_reference>
    <citation>Nguyen LH, Drew DA, Joshi AD, Guo CG, Ma W, Mehta RS, Sikavi DR, Lo CH, Kwon S, Song M, Mucci LA, Stampfer MJ, Willett WC, Eliassen AH, Hart JE, Chavarro JE, Rich-Edwards JW, Davies R, Capdevila J, Lee KA, Lochlainn MN, Varsavsky T, Graham MS, Sudre CH, Cardoso MJ, Wolf J, Ourselin S, Steves CJ, Spector TD, Chan AT. Risk of COVID-19 among frontline healthcare workers and the general community: a prospective cohort study. medRxiv. 2020 May 25:2020.04.29.20084111. doi: 10.1101/2020.04.29.20084111. Preprint.</citation>
    <PMID>32511531</PMID>
  </results_reference>
  <results_reference>
    <citation>Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.</citation>
    <PMID>32091533</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>October 4, 2021</last_update_submitted>
  <last_update_submitted_qc>October 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>NMC Specialty Hospital</investigator_affiliation>
    <investigator_full_name>Prashant Nasa</investigator_full_name>
    <investigator_title>Specialist Critical Care Medicine</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>Healthcare Workers</keyword>
  <keyword>occupational risk of COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_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/NCT04477213
org study id: NMCHCW-COVID
nct id: NCT04477213
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators propose to conduct a retrospective study to define and quantify the
      variable occupational and non-occupational risk among various HCWs who got COVID-19 . The
      investigators aim to determine the rates of acquisition of COVID-19, in the context of level
      of exposure , adequacy of PPE use and other infection control measuresrecommended for
      COVID-19 and also to define the risk of secondary disease transmission to other household
      members of HCWs.
Risk of transmission of COVID-19 virus to healthcare workers (HCWs) is matter of debate since
      the start of this pandemic. In absence of adequate research, the transmission risk is based
      on non-human studies, non-HCWs epidemiological studies and experiences from previous
      pandemics or epidemics. The true magnitude of the risk to HCWs has not been clearly
      estimated. In absence of good scientific data, general recommendations create confusion and
      mistrust among HCWs. Besides lots of myth and misconceptions among the HCWs including
      physician adds to emotional and physical challenge in reduction of nosocomial transmission of
      COVID-19.

      COVID-19 related lockdowns have disrupted the global supply-chain and good quality personal
      protective equipment (PPE) has become an intense matter of discussion from the start of
      pandemic. The rational use of PPE has become necessity to ensure sustained supply to those
      who need it in the frontline. In absence of reliable risk assessment and management based on
      true incidence calculation leads to either inadequate or overestimation of risk and
      unjustified use of PPE. The reported global data for occupational risk of COVID -19 for HCW
      varies greatly but it is reported to be higher than general populations. However, many of
      these studies has significant limitations, like inadequate risk assessment, community
      transmission is not accounted or all HCWs not included for analysis.

      The investigators propose to conduct a retrospective study to define and quantify the
      variable occupational and non-occupational risk among various HCWs, to determine the rates of
      acquisition in the context of level of PPE use and other infection control measures
      recommended for COVID-19 and also to define the risk of secondary disease transmission to
      other household members of participants.
observational model: Cohort
time perspective: Prospective
measure: Rate of COVID-19 in healthcare workers (HCWs)
time frame: 6 months
description: Positive HCW divided by total exposed HCWs in that category X 100 Rate will be calculated in 4 different categories.
Front line HCWs (doctors, nurses, respiratory therapist, physiotherapist, dialysis technician, patient assistant etc)
Front line support staffs (Customer care, pharmacist, billing assistance, ambulance driver etc.),
Clinical support staffs- (dietician, food service worker, laundry worker, housekeeping staffs, health record staffs- infection control team etc.)
Non-clinical support staffs- (Administrative support staff.)
measure: clinical severity of infection in HCWs
time frame: Within 28 days of illness.
description: WHO Ordinal scale
Uninfected No clinical or virological evidence of infection Score 0
Ambulatory : No limitation of activities Score 1, Limitation Score 2.
Hospitalised(Mild disease): No oxygen Score 3, Nasal prongs or Mask Score 4
hospitalised (Severe disease): noninvasive ventilation/high flow nasal canula- score 5, Intubation and mechanical ventilation Score 6, mechanical ventilation and any other oxygen support like vasopressors Score 7
dead score 8
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Helen King, RN DMS MBA
role: Principal Investigator
affiliation: Senior Vice President: Nursing & Quality Corporate Quality & Nursing
facility: 
country: United Arab Emirates
citation: Nguyen LH, Drew DA, Joshi AD, Guo CG, Ma W, Mehta RS, Sikavi DR, Lo CH, Kwon S, Song M, Mucci LA, Stampfer MJ, Willett WC, Eliassen AH, Hart JE, Chavarro JE, Rich-Edwards JW, Davies R, Capdevila J, Lee KA, Lochlainn MN, Varsavsky T, Graham MS, Sudre CH, Cardoso MJ, Wolf J, Ourselin S, Steves CJ, Spector TD, Chan AT. Risk of COVID-19 among frontline healthcare workers and the general community: a prospective cohort study. medRxiv. 2020 May 25:2020.04.29.20084111. doi: 10.1101/2020.04.29.20084111. Preprint.
PMID: 32511531
citation: Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
PMID: 32091533
responsible party type: Principal Investigator
investigator affiliation: NMC Specialty Hospital
investigator full name: Prashant Nasa
investigator title: Specialist Critical Care Medicine
mesh term: COVID-19