Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
Cairo, Non-US, 11566, Egypt
NCT Number: NCT04348214
A prospective investigation and screening of all HCWs working in all governmental university hospitals and the affiliated COVID-19 quarantine hospitals using an online survey and laboratory testing using rapid serological tests and PCR. To date, the Ministry of Higher Education has dedicated quarantine hospitals at the following governmental universities: Ain Shams, Cairo, Helwan, Alexandria, Mansoura, Assiut, Minia. This list may be expanded in the future. The project will be pilot tested in Ain Shams University, then extended to other universities subsequently. For risk categorization of HCWs exposed to COVID-19 virus and assessment of infection control needs, an online survey questionnaire will be administered to all HCWs in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals. For confirmation of infection and determination of the secondary infection rate, paired serological samples at baseline and after exposure will be collected. For measuring the validity of the available rapid serological tests, a respiratory sample will be taken for viral detection by RT-PCR. A real-time interactive map using geographical information system programming will be developed to flag hotspots for HCWs' risk and infection control needs that originated from the online survey risk categorization in governmental university and COVID-19 quarantine hospitals. Policy and decision makers will use the map to manage emergency healthcare resource mobilization based on HCWs' risk and infection control needs.
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Notify Me18 year and older
All sexes
Observational
Cairo, Non-US, 11566, Egypt
Research Approach and Methodology
To fulfill specific objectives, a prospective investigation of all HCWs working in all governmental university hospitals and the affiliated COVID-19 quarantine hospitals.
To date, the Ministry of Higher Education has dedicated quarantine hospitals at the following governmental universities: Ain Shams, Cairo, Helwan, Alexandria, Mansoura, Assiut, Minia. This list may be expanded in the future. The project will be pilot tested in Ain Shams University, then extended to other universities subsequently.
Study population For the purpose of this study, HCWs are defined as all staff in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals. These include those who have been present in the same area as the patient, as well as those who may not have provided direct care to the patient, but who have had contact with the patient's body fluids, potentially contaminated items or environmental surfaces. This includes health care professionals, allied health workers, auxiliary health workers (e.g. cleaning and laundry personnel, x-ray physicians and technicians, clerks, phlebotomists, respiratory therapist, nutritionists, social workers, physical therapists, lab personnel, cleaners, admission/reception clerks, patient transporters, catering staff etc.). Once a case of COVID-19 has been identified in these hospitals, a list of all health care workers with any exposure to COVID-19 patient will need to be drawn up.
Study tool and data collection For risk categorization of HCWs exposed to COVID-19 virus and assessment of infection control needs, an online survey questionnaire will be administered to all HCWs in the governmental university hospitals involved in emergency and intensive care and in the provision of care for COVID-19 patients in the affiliated COVID-19 quarantine hospitals.
The questionnaire will be adapted from the World Health Organization relevant protocols and interim guidance. The sections of the questionnaire will cover:
This online survey will be completed at baseline and at any future contact or possible exposure with the COVID-19 patients since the patient has been admitted to the hospital.
Other forms will complement the data collected in the online survey questionnaire. The complementary forms include:
These will be filled by HCWs, and dedicated teams and coordinators representing the hospital infection control focal points and the hospital management at each of the study hospitals. The forms will be electronically linked to the online survey for instant updates of HCW information using an automatically generated unique serial study number for each HCW to be used across all study forms.
For confirmation of seroconversion, determination of the secondary-infection attack rate, and the proportion of asymptomatic infection paired serological samples will be collected:
For measuring the validity of the available rapid serological tests:
A respiratory sample will be taken for viral detection by RT-PCR
To achieve this aim the following subtasks must be done:
Moreover, the platform backend is a database system to store and manipulate the HCWs' risk and infection control data.
Furthermore, this reporting service provides more insights on the survey results using the Artificial Intelligence techniques such as the association between the geographical information and the high HCWs' risk rate.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 9 months
To determine the risk categorization of HCWs for exposure to a COVID-19 patient using an online survey in governmental university and COVID-19 quarantine hospitals
Time frame: 9 months
To estimate the COVID-19 infection rate among HCWs in governmental university and quarantine hospitals.
Time frame: 9 months
To determine the risk factors for COVID-19 among health care workers in governmental university and quarantine hospitals.
Time frame: 9 months
To evaluate adherence of HCWs to infection prevention and control measures using an online survey in governmental university and COVID-19 quarantine hospitals.
Time frame: 9 months
To determine the validity (sensitivity and specificity) of the available rapid serological test for detecting COVID-19 virus infection among HCWs in governmental university and COVID-19 quarantine hospitals.
Time frame: 9 months
To characterize the risk factors, clinical spectrum, duration and severity of COVID-19 infections among HCWs in governmental university and quarantine hospitals.
Time frame: 9 months
To evaluate the effectiveness of infection prevention and control measures programs at health facility level using an online survey tool in governmental university and COVID-19 quarantine hospitals
Time frame: 9 months
To determine the emergency infection prevention and control needs among HCWs using an online survey tool in governmental university and COVID-19 quarantine hospitals
Time frame: 9 months
To determine the isolation rate among HCWs and the need for emergency HCW replacement in governmental university and COVID-19 quarantine hospitals.
Time frame: 9 months
To determine the serologic response for HCWs with symptomatic and possibly asymptomatic COVID-19 virus infection in governmental university and COVID-19 quarantine hospitals.
Ain Shams University
Other
Screening and Risk Assessment of Healthcare Workers and Infection Control in University and COVID-19 Quarantine Hospitals Using Real-time Geospatial Mapping for Emergency Healthcare Resource Mobilization and Management
Acronym: SARAH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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