NCT04348214: SARAH

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

Completed Last updated 20 April 2021

What this trial tests

trial in Coronavirus Disease (COVID-19) in 4,040 participants. Completed in 1 December 2020.

Timeline

22 April 2020

Primary endpoint
1 October 2020

1 December 2020

Quick facts

Lead sponsor	Ain Shams University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	4,040
Start date	22 April 2020
Primary completion	1 October 2020
Estimated completion	1 December 2020
Sites	1 location across Egypt

Conditions studied

• Coronavirus Disease (COVID-19) — all drugs for Coronavirus Disease (COVID-19) →

Sponsor

Ain Shams University

Who can join

18 and older, any sex, with Coronavirus Disease (COVID-19). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Mostafa A, Kandil S, El-Sayed MH, Girgis S, et al · · 2021 · cited 29× · PMID 33094320 · DOI 10.1093/ije/dyaa173
2. SARS-CoV-2 seroconversion among 4040 Egyptian healthcare workers in 12 resource-limited healthcare facilities: A prospective cohort study.
   Mostafa A, Kandil S, El-Sayed MH, Girgis S, et al · · 2021 · cited 15× · PMID 33484863 · DOI 10.1016/j.ijid.2021.01.037
3. SARS-Co-V2 infection in never, former, and current tobacco/nicotine users: a cohort study of 4040 Egyptian healthcare workers.
   Mostafa A, El-Sayed MH, El-Meteini M, Saleh A, et al · · 2021 · cited 3× · PMID 34182960 · DOI 10.1186/s12889-021-11290-x