Diagnostic Value of New COVID-19 Antibodies Testing Among Laboratory Healthcare Workers

COVID-19 Clinical Trial

Official title:

Diagnostic Value of New- Covid 19 Antibodies Testing Among Laboratory Healthcare Workers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04445415
• Other study ID #: COVID-19 antibodies testing
• Status: Not yet recruiting
• Start date: July 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: June 2020
• Source: Assiut University
• Contact: Samar Salah Eldin
• Phone: +201117296242
• Email: samarsalah166[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

COVID-19 antibodies testing among healthcare workers to evaluate the role of Covid 19Ab testing as screening method for detection of covid 19 infections among laboratory health care workers ,assess the relationship between the infection with Covid 19 and different laboratory categories/area and assessemt of efficiency personal protective equipment (PPE) in different laboratory categories/area.

Description:

In December 2019, a new corona virus (CoV) emerged in China to cause an acute respiratory disease known as corona virus disease 19 (COVID-19).The virus was identified to be a betacoronavirus related to severe acute respiratory syndrome corona virus (SARS-CoV) and thus, was named SARS-CoV-2 .

New Covid-19 virus is the third known corona virus to cross the species barrier and cause severe respiratory infections in humans following SARS-CoV in 2003 and Middle East respiratory syndrome in 2012, yet with pandemic spread compared to the earlier two. In comparison, to SARS-CoV and MERS-CoV, COVID-19 virus exhibits faster human-to-human transmission.

The World Health Organization (WHO) declared COVID-19 outbreak as a world pandemic on 12th March 2020. Diagnosis of suspected cases is confirmed by molecular techniques (real-time PCR), using respiratory samples. Serology tests are easier to perform than molecular testing, but their utility may be limited by the performance and the fact that antibodies appear later during the disease course.

In the absence of a vaccine, public health authorities in several countries has shown that shutdowns can only be safely ended if a systematic "test and trace" program is put in place to control the spread of the virus which depends on the widespread availability of mass diagnostic testing.

From this point of view, detecting carriers of the virus in asymptomatic laboratory health care worker is fundamental to response efforts. It ensures the quarantine of COVID-19 patients to prevent local spread and more broadly informs national response measures.

The main route of transmission is person-to-person spread. A vulnerable cohort for infection due to frequent and close contact to COVID-19 patients are healthcare workers. To avoid patient-to-staff transmission adherence to strict hygiene standards is important. The infection with the SARS-CoV-2 usually leads to seroconversion 11-14 days after the first symptoms . However, due to asymptomatic and oligosymptomatic infections testing only symptomatic individuals can lead to a significant underestimation of the SARS-CoV-2 seroprevalence Day,.

Antibody testing is multipurpose: these serological assays are of critical importance to determine seroprevalence, previous exposure and identify highly reactive human donors for the generation of convalescent serum as therapeutic. They will support contact tracing and screening of health care workers to identify those who are already immune. How many people really got infected, in how many did the virus escape the PCR diagnosis, and for what reasons, how many patients are asymptomatic, and what is the real mortality rate in a defined population? Only with comprehensive serology testing (and well-planned epidemiological studies) will we be able to answer these questions and reduce the ubiquitous undisclosed number in the current calculations. Several investigations are already underway in a wide variety of locations worldwide

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: September 1, 2021
• Est. primary completion date: June 1, 2021
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• • Covid 19 infected healthcare workers.

Exclusion Criteria:

• •Risky healthcare workers (diabetic, hypertensive and more than 50 years)

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• COVID-19 antibodies testing
antibodies aganist COVID-19 detected in the serum of patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Day M. Covid-19: identifying and isolating asymptomatic people helped eliminate virus in Italian village. BMJ. 2020 Mar 23;368:m1165. doi: 10.1136/bmj.m1165. — View Citation

Long QX, Liu BZ, Deng HJ, Wu GC, Deng K, Chen YK, Liao P, Qiu JF, Lin Y, Cai XF, Wang DQ, Hu Y, Ren JH, Tang N, Xu YY, Yu LH, Mo Z, Gong F, Zhang XL, Tian WG, Hu L, Zhang XX, Xiang JL, Du HX, Liu HW, Lang CH, Luo XH, Wu SB, Cui XP, Zhou Z, Zhu MM, Wang J, Xue CJ, Li XF, Wang L, Li ZJ, Wang K, Niu CC, Yang QJ, Tang XJ, Zhang Y, Liu XM, Li JJ, Zhang DC, Zhang F, Liu P, Yuan J, Li Q, Hu JL, Chen J, Huang AL. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med. 2020 Jun;26(6):845-848. doi: 10.1038/s41591-020-0897-1. Epub 2020 Apr 29. — View Citation

Salathé M, Althaus CL, Neher R, Stringhini S, Hodcroft E, Fellay J, Zwahlen M, Senti G, Battegay M, Wilder-Smith A, Eckerle I, Egger M, Low N. COVID-19 epidemic in Switzerland: on the importance of testing, contact tracing and isolation. Swiss Med Wkly. 2020 Mar 19;150:w20225. doi: 10.4414/smw.2020.20225. eCollection 2020 Mar 9. — View Citation

Zainol Rashid Z, Othman SN, Abdul Samat MN, Ali UK, Wong KK. Diagnostic performance of COVID-19 serology assays. Malays J Pathol. 2020 Apr;42(1):13-21. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic value of COVID-19 antibodies testing	these serological assays are of critical importance to determine previous exposure,How many people really got infected, and for what reasons, how many patients are asymptomatic, and what is the real mortality rate in a defined population	baseline
Primary	Role of COVID -19 Antibodies testing in treatment of Patients	these serological assays are of critical importance to determine seroprevalence, previous exposure and identify highly reactive human donors for the generation of convalescent serum as therapeutic method for infected persons	Baseline
Primary	Assement of COVID -19 prevalence among healthcare workers	Serological assay of COVID-19 antibodies testing will support contact tracing and screening of health care workers to identify those who are already immune. How many people really got infected, in how many did the virus escape the PCR diagnosis, and for what reasons, how many patients are asymptomatic, and what is the real mortality rate in a defined population	Baseline