Safe Return to Regular Clinical Operation After COVID-19 Pandemic
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04377802|
Recruitment Status : Not yet recruiting
First Posted : May 6, 2020
Last Update Posted : May 6, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID 19||Diagnostic Test: molecular testing for virus RNA using RT-PCR||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safe Return to Regular Clinical Operation After COVID-19 Pandemic; (Oncology Center, Prospective Cohort)|
|Estimated Study Start Date :||May 17, 2020|
|Estimated Primary Completion Date :||November 16, 2020|
|Estimated Study Completion Date :||December 30, 2020|
- 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
- Health care provider safe return to work [ Time Frame: two weeks from giving serum or swab sample ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377802
|king Fahad specialist hospital|
|Dammam, Eastern Province, Saudi Arabia, 31444|
|Contact: Hani Al Hashmi, MD 00966564773377 email@example.com|
|Principal Investigator: Hani Al Hashmi, MD|
|Sub-Investigator: Fahad Ibnshamsah, MD|
|Sub-Investigator: Salem Ghandourah, PhD|