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Risk Profiling of the Occupational Exposure of COVID-19 to Healthcare Workers.

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ClinicalTrials.gov Identifier: NCT04477213
Recruitment Status : Not yet recruiting
First Posted : July 20, 2020
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
Prashant Nasa, NMC Specialty Hospital

Brief Summary:
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.

Condition or disease
COVID19 Healthcare Workers

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk Profiling of the Occupational Exposure of COVID-19 to Healthcare Workers- A Multicentric Retrospective Study
Estimated Study Start Date : January 15, 2021
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : February 15, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Rate of COVID-19 in healthcare workers (HCWs) [ Time Frame: 6 months ]

    Positive HCW divided by total exposed HCWs in that category X 100 Rate will be calculated in 4 different categories.

    1. Front line HCWs (doctors, nurses, respiratory therapist, physiotherapist, dialysis technician, patient assistant etc)
    2. Front line support staffs (Customer care, pharmacist, billing assistance, ambulance driver etc.),
    3. Clinical support staffs- (dietician, food service worker, laundry worker, housekeeping staffs, health record staffs- infection control team etc.)
    4. Non-clinical support staffs- (Administrative support staff.)


Secondary Outcome Measures :
  1. clinical severity of infection in HCWs [ Time Frame: Within 28 days of illness. ]

    WHO Ordinal scale

    1. Uninfected No clinical or virological evidence of infection Score 0
    2. Ambulatory : No limitation of activities Score 1, Limitation Score 2.
    3. Hospitalised(Mild disease): No oxygen Score 3, Nasal prongs or Mask Score 4
    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
    5. dead score 8



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All Healthcare workers working actively in the included hospitals or clinics and are confirmed positive with COVID-19
Criteria

Inclusion Criteria:

1.2.1 All staffs that are currently working in included hospitals and clinic in 1.2.1.1 Laboratory confirmed positive case- A positive case is where COVID-19 virus is detected through real time polymerase chain reaction (RT PCR) either through oropharyngeal or nasopharyngeal swab which were conducted on HCWs based on national guidelines of UAE and are based on either symptoms, or as part of contact tracing or history of recent international travel.

1.2.1.2 Laboratory confirmed positive case with history of occupational exposure- through contact tracing after an exposure to a known COVID -19 patient in a healthcare setting.

1.2.1.3 Laboratory confirmed positive case with no history of occupational exposure- non-occupational exposures include situations where there was no probable workplace exposure for the healthcare worker, and a community source for the infection through household contact, travel, gathering in public places or visiting to affected area as most likely source of exposure is identified.

Exclusion Criteria:

Staff who refused to participate or withdraw there consent during the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04477213


Contacts
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Contact: Prashant Nasa, MD EDIC FNB 97142122255 prashant.nasa@nmc.ae
Contact: Surjaya Upadhyay, MD 97148108800 surjya.upadhyay@nmc.ae

Sponsors and Collaborators
NMC Specialty Hospital
Investigators
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Principal Investigator: Helen King, RN DMS MBA Senior Vice President: Nursing & Quality Corporate Quality & Nursing
Publications of Results:
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Responsible Party: Prashant Nasa, Specialist Critical Care Medicine, NMC Specialty Hospital
ClinicalTrials.gov Identifier: NCT04477213    
Other Study ID Numbers: NMCHCW-COVID
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prashant Nasa, NMC Specialty Hospital:
COVID-19
Healthcare Workers
occupational risk of COVID-19