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Safe Return to Regular Clinical Operation After COVID-19 Pandemic

Safe Return to Regular Clinical Operation After COVID-19 Pandemic; (Oncology Center, Prospective Cohort)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04377802
Enrollment
400
Registered
2020-05-06
Start date
2020-05-17
Completion date
2020-12-30
Last updated
2020-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID 19

Brief summary

. Coronavirus (SARS-CoV2) appeared first in China late 2019 and caused an acute respiratory disease referred to as Coronavirus disease 2019 (COVID-19). SARS-CoV2 is considered by the World Health Organization (WHO) as pandemic and affected nations worldwide, leading to close borders and major economical struggle. The ongoing viral threat due to the lack of effective therapies and vaccination might prolonged this economical challenge and many businesses will face huge financial constraints leading to laying off labors, an increase in the unemployment rate, and major companies' bankruptcies. However, returning to normal business operations should be done with a safety focus and not be at the cost of global health and wellbeing. Immunity against COVID-19 is going to be a major determinant for a future safe work environment and will reduce the viral infection risk. Therefore, PI is suggesting that if an employee has antibodies against SARS-CoV-2 confirmed by serological testing, he or she could go back to work safely with taking the necessary precautions.

Detailed description

Coronavirus (SARS-CoV2) appeared first in China late 2019 and caused an acute respiratory disease referred as Coronavirus disease 2019 (covid-19). SARS-CoV2 is considered by the World Health Organization (WHO) as pandemic and affected nations worldwide, leading to close borders and major economical struggle. The ongoing viral threat due to the lack of effective therapies and vaccination might prolonged this economical challenge and many businesses will face huge financial constrains leading to laying off labors, increase in the unemployment rate and major companies' bankruptcies. However, returning to normal business operation should be done with a safety focus and not be at the cost of the global health and wellbeing. Immunity against COVID-19 is going to be a major determinant for future safe work environment and will reduce the viral infection risk. Therefore, PI is suggesting that if an employee has antibodies against SARS-CoV-2 confirmed by serological testing, he or she could go back to work safely with taking the necessary precautions. Materials and Methods: Oncology medical staffs directly involved with patients will be serologically tested using the SARS-CoV-2 IgG assay kit (Abbott Diagnostics, US). If Participants were IgG positive, partcipants will be assumed as immune and therefore, could join the work forces. If partcipants tested negative, partcipants will undergo molecular testing using the RealStar® SARS-CoV-2 RT-PCR Kit RUO (Altona Diagnostics, Germany) to confirm freedom from COVID-19 and then partcipants could join as safe work environment. However, if Positive PCR, partcipants will be quarantined for 14 days or until 2 negative PCR obtained as per the standard Saudi Ministry of Health (MOH) guidelines. Conclusion: by confirming that healthcare providers have antibodies against SARS-CoV-2 virus and/or their respiratory samples prove the absence of the virus, they can be considered safe and can report to work. By doing so, PI could facilitate going back to normal life and ultimately help improving healthcare functionality as well as overall businesses operation.

Interventions

DIAGNOSTIC_TESTmolecular testing for virus RNA using RT-PCR

Serological testing will be performed using SARS-CoV-2 IgG assay kit (Abbott Diagnostics, US) to check for the immunity. The IgG serology test (200 individuals per run) will be done using ARCHITECT i2000SR system which provides the results within 60 minutes

Sponsors

King Fahad Specialist Hospital Dammam
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* all Health care provider at KFSH D

Exclusion criteria

* NA

Design outcomes

Primary

MeasureTime frameDescription
Health care provider safe return to worktwo weeks from giving serum or swab sampleby confirming that healthcare providers have antibodies against SARS-CoV-2 virus and/or their respiratory samples prove the absence of the virus, they can be considered safe and can report to work. By doing so, we could facilitate going back to normal life and ultimately help improving healthcare functionality as well as overall businesses operation.

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026