Screening & Risk Assessment of Healthcare Workers & Infection Control in University & COVID-19 Quarantine Hospitals

NCT04348214 | Completed DMC

• 1 other identifier: FMASU P18a/ 2020
• Study Type: observational
• Target: 4,040
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronavirus Disease (COVID-19)

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Clinical spectrum of COVID-19

  9 months

• Effectiveness of infection prevention in the health care facility

  9 months

• Emergency infection prevention and control needs

  9 months

• Isolation rate and emergency health care worker replacement needs

  9 months

• Rate of seroconversion

  9 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center

Cairo, Non-US, 11566, Egypt

Location

Related Publications (2)

• 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-Meteini M. SARS-CoV-2 seroconversion among 4040 Egyptian healthcare workers in 12 resource-limited healthcare facilities: A prospective cohort study. Int J Infect Dis. 2021 Mar;104:534-542. doi: 10.1016/j.ijid.2021.01.037. Epub 2021 Jan 20.

  PMID: 33484863 RESULT

• 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 screening of 4040 health care workers in a resource-limited setting: an Egyptian pilot model in a university with 12 public hospitals and medical centers. Int J Epidemiol. 2021 Mar 3;50(1):50-61. doi: 10.1093/ije/dyaa173.

  PMID: 33094320 RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Aya Mostafa

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Public health and Epidemiology

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 16, 2020
• Study Start: April 22, 2020
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)