Coronavirus Disease (COVID-19) Clinical Trial
— SARAHOfficial title:
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
Verified date | April 2021 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 4040 |
Est. completion date | December 1, 2020 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center | Cairo | Non-US |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Mostafa A, Kandil S, El-Sayed MH, Girgis S, Hafez H, Yosef M, Saber S, Ezzelarab H, Ramadan M, Afifi I, Hassan F, Elsayed S, Reda A, Fattuh D, Mahmoud A, Mansour A, Sabry M, Habeb P, Ebeid FS, Saleh A, Mansour O, Omar A, El-Meteini M. Universal COVID-19 s — View Citation
Mostafa A, Kandil S, El-Sayed MH, Girgis S, Hafez H, Yosef M, Saber S, Ezzelarab H, Ramadan M, Algohary E, Fahmy G, Afifi I, Hassan F, Elsayed S, Reda A, Fattuh D, Mahmoud A, Mansour A, Sabry M, Habeb P, Ebeid FS, Elanwar A, Saleh A, Mansour O, Omar A, El — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Risk categorization of healthcare workers | 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 | 9 months | |
Primary | COVID-19 infection rate among health care workers | To estimate the COVID-19 infection rate among HCWs in governmental university and quarantine hospitals. | 9 months | |
Primary | Risk factors for COVID-19 among health care workers | To determine the risk factors for COVID-19 among health care workers in governmental university and quarantine hospitals. | 9 months | |
Primary | Adherence of health care workers to infection prevention | To evaluate adherence of HCWs to infection prevention and control measures using an online survey in governmental university and COVID-19 quarantine hospitals. | 9 months | |
Primary | Validity of the available rapid serological test for detecting COVID-19 virus infection | 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. | 9 months | |
Secondary | Clinical spectrum of COVID-19 | To characterize the risk factors, clinical spectrum, duration and severity of COVID-19 infections among HCWs in governmental university and quarantine hospitals. | 9 months | |
Secondary | Effectiveness of infection prevention in the health care facility | 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 | 9 months | |
Secondary | Emergency infection prevention and control needs | To determine the emergency infection prevention and control needs among HCWs using an online survey tool in governmental university and COVID-19 quarantine hospitals | 9 months | |
Secondary | Isolation rate and emergency health care worker replacement needs | To determine the isolation rate among HCWs and the need for emergency HCW replacement in governmental university and COVID-19 quarantine hospitals. | 9 months | |
Secondary | Rate of seroconversion | To determine the serologic response for HCWs with symptomatic and possibly asymptomatic COVID-19 virus infection in governmental university and COVID-19 quarantine hospitals. | 9 months |
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