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

COVID19 Clinical Trial

Official title:

Risk Profiling of the Occupational Exposure of COVID-19 to Healthcare Workers- A Multicentric Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04477213
• Other study ID #: NMCHCW-COVID
• Status: Completed
• Start date: September 11, 2021
• Est. completion date: October 2, 2021

Study information

• Verified date: September 2021
• Source: NMC Specialty Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: October 2, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID19
• Healthcare Workers

Locations

Country	Name	City	State
United Arab Emirates	NMC Specialty Hospital, Al Nahda	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
NMC Specialty Hospital

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (2)

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, C — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of COVID-19 in healthcare workers (HCWs)	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.)	6 months
Secondary	clinical severity of infection in HCWs	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	Within 28 days of illness.