Safe Return to Regular Clinical Operation After COVID-19 Pandemic

COVID 19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04377802
• Other study ID #: KFSH-ONC-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 17, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: May 2020
• Source: King Fahad Specialist Hospital Dammam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 30, 2020
• Est. primary completion date: November 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• all Health care provider at KFSH D

Exclusion Criteria:

• NA

Related Conditions & MeSH terms

• COVID 19

Intervention

Diagnostic Test:
• molecular 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

Locations

Country	Name	City	State
Saudi Arabia	king Fahad specialist hospital	Dammam	Eastern Province

Sponsors (1)

Lead Sponsor	Collaborator
King Fahad Specialist Hospital Dammam

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health care provider safe return to work	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, we could facilitate going back to normal life and ultimately help improving healthcare functionality as well as overall businesses operation.	two weeks from giving serum or swab sample