COVID19NCT04477213
Risk Profiling of the Occupational Exposure of COVID-19 to Healthcare Workers.
An observational study of COVID19 and Healthcare Workers, run by NMC Specialty Hospital at 1 site in United Arab Emirates.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID19, Healthcare Workers
- How many people
- 286 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 11 Sep 2021to 2 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All Healthcare workers working actively in the included hospitals or clinics and are confirmed positive with COVID-19
Who may be able to join
- 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.
Who cannot join
- Staff who refused to participate or withdraw there consent during the study.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
NMC Specialty Hospital, Al Nahda
Dubai
About this study
Official title: Risk Profiling of the Occupational Exposure of COVID-19 to Healthcare Workers- A Multicentric Retrospective Study
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.
Read the 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.
- Conditions
- COVID19, Healthcare Workers
- Keywords
- COVID-19, Healthcare Workers, occupational risk of COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 6 months
Secondary outcomes (1)
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
Measured: Within 28 days of illness.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start11 Sep 2021
- Primary completion30 Sep 2021
- Study completion2 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMC Specialty Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prashant Nasa, NMC Specialty Hospital
- Investigators
- Helen King, RN DMS MBA, Principal investigator, Senior Vice President: Nursing & Quality Corporate Quality & Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477213
- Sponsor's protocol ID
- NMCHCW-COVID
- Status last verified
- Sep 2021
- First submitted
- 17 Jul 2020
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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 [Preprint]. 2020 May 25:2020.04.29.20084111. doi: 10.1101/2020.04.29.20084111.
PubMed 32511531Wu 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.
PubMed 32091533
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Profiling of the Occupational Exposure of COVID-19 to Healthcare Workers- A Multicentric Retrospective Study
- ClinicalTrials.gov ID
- NCT04477213
- Acronym / sponsor ID
- NMCHCW-COVID
- Conditions
- COVID19, Healthcare Workers
- Keywords
- COVID-19, Healthcare Workers, occupational risk of COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- NMC Specialty HospitalUniversity, hospital or other
- Study start
- 11 Sep 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 2 Oct 2021 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Healthcare workers working actively in the included hospitals or clinics and are confirmed positive with COVID-19
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Staff who refused to participate or withdraw there consent during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.)
1 secondary outcome
clinical severity of infection in HCWs
Time frame: Within 28 days of illness.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Results publication: PubMed 32511531Nguyen 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 [Preprint]. 2020 May 25:2020.04.29.20084111. doi: 10.1101/2020.04.29.20084111.
- Results publication: PubMed 32091533Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen King, RN DMS MBA principal investigator
Senior Vice President: Nursing & Quality Corporate Quality & Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID19 and Healthcare Workers, run by NMC Specialty Hospital at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of COVID-19 in healthcare workers (HCWs) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04477213, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.